Country: United States
Language: English
Source: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
PD-Rx Pharmaceuticals, Inc.
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 40 mg
ORAL
PRESCRIPTION DRUG
BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is 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 BENICAR HCT. 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
BENICAR HCT is supplied as follows: Tablets are packaged as follows: Storage Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature].
New Drug Application
BENICAR HCT- OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BENICAR HCT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENICAR HCT. BENICAR HCT (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 BENICAR HCT 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 BENICAR HCT is 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 BENICAR HCT ( 4) Anuria ( 4) Do not co-administer aliskiren with BENICAR HCT in patients with diabetes. ( 4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration. ( 5.2) Monitor renal function and potassium in susceptible patients ( 5.3) Observe for signs of fluid or electrolyte imbalance. ( 5.4) Acute angle-closure glaucoma ( 5.5) Sprue-like enteropathy has been reported. Consider discontinuation of Benicar HCT in cases wher Read the complete document