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 Limited

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Olmesartan medoxomil 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 olmesartan medoxomil. 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 Trea

Product summary:

Olmesartan medoxomil tablets 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 46708-131-30    bottle of 30 tablets NDC 46708-131-90    bottle of 90 tablets NDC 46708-131-91    bottle of 1000 tablets NDC 46708-131-10    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 46708-132-30    bottle of 30 tablets NDC 46708-132-90    bottle of 90 tablets NDC 46708-132-91    bottle of 1000 tablets NDC 46708-132-10    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 46708-133-30    bottle of 30 tablets NDC 46708-133-90    bottle of 90 tablets NDC 46708-133-91    bottle of 1000 tablets NDC 46708-133-10    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 LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN MEDOXOMIL
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).
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN
DEATH TO THE DEVELOPING FETUS (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 11/2016
INDICATIONS AND USAGE
Olmesartan medoxomil 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
INDICATION
STARTING
DOSE
DOSERANGE
Adult
Hypertension
(2.1)
20 mg once
daily
20 to 40 mg once
daily
Pediatric
Hypertension
(6 to 16 years)
(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
Olmesartan medoxomil may be administered with or without food.
If blood pressure is not controlled by olmesartan medoxomil alone, a
diuretic may be added.
Olmesartan medoxomil may be administered with other antihypertensive
agents.
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).
Children <1 year of age must not receive olmesartan medoxomil for
hypertension (5.2).
Observe for signs and symptoms of hypotension in volume- or
salt-depleted patients with treatment