SUMAVEL DOSEPRO sumatriptan injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Endo Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

SUMATRIPTAN SUCCINATE

Kompozīcija:

SUMATRIPTAN 6 mg in 0.5 mL

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

New Drug Application

Produkta apraksts

SUMAVEL DOSEPRO- SUMATRIPTAN INJECTION
ENDO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMAVEL DOSEPRO SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR SUMAVEL DOSEPRO.
SUMAVEL DOSEPRO (SUMATRIPTAN INJECTION), FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumavel
DosePro
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 prevention of migraine attacks. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only. (2.1, 2.2)
Acute treatment of migraine: 4 mg or 6 mg single dose. (2.1)
Acute treatment of cluster headache: 6 mg single dose. (2.1)
Maximum dose in a 24-hour period: 12 mg. Separate doses by at least 1
hour. (2.1)
Administer dose only to the abdomen or thigh. (2.2)
DO NOT USE SUMAVEL DOSEPRO IF THE TIP OF THE DEVICE IS TITLED OR
BROKEN OFF UPON
REMOVAL FROM PACKAGING. (2.2)
DOSAGE FORMS AND STRENGTHS
Sumavel DosePro: 4 mg or 6 mg prefilled, single-dose, needle-free
subcutaneous delivery systems.
CONTRAINDICATIONS
History of coronary artery disease or coronary 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)
Current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor
(4)
Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen)
(4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform
cardiac evaluation in patients with multi