OLMESARTAN MEDOXOMIL tablet, film coated 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:

Apotex Corp.

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, 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 Joint National Committee on Prevention, Detection, Eva

Product summary:

Olmesartan medoxomil tablets, 5 mg are light yellow to yellow, round, film-coated tablets debossed with‘C’ on one side and plain on the other side. They are supplied as follows: bottles of 30..............NDC 60505-4652-3 Olmesartan medoxomil tablets, 20 mg are white to off-white, round, film-coated tablets debossed with‘437’ on one side and plain on the other side. They are supplied as follows: bottles of 30..............NDC 60505-4653-3 bottles of 90 .............NDC 60505-4653-9 Olmesartan medoxomil tablets, 40 mg are white to off-white, oval, film-coated tablets debossed with‘438’ on one side and plain on the other side. They are supplied as follows: bottles of 30.............NDC 60505-4654-3 bottles of 90.............NDC 60505-4654-9 Storage Store at 20 ºto 25 ºC (68 º to 77 ºF); excursions permitted to 15 º to 30 ºC (59 º to 86 ºF)  [see USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
APOTEX CORP.
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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).
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
Olmesartan medoxomil tablets are 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 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 tablets may be administered with or without food.
If blood pressure is not controlled by olmesartan medoxomil tablets
alone, a diuretic may be added. Olmesartan
medoxomil tablets may be administered with other antihypertensive
agents.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 20 mg, or 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).
Children <1 year of age must not receive olmesartan medoxomil for
hypertension (5.2).
Observe for sign