IMITREX- sumatriptan spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GlaxoSmithKline LLC

INN (International Name):

SUMATRIPTAN

Composition:

SUMATRIPTAN 5 mg

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IMITREX nasal spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: IMITREX nasal spray is contraindicated in patients with: Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data) . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data) . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with mig

Product summary:

IMITREX nasal spray 5 mg (NDC 0173-0524-00) and 20 mg (NDC 0173-0523-00) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan. Store between 2°C and 30°C (36°F and 86°F). Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

IMITREX- SUMATRIPTAN SPRAY
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IMITREX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR IMITREX.
IMITREX (SUMATRIPTAN) NASAL SPRAY
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
IMITREX is a serotonin (5-HT
) receptor agonist (triptan) indicated for acute treatment of migraine
with or without
aura in adults. (1)
Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 5 mg and 20 mg (3, 16)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥1% and >placebo) were burning
sensation, disorder/discomfort of nasal cavity/sinuses,
throat discomfort, nausea and/or vomiting, bad/unusual taste, and
dizziness/vertigo. (6.1)
1B/1D
Use only if a clear diagnosis of migraine headache has been
established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. (2)
A second dose should only be considered if some response to the first
dose was observed. Separate doses by at least
2 hours. (2)
Maximum dose in a 24-hour period: 40 mg. (2)
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)
1
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor. (4)
Hypersensitivity to IMITREX (angioedema and anaphylaxis seen). (4)
Severe hepatic impairment (4)
Myocardial ischemia/infarction and Prin