Valsartan and Hydrochlorothiazide

(val sar′ tan) (hye″ droe klor″ oh thye′ a zide)

Brand Name(s): Diovan HCT®

IMPORTANT WARNING:

Tell your doctor if you are pregnant or plan to become pregnant. Do not take valsartan and hydrochlorothiazide if you are pregnant. If you become pregnant while you are taking valsartan and hydrochlorothiazide, stop taking valsartan and hydrochlorothiazide and call your doctor immediately. Valsartan and hydrochlorothiazide may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

WHY is this medicine prescribed?

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

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

The combination of valsartan and hydrochlorothiazide comes as a tablet to take by mouth. Take once a day with or without food. Take valsartan and hydrochlorothiazide at around the same time every day.

Take valsartan and hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of valsartan and hydrochlorothiazide and gradually increase your dose.

Valsartan and hydrochlorothiazide controls high blood pressure but does not cure it. Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of valsartan and hydrochlorothiazide. Continue to take valsartan and hydrochlorothiazide even if you feel well. Do not stop taking valsartan and hydrochlorothiazide without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking valsartan and hydrochlorothiazide,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

  • some medications should not be taken with valsartan and hydrochlorothiazide. Other medications may cause dosing changes or extra monitoring when taken with valsartan and hydrochlorothiazide. Make sure you have discussed any medications you are currently taking or plan to take before starting valsartan and hydrochlorothiazide with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking valsartan and hydrochlorothiazide, please get the advice of your doctor or pharmacist.

  • the following nonprescription or herbal products may interact with valsartan and hydrochlorothiazide: ibuprofen (Advil®, Motrin®), Naproxen (Aleve®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking valsartan and hydrochlorothiazide. Do not start any of these medications while taking valsartan and hydrochlorothiazide without discussing with your healthcare provider.

  • tell your doctor if you have kidney disease or decreased urination. Your doctor may tell you not to take valsartan and hydrochlorothiazide.

  • tell your doctor if you have or have ever had diabetes, asthma, gout, systemic lupus erythematosus (SLE, a chronic inflammatory condition), high cholesterol, gallstones, angioedema (a condition that causes hives, difficulty breathing, and painful swelling of the face, lips, throat, or tongue), low levels of potassium or magnesium in your blood, high levels of calcium in your blood, or heart or liver disease.

  • tell your doctor if you are breast-feeding. Do not breastfeed while you are taking valsartan and hydrochlorothiazide.

  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking valsartan and hydrochlorothiazide.

  • ask your doctor about the safe use of alcoholic beverages while you are taking valsartan and hydrochlorothiazide. Alcohol can make the side effects from valsartan and hydrochlorothiazide worse.

  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Valsartan and hydrochlorothiazide may make your skin sensitive to sunlight and increase your risk of skin cancer. Your doctor will check your skin for skin cancers during your treatment with valsartan and hydrochlorothiazide. Tell your doctor if you notice any new skin changes or growths.

  • you should know that valsartan and hydrochlorothiazide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking valsartan and hydrochlorothiazide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

  • you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor before using salt substitutes containing potassium. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Valsartan and hydrochlorothiazide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • runny nose or sore throat
  • hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

  • dry mouth; thirst; nausea; vomiting; weakness; tiredness; drowsiness; restlessness; confusion; muscle weakness, pain, or cramps; fast heartbeat; lack of energy; decreased urination; or seizures
  • changes in vision, eye pain, or swelling or redness in or around the eye
  • swelling of the face, throat, tongue, lips, or eyes; hives; rash; itching; blisters; or difficulty breathing or swallowing
  • unusual weight gain or swelling of the hands, feet, ankles, or lower legs
  • nausea, vomiting, constipation, stomach pain, increased urination, or muscle weakness or twitching

Valsartan and hydrochlorothiazide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

  • dizziness
  • fainting
  • fast or slow heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to valsartan and hydrochlorothiazide. Your doctor may order certain lab tests to check your body's response to valsartan and hydrochlorothiazide.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking valsartan and hydrochlorothiazide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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