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Amlodipine/ valsartan

Generic Name: amlodipine/valsartan (am-LOE-di-peen/val-SAR-tan)
Brand Name: Exforge

Amlodipine/valsartan 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. If you are planning to become pregnant, talk with your doctor about other treatment options.


Amlodipine/ valsartan is used for:

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

Amlodipine/valsartan is a calcium channel blocker and angiotensin II receptor blocker combination. It works by relaxing the blood vessels.

Do NOT use amlodipine/ valsartan if:

  • you are allergic to any ingredient in amlodipine/valsartan
  • you are pregnant
  • you are taking a medicine that contains aliskiren and you also have diabetes or kidney problems. Check with your doctor or pharmacist if you are not sure if a medicine you take contains aliskiren

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

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Before using amlodipine/ valsartan:

Some medical conditions may interact with amlodipine/valsartan. 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 able to become pregnant
  • 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 high blood potassium levels or low blood sodium levels, or are on a low-salt (sodium) diet
  • if you have a history of gallbladder or liver problems, kidney problems (eg, renal artery stenosis), stroke, heart attack, low blood pressure, blood vessel problems, diabetes, swelling or fluid retention, or heart problems (eg, angina, heart failure, narrowing of heart blood vessels)
  • if you are on dialysis or will be having surgery
  • if you drink alcohol
  • if you are taking another medicine for high blood pressure or heart problems

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

  • Diuretics (eg, furosemide, hydrochlorothiazide) or sildenafil because the risk of low blood pressure may be increased
  • Potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene) or potassium supplements because the risk of high blood potassium levels may be increased
  • ACE inhibitors (eg, lisinopril) or aliskiren because the risk of certain side effects (eg, kidney problems and high blood potassium levels may be increased
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen, celecoxib) because they make decrease amlodipine/valsartan's effectiveness and the risk of serious kidney problems may be increased
  • Clarithromycin, cobicistat, conivaptan, cyclosporine, itraconazole, ketoconazole, protease inhibitors (eg, ritonavir, telaprevir), rifamycins (eg, rifampin), or telithromycin because they may increase the risk of amlodipine/valsartan's side effects
  • Lithium or simvastatin because the risk of their side effects may be increased by amlodipine/valsartan

This may not be a complete list of all interactions that may occur. Ask your health care provider if amlodipine/valsartan 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:

Use amlodipine/valsartan as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with amlodipine/valsartan. Talk to your pharmacist if you have questions about this information.
  • Take amlodipine/valsartan by mouth with or without food.
  • Take amlodipine/valsartan on a regular schedule to get the most benefit from it. Taking amlodipine/valsartan at the same time each day will help you remember to take it.
  • If you miss a dose of amlodipine/valsartan, 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.

Important safety information:

  • Amlodipine/valsartan may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use amlodipine/valsartan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Amlodipine/valsartan 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 to work fully. Do not stop using amlodipine/valsartan or change your dose of amlodipine/valsartan without checking with your doctor.
  • 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.
  • If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions.
  • Tell your doctor or dentist that you take amlodipine/valsartan before you receive any medical or dental care, emergency care, or surgery.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • 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.
  • Although rare, a component of amlodipine/valsartan (amlodipine) has been known to increase chest pain and increase the risk of a heart attack, especially in patients with severe heart disease.
  • Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use amlodipine/valsartan. 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 with caution in the ELDERLY; they may be more sensitive to its effects.
  • Amlodipine/valsartan should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Amlodipine/valsartan 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. It is not known if amlodipine/valsartan is found in breast milk. Do not breast-feed while taking amlodipine/valsartan.

Possible side effects of amlodipine/ valsartan:

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; mild sore throat or discomfort when swallowing; stuffy nose; upper respiratory tract infection (head or chest cold).

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or arm pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; severe or persistent dizziness or light-headedness; severe or persistent muscle pain or aches; shortness of breath; sudden, severe nausea or vomiting; 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 sweating or weakness; worsening of angina pain (eg, longer, more often, more severe).

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; fast or slow heartbeat; flushing; severe dizziness.

Proper storage of amlodipine/valsartan:

Store amlodipine/valsartan 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 out of the reach of children and away from pets.

General information:

  • If you have any questions about amlodipine/valsartan, please talk with your doctor, pharmacist, or other health care provider.
  • Amlodipine/valsartan 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 should not be used to decide whether or not to take amlodipine/valsartan or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about amlodipine/valsartan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to amlodipine/valsartan. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using amlodipine/valsartan.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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