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FROVATRIPTAN SUCCINATE

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Overview

What is FROVA?

FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine (5-HT) receptor subtype agonist, as the active ingredient. Frovatriptan succinate is chemically designated as R-(+) 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate and it has the following structure:

The empirical formula is CHNO.CHO.HO, representing a molecular weight of 379.4. Frovatriptan succinate is a white to off-white powder that is soluble in water. Each FROVA tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains the inactive ingredients lactose NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, sodium starch glycolate NF, magnesium stearate NF, hydroxypropylmethylcellulose USP, polyethylene glycol 3000 USP, triacetin USP, and titanium dioxide USP.



What does FROVA look like?



What are the available doses of FROVA?

Sorry No records found.

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

Sorry No records found

How should I use FROVA?

FROVA is indicated for the acute treatment of migraine attacks with or without aura in adults.

FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see ). The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominately male, population.

The recommended dose is a single tablet of FROVA (frovatriptan 2.5 mg) taken orally with fluids.

If the headache recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of frovatriptan should not exceed 3 tablets (3 x 2.5 mg per day).

There is no evidence that a second dose of frovatriptan is effective in patients who do not respond to a first dose of the drug for the same headache.

The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.


What interacts with FROVA?

FROVA should not be given to patients with ischemic heart disease (e.g. angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina or other significant underlying cardiovascular disease (see ).


FROVA should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks.


FROVA should not be given to patients with peripheral vascular disease including (but is not limited to) ischemic bowel disease (see )


FROVA should not be given to patients with uncontrolled hypertension (see ).


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


FROVA should not be used within 24 hours of treatment with another 5-HT agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide.


FROVA is contraindicated in patients who are hypersensitive to frovatriptan or any of the inactive ingredients in the tablets.



What are the warnings of FROVA?

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

Because of the potential of this class of compound (5-HT agonists) to cause coronary vasospasm, frovatriptan should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD) (see ). It is strongly recommended that frovatriptan not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic, or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, frovatriptan should not be administered (see ).

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of frovatriptan take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received frovatriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following administration of FROVA in these patients with risk factors.

It is recommended that patients who are intermittent long-term users of 5-HT agonists, including FROVA and who have or acquire risk factors predictive of CAD, as described above, undergo periodic cardiovascular evaluation as they continue to use FROVA.

The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease would be inadvertently exposed to frovatriptan.

Cardiac Events and Fatalities with 5-HT Agonists:

Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm and death have been reported within a few hours of administration of 5-HT agonists. Considering the extent of use of 5-HT agonists in patients with migraine, the incidence of these events is extremely low.

Premarketing experience with frovatriptan:

Among more than 3000 patients with migraine who participated in premarketing clinical trials of FROVA no deaths or serious cardiac events were reported which were related to the use of FROVA.

Cerebrovascular Events and Fatalities with 5-HT Agonists:

Cerebral hemorrhage, subarachnoid hemorrhage, stroke and other cerebrovascular events have been reported in patients treated with 5-HT agonists; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g. stroke, hemorrhage, transient ischemic attack).

Other Vasospasm-Related Events:

5-HT agonists may cause vasospastic reactions other than coronary artery spasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported with 5-HT agonists.

Effects on Blood Pressure:

In young healthy subjects, there were statistically significant increases in systolic and diastolic blood pressure after single doses of 80 mg frovatriptan (32 times the clinical dose) and above. These increases were transient, resolved spontaneously and were not clinically significant. At the recommended dose of 2.5 mg, transient changes in systolic blood pressure were recorded in some elderly subjects (65 - 77 years). Any increases were generally small, resolved spontaneously, and blood pressure remained within the normal range. Frovatriptan is contraindicated in patients with uncontrolled hypertension (see ).

An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT agonist in a study evaluating subjects undergoing cardiac catheterization.

Serotonin Syndrome:

The development of a potentially life-threatening serotonin syndrome may occur with triptans, including FROVA treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with FROVA and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). (See ).


