AZOR- amlodipine besylate and olmesartan medoxomil tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)

Disponível em:

Physicians Total Care, Inc.

DCI (Denominação Comum Internacional):

AMLODIPINE BESYLATE

Composição:

AMLODIPINE 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents  , to lower blood pressure. 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor.  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 achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Eval

Resumo do produto:

Azor tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below. Azor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Azor tablets are supplied for oral administration in the following strength and package configurations: Tablet Strength (amlodipine equivalent/ olmesartan medoxomil) mg Package Configuration NDC# Product Code Tablet Color 5/20 mg Bottle of 30 Bottle of 30 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Status de autorização:

New Drug Application

Características técnicas

AZOR - AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZOR
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AZOR. AZOR (AMLODIPINE AND OLMESARTAN
MEDOXOMIL) TABLET, FILM COATED FOR ORAL
USE INITIAL U.S. APPROVAL: 2007
USE IN PREGNANCY
See full prescribing information for complete boxed warning.
WHEN PREGNANCY IS DETECTED, DISCONTINUE AZOR AS SOON AS POSSIBLE. WHEN
USED IN PREGNANCY DURING THE
SECOND AND THIRD TRIMESTERS, DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY
AND EVEN DEATH TO THE DEVELOPING FETUS (5.1).
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2011
INDICATIONS AND USAGE
Azor is a dihydropyridine calcium channel blocker and angiotensin II
receptor blocker combination product indicated for
the treatment of hypertension, alone or with other antihypertensive
agents, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial infarctions. (1).
Azor is indicated as initial therapy in patients likely to need
multiple antihypertensive agents to achieve their blood
pressure goals (1).
DOSAGE AND ADMINISTRATION
Substitute Azor for its individually titrated components for patients
on amlodipine and olmesartan medoxomil. Azor
may also be given with increased amounts of amlodipine, olmesartan
medoxomil, or both, as needed (2).
Azor may be used to provide additional blood pressure lowering for
patients not adequately controlled with amlodipine
(or another dihydropyridine calcium channel blocker) alone or with
olmesartan medoxomil (or another angiotensin
receptor blocker) alone (2).
Dosage may be increased after 2 weeks to a maximum dose of 10/40 mg
once daily, usually by increasing one
component at a time but both components can be raised to achieve more
rapid control (2).
Maximum antihypertensive effects are attained within 2 week