What is Exforge?

Exforge contains a combination of amlodipine and valsartan. Amlodipine is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

Valsartan is an angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Exforge is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Exforge is usually given after other blood pressure medicines have been tried without success.

Important information

Do not use Exforge if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use Exforge together with any medication that contains aliskiren (such as Amturnide, Tekturna, Valturna, or Tekamlo).

In rare cases, Exforge 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.

Do not use potassium supplements or salt substitutes while you are taking Exforge, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Before taking this medicine

You should not use Exforge if you are allergic to amlodipine (Norvasc) or valsartan (Diovan).

If you have diabetes, do not use this medicine together with any medication that contains aliskiren (such as Amturnide, Tekturna, Valturna, or Tekamlo).

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

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

• heart problems;

• a heart attack;

• kidney disease;

• liver disease; or

• if you are on a low-salt diet.

Do not use Exforge if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. This medicine can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

It is not known whether amlodipine and valsartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine before speaking with your doctor.

Exforge is not approved for use by anyone younger than 18 years old.

How should I take Exforge?

Take Exforge exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take Exforge with or without food.

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

You may have very low blood pressure while taking Exforge. Call your doctor if you have a light-headed feeling or feel like you might pass out. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery, tell the surgeon ahead of time that you are using Exforge.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Blood pressure medication is only part of a complete treatment program that may also include diet, exercise, regular blood pressure checks, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or stop taking any of your medications without your doctor's advice.

Store at room temperature away from moisture and heat.

Exforge dosing information

Usual Adult Dose for Hypertension:

Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day

Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day

Comments:
-May increase dose after 1 to 2 weeks of therapy.
-A patient who experiences dose-limiting adverse reactions from either drug component alone may be switched to Exforge which contains a lower dose of each drug component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Exforge?

Do not use potassium supplements or salt substitutes while you are taking Exforge, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may cause side effects.

Exforge may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Exforge side effects

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

Call your doctor at once if you have:

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

• swelling in your hands or feet, rapid weight gain; or

• signs of an electrolyte imbalance - dry mouth, increased thirst, drowsiness, confusion, feeling restless, vomiting, muscle pain or weakness, lack of energy, fast heartbeats, little or no urine, or a seizure.

Common Exforge side effects include:

• swelling in your hands or feet;

• headache and dizziness; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

What other drugs will affect Exforge?

Many drugs can interact with amlodipine and valsartan. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• all your heart or blood pressure medicines;

• cyclosporine;

• lithium;

• ritonavir;

• a diuretic or "water pill";

• vitamin or mineral supplements that contain potassium;

• simvastatin or other cholesterol medication;

• an antibiotic - clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;

• antifungal medicine - itraconazole, ketoconazole; 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 can interact with amlodipine and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use only for the indication prescribed.