Aliskiren & Amlodipine

Aliskiren/amlodipine is a prescription medication used to treat high blood pressure (hypertension). It is a single tablet containing 2 medications, aliskiren and amlodipine. 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 a a groups of drugs called calcium channel blockers, which work by relaxing blood vessels to lower blood pressure. 

Aliskiren/amlodipine comes in tablet form and is taken once daily. Fatty meals may decrease the amount of aliskiren/amlodipine your body is able to absorb. It is important you take aliskiren/amlodipine the same way, with or without food, everyday.

Aliskiren/amlodipine is a prescription medicine used to treat high blood pressure (hypertension). 

Aliskiren & Amlodipine may be found in some form under the following brand names:

• Tekamlo

Aliskiren/amlodipine may cause serious side effects:

• Harm to an unborn baby, causing injury or death
• Aliskiren, one of the medicines in aliskiren/amlodipine, can cause swelling of your face, lips, tongue, throat, arms and legs, or the whole body. Get medical help right away and tell your doctor if you get any one or more of these symptoms. Serious allergic reactions can happen at any time while you are taking aliskiren/amlodipine. 
• 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. Lie down if you feel faint or get dizzy. Call your doctor right away. 
• Possible increased chest pain or risk of heart attack.  It is rare, but when you first start taking aliskiren/amlodipine 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 a hospital emergency room.

The most common side effects of aliskiren/amlodipine include:

• Swelling of your lower legs

Common side effects of aliskiren/amlodipine include:

• diarrhea
• cough
• dizziness
• flu-like symptoms
• tiredness
• high levels of potassium in the blood (hyperkalemia)

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

These are not all of the possible side effects of aliskiren/amlodipine. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Aliskiren/amlodipine and certain other medicines may affect each other and cause side effects.

Especially tell your doctor if you take:

• a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
• water pills (also called “diuretics”)
• medicines for treating fungus or fungal infections
• cyclosporine (Gengraf, Neoral, Sandimmune), a medicine used to suppress the immune system
• potassium-containing medicines, potassium supplements, or salt substitutes containing potassium
• atorvastatin (Lipitor)
• non-steroidal anti-inflammatory drugs (like ibuprofen or naproxen)

Know your medicines. Keep a list of all your medicines. Show this list to your doctor or pharmacist when you get a new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

Do not take aliskiren/amlodipine:

• If you get pregnant, stop taking aliskiren/amlodipine and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure.
• If you have diabetes and are taking a kind of medicine called an angiotensin-receptor-blocker or angiotensin-converting-enzyme-inhibitor.
• If you are allergic (hypersensitive) to aliskiren, amlodipine or other dihydropyridines (calcium-channel blockers, a group of medicines to lower blood pressure to which amlodipine belongs) or any of the other ingredients of aliskiren/amlodipine.
• This medication can cause drowsiness. Do not drive or operate heavy machinery until you know how aliskiren/amlodipine affects you.

Before taking aliskiren/amlodipine, tell your doctor if you:

• have kidney problems
• have liver problems
• 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.
• have any other medical problems 
• are pregnant or planning to become pregnant. 
• are breastfeeding. It is not known if aliskiren/amlodipine passes into your breast milk and if it can harm your baby. You and your doctor should decide if you will take aliskiren/amlodipine or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Aliskiren/amlodipine and certain other medicines may affect each other and cause side effects.

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.

This medication falls into category D. Aliskiren/amlodipine can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking aliskiren/amlodipine, tell your doctor right away.

Tell your doctor if you are breastfeeding. It is not known if aliskiren/amlodipine passes into your breast milk and if it can harm your baby. You and your doctor should decide if you will take aliskiren/amlodipine or breastfeed. You should not do both.

• Take aliskiren/amlodipine exactly as prescribed by your doctor. It is important to take aliskiren/amlodipine every day to control your blood pressure.
• Take aliskiren/amlodipine one time a day, about the same time each day.
• Take aliskiren/amlodipine the same way every day, either with or without a meal.
• Your doctor may change your dose of aliskiren/amlodipine if needed. Do not change the amount of aliskiren/amlodipine you take without talking to your doctor.
• If you miss a dose of aliskiren/amlodipine, 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.
• If you take too much aliskiren/amlodipine, call your doctor or a Poison Control Center, or go to the nearest hospital emergency room.

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

If aliskiren/amlodipine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store aliskiren/amlodipine tablets at room temperature between 59°F to 86°F (15°C to 30°C). 
• Keep the original prescription bottle and store in a dry place. 
• Protect aliskiren/amlodipine from heat and moisture.
• Keep aliskiren/amlodipine and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

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