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:

Physicians Total Care, Inc.

INN (International Name):

RIZATRIPTAN BENZOATE

Composition:

RIZATRIPTAN 10 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. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate Orally Disintegrating Tablets. However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. Limitations of Use: - Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. - Rizatriptan benzoate orally disintegrating tablets are not indic

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 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 54868-6397-1 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
PHYSICIANS TOTAL CARE, 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
TABLE TS.
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:
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 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)
DOSAGE FORMS AND STRENGTHS
Rizatriptan Benzoate 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 (4)
WARNINGS AND PRECAUTIONS
Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina:
Perform cardiac evaluation in patients with
multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue dosing if occurs (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness;
Generally not ass