OLMESARTAN MEDOXOMIL tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

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  is supplied as yellow coloured round shape film coated tablets containing 5 mg of olmesartan medoxomil USP, as white to off-white coloured, round shape film coated tablets containing 20 mg of olmesartan medoxomil USP, and as white to off-white coloured,oval shape film coated tablets containing 40 mg of olmesartan medoxomil USP. Tablets are debossed with OLM on one side and 5,20 & 40 on the other side of the 5, 20, and 40 mg tablets, respectively. Tablets are supplied as follows: 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, COATED
ASCEND LABORATORIES, LLC
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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 TABLETS
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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.3, 5.6)
10/2019
INDICATIONS AND USAGE
Olmesartan medoxomil tablets 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)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DSE
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)
CONTRAINDICATIONS
Do not co-administer aliskiren with olmesartan medoxomil tablets in
patients with diabetes. (4)
WARNINGS AND PRECAUTIONS
· Avoid fetal (in utero) exposure (5.1).
· Use of olmesartan medoxomil tablets in children less than 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 b