Exforge HCT

Exforge HCT

What is Exforge HCT?

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

Valsartan is an angiotensin II receptor antagonist (sometimes called ARB) that prevents blood vessels from constricting, thereby lowering blood pressure and improving blood flow.

Exforge HCT is used to treat high blood pressure (hypertension).

Exforge HCT is usually given after other blood pressure medications have been tried without success in treating symptoms.

Warnings

You should not take Exforge HCT if you are allergic to sulfonamides or are unable to urinate.

Do not use if pregnant. Stop using the medicine and tell your doctor immediately if you become pregnant.

If you have diabetes, do not use Exforge HCT with medicines that contain aliskiren (a blood pressure medicine).

Before you take this medicine

You should not use Exforge HCT if you are allergic to amlodipine, hydrochlorothiazide or valsartan or:

• if you are allergic to a sulfa drug; or

• if you are unable to urinate.

If you have diabetes, do not use Exforge HCT with medicines that contain aliskiren (a blood pressure medicine).

You may also need to avoid taking Exforge HCT with aliskirenif you suffer from kidney disease.

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

• heart problems;

• an electrolyte imbalance (e.g. low levels of potassium or magnesium in your blood);

• high levels of calcium in the blood;

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

• liver disease;

• Glaucoma;

• gout or increased levels of uric acid in the blood;

• lupus;

• gallstones; or

• a penicillin allergy.

Do not use if pregnant. Stop using the medicine and tell your doctor immediately if you become pregnant.Taking valsartan in the second or third trimester may cause injury or death to your unborn baby.

You should not breast-feed while using Exforge HCT.

How should I take this medicine?

Take Exforge HCT exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

You can take Exforge HCT with or without food.

Your chest pain may get worse when you first take Exforge HCT or when your dose is increased. Call your doctor if your chest pain is severe or persistent.

It is easy to become dehydrated while taking Exforge HCT. Drink plenty of water every day.

Your blood pressure needs to be checked frequently.

Some things can cause your blood pressure to drop too low. These include vomiting, diarrhea or heavy sweating. Call your doctor if you experience vomiting or diarrhea.

If you need surgery or dental treatment, tell the surgeon or dentist in advance that you are using Exforge HCT.

It may take up to 2 weeks for your blood pressure to improve. Continue to use this medicine as directed, even if you feel well. High blood pressure often causes no symptoms. You may need to take blood pressure medication for the rest of your life.

Store at room temperature, protected from moisture and heat.

Dosage information

Usual adult dose for high blood pressure:

Initial dose: 1 tablet orally once daily (The dosage can be increased after 2 weeks of therapy. The full antihypertensive effect was achieved 2 weeks after taking the maximum dose.)

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

Comment:
-Indicated for patients whose blood pressure is adequately controlled by amlodipine, valsartan, and hydrochlorothiazide (as a single-component formulation or as a two-component formulation with a single-component formulation). Prior to administration of the fixed-dose combination, individual dose titration for each component is recommended.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid when taking this medicine?

Do not use potassium supplements or salt substitutes unless directed by your doctor.

Drinking alcohol with Exforge HCT can have 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 outdoors. Your doctor may want you to have regular skin checks.

Avoid getting up too quickly from sitting or lying down as this could cause you to feel dizzy. Avoid driving and dangerous activities until you know how this medicine affects you. Your reactions may be affected.

Side effects

If necessary, get emergency medical helpSigns of an allergic reaction to Exforge HCT:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• a light-headed feeling, as if you were going to faint;

• 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 heartbeat, fluttering in the chest, increased thirst or need to urinate, numbness or tingling, muscle weakness or feeling weak;

• Kidney problems- little or no urination, swelling of the feet or ankles, tiredness or shortness of breath;

• low magnesium levels– Dizziness, nervousness, muscle spasms, muscle spasms, coughing or choking feeling; or

• low sodium levels– Headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, unsteadiness.

Common side effects of Exforge HCT may include:

• Dizziness;

• headache, fatigue;

• nausea, stomach problems;

• stuffy nose, sinus pain, sore throat;

• back pain, muscle cramps; or

• Swelling of 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Exforge HCT?

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

Tell your doctor about all medications you are currently taking. Many medications can affect Exforge HCT, particularly:

• another a diuretic or “water pill”;

• any other blood pressure medications;

• insulin or oral diabetes medications;

• steroid medicine;

• vitamin or mineral supplements that contain potassium;

• a sedative or opioid medicine;

• cholesterol-lowering medicines;

• an antibiotic, antifungal, or antiviral drug; or

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

This list is not exhaustive and many other medications may interact with amlodipine, hydrochlorothiazide, and valsartan. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible drug interactions are listed here.

More information

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