FROVA frovatriptan succinate tablet film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Unit Dose Services

INN (الاسم الدولي):

FROVATRIPTAN SUCCINATE

تركيب:

FROVATRIPTAN 2.5 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application

خصائص المنتج

FROVA- FROVATRIPTAN SUCCINATE TABLET, FILM COATED
UNIT DOSE SERVICES
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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
RECENT MAJOR CHANGES
Warnings and Precautions ( ) 11/2012 5.6
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
FR