EDARBYCLOR azilsartan medoxomil and chlorthalidone tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AZILSARTAN KAMEDOXOMIL (UNII: WEC6I2K1FC) (AZILSARTAN - UNII:F9NUX55P23)

Disponible desde:

Takeda Pharmaceuticals America, Inc.

Designación común internacional (DCI):

AZILSARTAN KAMEDOXOMIL

Composición:

AZILSARTAN MEDOXOMIL 40 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

New Drug Application

Ficha técnica

EDARBYCLOR- AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE TABLET
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EDARBYCLOR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR EDARBYCLOR.
EDARBYCLOR (AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE) TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 2011
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Contraindications (4)
10/2012
INDICATIONS AND USAGE
Edarbyclor is an angiotensin II receptor blocker (ARB) and a
thiazide-like diuretic combination product indicated for the
treatment of hypertension, to lower blood pressure:
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Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets (azilsartan/chlorthalidone): 40/12.5 mg and 40/25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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WHEN PREGNANCY IS DETECTED, DISCONTINUE EDARBYCLOR AS SOON AS POSSIBLE
(5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.1)
In patients not adequately controlled with monotherapy (1)
As initial therapy in patients likely to need multiple drugs to help
achieve blood pressure goals (1)
Starting dose is 40/12.5 mg once daily (2.1)
Edarbyclor may be used to provide additional blood pressure lowering
for patients not adequately controlled on
azilsartan medoxomil 80 mg or chlorthalidone 25 mg (2.1)
Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to
achieve blood pressure goals (2.1)
Maximal dose is 40/25 mg (2.1)
May be administered with other antihypertensive agents (2.1)
Edarbyclor may be administered with or without food (2.1)
Replace volume in volume-depleted patients prior to use (2.2)
Anuria (4)
Do not coadminister aliskiren with Edarbyclor in patients with
diabe