Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Exforge HCT

Descriptions


Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a heart failure or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amlodipine, valsartan, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine, valsartan, and hydrochlorothiazide combination in the elderly. However, elderly patients are more likely to have unwanted effects which may require an adjustment in the dose for patients receiving this medicine.

Pregnancy

Information about this amlodipine-valsartan-and-hydrochlorothiazide-oral-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetyldigoxin
  • Amiodarone
  • Arsenic Trioxide
  • Atazanavir
  • Benazepril
  • Captopril
  • Carbamazepine
  • Ceritinib
  • Clarithromycin
  • Clopidogrel
  • Conivaptan
  • Cyclophosphamide
  • Dabrafenib
  • Dantrolene
  • Deslanoside
  • Digitalis
  • Digitoxin
  • Digoxin
  • Domperidone
  • Droperidol
  • Enalapril
  • Enalaprilat
  • Eslicarbazepine Acetate
  • Fentanyl
  • Flecainide
  • Fosinopril
  • Idelalisib
  • Ketanserin
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Methotrexate
  • Metildigoxin
  • Mitotane
  • Moexipril
  • Ouabain
  • Perindopril Erbumine
  • Piperaquine
  • Primidone
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Siltuximab
  • Simvastatin
  • Sotalol
  • St John's Wort
  • Tegafur
  • Telaprevir
  • Trandolapril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Aceclofenac
  • Acemetacin
  • Alacepril
  • Alprenolol
  • Amtolmetin Guacil
  • Aspirin
  • Atenolol
  • Avanafil
  • Benazepril
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bromfenac
  • Bucindolol
  • Bufexamac
  • Captopril
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Chlorpropamide
  • Cholestyramine
  • Choline Salicylate
  • Cilazapril
  • Clonixin
  • Dalfopristin
  • Delapril
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dilevalol
  • Diltiazem
  • Dipyrone
  • Enalaprilat
  • Enalapril Maleate
  • Esmolol
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ginkgo
  • Glipizide
  • Gossypol
  • Ibuprofen
  • Ibuprofen Lysine
  • Imatinib
  • Imidapril
  • Indinavir
  • Indomethacin
  • Itraconazole
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Labetalol
  • Levobunolol
  • Licorice
  • Lisinopril
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Nadolol
  • Naproxen
  • Nebivolol
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxprenolol
  • Oxyphenbutazone
  • Parecoxib
  • Penbutolol
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Pindolol
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Quinupristin
  • Ramipril
  • Rifapentine
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sotalol
  • Spirapril
  • Sulindac
  • Talinolol
  • Temocapril
  • Tenoxicam
  • Tertatolol
  • Tiaprofenic Acid
  • Timolol
  • Tolfenamic Acid
  • Tolmetin
  • Topiramate
  • Trandolapril
  • Valdecoxib
  • Zofenopril

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (severe chest pain) or
  • Diabetes or
  • Electrolyte imbalances (e.g., low levels of salt or sodium in the body) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Gallstones, or history of or
  • Glaucoma, acute angle-closure or
  • Gout, history of or
  • Heart attack, history of or
  • Heart or blood vessel disease (e.g., severe obstructive coronary artery disease) or
  • Hypercalcemia (high calcium in the blood) or
  • Hypercholesterolemia (high cholesterol in the blood) or
  • Hypertriglyceridemia (high triglycerides or fats in the blood) or
  • Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.
  • Angioedema (an allergic reaction) with other blood pressure medicines (e.g., benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of, or
  • Anuria (not able to pass urine) or
  • Diabetes patients who are also taking aliskiren (Tekturna®) or
  • Sulfa drug allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in patients with these conditions.
  • Aortic or mitral stenosis (problem with heart valve), severe—May cause side effects to become worse.
  • Asthma, history of—May increase likelihood of having an allergic reaction.
  • Congestive heart failure, severe—Use may lead to kidney problems.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any symptoms of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—One tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than amlodipine 10 milligrams (mg), valsartan 320 mg, and hydrochlorothiazide 25 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or uneven heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, or sweating.

Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Hyperkalemia (high potassium in the blood) may occur in certain people receiving this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use any medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Dizziness
  2. swelling

Rare

  1. Bladder pain
  2. bloody or cloudy urine
  3. blurred vision
  4. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  5. chest pain
  6. chills
  7. cold sweats
  8. coma
  9. confusion
  10. convulsions
  11. cough
  12. decreased urination
  13. diarrhea
  14. difficult or labored breathing
  15. difficult, burning, or painful urination
  16. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  17. dry mouth
  18. fast, pounding, or irregular heartbeat or pulse
  19. fever
  20. flushed, dry skin
  21. frequent urge to urinate
  22. fruit-like breath odor
  23. head congestion
  24. hoarseness or other voice changes
  25. increased hunger
  26. increased sweating
  27. increased thirst
  28. lightheadedness
  29. loss of appetite
  30. loss of consciousness
  31. lower back or side pain
  32. muscle aches and pains
  33. nausea or vomiting
  34. numbness or tingling in the hands, feet, or lips
  35. shivering
  36. sneezing
  37. sore throat
  38. stuffy or runny nose
  39. sweating
  40. tightness in the chest
  41. trouble sleeping
  42. unexplained weight loss
  43. unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. heartburn
  5. indigestion
  6. muscle spasms
  7. stomach discomfort, upset, or pain

Rare

  1. Bleeding after defecation
  2. body aches or pain
  3. burning feeling in the chest or stomach
  4. change in taste
  5. continuing ringing or buzzing or other unexplained noise in the ears
  6. decreased interest in sexual intercourse
  7. decreased weight
  8. depression
  9. difficulty having a bowel movement (stool)
  10. difficulty moving
  11. fear or nervousness
  12. feeling of constant movement of self or surroundings
  13. hearing loss
  14. inability to have or keep an erection
  15. increased appetite
  16. itching skin
  17. lack or loss of strength
  18. loss in sexual ability, desire, drive, or performance
  19. loss of taste
  20. muscle weakness
  21. neck pain
  22. pain in the arms or legs
  23. pain, swelling, or redness in the joints
  24. rash
  25. sensation of spinning
  26. shakiness in the legs, arms, hands, or feet
  27. sleeplessness
  28. sneezing
  29. swelling of the joints
  30. tender, swollen glands in the neck
  31. tenderness in the stomach area
  32. toothache
  33. trouble swallowing
  34. uncomfortable swelling around the anus
  35. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  36. upper abdominal or stomach pain
  37. voice changes
  38. weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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