VALSARTAN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Diovan

Category

• Antihypertensive

Description

Valsartan (val-SAR-tan) belongs to the class of medicines called angiotensinII inhibitors. It is used to treat high blood pressure (hypertension). Itis also used to treat heart failure and it can lower the need for hospitalizationthat happens from heart failure. Valsartan can also treat left ventriculardysfunction after a heart attack. Left ventricular dysfunction occurs whenthe left ventricle (the main pumping chamber of the heart) stiffens and enlargesand can cause the lungs to fill with blood.

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 the action of a substance in the body thatcauses blood vessels to tighten. As a result, valsartan relaxes blood vessels.This lowers blood pressure.

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 beweighed against the good it will do. This is a decision you and your doctorwill make. For valsartan, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to valsartan. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Use of valsartan during pregnancy, especially duringthe second and third trimesters (after the first 3 months) can cause low bloodpressure, severe kidney failure, or even death in the newborn. Therefore, it is important that you check with your doctor immediately ifyou think that you may have become pregnant. Be sure that you havediscussed this with your doctor before taking this medicine.

Breast-feeding?It is not known whether valsartan passes into breastmilk. However, valsartan passes into the milk of lactating rats. Because thismedicine may cause serious side effects, breast-feeding is generally not recommendedwhile you are taking it.

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

Older adults?This medicine has been tested in patients 65 yearsof age or older and has not been shown to cause different side effects orproblems in older people than it does in younger adults. However, blood levelsof valsartan and the time it takes for it to be eliminated from the body areincreased in the elderly. Additionally, elderly patients may be more sensitiveto its effects.

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. When you are takingvalsartan, it is especially important that your health care professional knowif you are taking any of the following:

• ACE inhibitors (high blood pressure medicine) (enalapril [e.g., Vasotec],lisinopril [e.g., Zestril], ramipril [e.g., Altace]) or
• Beta blockers (high blood pressure medicine) (metoprolol [e.g., Lopressor],nadolol [e.g., Corgard], sotalol [e.g., Betapace])?Taking valsartanwith both of these medicines can make your heart failure worse
• Diuretics (water pills)?Effects on blood pressure may be increased
• Potassium-sparing medicines, potassium supplements, or potassium-containingsalt substitutes?May increase blood potassium levels

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

• Dehydration?Blood pressure-lowering effects of valsartan maybe increased.

• Heart failure or problems?May cause a decrease in blood pressure

• Kidney disease?Effects of valsartan may make this conditionworse.

• Liver disease?Effects of valsartan may be increased becauseof slower removal of medicine from the body.

Proper Use of This Medicine

Take this medicine only as directed by your doctor. Do not take moreof it and do not take it more often than your doctor ordered. This medicinealso works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is bestto take the doses at the same time each day.

Valsartan may be taken with or without food.

Dosing?The dose of valsartan will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of valsartan. 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.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults?80 milligrams (mg) or 160 mg once a day. Your doctormay increase your dose as needed.
    • Children?Use and dose must be determined by your doctor.
  • For heart failure:
    • Adults?40 mg twice a day. Your doctor may increase your doseas needed.
    • Children?Use and dose must be determined by your doctor.
  • For left ventricular dysfunction after a heart attack:
    • Adults?20 mg twice a day as early as 12 hours after a heartattack. Your doctor may increase your dose as 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.
• 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 may cause birth defects or other problemsin the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor.This especially includes over-the-counter (nonprescription) medicines forappetite control, asthma, colds, cough, hay fever, or sinus problems, sincethey may tend to increase your blood pressure.

Dizziness or lightheadedness may occur, especially if you have been takinga diuretic (water pill). Make sure you know how you react to this medicinebefore you drive, use machines, or do anything else that could be dangerousif 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.

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:

Less common

Bloody urine; cold sweats; confusion; decreased frequency/amountof urine; difficult breathing; dizziness, faintness, or lightheadedness when getting up from lying position; fainting; increased bloodpressure; increased thirst; irregular heartbeat; loss of appetite; lower back/side pain; nausea; nervousness; numbness or tingling inhands, feet or lips; shortness of breath; swelling of face, fingers, lower legs; troubled breathing; unusual tiredness or weakness; vomiting; weakness orheaviness of legs; weight gain

Rare

Chills, fever, or sore throat; swellingof face, mouth, hands, or feet; trouble in swallowingor breathing (sudden)

Incidence not known

Dark urine; general tiredness and weakness; light-colored stools; upper right abdominal pain; yellow eyes and skin

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

Dizziness, lightheadedness, or fainting; hoarseness

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

Less common

Abdominal pain; blurred vision; back pain; cold or flu-like symptoms; coughing; diarrhea; difficulty in moving; headache; muscle pain or stiffness; pain, swelling,or redness in joints; unusual tiredness

Incidence not known

Hair loss; thinning of hair

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