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Exforge HCT

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Exforge HCT

Exforge HCT®
(amlodipine, valsartan, hydrochlorothiazide)  Film-coated Tablets

WARNING

FETAL TOXICITY

  • When pregnancy is detected, discontinue Exforge HCT as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

DRUG DESCRIPTION

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(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is:

Amlodipine besylate - Structural Formula Illustration

Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.

Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 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]-4yl]methyl]-L-valine; its structural formula is:

Valsartan - Structural Formula Illustration

Its empirical formula is C24H29N5O3 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-7sulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is:

Hydrochlorothiazide - Structural Formula Illustration

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 are the possible side effects of amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain, vision problems;
  • feeling like you might pass out;
  • swelling, rapid weight gain;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • slow, fast, or pounding heartbeats;
  • urinating less than usual, or not...

Read All Potential Side Effects and See Pictures of Exforge HCT »

What are the precautions when taking amlodipine valsartan hydrochlorothiazide tablets (Exforge HCT)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine, valsartan, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: an inability to make urine (anuria), kidney disease (such as renal artery stenosis), liver disease, severe loss of body water and/or minerals (volume depletion, dehydration), bile duct blockage, heart valve disorder (such aortic/mitral stenosis), untreated mineral...

Read All Potential Precautions of Exforge HCT »

Last reviewed on RxList: 6/20/2014
This monograph has been modified to include the generic and brand name in many instances.

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Exforge HCT - User Reviews

Exforge HCT User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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