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:

CELLTRION 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 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 is administered to treat any subsequent attacks. - Zolmitriptan tablets is 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 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 p

Product summary:

Zolmitriptan Tablets, USP 2.5 mg  Yellow colored, round, biconvex, film-coated, 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 72606-567-01). Zolmitriptan Tablets, USP 5 mg – Pink colored, round, biconvex, film-coated, 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 72606-568-01). Store Zolmitriptan Tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLMITRIPTAN- ZOLMITRIPTAN TABLET, FILM COATED
CELLTRION USA, INC.
----------
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
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, Tightness, and Pressure: _Generally, not
associated with myocardial ischemia; evaluate for
CAD in patients at high r