Amlodipine & Valsartan

Amlodipine/valsartan is a prescription medicine used to treat high blood pressure. It is a single tablet containing 2 prescription medications, amlodipine and valsartan. Amlodipine belongs to a group of drugs called calcium channel blockers. It works by relaxing muscle of the heart and blood vessels. Valsartan belongs to a group of medications called angiotensin receptor blockers (ARBs). It helps blood vessels to relax.

This medication comes in tablet form. It is taken by mouth, once a day, with or without food.

Common side effects of amlodipine/valsartan include swelling, nasal congestion, and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Amlodipine/valsartan is a prescription medicine used to treat high blood pressure.

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

Take amlodipine/valsartan exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The amlodipine/valsartan dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The maximum recommended daily amlodipine/valsartan dose is 10/320 mg.

WARNING: FETAL TOXICITY                                                    

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

• Amlodipine/valsartan can cause harm or death to an unborn baby. See "FDA Warning" section.
• Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
• If you get pregnant while taking amlodipine/valsartan, tell your doctor right away.

Amlodipine/valsartan may cause serious side effects including:

• harm to an unborn baby causing injury and even death
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
  • take water pills
  • are on a low salt diet
  • get dialysis treatments
  • have heart problems
  • get sick with vomiting or diarrhea
  • drink alcohol

Lie down if you feel faint or dizzy. Call your doctor right away.

• more heart attacks and chest pain (angina) in people that already have severe heart problems. This may happen when you start amlodipine/valsartan or when there is an increase in your dose of amlodipine/valsartan. Get emergency help if you get worse chest pain or chest pain that does not go away.
• kidney problems. Kidney problems may become worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and may need a lower dose of amlodipine/valsartan. Call your doctor if you have 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 amlodipine/valsartan.
• laboratory blood test changes in people with congestive heart failure. Some people with congestive heart failure who take valsartan, one of the medicines in amlodipine/valsartan, have changes in blood tests including increased potassium and decreased kidney function.

The most common side effects of amlodipine/valsartan include:

• swelling (edema) of the hands, ankles, or feet
• nasal congestion, sore throat and discomfort when swallowing
• upper respiratory tract infection (head or chest cold)
• dizziness

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

These are not all the possible side effects of amlodipine/valsartan. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and amlodipine/valsartan could affect each other, causing serious side effects.

Especially tell your doctor if you take:

• simvastatin or other cholesterol lowering medicine
• other medicines for high blood pressure or a heart problem
• water pills (diuretics)
• potassium supplements
• a salt substitute
• nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
• medicines used to prevent and treat fungal skin infections (such as Ketoconazole, itraconazole)
• medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
• 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 valsartan.
• lithium, a medicine used in some types of depression

Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine. 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.

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

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. See the Amlodipine/valsartan FDA Warning section for details regarding this medication and pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Amlodipine/valsartan may be excreted in human milk and may harm your nursing baby.

Avoid salt substitutes containing potassium while taking amlodipine/valsartan.

A common side effect of amlodipine/valsartan is swelling (edema) of the hands, ankles, or feet.

Amlodipine/valsartan can cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Lie down if you feel faint or dizzy. Call your doctor right away.