Description
Amlodipine and valsartan is a combination of medicines that are 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 reduces 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 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.
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 and valsartan 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 and valsartan combination in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, which may require caution in patients receiving amlodipine and valsartan combination.
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
- 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
- Asciminib
- Atazanavir
- Avacopan
- Benazepril
- Captopril
- Carbamazepine
- Ceftobiprole Medocaril
- Ceritinib
- Cilazapril
- Clarithromycin
- Clonidine
- Clopidogrel
- Conivaptan
- Cyclosporine
- Dantrolene
- Darolutamide
- Darunavir
- Digoxin
- Domperidone
- Droperidol
- Elexacaftor
- Eltrombopag
- Enalapril
- Enalaprilat
- Epirubicin
- Erythromycin
- Fedratinib
- Fexinidazole
- Fosinopril
- Fosnetupitant
- Furosemide
- Itraconazole
- Lacosamide
- Lisinopril
- Lithium
- Mavacamten
- Melphalan
- Moexipril
- Netupitant
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
- Amprenavir
- Amtolmetin Guacil
- Aprepitant
- Boceprevir
- Bromfenac
- Bufexamac
- Celecoxib
- 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
- Fluvoxamine
- Fosamprenavir
- Ibuprofen
- Idelalisib
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
- Electrolyte imbalances (e.g., low sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Heart attack, recent or
- Heart problems (e.g., aortic stenosis, heart failure) or
- Kidney problems or
- Patients undergoing surgery or dialysis—Use with caution. May make these conditions worse.
- Congestive heart failure, severe—Use may lead to kidney problems.
- Angioedema (an allergic reaction) with other blood pressure medicines (e.g., benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of or
- Diabetes patients who are also taking aliskiren (Tekturna®)—Should not be used in these patients.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Amlodipine and valsartan combination is used when a single medicine to lower your blood pressure is not enough. It is also used as the first medicine to treat your condition if your doctor feels that you need to take more than one blood pressure medicine.
This medicine comes with a patient information insert. Read and follow the instructions 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 signs 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) and valsartan 320 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. 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 this medicine before you drive, use machines, or do anything else 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.
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 which may cause 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.
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.
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.
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 tend to 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
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
Less common
- Body aches or pain
- chills
- cough
- difficulty with breathing
- dizziness
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Rare
- Ankle, knee, or great toe joint pain
- bloody or cloudy urine
- blurred or loss of vision
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- cold sweats
- confusion
- congestion
- cough producing mucus
- diarrhea
- difficult, burning, or painful urination
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- flushed, dry skin
- heart murmur
- hives
- hoarseness
- indigestion
- itching
- joint pain, stiffness, or swelling
- loss of appetite
- nausea
- pain in the lower back, bottom, or hips
- pain in the upper leg
- pain or tenderness around the eyes and cheekbones
- rash
- redness of the skin
- stomach cramps, tenderness, or pain
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- tightness of the chest
- trouble with swallowing
- troubled breathing
- vomiting
- watery or bloody diarrhea
- weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Chest discomfort
- cold, clammy skin
- fast, weak pulse
- flushing
- lightheadedness or fainting
- slow heartbeat
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:
Rare
- Acid or sour stomach
- back pain
- belching
- bone pain
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty having a bowel movement (stool)
- difficulty with moving
- fear or nervousness
- feeling sad or empty
- full or bloated feeling
- hearing loss
- heartburn
- inability to have or keep an erection
- increased sensitivity to sunlight
- irritability
- itching, pain, redness, or swelling of the eye or eyelid
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- muscle aching or cramping
- pain in the arms or legs
- passing gas
- pressure in the stomach
- redness in the joints
- redness of the skin
- sensation of spinning
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- swelling of the abdominal or stomach area
- tiredness
- toothache
- trouble concentrating
- unable to sleep
- unusually warm skin
- watering of the eyes
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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