Sumatriptan Succinate and Naproxen Sodium

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Overview

What is Sumatriptan Succinate 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 empirical formula is CHNOS∙CHO, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.

Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:

The empirical formula is CHNaO, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH.

Each Sumatriptan and Naproxen Sodium Tablets 85/500 mg tablet for oral administration contain 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin.

Each Sumatriptan and Naproxen Sodium Tablets 10/60 mg tablet for oral administration contain 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide.

What does Sumatriptan Succinate and Naproxen Sodium look like?

What are the available doses of Sumatriptan Succinate and Naproxen Sodium?

Tablets: 85 mg sumatriptan / 500 mg naproxen sodium ()

10 mg sumatriptan / 60 mg naproxen sodium ()

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

How should I use Sumatriptan Succinate and Naproxen Sodium?

Sumatriptan and Naproxen Sodium Tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.

The recommended dosage for adults is 1 tablet of Sumatriptan and Naproxen Sodium Tablets 85/500 mg. Sumatriptan and Naproxen Sodium Tablets 85/500 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 85/500 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 .

What interacts with Sumatriptan Succinate and Naproxen Sodium?

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What are the warnings of Sumatriptan Succinate and Naproxen Sodium?

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What are the precautions of Sumatriptan Succinate and Naproxen Sodium?

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What are the side effects of Sumatriptan Succinate and Naproxen Sodium?

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

Sumatriptan and Naproxen Sodium Tablets are contraindicated in the following patients:

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

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F)[see USP Controlled Room Temperature].Sumatriptan and Naproxen Sodium Tablets 85/500 mg contain 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with in bottles of 9 tablets with desiccant (NDC 44183-850-09).Sumatriptan and Naproxen Sodium Tablets 10/60 mg contain 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium and is supplied as light-blue film-coated tablets debossed on one side with and the other side with in bottles of 9 tablets with desiccant (NDC 44183-860-09).Sumatriptan and Naproxen Sodium Tablets 85/500 mg contain 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with in bottles of 9 tablets with desiccant (NDC 44183-850-09).Sumatriptan and Naproxen Sodium Tablets 10/60 mg contain 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium and is supplied as light-blue film-coated tablets debossed on one side with and the other side with in bottles of 9 tablets with desiccant (NDC 44183-860-09).

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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 Tablets have analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Sumatriptan and Naproxen Sodium Tablets, 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 vivo 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:

Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate tablets should be used with other pressor agents only with careful patient monitoring.

The use of Sumatriptan and Naproxen Sodium Tablets are 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 .

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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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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