Hydrochlorothiazide is a diuretic (water pill). Valsartan is an angiotensin II receptor blocker (sometimes called an ARB blocker).

Hydrochlorothiazide and valsartan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Hydrochlorothiazide and valsartan is given after other blood pressure medicines did not work or have stopped working.

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

You should not use hydrochlorothiazide and valsartan if you are unable to urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use hydrochlorothiazide and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take hydrochlorothiazide and valsartan with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated.

If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and valsartan.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet (12.5 mg-160 mg) orally once a day

Maintenance dose: Titrate as necessary (every 1 to 2 weeks) up to a maximum of 25 mg-320 mg orally once a day

Comment:
-Hydrochlorothiazide-valsartan may be substituted for the titrated components.

You should not use this medicine if you are allergic to valsartan or hydrochlorothiazide, or if you have:

• decreased urination or are unable to urinate; or

• an allergy to sulfa drugs.

If you have diabetes, do not use hydrochlorothiazide and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking hydrochlorothiazide and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• an electrolyte imbalance (such as low levels of potassium or magnesium, or high levels of calcium in your blood);

• liver disease;

• kidney disease;

• gallstones;

• lupus;

• congestive heart failure;

• gout, or high levels of uric acid in your blood;

• asthma or allergies;

• high cholesterol or triglyceride levels;

• an allergy to penicillin;

• glaucoma; or

• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Hydrochlorothiazide and valsartan is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Avoid driving or hazardous activity until you know how hydrochlorothiazide and valsartan will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have 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 unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Hydrochlorothiazide and valsartan may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• eye pain, vision problems;

• an unusual skin rash;

• little or no urinating;

• jaundice (yellowing of the skin or eyes);

• easy bruising, unusual bleeding;

• a seizure;

• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or

• signs of an electrolyte imbalance--dry mouth, increased thirst, confusion, feeling restless, vomiting, muscle pain or weakness, drowsiness, lack of energy, fast heartbeats, decreased urination.

Common side effects include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• dizziness; or

• headache.

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.

If you also take cholestyramine or colestipol, take your hydrochlorothiazide and valsartan dose 4 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your current medicines. Many drugs can affect hydrochlorothiazide and valsartan, especially:

• cyclosporine, digoxin, digitalis, lithium, or ritonavir;

• all your heart or blood pressure medicines;

• insulin or oral diabetes medicine;

• a diuretic or "water pill";

• opioid pain medicine;

• a sleeping pill;

• a muscle relaxer;

• an antibiotic--rifabutin, rifampin, rifamycin, rifapentine;

• cancer medicine--cyclophosphamide, methotrexate; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect hydrochlorothiazide and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.