OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE- olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide tabl

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponible des:

Sun Pharmaceutical Industries, Inc.

Designació comuna internacional (DCI):

OLMESARTAN MEDOXOMIL

Composición:

OLMESARTAN MEDOXOMIL 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are 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 olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. 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, su

Resumen del producto:

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

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE-
OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN
MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL, AMLODIPINE
AND
HYDROCHLOROTHIAZIDE TABLETS.
OLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL,
AMLODIPINE AND
HYDROCHLOROTHIAZIDE TABLETS 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
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a
combination of olmesartan
medoxomil, an angiotensin II receptor blocker, amlodipine, a
dihydropyridine calcium channel blocker, and
hydrochlorothiazide, a thiazide diuretic, indicated for the treatment
of hypertension, to lower blood
pressure. Lowering blood pressure reduces the risk of fatal and
nonfatal cardiovascular events, primarily
strokes and myocardial infarctions. (1).
Limitations of Use
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are
not indicated for initial therapy
(1).
DOSAGE AND ADMINISTRATION
Dose once daily. Dosage may be increased after 2 weeks to a maximum
dose of 40 /10 /25 mg once
daily (2).
Dose selection should be individualized based on previous therapy (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20 /5
/12.5 mg, 40 /5 /12.5 mg, 40 /5 /25
mg, 40 /10 /12.5 mg, 40 /10 /25 mg (3)
CONTRAINDICATIONS
Anuria: Hypersensitivity to sulfonamide-derived drugs (4).
Do not co-administer aliskiren with olmesartan medoxomil, am