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:

Macleods Pharmaceuticals Limited

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 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 tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. • Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache. Rizatriptan benzoate o

Product summary:

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 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 shaped uncoated tablets debossed with 'L58' on one side and plain on other side. They are available as follows: NDC 33342-093-48 PVC/PE/PVDC blister card of 10 tablets per triple laminated pouch,                                     4 Triple laminated pouches per carton (40 tablets total).   NDC 33342-093-04     Container pack of 12 tablets NDC 33342-093-23     Container pack of 18 tablets NDC33342-093-07      Container pack 30 tablets NDC33342-093-46      Container pack of 200 tablets NDC33342-093-12      Unit Dose Blister Package of 100 (10 x 10) tablets NDC33342-093-52      Unit Dose Blister Package of 3 (1 x 3) tablets NDC33342-093-73      Unit Dose Blister Package of 9 (3 x 3) tablets NDC33342-093-72      Unit Dose Blister Package of 18 (6 x 3) tablets NDC33342-093-41      Unit Dose Blister Package of 18 (3 x 6) tablets  NDC33342-093-45      Unit Dose Blister Package of 12 (2 x 6) tablets The 10 mg tablets are white to off-white, round shaped uncoated tablets debossed with 'L59' on one side and plain on other side. They are available as follows: NDC 33342-094-47 PVC/PE/PVDC blister card of 5 tablets per triple laminated pouch,                                     4 Triple laminated pouches per carton (20 tablets total).   NDC33342-094-04      Container pack of 12 tablets NDC33342-094-23      Container pack of 18 tablets NDC33342-094-07      Container pack 30 tablets NDC33342-094-46      Container pack of 200 tablets NDC33342-094-12      Unit Dose Blister Package of 100 (10 x 10) tablets NDC33342-094-52     Unit Dose Blister Package of 3 (1 x 3) tablets NDC33342-094-73     Unit Dose Blister Package of 9 (3 x 3) tablets NDC33342-094-72     Unit Dose Blister Package of 18 (6 x 3) tablets NDC33342-094-41    Unit Dose Blister Package of 18 (3 x 6) tablets NDC33342-094-45     Unit Dose Blister Package of 12 (2 x 6) tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Preserve in well-closed light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
MACLEODS PHARMACEUTICALS LIMITED
----------
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
INDICATIONS AND USAGE
Rizatriptan benzoate 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 less
than 40 kg (88 lb); 10 mg single dose
in patients 40 kg (88lb) or more (2.2)
Adjust dose if co-administered with propranolol (2.4)
DOSAGE FORMS AND STRENGTHS
• Rizatriptan Benzoate Orally Disintegrating Tablets: 5 mg 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