Friday, October 7, 2016

Amlodipine/Valsartan/Hydrochlorothiazide


Pronunciation: am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide
Generic Name: Amlodipine/Valsartan/Hydrochlorothiazide
Brand Name: Exforge HCT

Amlodipine/Valsartan/Hydrochlorothiazide may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.





Amlodipine/Valsartan/Hydrochlorothiazide is used for:

Treating high blood pressure. It may also be used for other conditions as determined by your doctor.


Amlodipine/Valsartan/Hydrochlorothiazide is a calcium channel blocker, angiotensin II receptor blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.


Do NOT use Amlodipine/Valsartan/Hydrochlorothiazide if:


  • you are allergic to any ingredient in Amlodipine/Valsartan/Hydrochlorothiazide or to any other sulfonamide medicine (eg, sulfamethoxazole)

  • you are pregnant

  • you have severe liver problems, severe kidney problems, or you are unable to urinate

  • you are taking dofetilide or ketanserin

Contact your doctor or health care provider right away if any of these apply to you.



Before using Amlodipine/Valsartan/Hydrochlorothiazide:


Some medical conditions may interact with Amlodipine/Valsartan/Hydrochlorothiazide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are a woman of childbearing age

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)

  • if you are dehydrated, have low blood volume, have swelling or fluid retention, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium)

  • if you have gallbladder, liver, or kidney problems; asthma; gout or high blood levels of uric acid; lupus; parathyroid gland problems; low blood pressure; blood vessel problems; heart problems (eg, heart failure, angina, narrowing of heart blood vessels), or high blood cholesterol or lipid levels

  • if you have a history of a stroke, heart attack, or recent kidney transplant

  • if you have diabetes, especially if you are also taking aliskiren

  • if you are on dialysis, will be having surgery, or you have recently had nerve surgery

  • if you are taking another medicine for blood pressure or heart problems

  • if you have never taken another medicine for high blood pressure

Some MEDICINES MAY INTERACT with Amlodipine/Valsartan/Hydrochlorothiazide. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Dofetilide or ketanserin because the risk of irregular heartbeat may be increased

  • Aliskiren, potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased

  • ACE inhibitors (eg, ramipril) because the risk of kidney problems and high blood potassium levels may be increased

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen) because they may decrease Amlodipine/Valsartan/Hydrochlorothiazide's effectiveness and the risk of serious kidney problems may be increased

  • Adrenocorticotropic hormone (ACTH), barbiturates (eg, phenobarbital), conivaptan, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), itraconazole, ketoconazole, narcotic pain relievers (eg, morphine), HIV protease inhibitors (eg, ritonavir), rifampin, sildenafil, or other medicines for high blood pressure because they may increase the risk of Amlodipine/Valsartan/Hydrochlorothiazide's side effects

  • Aspirin, cholestyramine, or colestipol because they may decrease Amlodipine/Valsartan/Hydrochlorothiazide's effectiveness

  • Carbamazepine, diazoxide, digoxin, lithium, or simvastatin because the risk of their side effects and toxic effects may be increased by Amlodipine/Valsartan/Hydrochlorothiazide

  • Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Amlodipine/Valsartan/Hydrochlorothiazide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amlodipine/Valsartan/Hydrochlorothiazide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Amlodipine/Valsartan/Hydrochlorothiazide:


Use Amlodipine/Valsartan/Hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Amlodipine/Valsartan/Hydrochlorothiazide. Talk to your pharmacist if you have questions about this information.

  • Take Amlodipine/Valsartan/Hydrochlorothiazide by mouth with or without food.

  • Amlodipine/Valsartan/Hydrochlorothiazide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.

  • If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Amlodipine/Valsartan/Hydrochlorothiazide.

  • Take Amlodipine/Valsartan/Hydrochlorothiazide on a regular schedule to get the most benefit from it. Taking Amlodipine/Valsartan/Hydrochlorothiazide at the same time each day will help you remember to take it.

  • Continue to take Amlodipine/Valsartan/Hydrochlorothiazide even if you feel well. Do not miss any doses.

  • If you miss a dose of Amlodipine/Valsartan/Hydrochlorothiazide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amlodipine/Valsartan/Hydrochlorothiazide.



Important safety information:


  • Amlodipine/Valsartan/Hydrochlorothiazide may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Amlodipine/Valsartan/Hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Amlodipine/Valsartan/Hydrochlorothiazide may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • It may take up to 2 weeks or more for Amlodipine/Valsartan/Hydrochlorothiazide to work fully. Do not stop using Amlodipine/Valsartan/Hydrochlorothiazide or change your dose of Amlodipine/Valsartan/Hydrochlorothiazide without checking with your doctor.

  • Amlodipine/Valsartan/Hydrochlorothiazide contains hydrochlorothiazide, a sulfonamide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Amlodipine/Valsartan/Hydrochlorothiazide. Contact your doctor immediately if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Your doctor may also prescribe a potassium supplement for you. If so, take the potassium supplement exactly as prescribed. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

  • Check with your doctor before you use a salt substitute or a product that has potassium in it.

  • If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.

  • Amlodipine/Valsartan/Hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Amlodipine/Valsartan/Hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Amlodipine/Valsartan/Hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Tell your doctor or dentist that you take Amlodipine/Valsartan/Hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.

  • Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.

  • Amlodipine/Valsartan/Hydrochlorothiazide may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Amlodipine/Valsartan/Hydrochlorothiazide.

  • Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Amlodipine/Valsartan/Hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Amlodipine/Valsartan/Hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects.

  • Amlodipine/Valsartan/Hydrochlorothiazide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Amlodipine/Valsartan/Hydrochlorothiazide may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Amlodipine/Valsartan/Hydrochlorothiazide is found breast milk. Do not breast-feed while taking Amlodipine/Valsartan/Hydrochlorothiazide.


Possible side effects of Amlodipine/Valsartan/Hydrochlorothiazide:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; headache; indigestion; light-headedness; mild back pain; muscle spasms; nausea; sore throat or discomfort when swallowing; stuffy nose; tiredness; upset stomach.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes (eg, decreased vision clearness); burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; eye pain; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); numbness of an arm or leg; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness, drowsiness, or light-headedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; sudden, severe headache; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual thirst, tiredness, or weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; flushing; severe or persistent dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, drowsiness; dry eyes; fast heartbeat; nausea; restlessness; unusual thirst, tiredness, or weakness; vomiting).


Proper storage of Amlodipine/Valsartan/Hydrochlorothiazide:

Store Amlodipine/Valsartan/Hydrochlorothiazide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amlodipine/Valsartan/Hydrochlorothiazide out of the reach of children and away from pets.


General information:


  • If you have any questions about Amlodipine/Valsartan/Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider.

  • Amlodipine/Valsartan/Hydrochlorothiazide is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Amlodipine/Valsartan/Hydrochlorothiazide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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