Sumatriptan and Naproxen Sodium

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Overview

What is Sumatriptan and Naproxen Sodium?

Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine (5-HT) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate 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 or almost white powder that is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure: The molecular formula is CHNaO, representing a molecular weight of 252.23. Naproxen sodium USP is a white to creamy crystalline powder, sparingly soluble in water, in methanol and in alcohol, practically insoluble in chloroform, in acetone and in toluene. Each sumatriptan and naproxen sodium 85 mg/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dextrose monohydrate, lecithin (soya), maltodextrin, microcrystalline cellulose, silicified microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethyl cellulose, sodium stearyl fumarate, talc, and titanium dioxide.

What does Sumatriptan and Naproxen Sodium look like?

What are the available doses of Sumatriptan and Naproxen Sodium?

Tablets: 85 mg sumatriptan/500 mg naproxen sodium

What should I talk to my health care provider before I take Sumatriptan and Naproxen Sodium?

Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

How should I use Sumatriptan and Naproxen Sodium?

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

Limitations of Use:

Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

The recommended dosage for adults is 1 tablet of sumatriptan and naproxen sodium 85 mg/500 mg. Sumatriptan and naproxen sodium tablets 85 mg/500 mg contain a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in sumatriptan and naproxen sodium tablets 85 mg/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions.

The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart.

The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals .

Pediatric use information for patients ages 12 to 17 years is approved for Pernix Ireland Ltd.’s TREXIMET (sumatriptan and naproxen sodium) Tablets. However, due to Pernix Ireland Ltd.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

What interacts with Sumatriptan and Naproxen Sodium?

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What are the warnings of Sumatriptan and Naproxen Sodium?

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What are the precautions of Sumatriptan and Naproxen Sodium?

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What are the side effects of Sumatriptan and Naproxen Sodium?

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What should I look out for while using Sumatriptan and Naproxen Sodium?

Sumatriptan and naproxen sodium tablets are contraindicated in the following patients:

Cardiovascular Thrombotic Events

Gastrointestinal Bleeding, Ulceration, and Perforation

What might happen if I take too much Sumatriptan and Naproxen Sodium?

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

Overdose of sumatriptan 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.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare .

Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

How should I store and handle Sumatriptan and Naproxen Sodium?

Sumatriptan and Naproxen Sodium Tablets, 85 mg/500 mgSumatriptan and Naproxen Sodium Tablets, 85 mg/500 mg

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Sumatriptan and naproxen sodium tablets contain sumatriptan and naproxen.

Sumatriptan binds with high affinity to cloned 5-HT receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release.

Sumatriptan and naproxen sodium has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of sumatriptan and naproxen sodium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Naproxen is a potent inhibitor of prostaglandin synthesis . Naproxen concentrations reached during therapy have produced effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because naproxen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Non-Clinical Toxicology

Sumatriptan and naproxen sodium tablets are contraindicated in the following patients:

Cardiovascular Thrombotic Events

Gastrointestinal Bleeding, Ulceration, and Perforation

The use of sumatriptan and naproxen sodium is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS .

Cardiovascular Events with Sumatriptan

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. Sumatriptan and naproxen sodium may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Cardiovascular Thrombotic Events Nonsteroidal Anti-inflammatory Drugs

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as naproxen, increases the risk of serious gastrointestinal (GI) events .

Status Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled clinical trials a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG

Post- Patients

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Perform a cardiovascular evaluation in patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan and naproxen sodium. If there is evidence of CAD or coronary artery vasospasm, sumatriptan and naproxen sodium is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan and naproxen sodium in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan and naproxen sodium. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan and naproxen sodium.

Physicians and patients should remain alert for the development of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the signs and/or symptoms of serious cardiovascular events and the steps to take if they occur.

The following serious adverse reactions are described below and elsewhere in labeling:

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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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Review

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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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Interactions

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