SUMATRIPTAN- sumatriptan succinate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

SUMATRIPTAN SUCCINATE

Composition:

SUMATRIPTAN 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: - Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks. - Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks. - Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache. Sumatriptan tablets are contraindicated in patients with:  - Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) 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 an

Product summary:

Sumatriptan Tablets USP, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate Sumatriptan Tablets USP, 50 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘33’ on other side. 9 TABLET in a BLISTER PACK/1 BLISTER PACK in a BOX (33261-663-01) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Cornoa, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUMATRIPTAN- SUMATRIPTAN SUCCINATE TABLET
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUMATRIPTAN TABLETS.
SUMATRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan tablets, USP are a serotonin (5-HT
) receptor agonist (triptan) indicated for acute treatment of migraine
with or without aura in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been
established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
DOSAGE AND ADMINISTRATION
Single dose of 25 mg, 50 mg, or 100 mg tablet.(2.1)
A second dose should only be considered if some response to the first
dose was observed. Separate doses by at least 2
hours. (2.1)
Maximum dose in a 24-hour period: 200 mg. (2.1)
Maximum single dose should not exceed 50 mg in patients with mild to
moderate hepatic impairment. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRAINDICATIONS
History of coronary artery disease or coronary artery vasospasm (4)
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 of an ergotamine-containing medication.
(4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor. (4)
Hypersensitivity to sumatriptan tablets (angioedema and anaphylaxis
seen). (4)
Severe hepatic impairment. (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform
cardiac evaluation in patients with multiple
cardiovascular risk factors. (5.1)
Arrhythmias: Discontinue sumatriptan if oc