What are the precautions of FROVA?

General:

As with other 5-HT agonists, sensations of pain, tightness, pressure and heaviness have been reported in the chest, throat, neck and jaw after treatment with FROVA. These events have not been associated with arrhythmias or ischemic ECG changes in clinical trials with FROVA. Because 5-HT agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD. Patients shown to have CAD and those with Prinzmetal’s variant angina should not receive 5-HT agonists (see ). Patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following the use of any 5-HT agonist are candidates for further evaluation. If a patient has no response for the first migraine attack treated with FROVA, the diagnosis of migraine should be reconsidered before frovatriptan is administered to treat any subsequent attacks.

Hepatically Impaired Patients:

There is no clinical or pharmacokinetic experience with FROVA in patients with severe hepatic impairment. The AUC of frovatriptan in patients with mild (Child-Pugh 5-6) to moderate (Child-Pugh 7-9) hepatic impairment was about twice that of young, healthy subjects, but within the range observed in healthy elderly subjects and was considerably lower than the values attained with higher doses of frovatriptan (up to 40 mg), which were not associated with any serious adverse effectsTherefore, no dosage adjustment is necessary when FROVA is given to patients with mild to moderate hepatic impairment (see ).

Binding to Melanin-Containing Tissues:

When pigmented rats were given a single oral dose of 5 mg/kg of radiolabeled frovatriptan, the radioactivity in the eye after 28 days was 87% of the value measured after 8 hours. This suggests that frovatriptan and/or its metabolites may bind to the melanin of the eye. Because there could be accumulation in melanin rich tissues over time, this raises the possibility that frovatriptan could cause toxicity in these tissues after extended use. However, no effects on the retina related to treatment with frovatriptan were noted in the toxicity studies. Although no systematic monitoring of ophthalmologic function was undertaken in clinical trials and no specific recommendations for ophthalmologic monitoring are made, prescribers should be aware of the possibility of long-term ophthalmologic effects.

Information for Patients

Physicians should instruct their patients to read the patient package insert before taking FROVA. 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 FROVA or other triptans, especially during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Laboratory Tests

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

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Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Due to a theoretical risk of a pharmacodynamic interaction, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and FROVA within 24 hours of each other should be avoided (see ).

Concomitant use of other 5HT agonists within 24 hours of FROVA treatment is not recommended (see ).

Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Drug/Laboratory Test Interactions

FROVA is not known to interfere with commonly employed clinical laboratory tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis:

Mutagenesis:

in vitro

in vivo

ex vivo

Impairment of Fertility:

Pregnancy: Pregnancy Category C

When pregnant rats were administered frovatriptan during the period of organogenesis at oral doses of 100, 500 and 1000 mg/kg/day (equivalent to 130, 650 and 1300 times the maximum recommended human dose [MRHD] on a mg/m basis) there were dose related increases in incidences of both litters and total numbers of fetuses with dilated ureters, unilateral and bilateral pelvic cavitation, hydronephrosis, and hydroureters. A no-effect dose for renal effects was not established. This signifies a syndrome of related effects on a specific organ in the developing embryo in all treated groups, which is consistent with a slight delay in fetal maturation. This delay was also indicated by a treatment related increased incidence of incomplete ossification of the sternebrae, skull and nasal bones in all treated groups. Slightly lower fetal weights and an increased incidence of early embryonic deaths in treated rats were observed; although not statistically significant compared to control, the latter effect occurred in both the embryo-fetal developmental study and in the prenatal-postnatal developmental study. There was no evidence of this latter effect at the lowest dose level studied, 100 mg/kg/day (equivalent to 130 times the MRHD on a mg/m basis). When pregnant rabbits were dosed throughout organogenesis at doses up to 80 mg/kg/day (equivalent to 210 times the MRHD on a mg/m basis) no effects on fetal development were observed.

