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:

Aurobindo Pharma Limited

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

Product summary:

Olmesartan Medoxomil Tablets, USP 5 mg are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘16’ on the other side.         Bottles of 30                                          NDC 65862-741-30         Bottles of 90                                          NDC 65862-741-90         Bottles of 100                                        NDC 65862-741-01         Bottles of 500                                        NDC 65862-741-05 Olmesartan Medoxomil Tablets, USP 20 mg are white colored, round shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘18’ on the other side.         Bottles of 30                                          NDC 65862-742-30         Bottles of 90                                          NDC 65862-742-90         Bottles of 100                                        NDC 65862-742-01         Bottles of 500                                        NDC 65862-742-05         Bottles of 1,000                                     NDC 65862-742-99         10 x 10 Unit-dose Tablets                     NDC 65862-742-78 Olmesartan Medoxomil Tablets, USP 40 mg are white colored, oval shaped, biconvex, film-coated tablets, debossed with ‘K’ on one side and ‘19’ on the other side.         Bottles of 30                                          NDC 65862-743-30         Bottles of 90                                          NDC 65862-743-90         Bottles of 100                                        NDC 65862-743-01         Bottles of 500                                        NDC 65862-743-05         Bottles of 1,000                                     NDC 65862-743-99         10 x 10 Unit-dose Tablets                     NDC 65862-743-78 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
AUROBINDO PHARMA LIMITED
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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 tablets are 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 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).
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 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 etiology i