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sumatriptan succinate, camphor, menthol

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Overview

What is Migranow?

Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

The molecular formula is CHNOS•CHO, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.



What does Migranow look like?



What are the available doses of Migranow?

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What should I talk to my health care provider before I take Migranow?

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How should I use Migranow?

Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see ). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.

In controlled clinical trials, single doses of 25, 50, or 100 mg of sumatriptan tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg may provide a greater effect than 25 mg (see ). There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of sumatriptan tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.

If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with sumatriptan succinate injection, additional single sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral sumatriptan, their combined use is contraindicated (see ).

Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered sumatriptan. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg (see for the basis of this recommendation).


What interacts with Migranow?

Sumatriptan tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia.


Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see ).


Because sumatriptan tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension.


Concurrent administration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see and ).


Sumatriptan tablets should not be administered to patients with hemiplegic or basilar migraine.


Sumatriptan tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should sumatriptan and another 5-HT agonist.


Sumatriptan tablets are contraindicated in patients with hypersensitivity to sumatriptan or any of their components.


Sumatriptan tablets are contraindicated in patients with severe hepatic impairment.



What are the warnings of Migranow?

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Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events



Drug-Associated Cardiac Events and Fatalities

Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of sumatriptan succinate injection or sumatriptan tablets. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low.

The fact that sumatriptan can cause coronary vasospasm, that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to sumatriptan use support the conclusion that some of these cases were caused by the drug. In many cases, however, where there has been known underlying coronary artery disease, the relationship is uncertain.

Premarketing Experience With Sumatriptan

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Postmarketing Experience With Sumatriptan

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Drug-Associated Cerebrovascular Events and Fatalities

Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral or subcutaneous sumatriptan, and some have resulted in fatalities. The relationship of sumatriptan to these events is uncertain. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should also be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., cerebrovascular accident, transient ischemic attack).

Other Vasospasm-Related Events

Sumatriptan may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Very rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of sumatriptan. Visual disorders may also be part of a migraine attack.

Serotonin Syndrome

Serotonin syndrome may occur with triptans, including Sumatriptan, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).Serotonin synd rome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g ., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperr eflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The on set of symptoms can occur within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Treatment with Sumatriptan treatment should be discontinued if serotonin syndrome is suspected.

Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. Sumatriptan is contraindicated in patients with uncontrolled hypertension (see . Sumatriptan should be administered with caution to patients with controlled hypertension as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.

Concomitant Drug Use

In patients taking MAO-A inhibitors, sumatriptan plasma levels attained after treatment with recommended doses are 7-fold higher following oral administration than those obtained under other conditions. Accordingly, the coadministration of sumatriptan tablets and an MAO-A inhibitor is contraindicated (see and ).

Hypersensitivity

Hypersensitivity (anaphylaxis/anaphylactoid) reactions have occurred on rare occasions in patients receiving sumatriptan. Such reactions can be life threatening or fatal. In general, hypersensitivity reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens (see ).


What are the precautions of Migranow?

General

Chest discomfort and jaw or neck tightness have been reported following use of sumatriptan tablets and have also been reported infrequently following administration of sumatriptan succinate Nasal Spray. Chest, jaw, or neck tightness is relatively common after administration of sumatriptan succinate injection. Only rarely have these symptoms been associated with ischemic ECG changes. However, because sumatriptan may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following sumatriptan should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of sumatriptan, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome following sumatriptan should be evaluated for atherosclerosis or predisposition to vasospasm  (see ).

Sumatriptan should also be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as impaired hepatic or renal function.

There have been rare reports of seizure following administration of sumatriptan. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine headache or who experience a headache that is atypical for them. There have been rare reports where patients received sumatriptan for severe headaches that were subsequently shown to have been secondary to an evolving neurologic lesion (see ).

For a given attack, if a patient does not respond to the first dose of sumatriptan, the diagnosis of migraine should be reconsidered before administration of a second dose.

Overuse:

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. Migraine patients should be informed about the risks of medication overuse, and encouraged to record headache frequency and drug use.

Information for Patients

See at the end of this labeling for the text of the separate leaflet provided for patients.

Patients should be cautioned about the risk of serotonin syndrome with the use of sumatriptan or other triptans, especially during combined use with SSRIs or SNRIs.

Laboratory Tests

No specific laboratory tests are recommended for monitoring patients prior to and/or after treatment with sumatriptan.

