RIZATRIPTAN BENZOATE- rizatriptan benzoate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

RIZATRIPTAN BENZOATE

Composition:

RIZATRIPTAN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rizatriptan benzoate 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 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 tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets is administered to treat any subsequent attacks. - Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . - Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache. Rizatriptan benzoate tablets are contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented si

Product summary:

Rizatriptan Benzoate Tablets, USP 5 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "123" on the other side. They are supplied as follows: NDC 51991-354-99, Blister of 6 tablets NDC 51991-354-78, Carton of 18 tablets (3 × 6 blisters) unit dose tablets. Rizatriptan Benzoate Tablets, USP 10 mg, are light pink to pink-colored, capsule-shaped, biconvex, uncoated tablets with "NAT" on one side and "121" on the other side. They are supplied as follows: NDC 51991-355-99, Blister of 6 tablets NDC 51991-355-78, Carton of 18 tablets (3 × 6 blisters) unit dose tablets. Storage Store at 20° – 25°C (68° – 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container, if product is subdivided.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIZATRIPTAN BENZOATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RIZATRIPTAN BENZOATE
TABLETS.
RIZATRIPTAN BENZOATE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Rizatriptan benzoate tablets are 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 mg 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
Rizatriptan Benzoate Tablets, USP: 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 or any of the excipients (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;
Ge