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:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

Rizatriptan Benzoate

Composition:

Rizatriptan 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rizatriptanbenzoate orally disintegrating tablets are indicated for the acute treatment ofmigraine with or without aura in adults and in pediatric patients 6 to 17 yearsold. 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 orally disintegrating tablets are administered to treat any subsequent attacks. 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 orally disintegrating tablets are administered to treat any subsequent attacks. - Riz

Product summary:

The 5 mg tablets are white to off-white, round, flat-face, beveled-edge tablets, debossed with 'C6 ' on one side and 'C ' on the other side, having a mixed flavor of strawberry and peppermint.    3 blister pack in carton                                                       NDC 59746-445-13         4 above cartons in another outer carton 12 (4x3’s)           NDC 59746-445-14                                The 10 mg tablets are white to off-white, round, flat-face, beveled-edge tablets, debossed with 'C7 ' on one side and 'C ' on the other side, having a mixed flavor of strawberry and peppermint.    3 blister pack in carton                                                       NDC 59746-446-13 4 above cartons in another outer carton 12 (4x3’s)           NDC 59746-446-14 Storage Store at 20ºC-25°C (68ºF-77ºF), excursions permitted to 15°C-30°C (59ºF-86ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Jubilant Cadista Pharmaceuticals Inc.
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PATIENT INFORMATION
Rizatriptan Benzoate Orally Disintegrating Tablets
(rye″ za trip′ tan ben′ zoe ate)
5 mg and 10 mg
Read this Patient Information before you start taking rizatriptan
benzoate orally disintegrating tablets and
each time you get a refill. There may be new information. This
information does not take the place of
talking to your doctor about your medical condition or your treatment.
Unless otherwise stated, the information in this Patient Information
leaflet applies to both rizatriptan
benzoate tablets and to rizatriptan benzoate orally disintegrating
tablets.
What are rizatriptan benzoate orally disintegrating tablets?
Rizatriptan benzoate orally disintegrating tablets are prescription
medicine that belongs to a class of
medicines called Triptans. Rizatriptan benzoate is available as a
traditional tablet and as an orally
disintegrating tablet.
Rizatriptan benzoate tablets and rizatriptan benzoate orally
disintegrating tablets are used to treat
migraine attacks with or without aura in adults and in children 6 to
17 years of age.
Rizatriptan benzoate orally disintegrating tablets are not to be used
to prevent migraine attacks.
Rizatriptan benzoate orally disintegrating tablets are not for the
treatment of hemiplegic or basilar
migraines.
It is not known if rizatriptan benzoate orally disintegrating tablets
are safe and effective for the treatment
of cluster headaches.
It is not known if taking more than 1 dose of rizatriptan benzoate
orally disintegrating tablets in 24 hours
is safe and effective in children 6 to 17 years of age.
It is not known if rizatriptan benzoate orally disintegrating tablets
are safe and effective in children under
6 years of age.
Who should not take rizatriptan benzoate orally disintegrating
tablets?
Do not take rizatriptan benzoate orally disintegrating tablets if you:
•
have or have had heart problems
•
have or have had a stroke or a transient ischemic attack (TIA)
•
have or have had blood vessel problems includi

Summary of Product characteristics

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET, ORALLY
DISINTEGRATING
JUBILANT CADISTA PHARMACEUTICALS INC.
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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
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
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 <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
Rizatriptan Benzoate Orally Disintegrating Tablets: 5 and 10 mg (3)
(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 benzoate (4)
WARNINGS AND PRECAUTIONS
Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's