Diovan HCT

Diovan HCT is a prescription medication used to treat high blood pressure. It is a single product containing 2 medications: valsartan and hydrochlorothiazide. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. Hydrochlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.  

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of Diovan HCT include nausea, a condition of excess uric acid in the blood (hyperuricemia), and upper respiratory tract infection. Diovan HCT can also cause dizziness. Do not drive or operate heavy machinery until you know how Diovan HCT affects you.

Diovan HCT is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Diovan HCT. See the "Diovan HCT Precautions" section.

Common side effects of Diovan HCT include the following:

• nausea
• a condition of excess uric acid in the blood (hyperuricemia)
• dizziness
• an infection that affects the nose, throat, and airways (upper respiratory tract infection)

This is not a complete list of Diovan HCT side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for high blood pressure or a heart problem
• water pills (diuretics)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically. 
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically. 
• antidiabetic medicines including insulin
• narcotic pain medicines
• sleeping pills
• lithium, a medicine used in some types of depression (Eskalith, Lithobid, Lithium Carbonate, Lithium Citrate)
• aspirin or other medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), like ibuprofen or naproxen 
• digoxin or other digitalis glycosides (a heart medicine)
• muscle relaxants (medicines used during operations)
• certain cancer medicines, like cyclophosphamide or methotrexate 
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

This is not a complete list of Diovan HCT drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Diovan HCT including the following:

• harm to an unborn baby causing injury and even death.
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
  • take water pills
  • are on a low salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea
  • drink alcohol
• allergic reactions. People with and without allergy problems or asthma who take Diovan HCT may get allergic reactions.
• worsening of lupus. Hydrochlorothiazide, one of the medicines in Diovan HCT, may cause lupus to become active or worse.
• fluid and electrolyte (salt) problems. Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems:
  • dry mouth
  • thirst
  • lack of energy (lethargy)
  • weakness
  • drowsiness
  • restlessness
  • confusion
  • seizures
  • muscle pain or cramps
  • muscle fatigue
  • very low urine output
  • fast heartbeat
  • nausea and vomiting
• kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes on blood tests for kidney function and may need a lower dose of Diovan HCT. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Diovan HCT.
• skin rash. Call your doctor right away if you have an unusual skin rash.
• eye problems. One of the medicines in Diovan HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Diovan HCT. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain

Do not take Diovan HCT if you:

• are allergic to Diovan HCT or to any of its ingredients, or medicines that contain sulfonamides
• make less urine due to kidney problems
• are a diabetic patient taking aliskiren

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods.  In the case of Diovan HCT, salt substitutes containing potassium should be avoided.

Before taking Diovan HCT, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are pregnant or plan to become pregnant
• are breastfeeding
• have liver problems
• have kidney problems
• have or had gallstones
• have lupus
• have high levels of uric acid in the blood
• have ever had a reaction called angioedema to another blood presure medication. Angioedema causes swelling of the face, lips, tongue, throat, and may cause difficulty breathing

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Diovan HCT falls into category D. It has been shown that use of Diovan HCT in pregnant women caused some babies to be born with problems. However, in some situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether valsartan is excreted in human milk. Hydrochlorothiazide is excreted in human breast milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Diovan HCT, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Take Diovan HCT exactly as prescribed.

Diovan HCT comes in tablet form and is taken once daily, with or without food. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time.  Do not take two doses of Diovan HCT at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.  The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight 
• your height
• your age
• your gender

The usual starting dose is Diovan HCT 160/12.5mg. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25mg tablet once daily to control blood pressure.

If you take too much Diovan HCT, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. If Diovan HCT is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Diovan HCT at room temperature in a closed container in a dry place.

Keep this and all medicines out of the reach of children.

WARNING: AVOID USE IN PREGNANCY

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