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:

Daiichi Sankyo 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 (CV) 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, Ev

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: Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF) [see USP Controlled Room Temperature] .

Status de autorização:

New Drug Application

Características técnicas

AZOR- AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED
DAIICHI SANKYO 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) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2007
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AZOR 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
Azor is a combination of amlodipine besylate, a dihydropyridine
calcium channel blocker, and
olmesartan medoxomil, an angiotensin II receptor blocker, 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 may also be used as initial therapy in patients likely to need
multiple antihypertensive agents to
achieve their blood pressure goals (1).
DOSAGE AND ADMINISTRATION
Recommended starting dose: 5/20 mg once daily (2).
Titrate as needed in two-week intervals up to a maximum of 10/40 mg
once daily (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/olmesartan medoxomil content) 5/20 mg, 10/20 mg,
5/40 mg, and 10/40 mg (3).
CONTRAINDICATIONS
Do not co-administer aliskiren with Azor in patients with diabetes
(4).
WARNINGS AND PRECAUTIONS
Anticipate hypotension in volume- or salt-depleted patients with
treatment initiation. Start treatment
under close supervision (5.2).
Increased angina or myocardial infarction may occur upon dosage
initiation or increase (5.3).
Impaired renal function: changes in renal function may occur (5.4).
Sprue-like enteropathy has been reported. Consider discontinuation of
Azor in cases where no other
etiology is found (5.6).
ADVERS