Diovan HCT

DRUG DESCRIPTION

Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.

Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2 '-(1H-tetrazol-5-yl)[1,1 '-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is

Valsartan Structural Formula Illustration

Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.

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

Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

What are the possible side effects of hydrochlorothiazide and valsartan (Diovan 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.

In rare cases, hydrochlorothiazide and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Stop using this medication and call your...

Read All Potential Side Effects and See Pictures of Diovan HCT

What are the precautions when taking valsartan and hydrochlorothiazide (Diovan HCT)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to valsartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged...

Read All Potential Precautions of Diovan HCT


Diovan HCT Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness 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.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 medication, tell your doctor or pharmacist if you are allergic to valsartan or hydrochlorothiazide; 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: gout, kidney disease, liver disease, lupus.

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.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, 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 valsartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Diovan HCT Patient Information Including Side Effects

Brand Names: Diovan HCT

Generic Name: hydrochlorothiazide and valsartan (Pronunciation: HYE droe klor oh THYE a zide and val SAR tan)

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

What is hydrochlorothiazide and valsartan (Diovan HCT)?

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 improves blood flow.

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

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

What are the possible side effects of hydrochlorothiazide and valsartan (Diovan 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.

In rare cases, hydrochlorothiazide and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • feeling light-headed, fainting;
  • swelling, rapid weight gain;
  • fast or pounding heartbeats;
  • urinating less than usual, or not at all;
  • 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:

  • stomach pain, diarrhea;
  • back pain;
  • headache, tired feeling, dizziness;
  • skin rash;
  • stuffy nose, sore throat; or
  • dry cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Do not use this medication if you are allergic to hydrochlorothiazide or valsartan, or if you are unable to urinate.

Do not use this medication without telling your doctor if you are pregnant. 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.

Before using hydrochlorothiazide and valsartan, tell your doctor if you have congestive heart failure, kidney or liver disease, asthma, low or high blood levels of potassium, gout, lupus, diabetes, or an allergy to sulfa drugs.

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

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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

In rare cases, hydrochlorothiazide and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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