aliskiren, amlodipine, and hydrochlorothiazide

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Pronunciation: AL is KYE ren, am LOE de peen, HYE droe klor oh THYE a zide

Brand: Amturnide

Amturnide 150-5-12.5 mg

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Amturnide 300-10-12.5 mg

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Amturnide 300-10-25 mg

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Amturnide 300-5-12.5 mg

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Amturnide 300-5-25 mg

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What is the most important information I should know about aliskiren, amlodipine, and hydrochlorothiazide?

You should not use this medicine 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 this medicine 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).

What is 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.

Aliskiren, amlodipine, and hydrochlorothiazide is a combination medicine used to treat high blood pressure (hypertension). This medicine is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

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

What should I discuss with my healthcare provider before taking aliskiren, amlodipine, and hydrochlorothiazide?

You should not take this medicine 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 this medicine 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 aliskiren, amlodipine, and hydrochlorothiazide if you have kidney disease.

To make sure aliskiren, amlodipine, and hydrochlorothiazide 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 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 aliskiren, amlodipine, and hydrochlorothiazide.

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

How should I take aliskiren, amlodipine, and hydrochlorothiazide?

Follow 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 aliskiren, amlodipine, and hydrochlorothiazide. You may need to stop using the medicine for a short time.

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 medicine for the rest of your life.

Store in the original container 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 aliskiren, amlodipine, and hydrochlorothiazide?

If you also take cholestyramine or colestipol, avoid taking these medicines within 4 hours before or 4 hours after you take aliskiren, amlodipine, and hydrochlorothiazide.

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.

What are the possible side effects of aliskiren, amlodipine, and hydrochlorothiazide?

Get emergency medical help if you have signs of an allergic reaction: 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 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.

What other drugs will affect aliskiren, amlodipine, and hydrochlorothiazide?

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.

Where can I get more information?

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

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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