Drug Interactions

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MAO-A inhibitors reduce sumatriptan clearance, significantly increasing systemic exposure. Therefore, the use of sumatriptan tablets in patients receiving MAO-A inhibitors is contraindicated (see and ).

Drug/Laboratory Test Interactions

Sumatriptan tablets are not known to interfere with commonly employed clinical laboratory tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis:

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Mutagenesis

Sumatriptan was not mutagenic in the presence or absence of metabolic activation when tested in 2 gene mutation assays (the Ames test and the in vitro mammalian Chinese hamster V79/HGPRT assay). In 2 cytogenetics assays (the in vitro human lymphocyte assay and the in vivo rat micronucleus assay) sumatriptan was not associated with clastogenic activity.

Impairment of Fertility

In a study in which male and female rats were dosed daily with oral sumatriptan prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with 50 and 500 mg/kg/day. The highest  no-effect  dose  for  this  finding  was  5 mg/kg/day,  or  approximately  one  half  of  the maximum recommended single human oral dose of 100 mg on a mg/m basis. It is not clear whether the problem is associated with treatment of the males or females or both combined. In a similar study by the subcutaneous route there was no evidence of impaired fertility at  60 mg/kg/day, the maximum dose tested, which is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m basis.

Pregnancy

Teratogenic Effects:Pregnancy Category C.  In reproductive toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, sumatriptan has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.

Embryolethality

Teratogenic Effects:Pregnancy Category C.  In reproductive toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, sumatriptan has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.

Teratogenicity

Teratogenic Effects:Pregnancy Category C.  In reproductive toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, sumatriptan has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.

Pup Deaths

Teratogenic Effects:Pregnancy Category C.  In reproductive toxicity studies in rats and rabbits, oral treatment with sumatriptan was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, sumatriptan has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, sumatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.

Nursing Mothers

Sumatriptan is excreted in human breast milk following subcutaneous administration. Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with sumatriptan tablets.

Pediatric Use

Safety and effectiveness of sumatriptan tablets in pediatric patients have not been established.

Completed placebo-controlled clinical trials evaluating oral sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These studies did not establish the efficacy of oral sumatriptan compared to placebo in the treatment of migraine in adolescents. Adverse events observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse events in theses patients appeared to be both dose- and age-dependent, with younger patients reporting events more commonly than older adolescents. Post-marketing experience includes a limited number of reports that describe pediatric patients who have experienced adverse events, some clinically serious, after use of subcutaneous sumatriptan and/or oral sumatriptan. These reports include events similar in nature to those reported rarely in adults. A myocardial infarct has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended.

Geriatric Use

The use of sumatriptan in elderly patients is not recommended because elderly patients are more likely to have decreased hepatic function, they are at higher risk for CAD, and blood pressure increases may be more pronounced in the elderly (see ).

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What are the side effects of Migranow?

Serious cardiac events, including some that have been fatal, have occurred following the use of sumatriptan succinate injection or tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation

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Incidence in Controlled Clinical Trials

Table 2 lists adverse events that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only events that occurred at a frequency of 2% or more in any group treated with sumatriptan tablets and were more frequent in that group than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

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Other events that occurred in more than 1% of patients receiving sumatriptan tablets and at least as often on placebo included nausea and/or vomiting, migraine, headache, hyposalivation, dizziness, and drowsiness/sleepiness.

Sumatriptan tablets are generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.

Table 2. Treatment Emergent Adverse Events Reported by at Least 2% of Patients in Controlled Migraine Trials
Adverse Event TypePercent of Patients Reporting
Atypical sensations4%5%6%6%
Paresthesia (all types)2%3%5%3%
Sensation warm/cold2%3%2%3%
Pain and other pressure sensations4%6%6%8%
Chest - pain/tightness/pressure and/or heaviness1%1%2%2%
Neck/throat/jaw - pain/ tightness/pressure2%3%
Pain - location specified1%2%1%1%
Other - pressure/tightness/ heaviness2%1%1%3%
Neurological
Vertigo2%
Other
Malaise/fatigue2%2%3%


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Other Events Observed in Association With the Administration of Sumatriptan Tablets

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Atypical Sensations

Frequent were burning sensation and numbness. Infrequent was tight feeling in head. Rare were dysesthesia.

