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Aliskiren/ amlodipine/ hydrochlorothiazide

Generic Name: aliskiren/amlodipine/hydrochlorothiazide (AL-is-KYE-ren/am-LOE-di-peen/HYE-droe-KLOR-oh-THYE-a-zide)
Brand Name: Amturnide

Aliskiren/amlodipine/hydrochlorothiazide may cause injury or death to the fetus if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.


Aliskiren/ amlodipine/ hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.

Aliskiren/amlodipine/hydrochlorothiazide is a renin inhibitor, calcium channel blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.

Do NOT use aliskiren/ amlodipine/ hydrochlorothiazide if:

  • you are allergic to any ingredient in aliskiren/amlodipine/hydrochlorothiazide or to any other sulfonamide (sulfa) medicine (eg, sulfamethoxazole)
  • you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by treatment with aliskiren/amlodipine/hydrochlorothiazide or another product that contains aliskiren
  • you are pregnant
  • you have severe kidney problems or are unable to urinate
  • you have either diabetes or kidney problems and you are also taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril) or an angiotensin receptor blocker (ARB) (eg, losartan)
  • you are taking cyclosporine, dofetilide, itraconazole, or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.

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Before using aliskiren/ amlodipine/ hydrochlorothiazide:

Some medical conditions may interact with aliskiren/amlodipine/hydrochlorothiazide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), especially when taking an ACE inhibitor (eg, lisinopril) or an ARB (eg, losartan)
  • if you are dehydrated, have low blood volume, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium)
  • if you have a history of gallbladder or liver problems, kidney problems (eg, renal artery stenosis, kidney stones), a stroke, a heart attack, seizures, asthma, gout or high blood levels of uric acid, lupus, parathyroid gland problems, low blood pressure, blood vessel problems, diabetes, swelling or fluid retention, or heart problems (eg, heart failure, angina, narrowing of heart blood vessels)
  • if you are on dialysis or will be having surgery, or you have recently had a certain type of nerve surgery (sympathectomy)
  • if you drink alcohol
  • if you are taking another medicine for high blood pressure or heart problems
  • if you have never taken another medicine for high blood pressure

Some MEDICINES MAY INTERACT with aliskiren/amlodipine/hydrochlorothiazide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • ACE inhibitors (eg, ramipril) or ARBs (eg, losartan) because the risk of certain side effects (eg, kidney problems, high blood potassium levels, low blood pressure) may be increased
  • Digoxin, dofetilide, or ketanserin because the risk of irregular heartbeat may be increased
  • Adrenocorticotropic hormone (ACTH), atorvastatin, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), cobicistat, conivaptan, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), narcotic pain relievers (eg, morphine), protease inhibitors (eg, ritonavir, telaprevir), or sildenafil because they may increase the risk of aliskiren/amlodipine/hydrochlorothiazide's side effects
  • Cholestyramine or colestipol because they may decrease aliskiren/amlodipine/hydrochlorothiazide's effectiveness
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease aliskiren/amlodipine/hydrochlorothiazide's effectiveness and the risk of kidney problems and high blood potassium levels may be increased
  • Diazoxide, lithium, potassium-sparing diuretics (eg, triamterene), potassium supplements, or simvastatin because the risk of their side effects may be increased by aliskiren/amlodipine/hydrochlorothiazide
  • Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by aliskiren/amlodipine/hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your health care provider if aliskiren/amlodipine/hydrochlorothiazide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use aliskiren/ amlodipine/ hydrochlorothiazide:

Use aliskiren/amlodipine/hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with aliskiren/amlodipine/hydrochlorothiazide. Talk to your pharmacist if you have questions about this information.
  • Take aliskiren/amlodipine/hydrochlorothiazide by mouth with or without food. However, you must take it the same way each time you take it. If you take aliskiren/amlodipine/hydrochlorothiazide on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
  • If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with aliskiren/amlodipine/hydrochlorothiazide.
  • You will need to take care not to become dehydrated while you are taking aliskiren/amlodipine/hydrochlorothiazide. This may increase your risk of low blood pressure. Talk with your doctor if you have questions about avoiding dehydration.
  • Take aliskiren/amlodipine/hydrochlorothiazide on a regular schedule to get the most benefit from it.
  • Taking aliskiren/amlodipine/hydrochlorothiazide at the same time each day will help you remember to take it.
  • Continue to take aliskiren/amlodipine/hydrochlorothiazide even if you feel well. Do not miss any doses.
  • If you miss a dose of aliskiren/amlodipine/hydrochlorothiazide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use aliskiren/amlodipine/hydrochlorothiazide.

Important safety information:

  • Aliskiren/amlodipine/hydrochlorothiazide may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use aliskiren/amlodipine/hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Aliskiren/amlodipine/hydrochlorothiazide may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
  • Aliskiren/amlodipine/hydrochlorothiazide may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
  • Aliskiren/amlodipine/hydrochlorothiazide contains a sulfonamide called hydrochlorothiazide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting aliskiren/amlodipine/hydrochlorothiazide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decrease in vision) or eye pain.
  • It may take up to 2 weeks to get the full benefit from aliskiren/amlodipine/hydrochlorothiazide. Do NOT change your dose or stop taking aliskiren/amlodipine/hydrochlorothiazide without checking with your doctor.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • High-fat meals may decrease the amount of aliskiren/amlodipine/hydrochlorothiazide that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take aliskiren/amlodipine/hydrochlorothiazide consistently with regard to meals.
  • If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions.
  • Aliskiren/amlodipine/hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to aliskiren/amlodipine/hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Aliskiren/amlodipine/hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Tell your doctor or dentist that you take aliskiren/amlodipine/hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.
  • Although rare, a component of aliskiren/amlodipine/hydrochlorothiazide (amlodipine) has been known to increase chest pain and increase the risk of a heart attack, especially in patients with severe heart disease.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use aliskiren/amlodipine/hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use aliskiren/amlodipine/hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects.
  • Aliskiren/amlodipine/hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Aliskiren/amlodipine/hydrochlorothiazide may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Aliskiren/amlodipine/hydrochlorothiazide is found in breast milk. Do not breast-feed while taking aliskiren/amlodipine/hydrochlorothiazide.

Possible side effects of aliskiren/ amlodipine/ hydrochlorothiazide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; headache; sore throat; stuffy or runny nose; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest, jaw, or arm pain; confusion; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased thirst; mental or mood changes; muscle pain, weakness, or cramps; seizures; severe or persistent dizziness or light-headedness; shortness of breath; stomach pain; sudden, severe nausea; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); unusual bruising or bleeding; unusual sweating, tiredness, or weakness; unusually dry mouth; vision changes (eg, blurred vision, decrease in vision); vomiting; worsening of angina pain (eg, longer, more often, more severe).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, decreased urination; dry mouth or eyes; fast heartbeat; unusual thirst, tiredness, or weakness).

Proper storage of aliskiren/amlodipine/hydrochlorothiazide:

Store aliskiren/amlodipine/hydrochlorothiazide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original container, away from heat, moisture, and light. Do not store in the bathroom. Keep aliskiren/amlodipine/hydrochlorothiazide out of the reach of children and away from pets.

General information:

  • If you have any questions about aliskiren/amlodipine/hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider.
  • Aliskiren/amlodipine/hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take aliskiren/amlodipine/hydrochlorothiazide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about aliskiren/amlodipine/hydrochlorothiazide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aliskiren/amlodipine/hydrochlorothiazide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using aliskiren/amlodipine/hydrochlorothiazide.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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