Amerge (Naratriptan Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

AMERGE^® is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

• •Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with AMERGE, reconsider the diagnosis of migraine before AMERGE is administered to treat any subsequent attacks.
• •AMERGE is not indicated for the prevention of migraine attacks.
• •Safety and effectiveness of AMERGE have not been established for cluster headache.

DOSAGE AND ADMINISTRATION

Dosing Information

The recommended dose of AMERGE 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.

Dosage Adjustment in Patients With Renal Impairment

AMERGE 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 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 1-mg starting dose is recommended [see Use in Specific Populations Clinical Pharmacology].

Dosage Adjustment in Patients With Hepatic Impairment

AMERGE is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations Clinical Pharmacology].

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 Clinical Pharmacology].

DOSAGE FORMS AND STRENGTHS

1-mg white tablets, D-shaped, film-coated, and debossed with “GX CE3”.

2.5-mg green tablets, D-shaped, film-coated, and debossed with “GX CE5”.

HOW SUPPLIED/STORAGE AND HANDLING

AMERGE Tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.

AMERGE Tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00).

AMERGE Tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00).

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].