ZOLMITRIPTAN tablet film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

ZOLMITRIPTAN

Samenstelling:

ZOLMITRIPTAN 2.5 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ZOLMITRIPTAN- ZOLMITRIPTAN TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLMITRIPTAN
TABLETS.
ZOLMITRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2.1, 2.3, 2.4) 09/2012
Warnings and Precautions (5.6) 09/2012
INDICATIONS AND USAGE
Zolmitriptan tablets are a serotonin (5-HT)
receptor agonist (triptan) indicated for the acute treatment of
migraine with
or without aura in adults (1)
LIMITATIONS OF USE:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
1B/1D
Use only after a 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)
Recommended starting dose: 1.25 mg or 2.5 mg (2.1)
Maximum single dose: 5 mg (2.1)
May repeat dose after 2 hours if needed; not to exceed 10 mg in any
24-hour period (2.1)
Moderate or severe hepatic impairment: 1.25 mg recommended (2.3, 8.6)
Tablets: 2.5 mg functionally-scored (3)
Tablets: 5 mg (not scored) (3)
History of coronary artery disease (CAD) or coronary vasospasm (4)
Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory
conduction pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (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 an ergotamine-containing medication
(4)
1
Monamine oxidase (MAO)-A inhibitor used in past 2 weeks (4)
Known hypersensitivity to zolmitriptan tablets (4)
_Myocardial Ischemia/Infarction, and Prinzmetal Angina:_ Perform
cardiac evaluation in patients with multiple
cardiovas