Candesartan Cilexetil (Oral Route)

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 of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Candesartan is an angiotensin II receptor blocker. It works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, candesartan relaxes blood vessels . This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Candesartan is also used to treat heart failure in adults and cut down on the number of hospital visits for heart problems .

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of candesartan in children 1 to 16 years of age.

Use of candesartan in newborn babies and infants up to 1 year of age is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of candesartan in the elderly. However, elderly patients may be more sensitive to the effects of candesartan than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving candesartan.

Pregnancy

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

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.

• Lithium

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


• Alclofenac


• Apazone


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Celecoxib


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Rofecoxib


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Valdecoxib


• Zomepirac

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:

• Dehydration (fluid and electrolyte loss due to excessive perspiration, vomiting, diarrhea, prolonged diuretic therapy, dialysis, or dietary salt restriction) or


• Heart failure or


• Hyponatremia (low sodium in the blood) or


• Hypovolemia (low blood volume)a€”Use with caution. The blood pressure-lowering effects of candesartan may be increased .

• Kidney disease or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change 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.

This medicine also works best when there is a constant amount in the blood . To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same time each day.

You may take this medicine with or without food.

If your child cannot swallow the tablets, an oral liquid may be given. Ask your doctor or pharmacist about this.

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 heart failure:
    
    
    
    • Adultsa€”At first, 4 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 32 mg.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”At first, 16 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 32 mg.
    
    
    • Children 6 to 16 years of age and weighing more than 50 kga€”Dose is based on body weight and must be determined by your doctor . The dose is usually 4 to 32 milligrams (mg) per day.
    
    
    • Children 6 to 16 years of age and weighing less than 50 kga€”Dose is based on body weight and must be determined by your doctor . The dose is usually 2 to 16 milligrams (mg) per day.
    
    
    • Children 1 to 5 years of agea€”Dose is based on body weight and must be determined by your doctor . The dose is usually 0.05 to 0.4 milligram (mg) per kilogram (kg) of body weight per day. However, the starting dose for oral suspension is 0.20 milligram (mg) per kilogram (kg) of body weight per day.
    
    
    • Children younger than 1 year of agea€”Use is not recommended .
    
    
    
    
  
  
  
  

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 or your child`s progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby . If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not take other medicines unless they have been discussed with your doctor . This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure .

Dizziness, lightheadedness, or fainting may occur after the first dose of this medicine, 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 not alert.

Dizziness, lightheadedness, or fainting also may occur 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.

Check with your doctor right away if you or your child 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 .

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child is having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin .

Hyperkalemia (high potassium in the blood) may occur while you are using 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.

Black patients may have a smaller response to the blood pressure-lowering effects of candesartan.

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:

Rare

• Arm, back, or jaw pain


• Bleeding gums


• Chest pain or discomfort


• Chest tightness or heaviness


• Chills


• Cough or hoarseness


• Dizziness


• Fainting


• Fast or irregular heartbeat


• Fever


• Joint pain


• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Lightheadedness


• Lower back or side pain


• Nausea


• Nosebleeds


• Pain or discomfort in the arms, jaw, back, or neck


• Painful or difficult urination


• Shortness of breath


• Sweating


• Swelling of the feet or lower legs


• Vomiting

Incidence not known

• Abdominal or stomach pain


• Black, tarry stools


• Bloody urine


• Coma


• Confusion


• Convulsions


• Dark urine


• Decreased urine output


• Difficult or troubled breathing


• General feeling of tiredness or weakness


• Headache


• Hives or welts


• Increased blood pressure


• Increased thirst


• Itching


• Light-colored stools


• Loss of appetite


• Muscle pain or cramps


• Nervousness


• Numbness or tingling in the hands, feet, or lips


• Pale skin


• Redness of the skin


• Skin rash


• Sore throat


• Sores, ulcers, or white spots on the lips or in the mouth


• Swelling of the face, ankles, or hands


• Unusual bleeding or bruising


• Unusual tiredness or weakness


• Upper right abdominal or stomach pain


• Weakness or heaviness of the legs


• Weight gain


• Yellow eyes or 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

• Ear congestion or pain


• Head congestion


• Nasal congestion


• Runny or stuffy nose


• Sneezing

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.