Diovan

Diovan is a prescription medication used to treat high blood pressure in adults and children, to treat heart failure in adults, and to improve the chance of living after a heart attack in adults. Diovan belongs to a group of drugs called angiotensin II receptor antagonists, which help blood vessels to relax.

This medication comes in tablet form and is usually taken once or twice a day. Diovan can be taken with or without food.

Common side effects of Diovan include headache, diarrhea, cough, and dizziness. Do not drive or operate machinery until you know how Diovan will affect you.

Diovan is a prescription medicine used in adults to:

• lower high blood pressure (hypertension) in adults and children, 6 to 16 years of age
• treat heart failure in adults
• improve the chance of living longer after a heart attack in adults

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Diovan may cause the following serious side effects:

Injury or death to an unborn baby. See “Drug Precautions”.

Low Blood Pressure (Hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down, if you feel faint or dizzy. Call your doctor right away.

Kidney problems. Kidney problems may get worse if you already have kidney disease. Some patients will have changes on blood tests for kidney function and may need a lower dose of Diovan. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing Diovan.

The most common side effects of Diovan used to treat people with high blood pressure include:

• headache
• dizziness
• flu symptoms
• tiredness
• stomach (abdominal) pain

Side effects were generally mild and brief. They generally have not caused patients to stop taking Diovan.

The most common side effects of Diovan used to treat people with heart failure include:

• dizziness
• low blood pressure
• diarrhea
• joint and back pain
• tiredness
• high blood potassium

Common side effects of Diovan used to treat people after a heart attack which caused them to stop taking the drug include:

• low blood pressure
• cough
• high blood creatinine (decreased kidney function)
• rash

Tell your doctor if you get any side effect that bothers you or that does not go away.

These are not all the possible side effects of Diovan. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• other medicines for high blood pressure or a heart problem
• water pills (also called “diuretics”)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically
• Nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Diovan.

Know the medicines you take. Keep a list of your medicines with you to show to your doctor and pharmacist when a new medicine is prescribed. Talk to your doctor or pharmacist before you start taking any new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

Do not take Diovan if you have diabetes and are currently taking aliskiren.  This combination is associated serious side effects.

Diovan can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Diovan, tell your doctor right away.

Diovan can cause dizziness. Do not drive or operate machinery until you know how Diovan will affect you.

Tell your doctor about all your medical conditions including whether you:

• have any allergies
• have a heart condition
• have diabetes
• have liver problems
• have kidney problems
• are pregnant or planning to become pregnant. See “Drug Precautions” and FDA Warning.
• are breastfeeding. It is not known if Diovan passes into your breast milk. You and your doctor should decide if you will take Diovan or breastfeed, but not both. Talk with your doctor about the best way to feed your baby if you take Diovan.
• have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue and/or throat, and may cause difficulty breathing.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become Diovan.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Diovan can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Diovan, tell your doctor right away. See FDA Warning.

Tell your doctor if you are breastfeeding. It is not known if Diovan passes into your breast milk. You and your doctor should decide if you will take Diovan or breastfeed, but not both. Talk with your doctor about the best way to feed your baby if you take Diovan.

• Take Diovan exactly as prescribed by your doctor.
• For treatment of high blood pressure, take Diovan one time each day, at the same time each day.
• If your child cannot swallow tablets, or if tablets are not available in the prescribed strength, your pharmacist will mix Diovan as a liquid suspension for your child. If your child switches between taking the tablet and the suspension, your doctor will adjust the dose as needed. Shake the bottle of suspension well for at least 10 seconds before pouring the dose of medicine to give to your child.
• For adult patients with heart failure or who have had a heart attack, take Diovan two times each day, at the same time each day. Your doctor may start you on a low dose of Diovan and may increase the dose during your treatment.
• Diovan can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much Diovan, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight (children)
• your age

Hypertension

The recommended dose range of Diovan  in adults is 80 mg to 320 mg daily, administered once a day.

The recommended dose range of Diovan in pediatrics 6 to 16 years of age is 1.3 mg/kg once daily to a maximum of 2.7 mg/kg (up to 160 mg) once daily.

Heart Failure

The recommended dose range of Diovan is 40 mg twice daily to a maximum daily dose of 320 mg in divided doses.

Post-Myocardial Infarction

The recommended dose of Diovan is 160 mg twice daily.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Diovan tablets at room temperature between 59º to 86ºF (15ºC - 30ºC).
• Keep Diovan tablets in a closed container in a dry place.
• Store bottles of Diovan suspension at room temperature less than 86ºF (30ºC) for up to 30 days, or refrigerate between 35ºF - 46ºF (2ºC - 8ºC) for up to 75 days.
• Keep Diovan and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

•  When pregnancy is detected, discontinue Diovan as soon as possible. 
•  Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.