ELETRIPTAN HYDROBROMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ELETRIPTAN HYDROBROMIDE

Composition:

ELETRIPTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Eletriptan hydrobromide tablets are contraindicated in patients with: Available human data on the use of eletriptan hydrobromide tablets 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 miscarria

Product summary:

Eletriptan Hydrobromide Tablets are available containing eletriptan hydrobromide equivalent to 20 mg or 40 mg eletriptan (base), respectively. The 20 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and EL4 on the other side. They are available as follows: NDC 0378-4287-85 carton of 6 unit-dose tablets (1 x 6) The 40 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and EL5 on the other side. They are available as follows: NDC 0378-4288-85 carton of 6 unit-dose tablets (1 x 6) NDC 0378-4288-08 carton of 12 unit-dose tablets (2 x 6) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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 tablets are a serotonin (5-HT
) receptor agonist (triptan) indicated for the 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
Tablets: 20 mg and 40 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 5% and > placebo) were asthenia,
nausea, dizziness, and somnolence. These reactions
appear to be dose-related. (6.1)
1B/1D
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)
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)
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)
1
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, clarithr