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Drugs reference index «Exforge HCT»

Exforge HCT


Exforge HCT

Generic Name: amlodipine, valsartan, and hydrochlorothiazide (Oral route)

am-LOE-di-peen BES-i-late, val-SAR-tan, hye-droe-klor-oh-THYE-a-zide

Oral routeTablet
  • Avoid use in pregnancy
    • When pregnancy is detected, discontinue amlodipine besylate/valsartan/hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus .

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s):

In the U.S.

  • Exforge HCT

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Exforge HCT

Amlodipine, valsartan, and hydrochlorothiazide is a combination of medicines that is used to treat high blood pressure (hypertension). This medicine will not cure your high blood pressure, but it does help control it. 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 stroke, heart failure, or kidney failure. High blood pressure may also increase the risk for heart attacks. These problems may be less likely to occur if high blood pressure is controlled.

Amlodipine is a calcium channel blocker. 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. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes 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.

Before Using Exforge HCT

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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies 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.

Breast Feeding

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.

Interactions with Medicines

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.

  • 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
  • Dantrolene
  • Deslanoside
  • Digitalis
  • Digitoxin
  • Digoxin
  • Droperidol
  • Fentanyl
  • Flecainide
  • Ketanserin
  • Levomethadyl
  • Lithium
  • Metildigoxin
  • Ouabain
  • Proscillaridin
  • Sotalol

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
  • Alclofenac
  • Alprenolol
  • Apazone
  • Atenolol
  • Benazepril
  • Benoxaprofen
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bromfenac
  • Bucindolol
  • Bufexamac
  • Calcium Carbonate
  • Captopril
  • Carbamazepine
  • Carprofen
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Chlorpropamide
  • Cholestyramine
  • Cilazapril
  • Clometacin
  • Clonixin
  • Clopidogrel
  • Conivaptan
  • Cyclophosphamide
  • Dalfopristin
  • Delapril
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dilevalol
  • Dipyrone
  • Droxicam
  • Enalaprilat
  • Enalapril Maleate
  • Esmolol
  • Etodolac
  • Etofenamate
  • Felbinac
  • Fenbufen
  • Fenoprofen
  • Fentiazac
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ginkgo
  • Glipizide
  • Gossypol
  • Ibuprofen
  • Imidapril
  • Indinavir
  • Indomethacin
  • Indoprofen
  • Isoxicam
  • Itraconazole
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Labetalol
  • Levobunolol
  • Licorice
  • Lisinopril
  • Lornoxicam
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mepindolol
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nabumetone
  • Nadolol
  • Naproxen
  • Nebivolol
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxprenolol
  • Oxyphenbutazone
  • Penbutolol
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Pindolol
  • Pirazolac
  • Piroxicam
  • Pirprofen
  • Propranolol
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Quinupristin
  • Ramipril
  • Rifapentine
  • Ritonavir
  • Rofecoxib
  • Saquinavir
  • Sotalol
  • Spirapril
  • St John's Wort
  • Sulindac
  • Suprofen
  • Talinolol
  • Temocapril
  • Tenidap
  • Tenoxicam
  • Tertatolol
  • Tiaprofenic Acid
  • Ticrynafen
  • Timolol
  • Tolmetin
  • Topiramate
  • Trandolapril
  • Valdecoxib
  • Zofenopril
  • Zomepirac

Interactions with Food/Tobacco/Alcohol

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
  • Gout, history of or
  • Hyperuricemia (high uric acid in the blood) or
  • Hypochloremic alkalosis (a metabolic disorder) or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Hyponatremia (low sodium in the blood) or
  • Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.
  • Anuria (not able to form urine) or
  • Kidney disease, severe or
  • Liver disease, severe or
  • Sulfonamide allergy (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®)—Should not be used in patients with these conditions.
  • Asthma, history of or
  • Dehydration or
  • Diarrhea, severe or
  • Heart attack, recent or
  • Heart disease or
  • Heart failure or
  • Vomiting, severe—May cause side effects to become worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Exforge HCT

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 condition. In fact, many patients 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.

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 if needed. However, the dose is usually not more than amlodipine 10 milligrams (mg), valsartan 320 mg, and hydrochlorothiazide 25 mg.
      • 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 While Using Exforge HCT

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and 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 occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

You may also have dizziness, lightheadedness, or fainting if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

This medicine may worsen the symptoms of angina (chest pain) or heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing.

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 or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Exforge HCT 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
  • Swelling
Rare
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning while urinating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • convulsions
  • cough
  • cough producing mucus
  • decreased urination
  • decreased urine output
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • dry mouth
  • ear congestion or pain
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • head congestion
  • headache
  • hoarseness or other voice changes
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urination
  • joint pain
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • lower back or side pain
  • mood changes
  • muscle aches and pains
  • nasal congestion
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • rapid breathing
  • runny nose
  • shivering
  • shortness of breath
  • sneezing
  • sore throat
  • stomach ache
  • sunken eyes
  • sweating
  • swelling of the face, ankles, or hands
  • tightness in the chest
  • trouble with sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • wheezing
  • wrinkled skin

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
  • Acid or sour stomach
  • back pain
  • belching
  • heartburn
  • indigestion
  • muscle spasms
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
Rare
  • Bleeding after defecation
  • body aches or pain
  • burning feeling in the chest or stomach
  • burning, numbness, pain, or tingling in all fingers except smallest finger
  • change in taste
  • congestion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased interest in sexual intercourse
  • decreased weight
  • depression
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • hearing loss
  • inability to have or keep an erection
  • increased appetite
  • indigestion
  • itching skin
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • loss of taste
  • muscle weakness
  • neck pain
  • pain in the arms or legs
  • pain, swelling, or redness in the joints
  • rash
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stomach upset
  • swelling of the joints
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • toothache
  • trembling or shaking of the hands or feet
  • trouble with swallowing
  • unable to sleep
  • uncomfortable swelling around the anus
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • upper abdominal pain
  • voice changes
  • 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.

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  • Exforge HCT Prescribing Information (FDA)
  • Exforge HCT MedFacts Consumer Leaflet (Wolters Kluwer)
  • Exforge HCT Consumer Overview

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