Candesartan (oral route)

Brand Name

US Brand Name

Atacand

Description

Candesartan is used alone or together with other medicines to treat high blood pressure (hypertension) in adults and children 1 to 16 years of age. 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. Lowering blood pressure can reduce the risk of strokes and heart attacks.

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

Candesartan is an angiotensin II receptor blocker (ARB). It works by blocking the action of a substance in the body that causes the blood vessels to tighten. As a result, candesartan 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of candesartan to treat hypertension in children 1 to 16 years of age.

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

No information is available on the relationship of age to the effects of candesartan to treat heart failure 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 candesartan in the elderly. However, elderly patients may be more sensitive to the effects of candesartan than younger adults.

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 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
Trimethoprim

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.

Proper Use

This medicine comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. 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.

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 high blood pressure:
  - Adults—At first, 16 milligrams (mg) once a day. Your doctor may change your dose as needed. However, the dose is usually not more than 32 mg per day.
  - Children 6 to 16 years of age and weighing more than 50 kilograms (kg)—The usual starting dose for the tablet is 8 to 16 mg once a day. Your doctor may change your dose as needed. However, the dose is usually not more than 32 mg per day.
  - Children 6 to 16 years of age and weighing less than 50 kg—The usual starting dose for the tablet is 4 to 8 mg once a day. Your doctor may change your dose as needed. However, the dose is usually not more than 16 mg per day.
  - Children 1 to 5 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.05 to 0.4 mg per kg of body weight per day.
  - Children younger than 1 year of age—Use is not recommended.
- For heart failure:
  - Adults—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 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

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Use the mixed oral liquid within 30 days after first opening the bottle. Do not freeze.

Precautions

It is very important that your doctor check the progress of you or your child 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. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this 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 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 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.

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.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

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

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.

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
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.

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