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:

Heritage Pharmaceuticals 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. Limitations of Use - Rizatriptan benzoate 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 tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. - Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . - Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache Rizatriptan benzoate tablets are contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, histo

Product summary:

NDC 23155-244-22, unit-of-use blister pack of 6 tablets; available in the carton of 12 tablets (2 x 6 tablets), NDC 23155-244-45 and carton of 18 tablets (3 x 6 tablets), NDC 23155-244-46 NDC 23155-245-22, unit-of-use blister pack of 6 tablets; available in the carton of 12 tablets (2 x 6 tablets), NDC 23155-245-45 and carton of 18 tablets (3 x 6 tablets), NDC 23155-245-46 Storage Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET
Heritage Pharmaceuticals Inc.
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PATIENT INFORMATION
RIZATRIPTAN BENZOATE TABLETS
5 mg and 10 mg
Rizatriptan benzoate tablets
Read this Patient Information before you start taking rizatriptan
benzoate tablets 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 is rizatriptan benzoate?
Rizatriptan benzoate is a prescription medicine that belongs to a
class of medicines called Triptans.
Rizatriptan benzoate is available as a traditional tablet and an
orally disintegrating tablet.
Rizatriptan benzoate tablets are used to treat migraine attacks with
or without aura in adults.
Rizatriptan benzoate is not to be used to prevent migraine attacks.
Rizatriptan benzoate is not for the treatment of hemiplegic or basilar
migraines.
It is not known if rizatriptan benzoate is safe and effective for the
treatment of cluster headaches.
It is not known if rizatriptan benzoate is safe and effective in
children under 6 years of age.
Who should not take rizatriptan benzoate tablets?
Do not take rizatriptan benzoate 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 including ischemic bowel
disease
•
have uncontrolled high blood pressure
•
have taken other Triptan medicines in the last 24 hours
•
have taken ergot-containing medicines in the last 24 hours
•
have hemiplegic or basilar migraines
•
take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor
within the last 2 weeks
•
are allergic to rizatriptan benzoate or any of the ingredients in
rizatriptan benzoate tablets. See the end
of this leaflet for a complete list of ingredients in rizatript

Summary of Product characteristics

RIZATRIPTAN BENZOATE- RIZATRIPTAN BENZOATE TABLET
HERITAGE PHARMACEUTICALS INC.
----------
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
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 mg 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 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. [see Indications and Usage (1)].
MAO-A inhibitor used in the past 2 weeks (4)
Hypersensitivity to rizatriptan benzoate 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(5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness;