Amlodipine & Olmesartan & Hydrochlorothiazide

Amlodipine/olmesartan/hydrochlorothiazide is a prescription medication used to treat high blood pressure. It is a single tablet containing 3 medications, olmesartan, amlodipine, and hydrochlorothiazide. Olmesartan, an angiotensin II receptor blocker (ARB), and amlodipine, a calcium channel blocker, both work by relaxing veins and arteries so that blood can more easily pass through them. Hydrochlorothiazide belongs to a group of drugs called diuretics ("water pills"), which help the body get rid of excess fluid.

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

Common side effects of amlodipine/olmesartan/hydrochlorothiazide include swelling, headache, nausea, diarrhea, and dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.

Amlodipine/olmesartan/hydrochlorothiazide is a prescription medication used to treat high blood pressure, known medically as hypertension. It should only be used in people who are already taking at least two high blood pressure medications.

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

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

• Tribenzor

Serious side effects have been reported with amlodipine/olmesartan/hydrochlorothiazide. See the “Amlodipine & Olmesartan & Hydrochlorothiazide Precautions” section.

Common side effects include:

• dizziness
• swelling (edema) of the ankles, feet, and hands
• headache
• tiredness
• stuffy or runny nose and sore throat
• muscle twitching (spasms)
• nausea
• upper respiratory tract infection
• diarrhea
• urinary tract infection
• swelling (edema) of the joints

This is not a complete list of amlodipine/olmesartan/hydrochlorothiazide 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:

• water pills (diuretics) such as chlorthalidone (Hygrotron, Thalitone) or hydrochlorothiazide (Microzide, Hydrodiuril)
• potassium-sparing diuretics such as:
  • spironolactone (Aldactone)
  • triamterene (Dyrenium)
  • amiloride (Midamor)
• aliskiren (Tekturna)
• 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)
• any type of medicine for diabetes
• narcotic pain medications such as morphine (MS Contin, Kadian), hydrocodone (Norco, Vicodin), oxymorphone (Opana, Percocet, Roxicet)
• sleeping pills and anti-seizure medicines called barbiturates
• lithium (Eskalith, Lithobid)
• steroids such as hydrocortisone (Cortef, Hydrocortone) and methylprednisolone (Medrol)
• cholesterol lowering medicines such as statins (atorvastatin, simvastatin, or rosuvastatin) and fibrates (fenofibrate, gemfibrozil)
• alcohol
• colesevelam (WelChol)

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

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

• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure, too. Lie down if you feel faint or dizzy. Call your doctor right away.
• kidney problems. Kidney problems may get worse in people that already have kidney disease. Blood tests for kidney function may be done while you are taking amlodipine/olmesartan/hydrochlorothiazide and the doctor may need to lower your dose of this medication. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing amlodipine/olmesartan/hydrochlorothiazide.
• worsening chest pain or heart attack. Get medical help right away if you have chest pain that gets worse, or that does not go away, during treatment with amlodipine/olmesartan/hydrochlorothiazide.
• allergic reactions. Hydrochlorothiazide, one of the active ingredients in amlodipine/olmesartan/hydrochlorothiazide, can cause allergic reactions.
• changes in body salts (such as sodium and potassium), and body fluids. Tell your doctor if you have any of these signs or symptoms during treatment with amlodipine/olmesartan/hydrochlorothiazide:
  • dry mouth
  • thirst
  • weakness
  • tiredness or sleepiness
  • restlessness
  • confusion
  • seizures
  • muscle pains or cramps
  • muscle tiredness
  • dizziness or fainting
  • low or no urine output
  • fast heartbeat
  • nausea and vomiting
• eye problems. One of the active ingredients in amlodipine/olmesartan/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
• severe diarrhea and weight loss (Sprue-like Enteropathy). Severe, chronic diarrhea with considerable weight loss may develop months to years after starting amlodipine/olmesartan/hydrochlorothiazide. Tell your doctor if you are experiencing these symptoms.

Amlodipine/olmesartan/hydrochlorothiazide can cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how this medication.

Do not take amlodipine/olmesartan/hydrochlorothiazide if you:

• have low or no urine output
• are allergic to other sulfonamide type medicines. Ask your doctor if you are not sure
• are taking aliskiren and have diabetes

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 this medication, salt substitutes containing potassium should be avoided. Also, drinking alcohol during treatment with amlodipine/olmesartan/hydrochlorothiazide can worsen the side effect of hypotension (low blood pressure).

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

• are allergic to any of the ingredients in this medication
• have liver problems
• have heart problems
• have kidney problems
• have lupus
• are vomiting or have a lot of diarrhea
• have any other medical conditions
• are pregnant or breastfeeding

Tell your 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.

This medication falls into category D. Amlodipine/olmesartan/hydrochlorothiazide is not usually recommended for use during pregnancy. See the “Amlodipine & Olmesartan & Hydrochlorothiazide FDA Warning” section.

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

It is not known whether amlodipine or olmesartan are excreted in human milk, but thiazides appear in 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.

• Take amlodipine/olmesartan/hydrochlorothiazide exactly as prescribed by your doctor. Your doctor may change your dose if needed.
• This medication comes in tablet form and is taken once a day, with or without food. You may take with food if this medication bothers your stomach.
• It is best to take amlodipine/olmesartan/hydrochlorothiazide at the same time every day.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of amlodipine/olmesartan/hydrochlorothiazide.

• Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
• Your doctor may start you on the 20/5/12.5 mg once daily dose of olmesartan/amlodipine/hydrochlorothiazide and may increase your dose as necessary to achieve the desired blood pressure response.
• The maximum recommended dose for this medication is 40 /10 /25 mg once daily.

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

If this medication 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 this medication at room temperature.
• Keep this and all medications out of the reach of children.

Fetal Toxicity:

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