SUMATRIPTAN SUCCINATE injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

REMEDYREPACK INC.

Spôsob podávania:

SUBCUTANEOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Sumatriptan Succinate 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 Succinate Injection, reconsider the diagnosis before Sumatriptan Succinate Injection is administered to treat any subsequent attacks. - Sumatriptan Succinate Injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan Succinate 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 w

Prehľad produktov:

Sumatriptan Succinate Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Prefilled Syringe and/or Autoinjector Pen: The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) that has the potential to cause allergic reactions in latex-sensitive individuals. Each pack contains a Patient Information and Instructions for Use leaflet. Sumatriptan Succinate Injection Kit, 6 mg, containing 1 autoinjector pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case NDC: 70518-2738-00 PACKAGING: 1 in 1 CARTON, 2 in 1 PACKAGE, 0.5 mL in 1 SYRINGE TYPE 2 Store between 2° and 30°C (36° and 86°F). Protect from light. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION, SOLUTION
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN SUCCINATE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN SUCCINATE.
SUMATRIPTAN SUCCINATE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan Succinate 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)
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 4 or 6 mg: Use the 6-mg
single-dose vial ( 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 4- and 6-mg single-dose prefilled syringe cartridges for
use with autoinjector pen ( 3)
Injection: 6-mg single-dose vial ( 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-HT1 agonist (e.g., another
triptan) or of an ergotamine-
containing medication ( 4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor (