"COPENHAGEN â€” An investigational agent that blocks a key headache-related receptor significantly reduces the number of mean monthly migraine days, new phase 2 data show.
Findings showed that after 52 weeks, 18.5% of patients with migra"...
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
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, 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
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”
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].
GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: August 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/21/2016
Additional Amerge Information
Amerge - User Reviews
Amerge User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.