Cardiovascular

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Ear, Nose, and Throat

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Endocrine and Metabolic

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Eye

Rare were disorders of sclera, mydriasis, blindness and low vision, visual disturbances, eye edema and swelling, eye irritation and itching, accommodation disorders, external ocular muscle disorders, eye hemorrhage, eye pain, and keratitis and conjunctivitis.

Gastrointestinal

Frequent were diarrhea and gastric symptoms. Infrequent were constipation, dysphagia, and gastroesophageal reflux. Rare were gastrointestinal bleeding, hematemesis, melena, peptic ulcer, gastrointestinal pain, dyspeptic symptoms, dental pain, feelings of gastrointestinal pressure, gastritis, gastroenteritis, hypersalivation, abdominal distention, oral itching and irritation, salivary gland swelling, and swallowing disorders.

Hematological Disorders

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Musculoskeletal

Frequent was myalgia. Infrequent was muscle cramps. Rare were tetany; muscle atrophy, weakness, and tiredness; arthralgia and articular rheumatitis; acquired musculoskeletal deformity; muscle stiffness, tightness, and rigidity; and musculoskeletal inflammation.

Neurological

Frequent were phonophobia and photophobia. Infrequent were confusion, depression, difficulty concentrating, disturbance of smell, dysarthria, euphoria, facial pain, heat sensitivity, incoordination, lacrimation, monoplegia, sleep disturbance, shivering, syncope, and tremor. Rare were aggressiveness, apathy, bradylogia, cluster headache, convulsions, decreased appetite, drug abuse, dystonic reaction, facial paralysis, hallucinations, hunger, hyperesthesia, hysteria, increased alertness, memory disturbance, neuralgia, paralysis, personality change, phobia, radiculopathy, rigidity, suicide, twitching, agitation, anxiety, depressive disorders, detachment, motor dysfunction, neurotic disorders, psychomotor disorders, taste disturbances, and raised intracranial pressure.

Respiratory

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Skin

Frequent was sweating. Infrequent were erythema, pruritus, rash, and skin tenderness. Rare were dry/scaly skin, tightness of skin, wrinkling of skin, eczema, seborrheic dermatitis, and skin nodules.

Breasts

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Urogenital

Infrequent were dysmenorrhea, increased urination, and intermenstrual bleeding. Rare were abortion and hematuria, urinary frequency, bladder inflammation, micturition disorders, urethritis, urinary infections, menstruation symptoms, abnormal menstrual cycle, inflammation of fallopian tubes, and menstrual cycle symptoms.

Miscellaneous

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used sumatriptane tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (N = 6,348) exposed to sumatriptan tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

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Other Events Observed in the Clinical Development of Sumatriptan

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Atypical Sensations

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Cardiovascular

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Chest Symptoms

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Endocrine and Metabolic

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Ear, Nose, and Throat

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Eye

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Gastrointestinal

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Injection Site Reaction

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Miscellaneous

Difficulty in walking, hypersensitivity to various agents, jaw discomfort, miscellaneous laboratory abnormalities, “serotonin agonist effect,” swelling of the extremities, and swelling of the face.

Mouth and Teeth

Disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).

Musculoskeletal

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Neurological

Bad/unusual taste, chills, diplegia, disturbance of emotions, sedation, globus hystericus, intoxication, myoclonia, neoplasm of pituitary, relaxation, sensation of lightness, simultaneous hot and cold sensations, stinging sensations, stress, tickling sensations, transient hemiplegia, and yawning.

Respiratory

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Skin

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Urogenital

The following adverse events occurred in clinical trials with sumatriptan succinate injection and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Postmarketing Experience (Reports for Subcutaneous or Oral Sumatriptan)

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Blood

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Cardiovascular

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Ear, Nose, and Throat

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Eye

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Gastrointestinal

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Hepatic

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Neurological

Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage.

Non-Site Specific

Angioneurotic edema, cyanosis, death (see ), temporal arteritis.

Psychiatry

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Respiratory

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.

Skin

Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported [see ]), photosensitivity.

Urogenital

The following section enumerates potentially important adverse events that have occurred in clinical practice and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of sumatriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of sumatriptan in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following sumatriptan use are likely to be similar regardless of route of administration.


What should I look out for while using Migranow?

Sumatriptan tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia.

Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see ).

Because sumatriptan tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension.

Concurrent administration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see and ).

Sumatriptan tablets should not be administered to patients with hemiplegic or basilar migraine.

Sumatriptan tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should sumatriptan and another 5-HT agonist.

