OLMESARTAN MEDOXOMIL tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Torrent Pharmaceuticals Limited

INN (International ime):

OLMESARTAN MEDOXOMIL

Sastav:

OLMESARTAN MEDOXOMIL 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 P

Proizvod sažetak:

Olmesartan medoxomil tablets, USP 5 mg are yellow colored, round, biconvex, film coated tablets debossed with '54' on one side and '5' on other side. Bottles of 30                           NDC 13668-248-30 Bottles of 90                           NDC 13668-248-90 Bottles of 500                         NDC 13668-248-05 Olmesartan medoxomil tablets, USP 20 mg are white to off-white colored, round, biconvex, film coated tablets debossed with '1249' on one side and '20' on other side. Bottles of 30                           NDC 13668-249-30 Bottles of 90                           NDC 13668-249-90 Bottles of 500                         NDC 13668-249-05 Olmesartan medoxomil tablets, USP 40 mg are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with '1250' on one side and '40' on other side. Bottles of 30                           NDC 13668-250-30 Bottles of 90                           NDC 13668-250-90 Bottles of 500                         NDC 13668-250-05 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].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET
TORRENT 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 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
(2)
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. C