FROVA- frovatriptan succinate tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Endo Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

FROVATRIPTAN SUCCINATE

Kompozīcija:

FROVATRIPTAN 2.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

FROVA 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 for the first migraine attack treated with FROVA, reconsider the diagnosis of migraine before FROVA is 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 FROVA, reconsider the diagnosis of migraine before FROVA is administered to treat any subsequent attacks. - FROVA is not indicated for the prevention of migraine attacks. FROVA is not indicated for the prevention of migraine attacks. - Safety and effectiveness of FROVA have not been established for cluster headache. Safety and effectiveness of FROVA have not been established for cluster headache. FROVA is contraindicated in patients with: - Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial

Produktu pārskats:

FROVA 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 63481-025-09) Store FROVA tablets at controlled room temperature, 25ºC (77ºF) excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].  Protect from moisture.

Autorizācija statuss:

New Drug Application

Produkta apraksts

FROVA- FROVATRIPTAN SUCCINATE TABLET, FILM COATED
ENDO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FROVA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FROVA .
FROVA (FROVATRIPTAN SUCCINATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
FROVA 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 FROVA (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 FROVA 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 hemorrhage, and stroke: Discontinue
FROVA if occurs (5.4)
Gastrointestinal ischemic reactions and peripheral vasospastic
react