AMERGE- naratriptan hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NARATRIPTAN HYDROCHLORIDE (UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)

Available from:

GlaxoSmithKline LLC

INN (International Name):

NARATRIPTAN HYDROCHLORIDE

Composition:

NARATRIPTAN 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMERGE is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use AMERGE is contraindicated in patients with: Risk Summary There are no adequate data on the developmental risk associated with use of AMERGE in pregnant women. Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have documented outcomes in women exposed to naratriptan during pregnancy; however, due to small sample sizes, no definitive conclusions can be drawn regarding the risk of birth defects following exposure to naratriptan [see Data] . In animal studies, naratriptan produced developmental toxicity (including embryolethality and fetal abnormalities) when administered to pregnant rats and rabbits. The lowest doses producing evidence of developmental toxicity in animals were associated with plasma exposures 2.5 (rabbit) to 11 (rat) times that in humans at the maximum recommended daily dose (MRDD) [see Data] . In the U.S. general population, the estimated bac

Product summary:

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].

Authorization status:

New Drug Application

Summary of Product characteristics

AMERGE- NARATRIPTAN HYDROCHLORIDE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMERGE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMERGE.
AMERGE (NARATRIPTAN HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
AMERGE is a serotonin (5-HT
) receptor agonist (triptan) indicated for the acute treatment of
migraine with or without
aura in adults. (1)
Limitations of Use
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg and 2.5 mg (3, 16)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥2 % and > placebo) were
paresthesias, nausea, dizziness, drowsiness, malaise/fatigue,
and throat/neck symptoms. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
1B/1D
Use only if a clear diagnosis of migraine has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Recommended dose: 1 mg or 2.5 mg. (2.1)
May repeat dose after 4 hours if needed; not to exceed 5 mg in any
24-hour period. (2.1)
Mild or moderate renal or hepatic impairment: recommended starting
dose is 1 mg not to exceed 2.5 mg in any 24-
hour period. (2.2, 2.3)
History of coronary artery disease or coronary artery vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT agonist (e.g., another
triptan) or an ergotamine-containing medication
(4)
1
Hypersensitivity to AMERGE (angioedema and anaphylaxis