There are no adequate and well-controlled studies in pregnant women; therefore, frovatriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether frovatriptan is excreted in human milk. Frovatriptan and/or its metabolites are excreted in the milk of lactating rats with the maximum concentration being four-fold higher than that seen in blood. Therefore, caution should be exercised when considering the administration of FROVA to a nursing woman.

Pediatric Use

Safety and effectiveness of FROVA in pediatric patients have not been established; therefore, FROVA is not recommended for use in patients under 18 years of age. Postmarketing experience with other triptans includes a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events that are similar in nature to those reported rarely in adults.

Use in the Elderly

Mean blood concentrations of frovatriptan in elderly subjects were 1.5- to 2-times higher than those seen in younger adults (see ). Because migraine occurs infrequently in the elderly, clinical experience with FROVA is limited in such patients.


What are the side effects of FROVA?

Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT agonists. 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 (see , and ).

Incidence in Controlled Clinical Trials:

Among 1554 patients treated with FROVA in four placebo-controlled trials (Trials 1, 3, 4 and 5 in ), only 1% (16) patients withdrew because of treatment-emergent adverse events. In a long term, open-label study where patients were allowed to treat multiple migraine attacks with FROVA for up to 1 year, 5% (26/496) patients discontinued due to treatment-emergent adverse events.

The treatment-emergent adverse events that occurred most frequently following administration of frovatriptan 2.5 mg (in at least 2% of patients), and at an incidence ≥1% greater than with placebo, in the four placebo-controlled trials were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation and chest pain.

Table 2 lists treatment-emergent adverse events reported within 48 hours of drug administration that occurred with frovatriptan 2.5 mg at an incidence of ≥ 2% and more often than on placebo, in the first attack in four placebo-controlled trials (Trials 1, 3, 4 and 5 in ). These studies involved 2392 patients (1554 frovatriptan 2.5 mg and 838 placebo). 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 incidence estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Other events that occurred at ≥2% on frovatriptan that were equally or more common in the placebo group were somnolence and nausea.

FROVA is generally well tolerated. The incidence of adverse events in clinical trials did not increase when up to 3 doses were used within 24 hours. The majority of adverse events were mild or moderate and transient. The incidence of adverse events in four placebo-controlled clinical trials was not affected by gender, age or concomitant medications commonly used by migraine patients. There were insufficient data to assess the impact of race on the incidence of adverse events.

Table 2: Treatment-Emergent Adverse Events (Incidence ≥ 2% and Greater Than Placebo) of Patients in Four Placebo-Controlled Migraine Trials
Array    Dizziness     Headache    Paresthesia
Array    Mouth dry    Dyspepsia
Array    Fatigue    Hot or cold sensation    Chest pain
Array    Skeletal pain3%2%
Array    Flushing4%2%


Other Events Observed in Association with FROVA:

In the paragraphs that follow, the incidence of less commonly reported adverse events in four placebo-controlled trials are presented. Variability associated with adverse event reporting, the terminology used to describe adverse events etc, limit the value of the incidence estimates provided. The incidence of each adverse event is calculated as the number of patients reporting the event at least once divided by the number of patients who used FROVA. All adverse events reported within 48 hours of drug administration in the first attack in four placebo controlled trials involving 2392 patients (1554 frovatriptan 2.5 mg and 838 placebo) are included, except those already listed in , those too general to be informative, those not reasonably associated with the use of the drug and those which occurred at the same or a greater incidence in the placebo group. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in at least 1/100 patients, infrequent adverse events are those occurring in between 1/100 and 1/1000 patients, and rare adverse events are those occurring in fewer than 1/1000 patients.

Central and peripheral nervous system:

Gastrointestinal:

Body as a whole:

Psychiatric:

Musculoskeletal:

Respiratory:

Vision disorders:

Skin and appendages:

Hearing and vestibular disorders:

Heart rate and rhythm:

Metabolic and nutritional disorders:

Special senses, other disorders:

Urinary system disorders:

Cardiovascular disorders, general:

Platelet, bleeding and clotting disorders:

Autonomic nervous system:

Postmarketing Experience

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. Information is often incomplete so that a definite causal relationship to drug exposure can often not be established.

