Amlodipine & Valsartan & Hydrochlorothiazide

Amlodipine/valsartan/hydrochlorothiazide is a prescription medication used to treat high blood pressure. This tablet is a single tablet containing 3 prescription medications: amlodipine, a calcium channel blocker, valsartan, an angiotensin receptor blocker, and hydrochlorothiazide, a diuretic (water pill). Amlodipine/valsartan/hydrochlorothiazide can help your blood vessels relax, and decrease the amount of blood, so your blood pressure is lower.

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

Amlodipine & Valsartan & Hydrochlorothiazide may be found in some form under the following brand names:

• Exforge HCT

This medication may cause serious side effects including:

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

Lie down if you feel faint or dizzy. If you faint (lose consciousness), stop taking amlodipine/valsartan/hydrochlorothiazide. Call your doctor right away.

• 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/hydrochlorothiazide. 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 this medication.
• 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/hydrochlorothiazide, have changes in blood tests including increased potassium and decreased kidney function.
• allergic reactions 
• skin rash. Call your doctor right away if you get an unusual skin rash.
• eye problems. One of the medicines in amlodipine/valsartan/hydrochlorothiazide can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting this medication. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain

The most common side effects include:

• dizziness 
• swelling (edema) of the hands, ankles, or feet
• headache
• indigestion
• tiredness
• muscle spasms
• back pain
• nausea.

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/hydrochlorothiazide. For more information, ask your doctor or pharmacist.

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 the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and amlodipine/valsartan/hydrochlorothiazide could affect each other, causing serious side effects. Especially tell your doctor if you take:

• other medicines for high blood pressure or a heart problem
• water pills (“diuretics”) 
• potassium supplements or using a salt substitute containing potassium
• diabetes medicine including insulin
• narcotic pain medicines
• sleeping pills and anti-seizure medicines called barbiturates
• lithium, a medicine used to treat some types of depression
• aspirin or other medicines called non-steriodal anti-inflammatory drugs (NSAIDs), like ibuprofen or naproxen
• steroids
• cholesterol lowering medicine
• alcohol
• digoxin or other digitalis glycosides (a heart medicine)
• muscle relaxants (medicines used during operations)
• certain cancer medicines, like cyclophosphamide or methotrexate

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.

• This medication 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 amlodipine/valsartan/hydrochlorothiazide, tell your doctor right away.

Do not take amlodipine/valsartan/hydrochlorothiazide if you have low or no urine output (anuria).

Tell your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. See “Drug Precautions”.
• are breastfeeding or plan to breastfeed. Amlodipine/valsartan/hydrochlorothiazide may pass into your milk. Do not breastfeed while you are taking this medication.
• are allergic to any of the ingredients in this medication.
• have heart problems
• have liver problems 
• have kidney problems
• are vomiting or having a lot of diarrhea 
• have or had gallstones
• have Lupus
• have low levels of potassium (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm) or magnesium in your blood
• have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
• have high levels of uric acid in the blood.

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 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.

• This medication 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 amlodipine/valsartan/hydrochlorothiazide, tell your doctor right away.

Tell your doctor if you are breastfeeding or plan to breastfeed. Amlodipine/valsartan/hydrochlorothiazide may pass into your milk. Do not breastfeed while you are taking this medication.

• Take amlodipine/valsartan/hydrochlorothiazide exactly as your doctor tells you.
• Take amlodipine/valsartan/hydrochlorothiazide one time each day.
• Amlodipine/valsartan/hydrochlorothiazide 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. Just take the next dose at the regular time. 
• If you take too much this medication, call your doctor or Poison Control Center, or go to the emergency room.
• Tell all your doctors and dentist you are taking amlodipine/valsartan/hydrochlorothiazide. This is especially important if you:
  • are going to have surgery
  • go for kidney dialysis

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

The maximum recommended dose of amlodipine/valsartan/hydrochlorothiazide is 10/320/25 mg/day.

If you take too much amlodipine/valsartan/hydrochlorothiazide call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If amlodipine/valsartan/hydrochlorothiazide 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 at room temperature between 59°F to 86°F (15°C to 30°C). 
• Keep this medication product dry (protect it from moisture).
• Keep this medication and all medicines out of the reach of children.

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.