Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)
Mylan Pharmaceuticals Inc.
ZOLMITRIPTAN
ZOLMITRIPTAN 2.5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
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 Прочетете целия документ