Naratriptan dosage and administration

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Naratriptan
NARATRIPTAN tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Naratriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Dosage and Administration

In controlled clinical trials, single doses of 1 and 2.5 mg of naratriptan tablets, USP taken with fluid were effective for the acute treatment of migraines in adults. A greater proportion of patients had headache response following a 2.5 mg dose than following a 1 mg dose (see CLINICAL TRIALS). Individuals may vary in response to doses of naratriptan tablets, USP. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of the 2.5 mg dose with the potential for a greater risk of adverse events. If the headache 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. There is evidence that doses of 5 mg do not provide a greater effect than 2.5 mg.

The safety of treating, on average, more than 4 headaches in a 30-day period has not been established.

Renal Impairment

The use of naratriptan tablets, USP is contraindicated in patients with severe renal impairment (creatinine clearance, <15 mL/min) because of decreased clearance of the drug (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). 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 lower starting dose should be considered.

Hepatic Impairment

The use of naratriptan tablets, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). In patients with mild or moderate hepatic impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a lower starting dose should be considered (seeCLINICAL PHARMACOLOGY).[1]

References

  1. "NARATRIPTAN TABLET, COATED [SANDOZ INC]".

Adapted from the FDA Package Insert.

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