Naratriptan Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Naratriptan Tablets, USP are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
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- Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Naratriptan Tablets, USP, reconsider the diagnosis of migraine before Naratriptan Tablets, USP is administered to treat any subsequent attacks.
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- Naratriptan Tablets, USP is not indicated for the prevention of migraine attacks.
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- Safety and effectiveness of Naratriptan Tablets, USP have not been established for cluster headache.
History
There is currently no drug history available for this drug.
Other Information
Naratriptan Tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D 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 C17H25N3O2S•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).
Sources
Naratriptan Hydrochloride Manufacturers
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Paddock Laboratories, Llc
![Naratriptan Hydrochloride Tablet, Film Coated [Paddock Laboratories, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Naratriptan Hydrochloride | Paddock Laboratories, Llc
2.1 Dosing InformationThe 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.
2.2 Dosage Adjustment in Patients With Renal ImpairmentNaratriptan Tablets, USP is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic ImpairmentNaratriptan Tablets, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
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