Description
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 age-related kidney, liver, or heart disease, which may require an adjustment in the dose for patients receiving this medicine.
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
- Sparsentan
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.
- Abametapir
- Acarbose
- Aceclofenac
- Acemetacin
- Acetyldigoxin
- Albiglutide
- Albuterol
- Alogliptin
- Amphetamine
- Amtolmetin Guacil
- Arsenic Trioxide
- Asciminib
- Aspirin
- Atazanavir
- Avacopan
- Benazepril
- Benzhydrocodone
- Benzphetamine
- Bromfenac
- Bromocriptine
- Bufexamac
- Buprenorphine
- Canagliflozin
- Captopril
- Carbamazepine
- Cefepime
- Ceftobiprole Medocaril
- Celecoxib
- Ceritinib
- Chlorpropamide
- Choline Salicylate
- Cilazapril
- Clarithromycin
- Clonidine
- Clonixin
- Clopidogrel
- Codeine
- Conivaptan
- Cyclosporine
- Dantrolene
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.
- Aceclofenac
- Acemetacin
- Aminolevulinic Acid
- Amprenavir
- Amtolmetin Guacil
- Aprepitant
- Bepridil
- Boceprevir
- Bromfenac
- Bufexamac
- Carbamazepine
- Celecoxib
- Cholestyramine
- Choline Salicylate
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Clonixin
- Cobicistat
- Crizotinib
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Diltiazem
- Dipyrone
- Dronedarone
- Droxicam
- Duvelisib
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Fluconazole
- Flufenamic Acid
- Flurbiprofen
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 (eg, 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 (eg, 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
- Kidney disease or
- Myopia (changes in the eyeball causing vision problems), acute or
- Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.
- Angioedema (an allergic reaction) with other blood pressure medicines (eg, 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, eg, 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.
Swallow the tablet whole. Do not break, crush, or chew it. 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.
- For high blood pressure:
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, especially in your second or third trimester. 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. You may need to stop using this medicine.
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, trouble breathing, or sweating.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
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 stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, 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.
This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.
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
- Dizziness
- swelling
Rare
- Bladder pain
- bloody or cloudy urine
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- cold sweats
- coma
- confusion
- 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
- hoarseness or other voice changes
- increased hunger
- increased sweating
- increased thirst
- lightheadedness
- loss of appetite
- loss of consciousness
- lower back or side pain
- muscle aches and pains
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- seizures
- shiny bump
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- trouble sleeping
- unexplained weight loss
- unusual tiredness or weakness
- white, yellow or waxy scar-like area
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
- 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
- sleeplessness
- swelling of the joints
- tender, swollen glands in the neck
- tenderness in the stomach area
- toothache
- trouble swallowing
- uncomfortable swelling around the anus
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- 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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