MAXALT- rizatriptan benzoate tablet MAXALT-MLT- 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:

MAXALT® and MAXALT-MLT® 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 - MAXALT 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 MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. - MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . - MAXALT is not indicated for the prevention of migraine attacks. - Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1)] . - Coronary artery vasospasm including Prinzmetal's

Product summary:

MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other: MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: Storage Store MAXALT Tablets at room temperature, 15-30°C (59-86°F). Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15-30°C (59-86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

MAXALT - RIZATRIPTAN BENZOATE TABLET
MAXALT-MLT - 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
MAXALT AND MAXALT-MLT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MAXALT AND
MAXALT-MLT.
MAXALT (RIZATRIPTAN BENZOATE) TABLETS, FOR ORAL USE
MAXALT-MLT (RIZATRIPTAN BENZOATE) ORALLY DISINTEGRATING TABLETS
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
MAXALT 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 <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)
DOSAGE FORMS AND STRENGTHS
MAXALT Tablets: 5 and 10 mg (3)
MAXALT-MLT 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 MAXALT (4)
WARNINGS AND PRECAUTIONS
Myocardial Ischemia, Myocardial Infarcti