RIZATRIPTAN BENZOATE- 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:

Panacea Biotec 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, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP 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 effectiv

Product summary:

Rizatriptan Benzoate Orally Disintegrating Tablets 5 mg, are white to off-white, uncoated, circular tablet plain on one side and '5' debossed on other side, and measuring '5.90 – 6.10 mm' (side-to-side) with a menthol flavor. 3 orally disintegrating tablets are packaged in a blister. They are supplied as follows: NDC 69452-156-74, 1 blister containing 3 unit-dose (1 x 3) orally disintegrating tablets. NDC 69452-156-73, 1 carton containing 18 unit-dose (6 blisters of 3 unit-dose (1 x 3)) orally disintegrating tablets along with leaflet. Rizatriptan Benzoate Orally Disintegrating Tablets 10 mg, are white to off-white, uncoated, circular tablet plain on one side and '10' debossed on other side, and measuring '7.90 – 8.10 mm' (side-to-side) with a menthol flavor. 3 orally disintegrating tablets are packaged in a blister. They are supplied as follows: NDC 69452-157-74, 1 blister containing 3 unit-dose (1 x 3) orally disintegrating tablets. NDC 69452-157-73, 1 carton containing 18 unit-dose (6 blisters of 3 unit-dose (1 x 3)) orally disintegrating tablets along with leaflet. Storage Store Rizatriptan Benzoate orally disintegrating tablets at room temperature 15ºC - 30ºC (59ºF to 86ºF). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
PANACEA BIOTEC LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RIZATRIPTAN BENZOATE
ORALLY DISINTEGRATING TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS,
USP.
RIZATRIPTAN BENZOATE ORALLY DISINTEGRATING TABLETS, USP
INITIAL U.S. APPROVAL: 1998
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 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 coadministered with propranolol ( 2.4)
DOSAGE FORMS AND STRENGTHS
Rizatriptan Benzoate Orally Disintegrating Tablets: 5 mg and 10 mg (
3)
CONTRAINDICATIONS
Hypersensitivity to rizatriptan benzoate ( 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