OLMESARTAN MEDOXOMIL tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Glenmark Pharmaceuticals Inc., USA

INN (Միջազգային անվանումը):

OLMESARTAN MEDOXOMIL

Կազմը:

OLMESARTAN MEDOXOMIL 5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

Olmesartan Medoxomil Tablets, USP 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: Olmesartan Medoxomil Tablets, USP 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: Olmesartan Medoxomil Tablets, USP 40 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘438’ on one side and plain on the other side. They are supplied as follows: Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Bottles: Keep tablets in tightly closed containers with desiccants.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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._
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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). (3)
CONTRAINDICATIONS
Do not co-administer aliskiren with olmesartan medoxomil tablets in
patients with diabetes (4).
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
The most common adverse reaction in adults was dizziness (3%) (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
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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).
Avoid fetal (_in utero_) exposure (5.1).
Use of olmesartan medoxomil children <1 year of age is not recommended
(5.2).
Observe for sig