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 40 mg

Prescription type:

PRESCRIPTION DRUG

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
Warnings and Precautions (5.6)
11/2016
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 volume- or
salt-depleted patients with treatment initiation (5.3).
Monitor for worsening renal function in patients with renal impairment
(5.4).
Sprue-like enteropathy has been reported. Consider discontinuation