Amlodipine & Olmesartan

Amlodipine/olmesartan is a prescription medication used to treat hypertension, or high blood pressure. It contains 2 medications, amlodipine and olmesartan. Amlodipine, a calcium channel blocker, and olmesartan, an angiotensin II receptor blocker (ARB), both work by relaxing veins and arteries so that blood can more easily pass through them.

This medication comes in tablet form and is taken once a day, with or without food.

Common side effects of amlodipine/olmesartan include swelling, flushing, and palpitations (a pounding or racing heartbeat). Amlodipine/olmesartan can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how amlodipine/olmesartan affects you.

Amlodipine/olmesartan is a prescription medication used to treat high blood pressure, known medically as hypertension.

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

• Take amlodipine/olmesartan exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended starting dose of amlodipine/olmesartan is 5/20 mg once daily.
• Your doctor may increase your dose as necessary to achieve the desired blood pressure.
• The maximum recommended dose of amlodipine/olmesartan is 10/40 mg once daily.

Fetal Toxicity:

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

Serious side effects have been reported with amlodipine/olmesartan including:

• hypotension. Excessive sweating and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
• coronary artery disease (CAD). When starting or increasing the dose of amlodipine/olmesartan, those with CAD may experience an increase in the frequency, duration, or severity of chest pain or a heart attack if these events do happen to occur.
• decline in kidney function. Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction. In addition, It is recommended to avoid use of both amlodipine/olmesartan and the medication aliskiren if you already have kidney impairment.
• liver dysfunction. Since amlodipine (an active ingredient of amlodipine/olmesartan) is broken down by the liver, your doctor may need to exercise extra caution when choosing the dose of amlodipine/olmesartan in those with severe liver dysfunction.
• severe diarrhea and weight loss. Severe, chronic diarrhea with considerable weight loss may develop months to years after starting this medication. Tell your doctor if you are experiencing these symptoms.

Amlodipine/olmesartan can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how amlodipine/olmesartan affects you.

Do not take amlodipine/olmesartan if you:

• are allergic to amlodipine/olmesartan or any of this medication’s ingredients
• are diabetic and also taking aliskiren (Tekturna, Tekturna HCT, Amturnide, Tekamlo, Valturna)

Serious side effects have been reported with amlodipine/olmesartan. See the “Drug Precautions” section.

Common side effects of amlodipine/olmesartan include:

• low blood pressure
• flushing of the cheeks
• palpitations (a pounding or racing heartbeat)
• drowsiness
• dizziness or orthostasis (feeling lightheaded when rising from a sitting or lying down position)
• edema (

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

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• simvastatin (Zocor)
• colesevelam (WelChol)
• potassium-sparing diuretics such as:
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
• angiotensin-converting enzyme (ACE) inhibitors such as:
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• other angiotensin receptor II blockers such as:
  • azilsartan (Edarbi)
  • candesartan (Atacand)
  • irbesartan (Avapro)
  • losartan (Cozaar)
  • olmesartan (Benicar)
  • telmisartan (Micardis, Twynsta)
  • valsartan (Diovan)
• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• potassium supplements
• aliskiren (Tekturna,Tekturna HCT, Amturnide, Tekamlo, Valturna)

This is not a complete list of amlodipine/olmesartan drug interactions. Ask your doctor or pharmacist for more information.

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.

Amlodipine/olmesartan falls into category D. Amlodipine/olmesartan is not usually recommended for use during pregnancy. See the “FDA Warning” section.

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

It is not known whether the components of amlodipine/olmesartan can pass into human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or to discontinue the drug. The importance of the drug to the mother should be taken into account.