EDARBYCLOR- azilsartan kamedoxomil and chlorthalidone tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Azilsartan kamedoxomil (UNII: WEC6I2K1FC) (AZILSARTAN - UNII:F9NUX55P23), chlorthalidone (UNII: Q0MQD1073Q) (chlorthalidone - UNII:Q0MQD1073Q)

Dostupno od:

Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)

INN (International ime):

Azilsartan kamedoxomil

Sastav:

AZILSARTAN MEDOXOMIL 40 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil. There are no controlled trials demonstrating risk reduction with Edarbyclor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achi

Proizvod sažetak:

Edarbyclor is supplied as fixed dose combination tablets that are round, biconvex, film-coated, and 9.7 mm in diameter. Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture and light. Do not repackage; dispense and store in original container.

Status autorizacije:

New Drug Application

Svojstava lijeka

EDARBYCLOR- AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE TABLET
AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)
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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._
WHEN PREGNANCY IS DETECTED, DISCONTINUE EDARBYCLOR AS SOON AS POSSIBLE
(5.1,
8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS (5.1, 8.1)
INDICATIONS AND USAGE
Edarbyclor is a combination of azilsartan medoxomil, an angiotensin II
receptor blocker (ARB) and
chlorthalidone, a thiazide-like diuretic combination product indicated
for the treatment of hypertension, to
lower blood pressure:
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)
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and
myocardial infarctions (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets (azilsartan/chlorthalidone): 40/12.5 mg and 40/25 mg (3)
CONTRAINDICATIONS
Anuria (4)
Do not coadminister aliskiren-containing products with Edarbyclor in
patients with diabetes (4)
WARNINGS AND PRECAU