Central and peripheral nervous system:


What should I look out for while using FROVA?

FROVA should not be given to patients with ischemic heart disease (e.g. angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina or other significant underlying cardiovascular disease (see ).

FROVA should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks.

FROVA should not be given to patients with peripheral vascular disease including (but is not limited to) ischemic bowel disease (see )

FROVA should not be given to patients with uncontrolled hypertension (see ).

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

FROVA should not be used within 24 hours of treatment with another 5-HT agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide.

FROVA is contraindicated in patients who are hypersensitive to frovatriptan or any of the inactive ingredients in the tablets.

FROVA should only be used where a clear diagnosis of migraine has been established.


What might happen if I take too much FROVA?

There is no direct experience of any patient taking an overdose of FROVA. The maximum single dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the clinical dose) and the maximum single dose given to healthy male subjects was 100 mg (40 times the clinical dose) without significant adverse events.

As with other 5-HT receptor agonists, there is no specific antidote for frovatriptan. The elimination half-life of frovatriptan is 26 hours, therefore if overdose occurs, the patient should be monitored closely for at least 48 hours and be given any necessary symptomatic treatment.

The effects of hemo- or peritoneal dialysis on blood concentrations of frovatriptan are unknown.


How should I store and handle FROVA?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in:Blister card of 9 tablets, 1 blister card per carton (NDC 63481-025-09)Store at controlled room temperature, 25°C (77°F) excursions permitted to 15 - 30°C (59°F - 86°F) [see USP Controlled Room Temperature]. Protect from moisture.U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.Rx OnlyManufactured for: Chadds Ford, PA 19317 Manufactured by:Almac Pharma Services LimitedCraigavon, BT63 5UA, UKFROVA is a registered trademark of Vernalis Development Limited. © 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Frovatriptan is a 5-HT receptor agonist that binds with high affinity for 5-HT and 5-HT receptors. Frovatriptan has no significant effects on GABA mediated channel activity and has no significant affinity for benzodiazepine binding sites.

Frovatriptan is believed to act on extracerebral, intracranial arteries and to inhibit excessive dilation of these vessels in migraine. In anesthetized dogs and cats, intravenous administration of frovatriptan produced selective constriction of the carotid vascular bed and had no effect on blood pressure (both species) or coronary resistance (in dogs).

Non-Clinical Toxicology
FROVA should not be given to patients with ischemic heart disease (e.g. angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina or other significant underlying cardiovascular disease (see ).

FROVA should not be given to patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks.

FROVA should not be given to patients with peripheral vascular disease including (but is not limited to) ischemic bowel disease (see )

FROVA should not be given to patients with uncontrolled hypertension (see ).

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

FROVA should not be used within 24 hours of treatment with another 5-HT agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide.

FROVA is contraindicated in patients who are hypersensitive to frovatriptan or any of the inactive ingredients in the tablets.

FROVA should only be used where a clear diagnosis of migraine has been established.

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Due to a theoretical risk of a pharmacodynamic interaction, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and FROVA within 24 hours of each other should be avoided (see ).

Concomitant use of other 5HT agonists within 24 hours of FROVA treatment is not recommended (see ).

Selective Serotonin Reuptake Inhibitors / Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

As with other 5-HT agonists, sensations of pain, tightness, pressure and heaviness have been reported in the chest, throat, neck and jaw after treatment with FROVA. These events have not been associated with arrhythmias or ischemic ECG changes in clinical trials with FROVA. Because 5-HT agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD. Patients shown to have CAD and those with Prinzmetal’s variant angina should not receive 5-HT agonists (see ). Patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome following the use of any 5-HT agonist are candidates for further evaluation. If a patient has no response for the first migraine attack treated with FROVA, the diagnosis of migraine should be reconsidered before frovatriptan is administered to treat any subsequent attacks.

Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT agonists. 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 (see , and ).

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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

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).