Exforge

Generic Name: amlodipine and valsartan (Oral route)

am-LOE-di-peen BES-i-late, val-SAR-tan

Oral route(Tablet)

When pregnancy is detected, discontinue amlodipine besylate/valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

Commonly used brand name(s)

In the U.S.

• Exforge

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Exforge

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. 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 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.

Before Using Exforge

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.

Pregnancy

	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.

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

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 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.

• Amiodarone


• Atazanavir


• Benazepril


• Conivaptan


• Dantrolene


• Droperidol


• Enalapril


• Enalaprilat


• Lisinopril


• Lithium


• Moexipril


• Perindopril


• Quinapril


• Ramipril


• Simvastatin


• 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


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Carteolol


• Carvedilol


• Celecoxib


• Celiprolol


• Clopidogrel


• Dalfopristin


• Diclofenac


• Diflunisal


• Dilevalol


• Diltiazem


• Esmolol


• Etodolac


• Fenoprofen


• Fluconazole


• Flurbiprofen


• Ibuprofen


• Imatinib


• Indinavir


• Indomethacin


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nepafenac


• Oxaprozin


• Oxprenolol


• Penbutolol


• Pindolol


• Piroxicam


• Propranolol


• Quinupristin


• Rifapentine


• Ritonavir


• Salsalate


• Sotalol


• St John's Wort


• Sulindac


• Talinolol


• Tertatolol


• Timolol


• Tolmetin

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


• 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


• Heart attack, recent or


• Heart failure—Use with caution. May make these conditions worse.

• Heart failure or


• 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

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.
    
    
  
  

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

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 occur, especially 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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help.

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.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or salt in the body).

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; shortness of breath; 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.

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.

Exforge 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

• Abnormal or decreased touch sensation


• ankle, knee, or great toe joint pain


• bladder pain


• bleeding after defecation


• bloody nose


• 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


• burning, numbness, pain, or tingling in all fingers except smallest finger


• 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


• double vision


• dry mouth


• dryness of the throat


• fast, irregular, pounding, or racing heartbeat or pulse


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• general feeling of discomfort or illness


• halos around lights


• heart murmur


• hives


• hoarseness


• increased hunger


• increased thirst


• increased urination


• indigestion


• irritation


• itching


• joint pain, stiffness, or swelling


• labored breathing


• loss of appetite


• loss of consciousness


• lower back or side pain


• muscle pains


• nausea


• night blindness


• overbright appearance of lights


• 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


• shivering


• shortness of breath or troubled breathing


• stomach cramps, tenderness, or pain


• stomachache


• sweating


• swelling of the eyelids, face, lips, hands, or feet


• swelling with pits or depressions on the skin


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tenderness in the stomach area


• tightness of the chest or wheezing


• tooth or gum pain


• trouble in swallowing


• trouble sleeping


• tunnel vision


• uncomfortable swelling around anus


• voice changes


• 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


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• difficulty with moving


• discouragement


• excess air or gas in the stomach or intestines


• fear or nervousness


• feeling of constant movement of self or surroundings


• 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


• muscle spasms or stiffness


• 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


• sleeplessness


• stomach soreness, discomfort, or upset


• 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.

See also: Exforge side effects (in more detail)

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More Exforge resources

• Exforge Side Effects (in more detail)
• Exforge Use in Pregnancy & Breastfeeding
• Drug Images
• Exforge Drug Interactions
• Exforge Support Group
• 27 Reviews for Exforge - Add your own review/rating

• Exforge Prescribing Information (FDA)


• Exforge MedFacts Consumer Leaflet (Wolters Kluwer)


• Exforge Consumer Overview

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