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Drug Catalog - Product Detail

AMLODIPINE BESYLATE/VALSARTAN/HCTZ TB 10/160/12.5MG 90

NDC Mfr Size Str Form
49884-0174-09 PAR PHARMACEUTICAL 90 10-160-12.5MG TABLET
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Description
11 DESCRIPTION Amlodipine/valsartan/hydrochlorothiazide is a fixed combination of amlodipine, valsartan and hydrochlorothiazide. Amlodipine/valsartan/hydrochlorothiazide contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]‑4-( o -chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is: Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its molecular weight is 567.1. Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT 1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is: Its empirical formula is C 24 H 29 N 5 O 3 and its molecular weight is 435.5. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is: Amlodipine/valsartan/hydrochlorothiazide film-coated tablets are formulated in 5 strengths for oral administration with a combination of amlodipine besylate, valsartan and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose, crospovidone, colloidal silicon dioxide, and magnesium stearate. Additionally, the 5/160/12.5 mg strength contains polyethylene glycol, polyvinyl alcohol, lactose monohydrate, triethyl citrate, hypromellose, titanium dioxide and talc; the 10/320/25 mg strength contains the same ingredients as the 5/160/12.5 mg strength with the exception of the talc; the 5/160/25 mg strength contains lactose monohydrate, hypromellose, triacetin, D&C Yellow #10, titanium dioxide, and FD&C Yellow #6; the 10/160/12.5 mg strength contains FD&C Yellow #6, triethyl citrate, yellow iron oxide, hypromellose and titanium dioxide; and the 10/160/25 mg strength contains hypromellose, titanium dioxide, D&C Yellow #10, macrogol and polysorbate. amlodipine-structure Valsartan-structure HCTZ-structure
How Supplied
16 HOW SUPPLIED Amlodipine/valsartan/hydrochlorothiazide is available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg and hydrochlorothiazide 12.5 mg or 25 mg providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg or 10/320/25 mg. All strengths are packaged in bottles of 30, 90 and 500 tablets. 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets - White to off-white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "172" on the other Bottles of 30 NDC 49884-172-11 Bottles of 90 NDC 49884-172-09 Bottles of 500 NDC 49884-172-05 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Peach to light brown, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "174" on the other. Bottles of 30 NDC 49884-174-11 Bottles of 90 NDC 49884-174-09 Bottles of 500 NDC 49884-174-05 5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Yellow, film-coated, oval shaped biconvex tablets debossed with “P” on one side of the tablet and “173” on the other. Bottles of 30 NDC 49884-173-11 Bottles of 90 NDC 49884-173-09 Bottles of 500 NDC 49884-173-05 10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Bright yellow, film-coated oval shaped, biconvex tablets debossed with “P” on one side of the tablet and “185” on the other. Bottles of 30 NDC 49884-185-11 Bottles of 90 NDC 49884-185-09 Bottles of 500 NDC 49884-185-05 10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets – White to off white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "175" on the other Bottles of 30 NDC 49884-175-11 Bottles of 90 NDC 49884-175-09 Bottles of 500 NDC 49884-175-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Indications & Usage
1 INDICATIONS AND USAGE Amlodipine/valsartan/hydrochlorothiazide is 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 amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine/valsartan/hydrochlorothiazide. 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 1 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 (e.g., 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. Limitation of Use Amlodipine/valsartan/hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration ( 2 )]. Amlodipine/valsartan/hydrochlorothiazide is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Amlodipine/Valsartan/Hydrochlorothiazide is 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 ) Limitation of Use Amlodipine/valsartan/hydrochlorothiazide is not indicated for initial treatment of hypertension.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg Amlodipine/valsartan/hydrochlorothiazide may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. Amlodipine/valsartan/hydrochlorothiazide may be substituted for its individually titrated components ( 2 ). 2.1 General Considerations Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of amlodipine/valsartan/hydrochlorothiazide. The maximum recommended dose of amlodipine/valsartan/hydrochlorothiazide is 10/320/25 mg. 2.2 Add-on / Switch Therapy Amlodipine/valsartan/hydrochlorothiazide may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of amlodipine/valsartan/hydrochlorothiazide may be switched to amlodipine/valsartan/hydrochlorothiazide containing a lower dose of that component to achieve similar blood pressure reductions. 2.3 Replacement Therapy Amlodipine/valsartan/hydrochlorothiazide may be substituted for the individually titrated components. 2.4 Use with Other Antihypertensive Drugs Amlodipine/valsartan/hydrochlorothiazide may be administered with other antihypertensive agents.