Aliskiren, Amlodipine And Hydrochlorothiazide

Aliskiren/amlodipine/hydrochlorothiazide is a prescription medication used to treat high blood pressure. It is a single product containing 3 medications: aliskiren, amlodipine, and hydrochlorothiazide. Aliskiren belongs to a group of drugs called renin inhibitors, which work by reducing renin production in the body to reduce blood pressure. Amlodipine belongs to a group of drugs called calcium channel blockers, which help relax blood vessels. This makes it easier for the heart to pump blood. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form and is typically given once daily with or without food. Make sure to take it the same way every time. For example, always take it with food or always take it without food. 

Common side effects of aliskiren/amlodipine/hydrochlorothiazide include retaining fluid (edema), headache, and infection of the nose and throat (nasopharyngitis).

Aliskiren/amlodipine/hydrochlorothiazide can also cause tiredness and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you. 

Aliskiren/amlodipine/hydrochlorothiazide is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Aliskiren, Amlodipine And Hydrochlorothiazide may be found in some form under the following brand names:

• Amturnide

Serious side effects have been reported with aliskiren/amlodipine/hydrochlorothiazide. See the "Aliskiren/amlodipine/hydrochlorothiazide Precautions" section. 

Common side effects of aliskiren/amlodipine/hydrochlorothiazide include the following:

• retaining fluid (edema) that causes swelling of your ankles, feet, and hands
• dizziness
• headache
• infection of the nose and throat (nasopharyngitis)
• cough
• tiredness
• high levels of potassium in the blood (hyperkalemia)

This is not a complete list of aliskiren/amlodipine/hydrochlorothiazide side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

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. 

Serious side effects have been reported with aliskiren/amlodipine/hydrochlorothiazide or its ingredients including the following:

• Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • swelling of the face, limbs, lips, tongue, throat
  • difficulty breathing
  • stomach (abdominal) pain (intestinal angioedema) with or without nausea or vomiting

• Harm to an unborn baby (fetal toxicity). Do not take this medication if you are pregnant or will become pregnant.
• Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Drinking alcohol and taking certain medicines (barbiturates or narcotics) can cause low blood pressure to get worse. Lie down if you feel faint or dizzy, and call your doctor right away.
• Worsening chest pain or heart attack. When you first start taking aliskiren/amlodipine/hydrochlorothiazide or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to the nearest hospital emergency room.
• Eye problems. One of the medicines in aliskiren/amlodipine/hydrochlorothiazide can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting this medication. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain
• Kidney impairment or failure. Aliskiren, one of the medicines in aliskiren/amlodipine/hydrochlorothiazide, may cause kidney disorder with symptoms such as severely decreased urine output or decreased urine output.
• Imbalances in the levels of salts and fluids in your body (electrolyte and fluid imbalance). Tell your healthcare provider right away if you have some or all of the following symptoms:
  • dry mouth
  • thirst
  • weakness
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • low blood pressure
  • low output of urine
  • fast heart rate
  • nausea
  • vomiting

Aliskiren/amlodipine/hydrochlorothiazide can cause tiredness and dizziness. Do not drive or operate heavy machinery until you know how aliskiren/amlodipine/hydrochlorothiazide affects you.

Do not take aliskiren/amlodipine/hydrochlorothiazide if you:

• are allergic to aliskiren, hydrochlorothiazide, amlodipine, other medicines that contain sulfonamide, or any other ingredients in aliskiren/amlodipine/hydrochlorothiazide
• have diabetes and are taking a kind of medicine called an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI)
• your kidneys do not produce urine (anuria)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of aliskiren/amlodipine/hydrochlorothiazide, salt substitutes containing potassium should be avoided. 

Before taking aliskiren/amlodipine/hydrochlorothiazide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to aliskiren, hydrochlorothiazide, amlodipine, other medicines that contain sulfonamide, or any other ingredients in this medication
• have diabetes and are taking a kind of medicine called an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI)
• your kidneys do not produce urine (anuria)
• have a kidney or liver problem
• have signs of systemic lupus erythematosus (SLE)
• have ever had an allergic reaction to another blood pressure medicine. Symptoms may include: swelling of the face, lips, tongue, throat, arms and legs, and trouble breathing (angioedema)
• suffer from heart disorders or if you experienced a heart attack
• are pregnant or planning to become pregnant
• are breastfeeding or plan to breastfeed

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aliskiren/amlodipine/hydrochlorothiazide falls into category D. When pregnancy is detected, discontinue aliskiren/amlodipine/hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the unborn baby.

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known whether aliskiren or amlodipine, two components of this medication, are excreted in human milk. Hydrochlorothiazide, the other component, has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from aliskiren/amlodipine/hydrochlorothiazide, a choice should be made whether to stop nursing or to stop taking this medication. The importance of the drug to the mother should be considered. 

• Take aliskiren/amlodipine/hydrochlorothiazide exactly as prescribed by your doctor.
• It is important to take aliskiren/amlodipine/hydrochlorothiazide every day to control your blood pressure.
• Take aliskiren/amlodipine/hydrochlorothiazide 1 time a day, at about the same time each day.
• Take aliskiren/amlodipine/hydrochlorothiazide the same way every day, either with or without a meal.
• Your doctor may change your dose of aliskiren/amlodipine/hydrochlorothiazide if needed. Do not change the amount of aliskiren/amlodipine/hydrochlorothiazide you take without talking to your doctor first.
• If you miss a dose of aliskiren/amlodipine/hydrochlorothiazide, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your blood pressure
• previous medications used and the doses tried
• how you respond to this medication

The maximum recommended daily dose of aliskiren/amlodipine/hydrochlorothiazide is aliskiren 300 mg, amlodipine 10 mg, and  hydrochlorothiazide 25 mg.

If you take too much aliskiren/amlodipine/hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store at room temperature between 59°F to 86°F (15°C to 30°C).
• Keep aliskiren/amlodipine/hydrochlorothiazide in the original container.
• Protect from heat and moisture.
• Keep this and all medications out of the reach of children. 

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue aliskiren/amlodipine/hydrochlorothiazide as soon as possible. 
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.