ZOLMITRIPTAN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Ingenus Pharmaceuticals, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Zolmitriptan tabletsare 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 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 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 conduction pathway

Podsumowanie produktu:

Zolmitriptan Tablets, USP 2.5 mg- Yellow colored, round, biconvex, filmcoated, debossed with ‘AC 322’ on one side and score line on other side and are supplied in cartons containing 6 tablets (1 blister of 6 unit dose tablets) (NDC 5074262506). Zolmitriptan Tablets, USP 5 mg – Pink colored, round, biconvex, filmcoated, debossed with ‘AC 323’ on one side and plain on other side and are supplied in cartons containing 3 tablets (1 blister of 3 unit dose tablets) (NDC 5074262603). Store Zolmitriptan Tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
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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
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)1B/1D 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 1 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 Angina: Perform
cardiac evaluation in patients with multiple_
_cardiovascular risk factors (5.1)_
_Arrhythmias: Discontinue zolmitriptan if occurs (5.2)_
_Chest/Throat