OLMESARTAN MEDOXOMIL tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Macleods Pharmaceuticals Limited

INN (Alþjóðlegt nafn):

OLMESARTAN MEDOXOMIL

Samsetning:

OLMESARTAN MEDOXOMIL 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Olmesartan medoxomil tablets are supplied as yellow, round, biconvex, film-coated, non-scored tablets debossed with "C51" on one side and plain on other side containing 5 mg of olmesartan medoxomil, as white, round, biconvex, film-coated, non-scored tablets debossed with "C53" on one side and plain on other side containing 20 mg of olmesartan medoxomil and as white, oval, biconvex, film-coated, non-scored tablets debossed with "C54" on one side and plain on other side containing 40 mg of olmesartan medoxomil. Tablets are supplied as follows: Storage  Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

OLMESARTAN MEDOXOMIL - OLMESARTAN MEDOXOMIL TABLET
MACLEODS PHARMACEUTICALS LIMITED
----------
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 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 - 40 mg once daily
Pediatric Hypertension
(6 years of age and older) (2.2)
20 to <35 kg 10 mg once daily
20 to <35 kg 10 - 20 mg once daily
≥35 kg 20 mg once daily
≥35 kg 20 - 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). (4)
WARNINGS AND PRECAUTIONS
• Avoid fetal (_in utero_) exposure (5.1).
• Use of olmesartan medoxomil tablets 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