Amlodipine is a calcium channel blocker. Hydrochlorothiazide is a thiazide diuretic (water pill). Valsartan is an angiotensin II receptor blocker (sometimes called an ARB).

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

amlodipine, hydrochlorothiazide, and valsartan is usually given after other blood pressure medication did not work.

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

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. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not use amlodipine, hydrochlorothiazide, and valsartan together with any medication that contains aliskiren (a blood pressure medicine).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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.

You can easily become dehydrated while taking this medicine Drink plenty of water each day.

Your blood pressure will need to be checked often.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you are sick with vomiting or diarrhea.

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.

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet orally once a day (The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose)

Maximum dose: Amlodipine/hydrochlorothiazide/valsartan 10 mg/25 mg/320 mg orally once a day

Comment:
-Indicated for patients whose blood pressure is adequately controlled on amlodipine, valsartan, and hydrochlorothiazide (as single component formulations or a dual component formulation with a single component formulation). Individual dose titration with each component is recommended before administering the fixed dose combination.

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

• 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 (a blood pressure medicine).

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

Tell your doctor if you have ever had:

• heart problems;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• high blood levels of calcium;

• kidney disease (or if you are on dialysis);

• liver disease;

• glaucoma;

• gout, or increased uric acid in your blood;

• lupus;

• gallstones; or

• a penicillin allergy.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

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

Drinking alcohol with this medicine can cause side effects.

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

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

Amlodipine, hydrochlorothiazide, and valsartan may cause serious side effects. 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 or low potassium levels--leg cramps, nausea, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• low magnesium level--dizziness, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or

• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects of amlodipine, hydrochlorothiazide, and valsartan may include:

• dizziness;

• headache, tiredness;

• nausea, upset stomach;

• stuffy nose, sinus pain, sore throat;

• 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect amlodipine, hydrochlorothiazide, and valsartan, especially:

• another a diuretic or "water pill";

• any other blood pressure medicines;

• insulin or oral diabetes medicine;

• steroid medicine;

• vitamin or mineral supplements that contain potassium;

• a sedative or opioid medicine;

• cholesterol-lowering medicine;

• an antibiotic, antifungal, or antiviral medicine; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and others.

This list is not complete and many other drugs may affect amlodipine, hydrochlorothiazide, and valsartan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.