RIZATRIPTAN BENZOATE- 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:

Jubilant Cadista 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 have not been established for cluster headache. Rizatriptan benzoate is contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent

Product summary:

Rizatriptan benzoate tablets 5 mg are pale pink to pink colored, biconvex, capsule-shaped, uncoated tablets, debossed with ‘414’ on one side and ‘C’ on the other side.   Unit-dose blister pack of 12 (2 x 6) tablets, NDC 59746-414-14 Unit-dose child-resistant blister pack of 18 (3 x 6) tablets, NDC 59746-414-19 Rizatriptan benzoate tablets 10 mg are pale pink to pink colored, biconvex, capsule-shaped, uncoated tablets, debossed with ‘415’ on one side and ‘C’ on the other side.   Unit-dose blister pack of 12 (2 x 6) tablets, NDC 59746-415-14 Unit-dose child-resistant blister pack of 18 (3 x 6) tablets, NDC 59746-415-19 Storage Store rizatriptan benzoate tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C 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
Jubilant Cadista Pharmaceuticals Inc.
----------
PATIENT INFORMATION
Rizatriptan Benzoate Tablets
Read this Patient Information before you start taking rizatriptan
benzoate 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 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 as 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 rizatriptan
benzoate tablets.
Talk to

Summary of Product characteristics

RIZATRIPTAN BENZOATE - RIZATRIPTAN BENZOATE TABLET
JUBILANT CADISTA 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 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 co-administered with propranolol (2.4)
DOSAGE FORMS AND STRENGTHS
Rizatriptan Benzoate Tablets: 5 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 cardiovascular risk factors (5.1)
Arrhythmias: Discontinue dosing if occurs (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness;
Generally not associated