ZOLMITRIPTAN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolmitriptan tablets are 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 tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of zolmitriptan 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 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

Product summary:

Zolmitriptan Tablets USP, 2.5 mg are light yellow to yellow colored, round-shaped, biconvex, film-coated tablets with breakline on one side and debossed with "7" on other side and are supplied as follows: NDC 68382-712-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets Zolmitriptan Tablets USP, 5 mg are light orange to orange colored, round-shaped, biconvex beveled edge, film-coated tablets debossed with '714' on one side and plain on other side and are supplied as follows: NDC 68382-714-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN - ZOLMITRIPTAN TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA 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 tablets are 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 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, Tightnes