Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Solco Healthcare US, LLC
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE- OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET SOLCO HEALTHCARE US, LLC ---------- 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._ • • INDICATIONS AND USAGE • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40/12.5 mg; 40/25 mg (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • 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 Pročitajte cijeli dokument