OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponible des:

Solco Healthcare US, LLC

Designació comuna internacional (DCI):

OLMESARTAN MEDOXOMIL

Composición:

OLMESARTAN MEDOXOMIL 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)] . 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 and hydrochlorothiazide 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

Resumen del producto:

Olmesartan medoxomil and hydrochlorothiazide tablets are supplied as follows: Olm/HCTZ Shape Color Debossing Side 1 Side 2 20/12.5 mg Round Pink S551 plain 40/12.5 mg Capsule-shaped Pink S552 plain 40/25 mg Capsule-shaped White S553 plain Tablets are packaged as follows: NDC 43547-xxx-xx 20/12.5 mg 40/12.5 mg 40/25 mg Bottle of 30 tablets 391-03 392-03 393-03 Bottle of 90 tablets 391-09 392-09 393-09 Bottle of 1000 tablets 391-11 392-11 393-11 Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30o C (59-86o F) [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET
SOLCO HEALTHCARE US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OLMESARTAN
MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE
TABLETS.
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg;
40/12.5 mg; 40/25 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2%) are nausea,
hyperuricemia, dizziness, and upper
respiratory infection (6.1)
WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL AND
HYDROCHLOROTHIAZIDE TABLETS 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).
Olmesartan medoxomil and hydrochlorothiazide tablets are a combination
of olmesartan, an
angiotensin II receptor blocker and hydrochlorothiazide, a thiazide
diuretic 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. (1)
Recommended starting dose in patients not adequately controlled with
olmesartan monotherapy,
40/12.5 mg (2)
Recommended starting dose in patients not adequately controlled with
hydrochlorothiazide
monotherapy, 20/12.5 mg (2)
Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25
mg olmesartan /
hydrochlorothiazide (2)
Hypersensitivity to any component of olmesartan medoxomil and
hydrochlorothiazide tablets (4)
Anuria (4)
Do no