Country: United States
Language: English
Source: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Sun Pharmaceutical Industries, Inc.
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
ORAL
PRESCRIPTION DRUG
Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] . 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 olmesartan medoxomil 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 go
Olmesartan medoxomil and hydrochlorothiazide tablets are supplied as follows: Tablets are packaged as follows: Storage Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature].
New Drug Application Authorized Generic
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN MEDOXOMIL-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 AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS 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). INDICATIONS AND USAGE Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of olmesartan, an angiotensin II receptor 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) DOSAGE AND ADMINISTRATION Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg (2) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg (2) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide (2) DOSAGE FORMS AND STRENGTHS Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40/12.5 mg; 40/25 mg (3) CONTRAINDICATIONS Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets(4) Anuria (4) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with diabetes. (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration. ( Read the complete document