Sumatriptan tablets are contraindicated in patients with hypersensitivity to sumatriptan or any of their components.

Sumatriptan tablets are contraindicated in patients with severe hepatic impairment.

Sumatriptan tablets should only be used where a clear diagnosis of migraine headache has been established.

bold italics


What might happen if I take too much Migranow?

Patients (N = 670) have received single oral doses of 140 to 300 mg without significant adverse effects. Volunteers (N = 174) have received single oral doses of 140 to 400 mg without serious adverse events.

Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. The elimination half-life of sumatriptan is approximately 2.5 hours (see and therefore monitoring of patients after overdose with sumatriptan tablets should continue for at least 12 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.


How should I store and handle Migranow?

Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Sumatriptan tablets USP, 25, 50, and 100 mg of sumatriptan (base) as the succinate.     Sumatriptan tablets USP, 25 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “291” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-291-30Bottles of 36                                                   NDC 55111-291-36Bottles of 90                                                   NDC 55111-291-90Bottles of 100                                                 NDC 55111-291-01Bottles of 500                                                 NDC 55111-291-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-291-09     Unit dose package of 100 (10 x 10)               NDC 55111-291-78     Sumatriptan tablets USP, 50 mg are white, round, biconvex film-coated tablets debossed with “RDY” on one side and “292” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-292-30Bottles of 36                                                   NDC 55111-292-36Bottles of 90                                                   NDC 55111-292-90Bottles of 100                                                 NDC 55111-292-01Bottles of 500                                                 NDC 55111-292-05Unit of use blister pack of 9 (1 x 9)                NDC 55111-292-09 Unit dose package of 100 (10 x 10)               NDC 55111-292-78     Sumatriptan tablets USP, 100 mg are white, capsule shaped, biconvex film-coated tablets debossed with “RDY” on one side and “293” on the other side. The tablets are supplied in bottles of 30, 36, 90 100, 500, unit of use blister pack of 9's and unit dose package of 100's.  Bottles of 30                                                   NDC 55111-293-30Bottles of 36                                                   NDC 55111-293-36Bottles of 90                                                   NDC 55111-293-90Bottles of 100                                                 NDC 55111-293-01Bottles of 500                                                 NDC 55111-293-05Unit of use blister pack of 9 (1 x 9)               NDC 55111-293-09Unit dose package of 100 (10 x 10)               NDC 55111-293-78 Store at 20to 25°C (68 – 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sumatriptan is an agonist for a vascular 5-hydroxytryptamine receptor subtype (probably a member of the 5-HT family) having only a weak affinity for  5-HT, 5-HT, and 5-HT receptors and no significant affinity (as measured using standard radioligand binding assays) or pharmacological activity at 5-HT, 5-HT, or 5-HT receptor subtypes or at alpha, alpha, or beta-adrenergic; dopamine; dopamine; muscarinic; or benzodiazepine receptors.

The vascular 5-HT receptor subtype that sumatriptan activates is present on cranial arteries in both dog and primate, on the human basilar artery, and in the vasculature of human dura mater and mediates vasoconstriction. This action in humans correlates with the relief of migraine headache. In addition to causing vasoconstriction, experimental data from animal studies show that sumatriptan also activates 5-HT receptors on peripheral terminals of the trigeminal nerve innervating cranial blood vessels. Such an action may also contribute to the antimigrainous effect of sumatriptan in humans.

In the anesthetized dog, sumatriptan selectively reduces the carotid arterial blood flow with little or no effect on arterial blood pressure or total peripheral resistance. In the cat, sumatriptan selectively constricts the carotid arteriovenous anastomoses while having little effect on blood flow or resistance in cerebral or extracerebral tissues.

Non-Clinical Toxicology
Sumatriptan tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive sumatriptane tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia.

Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see ).

Because sumatriptan tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension.

Concurrent administration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see and ).

Sumatriptan tablets should not be administered to patients with hemiplegic or basilar migraine.

Sumatriptan tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should sumatriptan and another 5-HT agonist.

Sumatriptan tablets are contraindicated in patients with hypersensitivity to sumatriptan or any of their components.

Sumatriptan tablets are contraindicated in patients with severe hepatic impairment.

Sumatriptan tablets should only be used where a clear diagnosis of migraine headache has been established.

Array

Serious cardiac events, including some that have been fatal, have occurred following the use of sumatriptan succinate injection or tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation

.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).