Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), AMLODIPINE (UNII: 1J444QC288) (AMLODIPINE - UNII:1J444QC288), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Torrent Pharmaceuticals Limited
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
ORAL
PRESCRIPTION DRUG
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are 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 (CV) 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, amlodipine 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. For specific advice on goals and management, see published guidelines, su
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP, amlodipine besylate, USP at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide, USP in the strengths described below. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are differentiated by tablet color/size. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are supplied for oral administration in the following strength and package configurations: 20/5/12.5 mg tablets are orange white colored, round, biconvex, film coated debossed with '26' on one side and plain on the other side. Bottles of 30 NDC 13668-397-30 Bottles of 90 NDC 13668-397-90 Bottles of 500 NDC 13668-397-05 40/5/12.5 mg tablets are light yellow to yellow colored, round, biconvex, film coated debossed with '1386' on one side and plain on the other side. Bottles of 30 NDC 13668-386-30 Bottles of 90 NDC 13668-386-90 Bottles of 500 NDC 13668-386-05 40/5/25 mg tablets are light yellow to yellow colored, oval shaped, biconvex, film coated debossed with '1385' on one side and plain on the other side. Bottles of 30 NDC 13668-385-30 Bottles of 90 NDC 13668-385-90 Bottles of 500 NDC 13668-385-05 40/10/12.5 mg tablets are grayish red colored, round, biconvex, film coated, debossed with '1383' on one side and plain on the other side. Bottles of 30 NDC 13668-383-30 Bottles of 90 NDC 13668-383-90 Bottles of 500 NDC 13668-383-05 40/10/25 mg tablets are grayish red colored, oval shaped, biconvex, film coated, debossed with '1382' on one side and plain on the other side. Bottles of 30 NDC 13668-382-30 Bottles of 90 NDC 13668-382-90 Bottles of 500 NDC 13668-382-05 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 20/5/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 20/5/12.5 MG TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/12.5 MG TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/25 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/25 MG TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/12.5 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/12.5 MG TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/25 MG- OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/25 MG TABLET TORRENT PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2010 WARNING: FETAL TOXICITY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. WHEN PREGNANCY IS DETECTED, DISCONTINUE OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 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). INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoximil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel 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). Limitations of Soma hati kamili