FROVATRIPTAN SUCCINATE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

FROVATRIPTAN SUCCINATE (UNII: D28J6W18HY) (FROVATRIPTAN - UNII:H82Q2D5WA7)

Fáanlegur frá:

Par Pharmaceutical

INN (Alþjóðlegt nafn):

FROVATRIPTAN SUCCINATE

Samsetning:

FROVATRIPTAN 2.5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Frovatriptan succinate tablets , containing 2.5 mg of frovatriptan (base) as the succinate salt, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in: Blister card of 9 tablets, 1 blister card per carton (NDC 0603-3718-34) Store frovatriptan succinate tablets at controlled room temperature, 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].  Protect from moisture.

Leyfisstaða:

New Drug Application

Vara einkenni

FROVATRIPTAN SUCCINATE- FROVATRIPTAN SUCCINATE TABLET, FILM COATED
PAR PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FROVATRIPTAN SUCCINATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FROVATRIPTAN
SUCCINATE TABLETS.
FROVATRIPTAN SUCCINATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Frovatriptan succinate 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
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
DOSAGE AND ADMINISTRATION
1 tablet taken with fluids. Second tablet may be taken 2 hours after
initial dose if headache recurs following initial relief.
Total dose not to exceed 3 tablets in any 24-hour period (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg (3)
CONTRAINDICATIONS
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 treatment with another 5-HT agonist,
or an ergotamine-containing medication (4)
Hypersensitivity to frovatriptan succinate tablets (angioedema and
anaphylaxis seen) (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction or Prinzmetal’s angina: Perform
cardiac evaluation in patients with multiple
cardiovascular risk factors (5.1)
Arrhythmias:Discontinue frovatriptan succinate tablets if occurs (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or
heaviness:Generally not associated with myocardial ischemia;
evaluate high risk patients for coronary artery disease (5.3)
Cerebral hemorrhage, subarachnoid hemorrhag