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Naratriptan

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Overview

What is Naratriptan?

Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT receptor agonist. Naratriptan hydrochloride, USP is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:

The empirical formula is CHNOS•HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride, USP is a white to pale yellow powder that is sparingly soluble in water.

Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.



What does Naratriptan look like?



What are the available doses of Naratriptan?

Tablets: 1 mg and 2.5 mg. (3, 16)

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

How should I use Naratriptan?

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

Limitations of Use:

The recommended dose of naratriptan tablets is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24 hour period.

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


What interacts with Naratriptan?

Sorry No Records found


What are the warnings of Naratriptan?

Sorry No Records found


What are the precautions of Naratriptan?

Sorry No Records found


What are the side effects of Naratriptan?

Sorry No records found


What should I look out for while using Naratriptan?

Naratriptan tablets are contraindicated in patients with:


What might happen if I take too much Naratriptan?

Adverse reactions observed after overdoses of up to 25 mg included increases in blood pressure resulting in lightheadedness, neck tension, tiredness, and loss of coordination. Also, ischemic ECG changes likely due to coronary artery vasospasm have been reported.

The elimination half-life of naratriptan is about 6 hours , therefore monitoring of patients after overdose with naratriptan tablets should continue for at least 24 hours or while symptoms or signs persist. There is no specific antidote to naratriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of naratriptan.


How should I store and handle Naratriptan?

Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 42043-130-09Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 42043-131-09Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Naratriptan binds with high affinity to human cloned 5-HT receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of naratriptan tablets for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Non-Clinical Toxicology
Naratriptan tablets are contraindicated in patients with:

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri. (See .)

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

Naratriptan tablets are contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of naratriptan tablets. Some of these reactions occurred in patients without known CAD. Naratriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

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

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

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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

Interactions

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