Amlodipine/Valsartan/Hydrochlorothiazide Tablets

Amlodipine, valsartan, hydrochlorothiazide, or the brand name - Exforge HCT, is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Garvan

Pharmacist - M.B.A. (Public Health) D.I.C.

Amlodipine/Valsartan/Hydrochlorothiazide Tablets

What is Exforge HCT? Amlodipine is a calcium…

Garvan J. Lynch
MBA (Public Health)

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What is Exforge HCT?

  • 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.

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.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Amphetamine
  • Amtolmetin Guacil
  • Arsenic Trioxide
  • Aspirin
  • Atazanavir


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.

  • Aminolevulinic Acid
  • Bepridil
  • Bromfenac
  • Bufexamac
  • Carbamazepine
  • Celecoxib
  • Cholestyramine


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 medicine
  • 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.

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

  • Dizziness
  • swelling

Rare

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • convulsions
  • cough
  • decreased urination
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • head congestion


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

Rare

  • Bleeding after defecation
  • body aches or pain
  • burning feeling in the chest or stomach
  • change in taste
  • 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 moving
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • hearing loss
  • inability to have or keep an erection
  • increased appetite
  • itching skin
  • lack or loss of strength


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

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.

References:

http://www.exforge.com/index.jsp

https://www.ema.europa.eu/en/documents/product-information/exforge-hct-epar-product-information_en.pdf

https://www.medicines.ie/medicines/exforge-hct-film-coated-tablets-32099/patient-info

https://www.webmd.com/drugs/2/drug-152359/exforge-hct-oral/details

https://www.rxlist.com/exforge-hct-side-effects-drug-center.htm

https://www.rxlist.com/exforge-hct-drug.htm

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