amlodipine, hydrochlorothiazide, and valsartan

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Pronunciation: am LOE di peen, HYE droe klor oh THYE a zide, val SAR tan

Brand: Exforge HCT

What is the most important information I should know about this medicine?

You should not take this medicine if you are allergic to sulfa drugs, or if you are unable to urinate.

Do not use 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 amlodipine, hydrochlorothiazide, and valsartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

What is amlodipine, hydrochlorothiazide, and valsartan?

Amlodipine is a calcium channel blocker that relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

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

Amlodipine, hydrochlorothiazide, and valsartan is a combination medicine used to treat high blood pressure (hypertension).

This medicine is usually given after other blood pressure medicines have been tried without successful treatment of symptoms.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to amlodipine, hydrochlorothiazide, or valsartan, or:

  • if you have ever had a severe allergic reaction to another blood pressure medicine;
  • if you are allergic to any sulfa drug; or
  • if you are unable to urinate.

If you have diabetes, do not use amlodipine, hydrochlorothiazide, and valsartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

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

To make sure amlodipine, hydrochlorothiazide, and valsartan is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);
  • liver disease;
  • heart disease;
  • an electrolyte imbalance (such as high levels of calcium, or low levels of potassium or magnesium in your blood);
  • low blood pressure;
  • glaucoma;
  • lupus;
  • a history of gallstones;
  • gout;
  • diabetes; or
  • a penicillin allergy.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Valsartan 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, hydrochlorothiazide, and valsartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take this medicine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Your chest pain may become worse when you first start taking this medicine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Your blood pressure will need to be checked often.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking amlodipine, hydrochlorothiazide, and valsartan. Drink plenty of water each day while you are taking this medication.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using this medicine.

It may take up to 2 weeks before your blood pressure improves. 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.

Store at room temperature away from moisture and heat.

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 this medicine?

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

Drinking alcohol can further lower your blood pressure and may increase certain side effects of this medicine.

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.

What are the possible side effects of this medicine?

Get emergency medical help if you have signs of an allergic reaction: 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;
  • an unusual skin rash;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • high potassium --nausea, slow or unusual heart rate, weakness, loss of movement;
  • low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling; or
  • kidney problems --little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

  • dizziness;
  • headache, tired feeling;
  • nausea, upset stomach;
  • back pain, muscle spasms; or
  • swelling in your hands, ankles, or feet.

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 amlodipine, hydrochlorothiazide, and valsartan?

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

  • any other blood pressure medicines;
  • cyclosporine;
  • lithium;
  • ritonavir;
  • a diuretic or "water pill";
  • insulin or oral diabetes medicine;
  • a muscle relaxer;
  • steroid medicine;
  • vitamin or mineral supplements that contain potassium;
  • an antibiotic --clarithromycin, telithromycin;
  • antifungal medicine --itraconazole, ketoconazole;
  • a barbiturate --butabarbital, phenobarbital, secobarbital;
  • cancer medicine --cyclophosphamide, methotrexate;
  • cholesterol-lowering medicines --simvastatin, Zocor, and others;
  • heart medication --digoxin (digitalis), and others;
  • narcotic pain medicine --OxyContin, Vicodin, and others;
  • NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others; or
  • tuberculosis medication --rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with amlodipine, hydrochlorothiazide, and valsartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about amlodipine, hydrochlorothiazide, and valsartan.

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

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