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Drug Catalog - Product Detail

OLMESARTAN MEDOXOMIL/AMLODIPINE AND HCTZ 40/5/25MG TB 30CT

NDC Mfr Size Str Form
13668-0385-30 TORRENT PHARMACEUTICALS 30 40-5-25MG TABLET
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Generic Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/25 MG
Substance Name
AMLODIPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203580
Description
11 DESCRIPTION Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets provided as a tablet for oral administration, are a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1- methylethyl)-2-propyl-1-[ p-(o- 1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 . The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 CIN 3 O 4 S 2 . The structural formula for olmesartan medoxomil, USP is: The structural formula for amlodipine besylate, USP is: The structural formula for hydrochlorothiazide, USP is: Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, USP a white to light yellowish-white powder or crystalline powder, amlodipine besylate, USP a white to off-white crystalline powder, and hydrochlorothiazide, USP a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, maize starch, pregelatinized maize starch, silicified microcrystalline cellulose, and talc. The color coating contains opadry II pink (20/5/12.5 mg, 40/10/12.5 mg and 40/10/25 mg tablets), and opadry II yellow (40/5/12.5 mg and 40/5/25 mg tablets). The color coating material contains the following ingredients. Strength Ingredients 40/10/12.5 mg and 40/10/25 mg Polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, iron oxide yellow and iron oxide red 20/5/12.5 mg Polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, iron oxide yellow, iron oxide red and iron oxide black 40/5/12.5 mg and 40/5/25 mg Polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc and iron oxide yellow Olme Amlo HCTZ
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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].
Indications & Usage
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 Use Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is not indicated for initial therapy ( 1 ). 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, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 /10 /25 mg once daily ( 2 ). Dose selection should be individualized based on previous therapy ( 2 ). Dose once daily. Dosage may be increased in 2-week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is 40/10/25 mg. Dose selection should be individualized based on previous therapy.