RIZATRIPTAN BENZOATE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

rizatriptan benzoate (UNII: WR978S7QHH) (rizatriptan - UNII:51086HBW8G)

متاح من:

Par Pharmaceutical Inc.

INN (الاسم الدولي):

rizatriptan benzoate

تركيب:

rizatriptan 5 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

New Drug Application Authorized Generic

خصائص المنتج

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET
RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIZATRIPTAN BENZOATE TABLETS AND ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR RIZATRIPTAN BENZOATE.
RIZATRIPTAN BENZOATE TABLETS, FOR ORAL USE
RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist
(triptan) indicated for the acute treatment of migraine
with or without aura in adults and in pediatric patients 6 to 17 years
of age (1)
Limitations of Use:
Use only after 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
Adults: 5 or 10 mg single dose; separate repeat doses by at least two
hours; maximum dose in a 24-hour period: 30 mg
(2.1)
Pediatric patients 6 to 17 years: 5 mg single dose in patients less
than 40 kg (88 lb); 10 mg single dose in patients 40 kg
(88 lb) or more (2.2)
Adjust dose if co-administered with propranolol (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 and 10 mg (3)
Orally Disintegrating Tablets: 5 and 10 mg (3)
CONTRAINDICATIONS
History of ischemic heart disease or coronary artery vasospasm (4)
History of stroke or transient ischemic attack (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 of an ergotamine-containing medication
(4)
Hemiplegic or basilar migraine (4)
MAO-A inhibitor used in the past 2 weeks (4)
Hypersensitivity to rizatriptan benzoate tablets or orally
disintegrating tablets (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia, myocardial infarction, and Prinzmetal's angina:
Perform cardiac evaluation in pa