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aliskiren and amlodipine

Generic Name: aliskiren and amlodipine (AL is KYE ren and am LOE de peen)
Brand Name: Tekamlo

What is this drug?

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.

Aliskiren and amlodipine is a combination medicine used to treat high blood pressure (hypertension).

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

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

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

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You should not take aliskiren and amlodipine if you are also using cyclosporine or itraconazole.

What should I discuss with my health care provider before taking this drug?

You should not take this medcine if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine or itraconazole.

If you have diabetes, you should not use aliskiren and amlodipine 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 and amlodipine if you have kidney disease.

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

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

  • liver disease;

  • congestive heart failure;

  • coronary artery disease (hardened arteries);

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

  • if you are on a low-salt diet; or

  • if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

FDA pregnancy category D. Do not use aliskiren and amlodipine if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether aliskiren and amlodipine 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 drug?

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, but take it the same way every time.

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.

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

If you need surgery or medical tests, tell the doctor ahead of time that you are using aliskiren and amlodipine. 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 this drug?

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb aliskiren.

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

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

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.

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; vomiting, severe stomach pain; dizziness, difficult 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;

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • little or no urinating; or

  • high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling.

Common side effects may include:

  • swelling in your hands, ankles, or feet;

  • dizziness, tired feeling;

  • cough;

  • diarrhea;

  • stomach pain, upset stomach; or

  • flu symptoms (fever, chills, body aches).

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.

See also: Side effects (in more detail)

Aliskiren and amlodipine dosing information

Usual Adult Dose for Hypertension:

Initial or add-on therapy: 150 mg/5 mg orally once a day. Titrate as needed up to a maximum of 300 mg/10 mg.

The blood pressure lowering effect is largely attained within 1 to 2 weeks.

Maximum dose: 300 mg/10 mg

Comments:
-The combination product may be substituted for patients receiving aliskiren and amlodipine 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).

Usual Geriatric Dose for Hypertension:

Exposure to aliskiren and amlodipine is increased in elderly patients. Lower initial doses of aliskiren-amlodipine should be considered.

What other drugs will affect this drug?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aliskiren and amlodipine, especially:

  • antifungal medicine;

  • any other heart or blood pressure medicines;

  • atorvastatin (Lipitor) or simvastatin (Zocor);

  • a diuretic or "water pill";

  • HIV or AIDS medicine, such as indinavir or ritonavir;

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

  • salt substitutes that contain potassium; 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 and amlodipine, 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 and amlodipine.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2014-06-18, 1:29:14 PM.

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