VALSARTANAND HYDROCHLOROTHIAZIDE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Diovan HCT

Category

• Antihypertensive

Description

Valsartan (val-SAR-tan) and Hydrochlorothiazide (hye-droe-klor-oh-THYE-a-zide)

This combination medicine belongs to the class of medicines called highblood pressure medicines (antihypertensives). It is used to treat high bloodpressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. Ifit continues for a long time, the heart and arteries may not function properly.This can damage the blood vessels of the brain, heart, and kidneys, resultingin a stroke, heart failure, or kidney failure. High blood pressure may alsoincrease the risk of heart attacks. These problems may be less likely to occurif blood pressure is controlled.

Valsartan works by blocking a substance in the body that causes blood vesselsto tighten. As a result, valsartan relaxes blood vessels. This lowers bloodpressure and increases the supply of blood and oxygen to the heart. Hydrochlorothiazidehelps reduce the amount of salt and water in the body by acting on the kidneysto increase the flow of urine; this also helps to lower blood pressure.

This combination may also be used for other conditions as determined byyour doctor.

This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For valsartan and hydrochlorothiazide,the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to valsartan, sulfonamides (sulfa drugs), bumetanide, furosemide,acetazolamide, dichlorphenamide, or methazolamide or to hydrochlorothiazideor any of the other thiazide diuretics (water pills). Also tell your healthcare professional if you are allergic to any other substances, such as foods,sulfites or other preservatives, or dyes.

Pregnancy?Use of valsartan during pregnancy, especially afterthe first three months, can cause low blood pressure, kidney failure, toomuch potassium, or death in newborns. Additionally, when hydrochlorothiazideis used during pregnancy, it may cause jaundice, blood problems, and otherside effects in the newborn baby. Therefore, it is importantthat you check with your doctor immediately if you think that you may be pregnant.

Breast-feeding?It is not known whether valsartan passes into breastmilk. However, it does pass into the milk of lactating rats. Hydrochlorothiazidedoes pass into breast milk. Be sure that you discuss this with your doctorif you decide to breast feed while taking these medicines.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of valsartanand hydrochlorothiazide combination in children with use in other age groups.

Older adults?Elderly patients may be more sensitive than youngeradults to the effects of this medicine.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of valsartan and hydrochlorothiazide. Make sureyou tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus?Hydrochlorothiazide mayraise blood sugar levels

• Fluid or electrolyte (e.g., potassium, chloride, sodium) imbalance(due to excessive perspiration, vomiting, diarrhea, etc.)?The side effectsof valsartan and hydrochlorothiazide may be increased

• Gout?Hydrochlorothiazide may increase the amount of uric acidin the body, which may activate or aggravate this condition

• Heart failure, severe?Lowering of blood pressure by these medicinesmay make this condition worse

• Kidney disease or
• Liver disease?These conditions may be aggravated by valsartanand hydrochlorothiazide

Proper Use of This Medicine

This medicineworks best if there is a constant amount in the blood. To help keep this amountconstant, do not miss any doses and take the medicineat the same time each day.

In addition to the use of the medicine your doctor has prescribed, treatmentfor your high blood pressure may include weight control and care in the typesof foods you eat, especially foods high in sodium. Your doctor will tell youwhich of these is most important for you. You should check with your doctorbefore changing your diet.

Many patients who have high blood pressure will not notice any signs ofthe problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and thatyou keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure butit does help control it. Therefore, you must continue to take it as directedif you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problemssuch as heart failure, blood vessel disease, stroke, or kidney disease.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of this medicine. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking valsartan and hydrochlorothiazide.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults?1 tablet once a day. Your doctor may increase your doseif needed.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It isimportant that your doctor check your progress at regular visits to make surethat this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think thatyou may be pregnant. Valsartan and hydrochlorothiazide may cause birthdefects or other problems in the baby if taken during pregnancy.

Check with your doctor immediately if lightheadednessor fainting occurs while you are taking this medicine. A dosage adjustmentor change in medication may be necessary.

For diabetic patients:

• Hydrochlorothiazide may raise blood sugar levels. Check with yourdoctor if any changes in your blood sugar levels occur.

Do not take other medicines unless they have been discussedwith your doctor. This especially includes potassium supplements orsalt substitutes that contain potassium, since they may alter your blood potassiumlevels, or over-the-counter (nonprescription) medicines for appetite control,asthma, colds, cough, hay fever, or sinus problems, since they may tend toincrease your blood pressure.

Dizziness, lightheadedness, or fainting may occur with this medicine. Makesure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you experience these effects.

Check with your doctor right away if you become sick while taking thismedicine, especially with severe or continuing nausea and vomiting or diarrhea.These conditions may cause you to lose too much water and lead to low bloodpressure.

Dizziness, lightheadedness, or fainting may also occur if you exerciseor if the weather is hot. Heavy sweating can cause loss of too much waterand result in low blood pressure. Use extra care during exercise or hot weather.

Before having any kind of surgery (including dental surgery) or emergencytreatment, tell the medical doctor or dentist in charge that you are takingthis medicine.

Avoid alcoholic beverages until you have discussed their use with yourdoctor. Alcohol may make the low blood pressure effect worse and/or increasethe possibility of dizziness or fainting.

Hydrochlorothiazide may cause your skin to be more sensitive to sunlightthan it is normally. Be sure to wear protective clothing and a hat or applya product to the skin that prevents sunburn before going outside.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

Rare

Itching, pain, redness, or swelling of eye or eyelid, wateringof eyes, troubled breathing or wheezing, severe skin rash or hives, and flushing; chills, fever, and sore throat; bloating or pain of the stomach, fever, nausea, and vomiting; fainting; yellow eyes or skin

Symptoms of fluid and electrolyte imbalance

Confusion; convulsions (seizures); dizziness or lightheadedness; diminishedurine output; drowsiness or sluggishness; dry mouth; fast heartbeat; muscle cramps or pain; muscle fatigue; nausea and vomiting; restlessness; thirst; weakness

Check with your doctor as soon as possible if any of the followingside effects occur:

Less common

Cold or flu-like symptoms; dizziness; fatigue; sore throat,difficulty swallowing, tender or swollen lymph nodes in the neck

Rare

Abdominal pain; rash; sudden occurrence of joint pain, usually in the ankle, knee, or great toe;joint stiffness, or swelling

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

Less common

Cough; diarrhea (mild); headache

Rare

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.