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:

Alembic Pharmaceuticals Inc.

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 olmesartan medoxomil 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 goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Join

Product summary:

Olmesartan medoxomil tablets, USP are supplied as follows: 5 mg: yellow, film coated, round, biconvex tablets debossed with ‘322’ on one side and ‘L’ on the other side. NDC 62332-131-30                bottle of 30 tablets with child-resistant closure NDC 62332-131-90                bottle of 90 tablets with child-resistant closure NDC 62332-131-91                bottle of 1000 tablets NDC 62332-131-10                carton of 100 tablets (10 x 10 Unit-Dose) 20 mg: yellow, film coated, round, biconvex tablets debossed with ‘323’ on one side and ‘L’ on the other side. NDC 62332-132-30                bottle of 30 tablets with child-resistant closure NDC 62332-132-90                bottle of 90 tablets with child-resistant closure NDC 62332-132-91                bottle of 1000 tablets NDC 62332-132-10                carton of 100 tablets (10 x 10 Unit-Dose) 40 mg: yellow, film coated, oval shape, biconvex tablets debossed with ‘L324’ on one side and plain on other side. NDC 62332-133-30                bottle of 30 tablets with child-resistant closure NDC 62332-133-90                bottle of 90 tablets with child-resistant closure NDC 62332-133-91                bottle of 1000 tablets NDC 62332-133-10                carton of 100 tablets (10 x 10 Unit-Dose)      Storage Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLMESARTAN MEDOXOMIL - OLMESARTAN MEDOXOMIL TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN
MEDOXOMIL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
OLMESARTAN MEDOXOMIL TABLETS.
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 OLMESARTAN MEDOXOMIL AS SOON
AS
POSSIBLE (5.1, 8.1).
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS (5.1, 8.1).
INDICATIONS AND USAGE
Olmesartan medoxomil is an angiotensin II receptor blocker (ARB)
indicated for the treatment of
hypertension in adult and pediatric patients six years of age and
older, 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). (1)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING
DOSE
DOSE RANGE
Adult
Hypertension
(2.1)
20 mg once
daily
20 to 40 mg once
daily
Pediatric
Hypertension
(6 years of age
and older)
(2.2)
20 to <35 kg
10 mg once
daily_ _
_≥_35 kg
20 mg once
daily
20 to <35 kg
10 to 20 mg once
daily_ _
_≥_35 kg
20 to 40 mg once
daily
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 20 mg, and 40 mg (3). (3)
CONTRAINDICATIONS
Do not co-administer aliskiren with olmesartan medoxomil in patients
with diabetes (4). (4)
WARNINGS AND PRECAUTIONS
Avoid fetal (_in utero_) exposure (5.1).
Use of olmesartan medoxomil in children <1 year of age is not
recommended (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 alternative
antihypertensive therapy in cases
where no other e