SUMATRIPTAN SUCCINATE injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Sun Pharmaceutical Industries, Inc.

INN (Mezinárodní Name):

SUMATRIPTAN SUCCINATE

Složení:

SUMATRIPTAN 6 mg in 0.5 mL

Podání:

SUBCUTANEOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Sumatriptan injection, USP, 6 mg/0.5 mL contains sumatriptan 6 mg (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: The needle shield of the pre-filled syringe contains dry natural rubber (a latex derivative) that has the potential to cause allergic reactions in latex-sensitive individuals. (NDC 47335-276-40) sumatriptan injection autoinjector with 1 prefilled single-dose syringe and instructions for use. (NDC 47335-276-41) sumatriptan injection autoinjector with 1 prefilled single-dose syringe, two such autoinjectors and instructions for use are packaged in carton. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE INJECTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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
INDICATIONS AND USAGE
Sumatriptan 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 4 mg or 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)
The needle shield of the prefilled syringe contains dry natural rubber
(a latex derivative) which may
cause allergic reactions in latex-sensitive patients. (2.2)
Patients receiving doses other than 6 mg: Use the 6 mg single-dose
vial (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 6 mg single-dose prefilled syringe with sumatriptan
injection 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