ELETRIPTAN HYDROBROMIDE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

eletriptan hydrobromide (UNII: M41W832TA3) (eletriptan - UNII:22QOO9B8KI)

Tilgængelig fra:

Quality Care Products, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: - Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. - Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. - Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache. Eletriptan hydrobromide tablets are 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

Produkt oversigt:

Eletriptan hydrobromide tabletscontaining 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. Eletriptan hydrobromide tabletsare orange, round, biconvex, film-coated tablets with appropriate debossing. They are supplied in the following strengths and package configurations: Eletriptan hydrobromide tablets 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].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
QUALITY CARE PRODUCTS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELETRIPTAN
HYDROBROMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ELETRIPTAN HYDROBROMIDE TABLETS.
ELETRIPTAN HYDROBROMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Eletriptan hydrobromide tablets 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 hydrobromide tablets (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 hydrobromide tablets if occurs
(5.2)
Chest/throat/