ZOLMITRIPTAN tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

zolmitriptan (UNII: 2FS66TH3YW) (zolmitriptan - UNII:2FS66TH3YW)

Disponível em:

Curae Pharma360 Inc

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

2.5 mg Tablets – Yellow colored, round, biconvex film-coated tablets debossed with 101 on one side and deep breakline on other side and are supplied in cartons containing a blister pack of 6 tablets (NDC 73358-101-06) 5 mg Tablets – Pink colored, round, biconvex film-coated tablets debossed with 102 on one side and plain on other side and are supplied in cartons containing a blister pack of 3 tablets (NDC 63548-0102-3). Store Zolmitriptan tablets at 20° to 25°C (68° to 77°F); [see USP]. Protect from light and moisture.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ZOLMITRIPTAN- ZOLMITRIPTAN TABLET, FILM COATED
CURAE PHARMA360 INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLMITRIPTAN.
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 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 tablets (4)
WARNINGS AND PRECAUTIONS
_Myocardial Ischemia/Infarction, and Prinzmetal 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 Pressu