ELETRIPTAN HYDROBROMIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Aurobindo Pharma Limited

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 pa

Podsumowanie produktu:

Eletriptan hydrobromide tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. Eletriptan Hydrobromide Tablets 20 mg are orange colored, round, biconvex, film-coated tablets debossed with ‘EL’ on one side and ‘20’ on the other side. They are supplied as follows:   Carton of 6 (1 X 6) Unit-dose Tablets          NDC 59651-104-69 Eletriptan Hydrobromide Tablets 40 mg are orange colored, round, biconvex, film-coated tablets debossed with ‘EL’ on one side and ‘40’ on the other side. They are supplied as follows:     Carton of 6 (1 X 6) Unit-dose Tablets      NDC 59651-105-69    Carton of 12 (2 X 6) Unit-dose Tablets    NDC 59651-105-93 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ELETRIPTAN HYDROBROMIDE - ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
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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 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 if occurs (5.2)
Chest/throat/neck/jaw pain, ti