Pronunciation:

val-SAR-tan

Brand Names:

• Diovan

Dosage Forms:

• Tablet
• Capsule

Warnings:

When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, valsartan should be discontinued as soon as possible .

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Valsartan belongs to the class of medicines called angiotensin II inhibitors. It is used to treat high blood pressure (hypertension). It is also used to treat heart failure and it can lower the need for hospitalization that happens from heart failure. Valsartan can also treat left ventricular dysfunction after a heart attack. Left ventricular dysfunction occurs when the left ventricle (the main pumping chamber of the heart) stiffens and enlarges and can cause the lungs to fill with blood .

High blood pressure adds to the workload of the heart and arteries. If it 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, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Valsartan works by blocking the action of a substance in the body that causes 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of valsartan in children below 6 years of age. Safety and efficacy have not been established. Also, this medicine should not be used in children with severe kidney disease .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of valsartan in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults .

Pregnancy—

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lithium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dehydration—Blood pressure-lowering effects of valsartan may be increased.

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

• Kidney disease—Effects of valsartan may make this condition worse.

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

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine also 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 best to take the doses at the same time each day.

Valsartan may be taken with or without food.

For children who cannot swallow the tablets, your pharmacist will mix this medicine as a liquid suspension. Shake the bottle of suspension well for at least 10 seconds before giving it to your child .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—80 milligrams (mg) or 160 mg once a day. Your doctor may increase your dose as needed.
    • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 1.3 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may increase your dose as needed.
    • Children below 6 years of age—Use and dose must be determined by your doctor .
  • For heart failure:
    • Adults—40 mg twice a day. Your doctor may increase your dose as 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 heart attack. 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 as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the bottle of suspension at room temperature for up to 30 days, or in the refrigerator for up to 75 days.

Precautions While Using This Medicine:

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

Check with your doctor immediately if you think that you may be pregnant. Valsartan may cause birth defects or other problems in 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 for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness or lightheadedness may occur, especially if you have been taking a diuretic (water pill). Make sure 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 this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and 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 may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Less common

Bloody urine

cold sweats

confusion

decreased frequency/amount of urine

difficult breathing

dizziness, faintness, or lightheadedness when getting up from a lying position

fainting

increased blood pressure

increased thirst

irregular heartbeat

loss of appetite

lower back/side pain

nausea

nervousness

numbness or tingling in the hands, feet, or lips

shortness of breath

swelling of face, fingers, or lower legs

troubled breathing

unusual tiredness or weakness

vomiting

weakness or heaviness of legs

weight gain

Rare

Chills, fever, or sore throat

dizziness, lightheadedness, or fainting

hoarseness

swelling of face, mouth, hands, or feet

trouble in swallowing or breathing (sudden)

Incidence not known

Dark urine

general tiredness and weakness

light-colored stools

upper right abdominal pain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal pain

back pain

blurred vision

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.