ZOLMITRIPTAN - zolmitriptan tablet, film coated ZOLMITRIPTAN - zolmitriptan tablet, orally disintegrating

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Macleods Pharmaceuticals Limited

INN:

ZOLMITRIPTAN

composition:

ZOLMITRIPTAN 2.5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 are 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 (

leaflet_short:

2.5 mg Tablets - Yellow, biconvex, round, film-coated, functionally-scored tablets containing 2.5 mg of zolmitriptan identified with “CL 82” and break line on one side are supplied in : Bottle of 90 tablets NDC 33342-112-10 Cartons of 100 (10×10) unit dose blister tablets NDC 33342-112-12 Cartons of 6 (2×3) unit dose blister tablets NDC 33342-112-74 Cartons of 3 (1×3) unit dose blister tablets NDC 33342-112-52 5 mg Tablets – Pink, biconvex, round, film-coated tablets containing 5 mg of zolmitriptan identified with “CL 83” debossed on one side and plain on other side are supplied in: Bottle of 90 tablets NDC 33342-113-10 Cartons of 100 (10×10) unit dose blister tablets NDC 33342-113-12 Cartons of 6 (2×3) unit dose blister tablets NDC 33342-113-74 Cartons of 3 (1×3) unit dose blister tablets NDC 33342-113-52 2.5 mg Orally disintegrating tablets - White to off white, round, flat faced,uncoated, bevelled tablet containing 2.5 mg of zolmitriptan identified with a debossed “CL 84” on one side and plain on other side are supplied as follows: Bottles of 90 tablets NDC 33342-139-10 Carton of 100 (10 x 10) unit dose blister tablets NDC 33342-139-12 Cartons of 6 (2×3) unit dose blister tablets NDC 33342-139-74 Cartons of 3 (1×3) unit dose blister tablets NDC 33342-139-52 5 mg Orally disintegrating tablets - White to off white, flat faced, round, uncoated, bevelled tablet containing 5 mg of zolmitriptan identified with a debossed “CL 85” on one side and plain on the other are supplied as follows: Bottles of 90 tablets NDC 33342-140-10 Carton of 100 (10 x 10) unit dose blister tablets NDC 33342-140-12 Cartons of 6 (2×3) unit dose blister tablets NDC 33342-140-74 Cartons of 3 (1×3) unit dose blister tablets NDC 33342-140-52 Store both zolmitriptan tablets and zolmitriptan orally disintegrating tablets at 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature.] and away from children. Protect from moisture. Discard when expired.

authorization_status:

Abbreviated New Drug Application

SPC

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, FILM COATED
ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN TABLETS OR
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR ZOLMITRIPTAN TABLETS OR ZOLMITRIPTAN ORALLY
DISINTEGRATING TABLETS.
ZOLMITRIPTAN TABLETS, FOR ORAL USE
ZOLMITRIPTAN, ORALLY DISINTEGRATING TABLETS
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)
Do not break zolmitriptan orally disintegrating tablets (2.2)
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)
Orally Disintegrating Tablets: 2.5 mg and 5 mg (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-HT1 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 or zolmitriptan orally
disintegrating tablets (4)
WARNI