RIZATRIPTAN BENZOATE- rizatriptan benzoate tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

RIZATRIPTAN BENZOATE

Composition:

RIZATRIPTAN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: Rizatriptan benzoate orally disintegrating tablets are contraindicated in patients with: There are no adequate and well-controlled studies in pregnant women. Rizatriptan benzoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In a general reproductive study in rats, birth weights and pre- and post-weaning weight gain were reduced in the offspring of females treated prior to and during mating and throughout gestation and lactation with doses of 10 and 100 mg/kg/day. In a pre- and post-natal developmental toxicity study in rats, an increase in mortality of the offspring at birth and for the first 3 days after birth, a decrease in pre- and post-weaning weight gain, and decreased performance in a passive avoidance test (which indicates a decrease in learning capa

Product summary:

Rizatriptan Benzoate Orally Disintegrating Tablets are available in strengths of 5 mg and 10 mg containing 7.265 mg or 14.53 mg of rizatriptan benzoate, USP equivalent to 5 mg or 10 mg of rizatriptan, respectively. The 5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 701 on one side of the tablet. They are available as follows: NDC 0378-3701-59 bottles of 9 tablets The 10 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and 702 on one side of the table. They are available as follows: NDC 0378-3702-59 bottles of 9 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
MYLAN PHARMACEUTICALS INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indications and Usage
Acute Treatment of Migraine (1) 12/2011
Dosage and Administration
Pediatric Patients (Age 6 to 17 Years) (2.2) 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Rizatriptan Benzoate Orally Disintegrating Tablets: 5 and 10 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
Pediatric Patients 6 to 17 Years: 5 mg single dose in patients < 40 kg
(88 lb); 10 mg single dose in patients ≥ 40 kg (88
lb) (2.2)
Adjust dose if co-administered with propranolol (2.4)
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)
Hypersensiti