BENICAR HCT- olmesartan medoxomil-hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

A-S Medication Solutions

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 50090-1083 NDC: 50090-1083-0 30 TABLET, FILM COATED in a BOTTLE

Authorization status:

New Drug Application

Summary of Product characteristics

BENICAR HCT- OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE TABLET, FILM
COATED
A-S MEDICATION SOLUTIONS
----------
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 where no other etio