ELETRIPTAN- eletriptan hydrobromide tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI)

Dostupno od:

Greenstone LLC

INN (International ime):

ELETRIPTAN HYDROBROMIDE

Sastav:

ELETRIPTAN 20 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Eletriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Eletriptan is contraindicated in patients with: Risk Summary Available human data on the use of eletriptan in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, oral administration of eletriptan during pregnancy or throughout pregnancy and lactation was associated with developmental toxicity (decreased fetal and pup weights, increased incidences of fetal structural abnormalities, decreased pup viability) at clinically-relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and 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 migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in

Proizvod sažetak:

Eletriptan hydrobromide tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. Eletriptan hydrobromide tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing. They are supplied in the following strengths and package configurations: Blister of 6 tablets 20 mg 59762-2321-1 REP20 and Pfizer Blister of 6 tablets 40 mg 59762-2322-1 REP40 and Pfizer Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

ELETRIPTAN- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELETRIPTAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELETRIPTAN.
ELETRIPTAN HYDROBROMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Eletriptan is a serotonin (5-HT
) receptor agonist (triptan) indicated for the acute treatment of
migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
DOSAGE AND ADMINISTRATION
Single dose: 20 mg or 40 mg (2)
Maximum single dose: 40 mg (2)
May repeat dose after 2 hours if needed; not to exceed 80 mg in any
24-hour period (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg and 40 mg (3)
CONTRAINDICATIONS
History of coronary artery disease (CAD) or coronary artery vasospasm
(4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or history or current
evidence of hemiplegic or basilar
migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Within 24 hours of treatment with another 5-HT agonist, or an
ergotamine-containing medication (4)
Hypersensitivity to eletriptan (angioedema and anaphylaxis seen) (4)
Within at least 72 hours of treatment with the following potent CYP3A4
inhibitors: ketoconazole,
itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir,
or nelfinavir (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction or Prinzmetal's angina: Perform cardiac
evaluation in patients with
multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue eletriptan if occurs (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness:
Generally not myocardial ischemia;
evaluate high risk patients for CAD (5.3)
Cereb