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Exforge HCT
Overview
What is Exforge HCT?
Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide.
Exforge HCT 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-(-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is:
Its empirical formula is CHClNO•CHOS and its molecular weight is 567.1.
Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT 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′-(1-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:
Its empirical formula is CHNO 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 -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-2-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is CHClNOS, its molecular weight is 297.73, and its structural formula is:
Exforge HCT 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 anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide.
What does Exforge HCT look like?
What are the available doses of Exforge HCT?
Tablets: (amlodipine/valsartan/hydrochlorothiazide mg) 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25, 10/320/25 ()
What should I talk to my health care provider before I take Exforge HCT?
Nursing Mothers:
Geriatric Patients:
Hepatic Impairment:
How should I use Exforge HCT?
Exforge HCT (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 Exforge HCT.
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.
This fixed combination drug is not indicated for the initial therapy of hypertension .
Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg.
What interacts with Exforge HCT?
Sorry No Records found
What are the warnings of Exforge HCT?
Sorry No Records found
What are the precautions of Exforge HCT?
Sorry No Records found
What are the side effects of Exforge HCT?
Sorry No records found
What should I look out for while using Exforge HCT?
Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product.
Do not coadminister aliskiren with Exforge HCT in patients with diabetes .
What might happen if I take too much Exforge HCT?
Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Amlodipine
Single oral doses of amlodipine maleate equivalent to 40 mg/kg and 100 mg/kg amlodipine in mice and rats, respectively, caused deaths. Single oral doses equivalent to 4 or more mg/kg amlodipine in dogs (11 or more times the maximum recommended human dose on a mg/m basis) caused a marked peripheral vasodilation and hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension. In humans, experience with intentional overdosage of amlodipine is limited. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, initiate cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Valsartan
Depressed level of consciousness, circulatory collapse, and shock have been reported.
Valsartan is not removed from the plasma by hemodialysis.
Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose (MRHD) on a mg/m basis). (Calculations assume an oral dose of 320 mg/day and a 60 kg patient.)
Hydrochlorothiazide
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
The oral LDof hydrochlorothiazide is greater than 10 g/kg in both mice and rats, 2000 and 4000 times, respectively, the MRHD on a mg/mbasis. (Calculations assume an oral dose of 25 mg/day and a 60-kg patient.)
Valsartan and Hydrochlorothiazide
In rats and marmosets, single oral doses of valsartan up to 1524 and 762 mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238 mg/kg, respectively, were very well tolerated without any treatment-related effects. These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the MRHD of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on a mg/mbasis. (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60 kg patient.)
How should I store and handle Exforge HCT?
Vials should be stored refrigerated at 2 to 8°C (36 to 46°F). Vials may be transferred to room temperature storage* for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first).* Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Vials should be stored refrigerated at 2 to 8°C (36 to 46°F). Vials may be transferred to room temperature storage* for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first).* Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).Exforge HCT (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, and 10/320/25 mg. All strengths are packaged in bottles and blisters of 30 tablets.5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0559-15 Unit Dose (blister pack of 30) NDC 0078-0559-3010 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0561-15 Unit Dose (blister pack of 30) NDC 0078-0561-305 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0560-15 Unit Dose (blister pack of 30) NDC 0078-0560-3010 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0562-15 Unit Dose (blister pack of 30) NDC 0078-0562-3010 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets Bottles of 30 NDC 0078-0563-15 Unit Dose (blister pack of 30) NDC 0078-0563-30Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.]Protect from moisture.Dispense in tight container (USP).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The active ingredients of Exforge HCT target 3 separate mechanisms involved in blood pressure regulation. Specifically, amlodipine blocks the contractile effects of calcium on cardiac and vascular smooth muscle cells; valsartan blocks the vasoconstriction and sodium retaining effects of angiotensin II on cardiac, vascular smooth muscle, adrenal and renal cells; and hydrochlorothiazide directly promotes the excretion of sodium and chloride in the kidney leading to reductions in intravascular volume. A more detailed description of the mechanism of action of each individual component follows.
Amlodipine
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Valsartan
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.
There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20000-fold) for the AT receptor than for the AT receptor. The increased plasma levels of angiotensin following AT receptor blockade with valsartan may stimulate the unblocked AT receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT receptor about one-200 that of valsartan itself.
Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
Hydrochlorothiazide
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
The mechanism of the antihypertensive effect of thiazides is unknown.
Non-Clinical Toxicology
Do not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product.Do not coadminister aliskiren with Exforge HCT in patients with diabetes .
Drugs With Ototoxic Potential (see )
Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.
Drugs With Nephrotoxic Potential
There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential. Therefore, the simultaneous administration of these drugs should be avoided.
Lithium
Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.
Probenecid
Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide. This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide. Thus, probenecid should not be administered concurrently with bumetanide.
Indomethacin
Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity. Concurrent therapy with bumetanide is thus not recommended.
Antihypertensives
Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.
Digoxin
Interaction studies in humans have shown no effect on digoxin blood levels.
Anticoagulants
Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Exforge HCT as soon as possible
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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