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Drugs & Medications

aliskiren-amlodipine-hydrochlorothiazide

COMMON BRAND NAME(S): Amturnide

GENERIC NAME(S): ALISKIREN HEMIFUMARATE/AMLODIPINE/HYDROCHLOROTHIAZIDE

WARNINGS:

This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.

Who should not take aliskiren-amlodipine-hydrochlorothiazide?
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Uses

This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This product contains 3 medications: aliskiren, amlodipine, and hydrochlorothiazide. Aliskiren is a direct renin inhibitor and amlodipine is a calcium channel blocker. They both work to relax the blood vessels so that blood can flow more easily. Hydrochlorothiazide is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water. This effect may increase the amount of urine you make when you first start the medication. It also helps to relax the blood vessels so that blood can flow more easily.

These medications are used together when 2 drugs alone are not controlling your blood pressure. Your doctor may direct you to start taking the individual medications first, and then switch you to this combination product if it is the best dose combination for you.

How to use aliskiren-amlodipine-hydrochlorothiazide

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Some foods may decrease how well this drug is absorbed by the body. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. Also, if you take this drug too close to bedtime, you may need to wake up to urinate. Therefore, it is best to take this medication at least 4 hours before your bedtime. If you have any questions about how and when to take this medication, ask your doctor or pharmacist.

Do not take with fruit juices (such as apple, grapefruit, or orange) since they may decrease the absorption of this drug.

The dosage is based on your medical condition and response to treatment.

If you also take certain drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 4 hours before or at least 4 to 6 hours after these medications.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

It may take 2 weeks before you get the full benefit of this medication. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).

Side Effects

Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet, flushing, headache, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, confusion, decreased urination.

Tell your doctor right away if you have any serious side effects, including: fainting, eye pain, decreased vision, toe/joint pain, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren, amlodipine, or hydrochlorothiazide; or to other calcium channel blockers (such as nifedipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, kidney disease, liver disease, lupus, gout, untreated mineral imbalance (such as high/low potassium, low sodium, high calcium), dehydration, heart valve disorder (such as aortic stenosis).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Too much sweating, diarrhea, or vomiting may cause dehydration and increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may affect your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the effects of this product, especially dizziness and diarrhea.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if aliskiren or amlodipine passes into breast milk. Hydrochlorothiazide passes into breast milk. Consult your doctor before breast-feeding.

Interactions

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: dofetilide, lithium, drugs that may increase the level of potassium in the blood (including amiloride, triamterene, ACE inhibitors such as lisinopril/fosinopril/quinapril, ARBs such as irbesartan/candesartan/telmisartan, birth control pills containing drospirenone).

Other medications can affect the removal of aliskiren from your body, which may affect how aliskiren works. Examples include azole antifungals (such as itraconazole), cyclosporine, quinidine, among others.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist for more details.

This product may interfere with certain laboratory tests (including parathyroid test, protein-bound iodide test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, fast heartbeat.

Notes

Do not share this medication with others.

Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Laboratory and/or medical tests (including kidney function, blood mineral levels such as potassium) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Images

AMTURNIDE 300-5-12.5 MG TAB
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AMTURNIDE 150-5-12.5 MG TAB
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AMTURNIDE 300-5-12.5 MG TAB
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Identification

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This medicine is a light pink, oval, film-coated tablet imprinted with "LIL" and "NVR".
AMTURNIDE 300-10-12.5 MG TAB
AMTURNIDE 300-10-12.5 MG TAB

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This medicine is a light red, oval, film-coated tablet imprinted with "UIU" and "NVR".
AMTURNIDE 300-10-25 MG TAB
AMTURNIDE 300-10-25 MG TAB

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This medicine is a brown, oval, film-coated tablet imprinted with "VIV" and "NVR".
AMTURNIDE 300-5-25 MG TAB
AMTURNIDE 300-5-25 MG TAB

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This medicine is a pale orange brown, oval, film-coated tablet imprinted with "OIO" and "NVR".
AMTURNIDE 150-5-12.5 MG TAB
AMTURNIDE 150-5-12.5 MG TAB

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This medicine is a violet white, oval, film-coated tablet imprinted with "YIY" and "NVR".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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