Diovan

Diovan is used in adults and in children 1 year of age and older alone or in combination with other medications to treat high blood pressure.

Diovan is also used in adults to treat heart failure (a condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack.

Diovan belomgs to a class of medications called angiotensin II receptor antagonists. Valsartan works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

Take Diovan exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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.

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 Diovan.

It may take 2 to 4 weeks before your blood pressure is under control. If you have high blood pressure, keep using Diovan 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 at room temperature away from moisture and heat.

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

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

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

In rare cases, Diovan 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, and dark colored urine.

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

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

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

To make sure Diovan is safe for you, tell your doctor if you have ever had:

• a heart condition other than one being treated with Diovan;
• 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.

Get emergency medical help if you have signs of an allergic reaction to Diovan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diovan 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 Diovan side effects 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.

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.

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).

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.

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 interact with valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: valsartan. Inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.

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