Aliskiren-amlodipine

Name: Aliskiren-amlodipine

Aliskiren-amlodipine Interactions

Avoid taking this medicine with a high-fat meal, which can make it harder for your body to absorb aliskiren.

Do not use salt substitutes or potassium supplements while taking this medicine, unless your doctor has told you to.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of aliskiren and amlodipine.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with aliskiren and amlodipine, especially:

  • antifungal medicine;
  • any other heart or blood pressure medicines;
  • atorvastatin (Lipitor) or simvastatin (Zocor);
  • a diuretic or "water pill";
  • HIV or AIDS medicine, such as indinavir or ritonavir;
  • a potassium supplement such as K-Dur, Klor-Con;
  • salt substitutes that contain potassium; or
  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with aliskiren and amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Aliskiren-amlodipine Dosage

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food, but take it the same way every time.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you feel very dizzy.

Your blood pressure will need to be checked often.

Your chest pain may become worse when you first start taking aliskiren and amlodipine, or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

If you need surgery or medical tests, tell the doctor ahead of time that you are using aliskiren and amlodipine. You may need to stop using the medicine for a short time.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store in the original container at room temperature, away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Adverse Effects

Adverse reactions reported with combination product and individual agents

>10%

Amlodipine

  • Peripheral edema (2-15%)

1-10%

Peripheral edema (6.2-8.9%)

Aliskiren

  • Diarrhea (2.3%)
  • Cough (1.1%)
  • Increased creatinine kinase (1%)
  • Increased BUN (≤ 7%)
  • Hyperkalemia (≤1%)
  • Rash (1%)

Amlodipine

  • Flushing (1-5%)
  • Palpitation (1-5%)
  • Dizziness (1-3%)
  • Fatigue (5%)
  • Somnolence (1-2%)
  • Rash (1-2%)
  • Pruritus (1-2%)
  • Male sexual dysfunction (1-2%)
  • Nausea (3%)
  • Dyspepsia (1-2%)
  • Abdominal pain (1-2%)
  • Muscle cramps (1-2%)
  • Dyspnea (1-2%)
  • Weakness (1-2%)

<1%

Angioedema

Increased BUN

Increased creatinine

Hyperkalemia

Hypotension

Aliskiren

  • Gastroesophageal reflux
  • Periorbital edema
  • Toxic epiderma necrolysis
  • Increased uric acid
  • Severe hypotension
  • Stevens Johnson syndrome

Amlodipine

  • Abnormal vision
  • Arthralgia
  • Chest pain
  • Abnormal dreams
  • Increased apetite
  • Acute interstitial nephritis
  • Alopecia
  • Conjunctivitis
  • Cough
  • Depression
  • Dysphagia
  • Flatulence

Postmarketing Reports

Nausea/vomiting

Aliskiren

  • Hyponatremia

Aliskiren & Amlodipine Overview

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.

Common side effects of aliskiren/amlodipine include diarrhea, cough, dizziness, and tiredness. Do not drive or operate heavy machinery until you know how aliskiren/amlodipine affects you.

Uses of Aliskiren & Amlodipine

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

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

Side Effects of Aliskiren & Amlodipine

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. 

Aliskiren & Amlodipine and Lactation

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.

Other Requirements

  • 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.
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