Exforge HCT

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 C20H25ClN2O5C6H6O3S 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

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-7-sulfonamide 1,1-dioxide.

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

Exforge HCT film-coated tablets are formulated in five 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:

  • 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...

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, loss of too much body water (dehydration), bile duct blockage, heart valve disorder (such aortic/mitral stenosis), untreated mineral imbalance (such as high/low potassium,...

Read All Potential Precautions of Exforge HCT


Exforge HCT Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, or headache may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea/vomiting, severe dizziness, confusion, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain, swelling hands/ankles/feet, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, chills, persistent sore throat), unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), muscle pain/tenderness, yellowing eyes/skin, dark urine, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, loss of too much body water (dehydration), bile duct blockage, heart valve disorder (such aortic/mitral stenosis), untreated mineral imbalance (such as high/low potassium, low magnesium, high calcium), lupus, gout, high levels of fats in the blood (cholesterol/triglycerides).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this product may change your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

Before having surgery or a procedure, tell your doctor or dentist that you are taking this medication.

This product may increase or decrease the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if amlodipine or valsartan pass into breast milk. Hydrochlorothiazide passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Exforge HCT Patient Information Including Side Effects

Brand Names: Exforge HCT

Generic Name: amlodipine, hydrochlorothiazide, and valsartan (Pronunciation: am LOE di peen, HYE droe klor oh THYE a zide, val SAR tan)

  • What is amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • What are the possible side effects of amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • What is the most important information I should know about amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • What should I discuss with my healthcare provider before taking amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • How should I take amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • What happens if I miss a dose (Exforge HCT)?
  • What happens if I overdose (Exforge HCT)?
  • What should I avoid while taking amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • What other drugs will affect amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?
  • Where can I get more information?

What is amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Valsartan is in a group of drugs called angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine, hydrochlorothiazide, and valsartan is used to treat high blood pressure (hypertension).

This medication is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for other purposes not listed in this medication guide.

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:

  • 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 at all;
  • easy bruising or bleeding, unusual weakness;
  • numbness, burning, pain, or tingly feeling; or
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).

Less serious side effects may include:

  • dizziness;
  • headache, tired feeling;
  • nausea, upset stomach;
  • muscle spasms, back pain; or
  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amlodipine, hydrochlorothiazide, and valsartan (Exforge HCT)?

Your chest pain may become worse when you first start taking this medication or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

You should not take this medication if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate.

Before taking amlodipine, hydrochlorothiazide, and valsartan, tell your doctor if you have kidney or liver disease, congestive heart failure, asthma or allergies, low or high blood levels of potassium, gout, lupus, or diabetes.

Do not use this medication without telling your doctor if you are pregnant. Amlodipine, hydrochlorothiazide, and valsartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of amlodipine, hydrochlorothiazide, and valsartan.

Do not use potassium supplements or salt substitutes while you are taking amlodipine, hydrochlorothiazide, and valsartan, unless your doctor has told you to.

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