SUMATRIPTAN SUCCINATE injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Sumatriptan Succinate (UNII: J8BDZ68989) (Sumatriptan - UNII:8R78F6L9VO)

Disponibbli minn:

Dr. Reddy's Laboratories Limited

INN (Isem Internazzjonali):

Sumatriptan Succinate

Kompożizzjoni:

Sumatriptan 6 mg in 0.5 mL

Rotta amministrattiva:

SUBCUTANEOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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)]. - His

Sommarju tal-prodott:

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: NDC 55111-693-12 Sumatriptan Injection USP Autoinjector System includes 2 Autoinjectors, each with an associated single-dose prefilled syringe which contains 6 mg of sumatriptan (as the succinate salt) and 3.5 mg of sodium chloride in 0.5 mL of solution. Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION
DR. REDDY'S LABORATORIES LIMITED
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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, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration, Dosing Information (2.1) 12/2021
Removal of Dosage and Administration, Administration of Doses of
sumatriptan injection Other than 6 mg
(2.3) 12/2021
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)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg single-dose prefilled syringe assembled in an
autoinjector (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 PRECAUTI