Aliskiren, amlodipine, and hydrochlorothiazide

Name: Aliskiren, amlodipine, and hydrochlorothiazide

Aliskiren, Amlodipine And Hydrochlorothiazide Interactions

No drug interactions have been evaluated by the manufacturer for the combination of aliskiren/amlodipine/hydrochlorothiazide. However, you should tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. Medicines that may cause interactions due to the medicines in aliskiren/amlodipine/hydrochlorothiazide include the following:

  • a kind of medicine to control blood pressure called an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI)
  • medicines used to lower blood pressure, water pills (also called “diuretics”),especially potassium sparing diuretics
  • medicines for treating fungus or fungal infections (like itraconazole or ketoconazole)
  • cyclosporine (Gengraf , Neoral, Sandimmune), a medicine used to suppress the immune system
  • potassium-containing medicines, potassium supplements, or salt substitutes containing potassium
  • cholesterol lowering medicines such as simvastatin (Zocor ) or atorvastatin (Lipitor ), cholestyramine (Questran, Questran Light, Cholestyramine Light, Locholest Light, Locholest, Prevalite), and colestipol (Colestipol hydrochloride, Colestid, Flavored Colestid)
  • medicines used to treat diabetes, including insulin
  • lithium, a medicine used to treat some types of depression
  • nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen or naproxen), including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors)
  • medicines used to treat AIDS or HIV infections (such as ritonavir, indinavir).

Do not drink alcohol while taking this medication.

Ask your doctor or pharmacist for more information. 

Precautions While Using aliskiren, amlodipine, and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure aliskiren, amlodipine, and hydrochlorothiazide is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using aliskiren, amlodipine, and hydrochlorothiazide while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using aliskiren, amlodipine, and hydrochlorothiazide, tell your doctor right away.

Call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.

You should not use aliskiren, amlodipine, and hydrochlorothiazide (unless your doctor specifically tells you to) if you are also receiving cyclosporine (Gengraf®, Neoral®, Sandimmune®), itraconazole (Sporanox®), or lithium (Eskalith®, Lithobid®).

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Check with your doctor right away if you become sick while taking aliskiren, amlodipine, and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

aliskiren, amlodipine, and hydrochlorothiazide may worsen the symptoms of angina (chest pain) or cause a heart attack, especially in patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck. shortness of breath, or sweating.

Hyperkalemia (high potassium in the blood) may occur while you are using aliskiren, amlodipine, and hydrochlorothiazide. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

aliskiren, amlodipine, and hydrochlorothiazide may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

aliskiren, amlodipine, and hydrochlorothiazide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Dizziness
Rare
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • fever
  • headache
  • itching skin
  • lack or loss of strength
  • muscle aches
  • rash
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

What are some other side effects of Aliskiren, Amlodipine, and Hydrochlorothiazide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Cough.
  • Loose stools (diarrhea).
  • Headache.
  • Sore throat.
  • Stuffy nose.
  • Runny nose.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pharmacology

Aliskiren: Decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin I.

Amlodipine: Inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Hydrochlorothiazide: Inhibits sodium reabsorption in the distal tubules causing increased excretion of sodium and water as well as potassium and hydrogen ions.

Dietary Considerations

May be taken with or without food; however, a high-fat meal reduces absorption. Consistent administration with regards to meals is recommended. Avoid salt substitutes containing potassium.

Storage

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) in original container; protect from heat and moisture.

ALERT U.S. Boxed Warning

Fetal toxicity:

When pregnancy is detected, discontinue therapy as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus.

For the Consumer

Applies to aliskiren / amlodipine / hydrochlorothiazide: oral tablet

Along with its needed effects, aliskiren / amlodipine / hydrochlorothiazide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aliskiren / amlodipine / hydrochlorothiazide:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss
Less common
  • Dizziness
Rare
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of aliskiren / amlodipine / hydrochlorothiazide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • fever
  • headache
  • itching skin
  • lack or loss of strength
  • muscle aches
  • rash
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose

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