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:

Zydus Pharmaceuticals USA 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: - 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, reconsider the diagnosis of migraine before eletriptan hydrobromideis administered to treat any subsequent attacks. - Eletriptan hydrobromidetablets arenot intended for the prevention of migraine attacks. - Safety and effectiveness of eletriptan hydrobromidehave not been established for cluster headache. Eletriptan hydrobromide is 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 pathway disorde

Product summary:

Eletriptan hydrobromide  Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. Eletriptan Hydrobromide Tablets, 20 mg are orange to mottled orange colored, round shaped, biconvex with beveled edge, film-coated tablets, debossed with "922" on one side and plain on the other side and are supplied as follows: NDC 68382-922-06 in bottle of 30 tablets NDC 68382-922-10 in bottle of 1000 tablets NDC 68382-922-86 in unit-dose blister cartons of 6 (1 x 6) unit-dose tablets NDC 68382-922-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Eletriptan Hydrobromide Tablets, 40 mg are brown colored, round shaped, biconvex with beveled edge, film-coated tablets, debossed with "923" on one side and plain on the other side and are supplied as follows: NDC 68382-923-06 in bottle of 30 tablets NDC 68382-923-05 in bottle of 500 tablets NDC 68382-923-86 in unit-dose blister cartons of 6 (1 x 6) unit-dose tablets NDC 68382-923-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
Zydus Pharmaceuticals USA Inc.
----------
Patient Information
Eletriptan hydrobromide (el" e trip' tan hye" droe broe' mide) Tablets
Please read this information before you start taking eletriptan
hydrobromide tablets and each time you get
a refill. There may be new information. This information does not take
the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about eletriptan
hydrobromide tablets?
Eletriptan hydrobromide tablets can cause serious side effects,
including:
Heart attack and other heart problems. Heart problems may lead to
death.
Stop taking eletriptan hydrobromide tablets and get emergency medical
help right away if you have any
of the following symptoms of a heart attack:
•
discomfort in the center of your chest that lasts for more than a few
minutes, or that goes away and
comes back
•
chest pain or chest discomfort that feels like an uncomfortable heavy
pressure, squeezing, fullness,
or pain
•
pain or discomfort in your arms, back, neck, jaw, or stomach
•
shortness of breath with or without chest discomfort
•
breaking out in a cold sweat
•
nausea or vomiting
•
feeling lightheaded
Eletriptan hydrobromide tablets are not for people with risk factors
for heart disease unless a heart exam
is done and shows no problem. You have a higher risk for heart disease
if you:
•
have high blood pressure
•
have high cholesterol levels
•
smoke
•
are overweight
•
have diabetes
•
have a family history of heart disease
•
are a female who has gone through menopause
•
are a male over age 40
Serotonin syndrome. Serotonin syndrome is a serious and
life-threatening problem that can happen in
people taking eletriptan hydrobromide tablets, especially if
eletriptan hydrobromide tablets is taken with
anti-depressant medicines called selective serotonin reuptake
inhibitors (SSRIs) or serotonin and
norepinephrine reuptake inhibitors (SNRIs).
As

Summary of Product characteristics

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS USA INC.
----------
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:
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 (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