Naratriptan Hydrochloride

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Overview

What is Naratriptan Hydrochloride?

Naratriptan Tablets, USP contains naratriptan hydrochloride, a selective 5-HT receptor agonist. Naratriptan hydrochloride 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 is a white to pale yellow powder that is readily soluble in water. Each Naratriptan Tablets, USP tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, titanium dioxide, hypromellose, magnesium stearate, triacetin, D&C yellow #10 aluminum lake (2.5-mg tablet only), FD&C blue #1 aluminum lake (2.5-mg tablet only), FD&C red #40 aluminum lake (2.5-mg tablet only).

What does Naratriptan Hydrochloride look like?

What are the available doses of Naratriptan Hydrochloride?

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

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

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

How should I use Naratriptan Hydrochloride?

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

Limitations of Use:

The recommended dose of Naratriptan Tablets, USP 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 Hydrochloride?

Sorry No Records found

What are the warnings of Naratriptan Hydrochloride?

Sorry No Records found

What are the precautions of Naratriptan Hydrochloride?

Sorry No Records found

What are the side effects of Naratriptan Hydrochloride?

Sorry No records found

What should I look out for while using Naratriptan Hydrochloride?

Naratriptan Tablets, USP is contraindicated in patients with:

What might happen if I take too much Naratriptan Hydrochloride?

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 [], and therefore monitoring of patients after overdose with Naratriptan Tablets, USP 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 Hydrochloride?

Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.Keep ADASUVE in pouch until time of use. ADASUVE contains a lithium battery. Dispose of ADASUVE in accordance with all federal, state and local laws.Naratriptan Tablets, USP Tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets, USP, 1 mg, are white, round, film-coated tablets debossed with “PAD” on one side and “214” on the other side in blister packs of 9 tablets (NDC 0574--09). Naratriptan Tablets, USP, 2.5 mg, are green, round, film-coated tablets debossed with “PAD” on one side and “215” on the other side in blister packs of 9 tablets (NDC 0574--09). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]Naratriptan Tablets, USP Tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.Naratriptan Tablets, USP, 1 mg, are white, round, film-coated tablets debossed with “PAD” on one side and “214” on the other side in blister packs of 9 tablets (NDC 0574--09). Naratriptan Tablets, USP, 2.5 mg, are green, round, film-coated tablets debossed with “PAD” on one side and “215” on the other side in blister packs of 9 tablets (NDC 0574--09). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

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Clinical Information

Chemical Structure

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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, USP 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, USP is contraindicated in patients with:

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested with barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin and tetracyclines.

Naratriptan Tablets, USP is 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, USP. Some of these reactions occurred in patients without known CAD. Naratriptan Tablets, USP 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, USP. If there is evidence of CAD or coronary artery vasospasm, Naratriptan Tablets, USP is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of Naratriptan Tablets, USP in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of Naratriptan Tablets, USP. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Naratriptan Tablets, USP.

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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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

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).

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