OLMESARTAN MEDOXOMIL tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Sun Pharmaceutical Industries, Inc.

INN (nemzetközi neve):

OLMESARTAN MEDOXOMIL

Összetétel:

OLMESARTAN MEDOXOMIL 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Olmesartan medoxomil is 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. 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 Commit

Termék összefoglaló:

Olmesartan medoxomil is supplied as yellow, round, film-coated, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated, non-scored tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped, film-coated, non-scored tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20, and 40 mg tablets, respectively. Tablets are supplied as follows: Storage Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature] .

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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).
RECENT MAJOR CHANGES
Warnings and Precautions (5.3, 5.6)
10/2019
INDICATIONS AND USAGE
Olmesartan medoxomil 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 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
_≥_35 kg
20 mg once daily
20 to <35 kg
10 - 20 mg once daily
_≥_35 kg
20 - 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 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