ZOLMITRIPTAN tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp

INN (International Name):

ZOLMITRIPTAN

Composition:

ZOLMITRIPTAN 2.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN- ZOLMITRIPTAN TABLET, FILM COATED
ZOLMITRIPTAN- ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING
APOTEX CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN TABLETS OR
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR
ZOLMITRIPTAN TABLETS AND ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS.
ZOLMITRIPTAN TABLETS, FOR ORAL USE
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS
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 is a serotonin (5-HT)
receptor agonist (triptan) indicated for the acute treatment of
migraine with or
without aura in adults (1)
Limitations of Use:
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)
DOSAGE AND ADMINISTRATION
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)
Do not break zolmitriptan orally disintegrating tablets (2.2)
Moderate or Severe Hepatic Impairment: 1.25 mg recommended (2.3, 8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg functionally-scored (3)
Tablets: 5 mg (not scored) (3)
Orally Disintegrating Tablets: 2.5 mg and 5 mg (3)
CONTRAINDICATIONS
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)
Monamine oxidase (MAO)-A inhibitor used in past 2 weeks (4)
Known hyperse