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:

Sandoz 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. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.’s Rizatriptan Benzoate 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 tablets are contraindicated in patients with: Pregnancy Category C 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/d

Product summary:

Rizatriptan benzoate tablets are available as follows 5 mg, white to grey-white, round, flat tablet, debossed with ‘SZ’ on one side and ‘272’ on the other side. 10 mg, white to grey-white, round, flat tablet, debossed with ‘SZ’ on one side and ‘273’ on the other side. Storage Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET
SANDOZ INC
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Indication and Usage
Acute Treatment of Migraine (1) 12/2011
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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in adults were (incidence ≥ 5% and
greater than placebo): asthenia/fatigue,
somnolence, pain/pressure sensation and dizziness (6.1).
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 or 10 mg single dose; separate repeat doses by at least two
hours; maximum dose in a 24-hour period: 30
mg (2.1)
Adjust dose if co-administered with propranolol (2.4)
Rizatriptan benzoate tablets: 5 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 Prinzmetal's Angina:
Perform cardiac evaluation in patients w