ELETRIPTAN HYDROBROMIDE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Zydus Lifesciences Limited

INN (Nome Internazionale):

ELETRIPTAN HYDROBROMIDE

Composizione:

ELETRIPTAN 20 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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 70771-1107-3 in bottle of 30 tablets NDC 70771-1107-0 in bottle of 1000 tablets NDC 70771-1107-6 in unit-dose blister cartons of 6 (1 x 6) unit-dose tablets NDC 70771-1107-4 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 70771-1108-3 in bottle of 30 tablets NDC 70771-1108-5 in bottle of 500 tablets NDC 70771-1108-6 in unit-dose blister cartons of 6 (1 x 6) unit-dose tablets NDC 70771-1108-4 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
Cadila Healthcare Limited
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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 selective norepinephrine
reuptake inhibitors (SNRIs).
Ask your docto

Scheda tecnica

ELETRIPTAN HYDROBROMIDE - ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
ELETRIPTAN HYDROBROMIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Eletriptan hydrobromide Tablets, 20 mg
NDC 70771-1107-3
Rx only
30 Tablets
Eletriptan hydrobromide Tablets, 40 mg
NDC 70771-1108-3
Rx only
30 Tablets
ELETRIPTAN HYDROBROMIDE
eletriptan hydrobromide tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1107
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN -
UNII:22QOO9B8KI)
ELETRIPTAN
20 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)
POVIDONE K30 (UNII: U725QWY32X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
PRODUCT CHARACTERISTICS
COLOR
ORANGE (ORANGE TO MOTTLED ORANGE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
922
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1107-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
07/12/2017
2
NDC:70771-
1107-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
07/12/2017
3
NDC:70771-
1107-4
10 in 1 CARTON
07/12/2017
3
NDC:70771-
1107-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
4
NDC:70771-
1107-6
1 in 1 CARTON
07/12/2017
4
6 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206409
07/12/2017
ELETRIPTAN HYDROBROMIDE
eletriptan hydrobromide tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE