OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Jubilant Cadista Pharmaceuticals Inc.

INN (Nome Internazionale):

OLMESARTAN MEDOXOMIL

Composizione:

OLMESARTAN MEDOXOMIL 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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, Detectio

Dettagli prodotto:

Olmesartan medoxomil tablets 5 mg are light yellow, circular, film coated tablet, with ‘C8 ’ debossed on one side and ‘C’ on the other side. Bottle of 30’s (Child-Resistant)                                    NDC 59746-463-30 Bottle of 100’s (Child-Resistant)                                  NDC 59746-463-01 Bottle of 1000’s (Ribbed Stock)                                   NDC 59746-463-10 Carton 3x10’s (Child-Resistant)                                   NDC 59746-463-32 Olmesartan medoxomil tablets 20 mg are white, circular, film coated tablet, with ‘D1’ debossed on one side and ‘C’ on the other side. Bottle of 30’s (Child-Resistant)                                                NDC 59746-465-30 Bottle of 90’s (Child-Resistant)                                                NDC 59746-465-90 Bottle of 100’s (Child-Resistant)                                              NDC 59746-465-01 Bottle of 1000’s (Ribbed Stock)                                               NDC 59746-465-10 Carton 3x10’s (Child-Resistant)                                               NDC 59746-465-32 Olmesartan medoxomil tablets 40 mg are white, oval, film coated tablet, with ‘466’ debossed on one side and ‘C’ on the other side. Bottle of 30’s (Child-Resistant)                                                NDC 59746-466-30 Bottle of 90’s (Child-Resistant)                                                NDC 59746-466-90 Bottle of 100’s (Child-Resistant)                                              NDC 59746-466-01 Bottle of 1000’s (Ribbed Stock)                                               NDC 59746-466-10 Carton 3x10’s (Child-Resistant)                                               NDC 59746-466-32 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

OLMESARTAN MEDOXOMIL - OLMESARTAN MEDOXOMIL TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
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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._
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 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 - 40 mg once daily
Pediatric Hypertension (6 - 16 years) (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
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 co-administer 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-depleted pa