BENICAR- olmesartan medoxomil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)

Available from:

Bryant Ranch Prepack

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benicar is 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. 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. 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, Evaluation, and Treatment of High Blood Pressu

Product summary:

Benicar is supplied as yellow, round, film-coated, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated, non-scored tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped, film-coated, non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20, and 40 mg tablets, respectively. Tablets are supplied as follows: Storage Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Summary of Product characteristics

BENICAR- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENICAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BENICAR.
BENICAR (OLMESARTAN MEDOXOMIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
When pregnancy is detected, discontinue Benicar 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).
RECENT MAJOR CHANGES
Boxed Warning 3/2012
Indications and Usage (1) 2/2012
Contraindications (4) 9/2012
Dosage and Administration:
Pediatric Hypertension (6 to 16 years of age) (2.2) 2/2012
Warnings and Precautions:
Pregnancy (5.1) 3/2012
Morbidity in Infants (5.2) 2/2012
INDICATIONS AND USAGE
Benicar is an angiotensin II receptor blocker (ARB) 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).
DOSAGE AND ADMINISTRATION
INDIC ATIO N
STARTING DOSE
DOSE RANGE
Adult Hypertension (2.1)
20 mg once daily
20 - 40 mg once daily
Pediatric Hypertension (6 - 16 years) (2.2)
20 to <35 kg 10 mg once daily
≥35 kg 20 mg once daily
20 to <35 kg 10 - 20 mg once daily
≥35 kg 20 - 40 mg once daily
Benicar may be administered with or without food.
If blood pressure is not controlled by Benicar alone, a diuretic may
be added. Benicar may be administered with other
antihypertensive agents.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 20 mg, and 40 mg (3).
CONTRAINDICATIONS
Do not co-administer aliskiren with Benicar in patients with diabetes
(4).
WARNINGS AND PRECAUTIONS
Avoid fetal (in utero) exposure (5.1).
Children <1 year of age must not receive Benicar for hypertension
(5.2).
Observe for signs and symptoms of hypotension in