Amturnide contains a combination of aliskiren, amlodipine, and hydrochlorothiazide. Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine 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.

Amturnide is used to treat high blood pressure (hypertension).

Amturnide is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

You should not use Amturnide if you are unable to urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. If you become pregnant, stop taking Amturnide and tell your doctor right away.

If you have diabetes, you should not use this medicine together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

Before you take Amturnide, tell your doctor if you have kidney or liver disease, glaucoma, lupus, asthma, congestive heart failure, angina (chest pain), coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), a penicillin allergy, if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

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

Take Amturnide exactly as prescribed by your doctor. Take Amturnide exactly as prescribed by your doctorFollow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you feel very dizzy.

Your blood pressure will need to be checked often.

If you need surgery or medical tests, tell the surgeon ahead of time that you are using Amturnide. You may need to stop using the medicine for a short time.

Keep using Amturnide as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: 1 tablet orally daily
The dosage may be increased after 2 weeks of therapy.

Maximum dose: Aliskiren/amlodipine/hydrochlorothiazide 300/10/25 mg orally daily

Comments:
-The combination product may be substituted for patients receiving aliskiren, amlodipine, and hydrochlorothiazide from separate tablets.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).

You should not take Amturnide if you are allergic to aliskiren, amlodipine, or hydrochlorothiazide, or if:

• you are unable to urinate; or

• you are allergic to sulfa drugs.

If you have diabetes, you should not use Amturnide together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or

• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with Amturnide if you have kidney disease.

To make sure Amturnide is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• heart disease or prior heart attack;

• coronary artery disease (hardened arteries);

• glaucoma;

• asthma or allergies;

• gout;

• diabetes;

• systemic lupus erythematosus (SLE);

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

• if you are on a low-salt diet; or

• an allergy to penicillin.

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

This medicine is not approved for use by anyone younger than 18 years old.

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.

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

If you also take cholestyramine or colestipol, avoid taking these medicines within 4 hours before or 4 hours after you take Amturnide.

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

Avoid taking with foods that are high in fat, which can make it harder for your body to absorb aliskiren.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the 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.

Get emergency medical help if you have signs of an allergic reaction to Amturnide: hives; vomiting, severe stomach pain; dizziness, difficulty breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination;

• eye pain, vision problems;

• low levels of sodium in the body - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

• high potassium - nausea, slow or unusual heart rate, weakness, loss of movement;

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• lupus-like symptoms - joint pain with fever, skin sores, butterfly-shaped skin rash on your cheeks and nose, numbness or pale appearance of your fingers or toes;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Amturnide side effects may include:

• swelling in your hands, ankles, or feet;

• headache, dizziness, tired feeling;

• cough;

• diarrhea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cyclosporine;

• lithium;

• any heart or blood pressure medicines;

• a diuretic or "water pill";

• insulin or oral diabetes medicine;

• a potassium supplement such as K-Dur, Klor-Con;

• salt substitutes that contain potassium;

• antifungal medicine - itraconazole, ketoconazole;

• cholesterol medication - atorvastatin, cholestyramine, colestipol, simvastatin, Lipitor, Zocor;

• HIV or AIDS medicine - indinavir, ritonavir, and others; or

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

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