SUMATRIPTAN SUCCINATE- sumatriptan succinate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

SUMATRIPTAN SUCCINATE

Composition:

SUMATRIPTAN 6 mg in 0.5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: - Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan injection, reconsider the diagnosis before Sumatriptan injection is administered to treat any subsequent attacks. - Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan injection is 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 and Precautions (5.2)] . - Hi

Product summary:

Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Store between 2° and 25°C (36° and 77°F). Protect from light. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE INJECTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN INJECTION.
SUMATRIPTAN INJECTION, USP FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan injection is a serotonin (5-HT
) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (1)
Acute treatment of cluster headache in adults (1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been
established (1)
Not indicated for the prophylactic therapy of migraine or cluster
headache attacks (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only (2.1)
Acute treatment of migraine: single dose of 1 to 6 mg (2.1)
Acute treatment of cluster headache: single dose of 6 mg (2.1)
Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1
hour (2.1)
Patients receiving doses other than 6 mg: Use the 6-mg single-dose
vial (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 6-mg single-dose vial. Each 0.5 mL injection contains 8.4
mg of sumatriptan succinate
equivalent to 6 mg of sumatriptan (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 injection (angioedema and anaphylaxis
seen) (4)
Severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal's angina: Perform
car