ZOLMITRIPTAN tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Rising Pharmaceuticals, Inc.

INN (Nome Internazionale):

ZOLMITRIPTAN

Composizione:

ZOLMITRIPTAN 2.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use - Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. - Zolmitriptan is not indicated for the prevention of migraine attacks. - Safety and effectiveness of zolmitriptan have not been established for cluster headache. Zolmitriptan is contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions (5.1) ] - Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] - H

Dettagli prodotto:

2.5 mg Tablets - Yellow, film-coated, round, biconvex tablets debossed with L357 on one side and scoring on otherside. NDC 64980-203-16                   Carton of 6 (1 x 6) Unit-dose Tablets 5 mg Tablets - Pink, film-coated, round, biconvex tablets debossed with 358 on one side and L on other side. NDC 64980-204-13                   Carton of 3 (1 x 3) Unit-dose Tablets Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature] Protect from light and moisture.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, FILM COATED
RISING PHARMACEUTICALS, INC.
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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
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)
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)
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 hypersensitivity to zolmitriptan (4)
WARNINGS AND PRECAUTIONS
_Myocardial Ischemia/Infarction, and Prinzmetal's Angina:_ Perform
cardiac evaluation in patients with multiple
cardiovascular risk factors (5.1)
_Arrhythmias:_ Discontinue zolmitriptan if occurs (5.2)
_Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure:_ Generally not
associated with myocardial ischemia; evaluate for
CAD in patients at hig