Diovan is used to treat high blood pressure (hypertension) in adults and children who are at least 1 year old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Valsartan is used to treat high blood pressure (hypertension) in adults and children who are at least 6 year old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Valsartan is also used in adults to treat heart failure and lower your risk of needing to be hospitalized, and to lower your risk of death after a heart attack.

Valsartan may also be used for purposes not listed in this medication guide.

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

If you have diabetes, do not take valsartan 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.

Take the medicine at the same time each day, with or without food.

For a child who cannot swallow a tablet whole, a pharmacist can mix the medicine into a liquid.

Your dose needs may change if you switch to a different form of valsartan. Avoid medication errors by using only the medicine your doctor prescribes.

Shake the oral suspension (liquid) for 10 seconds before you measure a dose. Measure a dose with the supplied measuring device (not a kitchen spoon).

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking valsartan.

It may take 2 to 4 weeks before your blood pressure is under control. If you have high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms.

Your treatment may also include diet, exercise, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

Store the tablets or the oral suspension at room temperature away from moisture and heat.

Keep valsartan oral suspension in the bottle tightly closed when not in use.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 40 mg orally twice a day
Maintenance dose: 80 to 160 mg twice a day. The dose should be increased to the highest dose tolerated by the patient.

Usual Adult Dose for Hypertension:

Initial dose: 80 to 160 mg orally once a day.
Maintenance dose: 80 to 320 mg orally once a day

Usual Adult Dose for Myocardial Infarction:

Initial dose: 20 mg orally twice a day
Maintenance dose: The initial dosage may be titrated upward within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice a day as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.

Comment: Valsartan may be initiated as early as 12 hours after a myocardial infarction, and may be given with other standard postmyocardial infarction treatment, including thrombolytics, aspirin, beta blockers, and statins.

Usual Pediatric Dose for Hypertension:

6 to 16 years:
Initial dose: 1.3 mg/kg once a day (up to 40 mg)
Maintenance dose: up to 2.7 mg/kg (up to 160 mg) once a day titrated according to patient response

Comments:
-If the calculated dosage does not correspond to the available tablet strengths, or if children are unable to swallow tablets, the use of a suspension (which can be prepared from the tablets) is recommended. The valsartan dose may need to be increased if the suspension is replaced by a tablet.
-No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min.

You should not use valsartan if you are allergic to it.

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

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

Tell your doctor if you have ever had:

• a heart condition other than one being treated with valsartan;

• if you are on a low-salt diet;

• liver disease; o

• kidney disease (or if you are on dialysis).

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.

Do not breastfeed.

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.

Overdose symptoms may include irregular heart rate or low blood pressure (feeling like you might pass out).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). The suspension can be stored for 30 days at room temperature or for 75 days in a refrigerator; after these times it must be discarded.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

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

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; difficult breathing; swelling of your face, lips, tongue, or throat.

Valsartan may cause serious side effects. Call your doctor at once if you have:

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

• little or no urination; or

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of valsartan may include:

• high blood potassium;

• headache, dizziness, feeling light-headed;

• cough, flu symptoms, tiredness;

• stomach pain, diarrhea;

• back pain, joint pain; or

• abnormal kidney test.

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.

Tell your doctor about all your other medicines, especially:

• lithium;

• cyclosporine;

• ritonavir;

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

• a diuretic or "water pill" or other heart or blood pressure medication; 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 valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to valsartan.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Diovan® HCT (containing Hydrochlorothiazide, Valsartan)
• Exforge® (containing Amlodipine, Valsartan)
• Exforge® HCT (containing Amlodipine, Hydrochlorothiazide, Valsartan)
• Valturna® (containing Aliskiren, Valsartan)