ZOLMITRIPTAN OD- zolmitriptan tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zolmitriptan (UNII: 2FS66TH3YW) (Zolmitriptan - UNII:2FS66TH3YW)

Available from:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Name):

Zolmitriptan

Composition:

Zolmitriptan 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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:x - 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 Precaution

Product summary:

2.5 mg Orally Disintegrating Tablets : White, round,  flat faced, beveled edged tablets, debossed with ‘C’ on one side and ‘J’ on the other side. Carton of 6 (2 × 3) unit-dose tablets        NDC 59746-461-16 5 mg Orally Disintegrating Tablets :White, round, flat faced, beveled edged tablets, debossed with ‘C’ on one side and ‘K’on the other side. Carton of 3 (1 × 3) unit-dose tablets        NDC 59746-462-13 Store at 20ºC-25°C (68ºF-77ºF), excursions permitted to 15°C -30°C (59ºF-86ºF) [See USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN OD - ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING
JUBILANT CADISTA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS.
ZOLMITRIPTAN ORALLY DISINTEGRATING 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)
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
• 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-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 and zolmitriptan orally
disintegrating tablets (4)
WARNINGS AND PRECAUTIONS
_Myocardial Ischemia/Infarction, and Prinzme