OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Teva Pharmaceuticals USA, Inc.

INN (International namn):

OLMESARTAN MEDOXOMIL

Sammansättning:

OLMESARTAN MEDOXOMIL 5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Olmesartan medoxomil tablets are indicated for the treatment of hypertension, 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 Joint National Committee on Prevention, Detection, Eva

Produktsammanfattning:

Olmesartan medoxomil tablets are available as follows: 5 mg – yellow, round standard convex with bevel, film-coated tablets, debossed with “TV” on one side and with “B3” on the other side, containing 5 mg of olmesartan medoxomil. 20 mg – white, round standard convex with bevel, film-coated tablets, debossed with “TV” on one side and with “B4” on the other side, containing 20 mg of olmesartan medoxomil. 40 mg – white, oval-shaped, film-coated tablets, debossed with “TV” on one side and with “7612” on the other side, containing 40 mg of olmesartan medoxomil. Tablets are supplied as follows: 5 mg 20 mg 40 mg Bottles of 30 tablets NDC 0093-7610-56 NDC 0093-7611-56 NDC 0093-7612-56 Bottles of 90 tablets NDC 0093-7611-98 NDC 0093-7612-98 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

OLMESARTAN MEDOXOMIL- OLMESARTAN MEDOXOMIL TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, 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).
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.1).
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 11/2016
INDICATIONS AND USAGE
Olmesartan medoxomil tablets are an angiotensin II receptor blocker
(ARB) indicated for the treatment of
hypertension, 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
INDIC ATIO N
STARTING DOSE
DOSE RANGE
Adult Hypertension (2.1)
20 mg once daily
20 to 40 mg once daily
Pediatric Hypertension (6 to 16 years)
(2.2)
20 to < 35 kg
10 mg once daily
20 to < 35 kg
10 to 20 mg once daily
≥ 35 kg
20 mg once daily
≥ 35 kg
20 to 40 mg once daily
Olmesartan medoxomil tablets may be administered with or without food.
If blood pressure is not controlled by olmesartan medoxomil tablets
alone, a diuretic may be added. Olmesartan
medoxomil tablets may be administered with other antihypertensive
agents.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 20 mg, and 40 mg (3).
CONTRAINDICATIONS
Do not coadminister aliskiren with olmesartan medoxomil in patients
with diabetes (4).
WARNINGS AND PRECAUTIONS
Avoid fetal (_in utero_) exposure (5.1).
Children < 1 year of age must not receive olmesartan medoxomil for
hypertension (5.2).
Observe for signs and symptoms of hypotension in volume- or
salt-deplete