RIZATRIPTAN BENZOATE tablet orally disintegrating

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

RIZATRIPTAN BENZOATE (UNII: WR978S7QHH) (RIZATRIPTAN - UNII:51086HBW8G)

متاح من:

Preferred Pharmaceuticals Inc.

INN (الاسم الدولي):

RIZATRIPTAN BENZOATE

تركيب:

RIZATRIPTAN 10 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
PREFERRED PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING
TABLETS.
RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage
Acute Treatment of Migraine (1) 12/2011
INDICATIONS AND USAGE
Rizatriptan benzoate is a serotonin (5-HT)
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:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions in adults were (incidence ≥ 5% and
greater than placebo): asthenia/fatigue,
1B/1D
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)
Adults: 5 mg or 10 mg single dose; separate repeat doses by at least 2
hours; maximum dose in a 24-hour period: 30
mg (2.1)
Adjust dose if coadministered with propranolol (2.4)
Rizatriptan Benzoate Orally Disintegrating Tablets: 5 mg and 10 mg (3)
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)
1
Hemiplegic or basilar migraine (4)
MAO-A inhibitor used in the past 2 weeks (4)
Hypersensitivity to rizatriptan benzoate (4)
Myocardial Ischemia, Myocardial Infarction, and Prinzm