ZOMIG- zolmitriptan tablet ZOMIG ZMT- zolmitriptan tablet, orally disintegrating

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Amneal Pharmaceuticals

INN (Internationale Bezeichnung):

ZOLMITRIPTAN

Zusammensetzung:

ZOLMITRIPTAN 2.5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZOMIG is contraindicated in patients with: Risk Summary There are no adequate data on the developmental risk associated with the use of ZOMIG in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of pree

Produktbesonderheiten:

2.5 mg Tablets - Yellow, biconvex, round, film-coated, functionally-scored tablets containing 2.5 mg of zolmitriptan identified with “ZOMIG” and “2.5” debossed on one side are supplied in cartons containing a blister pack of 6 tablets (NDC 64896-671-51). 5 mg Tablets – Pink, biconvex, round, film-coated tablets containing 5 mg of zolmitriptan identified with “ZOMIG” and “5” debossed on one side are supplied in cartons containing a blister pack of 3 tablets (NDC 64896-672-50). 2.5 mg Orally disintegrating tablets - White, flat-faced, round, uncoated, bevelled tablets containing 2.5 mg of zolmitriptan identified with a debossed “Z” on one side are supplied in cartons containing a blister pack of 6 orally disintegrating tablets (NDC 64896-691-51). 5 mg Orally disintegrating tablets - White, flat-faced, round, uncoated, bevelled tablets containing 5 mg of zolmitriptan identified with a debossed “Z” and “5” on one side and plain on the other are supplied in cartons containing a blister pack of 3 orally disintegrating tablets (NDC 64896-692-50). Store ZOMIG Tablets and ZOMIG‑ZMT Tablets at controlled room temperature, 20‑25ºC (68‑77ºF) [see USP]. Protect from light and moisture.

Berechtigungsstatus:

New Drug Application

Fachinformation

ZOMIG- ZOLMITRIPTAN TABLET
ZOMIG ZMT- ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING
AMNEAL PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOMIG OR ZOMIG-ZMT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOMIG OR ZOMIG-ZMT.
ZOMIG (ZOLMITRIPTAN) TABLETS, FOR ORAL USE
ZOMIG-ZMT (ZOLMITRIPTAN), ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
ZOMIG 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
Do not break ZOMIG Orally Disintegrating Tablets (2.2)
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)
Orally Disintegrating Tablets: 2.5 mg and 5 mg (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
Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks (4)
Known hypersensitivity to ZOMIG or ZOMIG-ZMT (4)
_Myocardial Ischemia/Infarction, a