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US Brand Names

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Description

Carvedilol belongs to a group of medicines called beta-adrenergic blocking agents, beta-blocking agents, or, more commonly, beta-blockers. Beta-blockers work by affecting the response to some nerve impulses in certain parts of the body. As a result, they decrease the heart's need for blood and oxygen by reducing its workload. They also help the heart to beat more regularly.

Carvedilol 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 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.

Carvedilol also is used to prevent further worsening of congestive heart failure. It is used to treat left ventricular dysfunction after a heart attack. Left ventricular dysfunction occurs when the left ventricle (the main pumping chamber of the heart) stiffens and enlarges and can cause the lungs to fill with blood. Carvedilol may also be used for other conditions as determined by your doctor.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet
• Capsule, Extended Release

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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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of carvedilol in children with use in other age groups.

Geriatric

Although this medicine has not been shown to cause different side effects or problems in older people than it does in younger adults, blood levels of carvedilol may be increased in the elderly. Elderly patients also may experience dizziness more frequently than will younger adults.

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.

• Albuterol
• Amiodarone
• Arformoterol
• Bambuterol
• Bitolterol
• Broxaterol
• Clenbuterol
• Clonidine
• Colterol
• Diltiazem
• Epinephrine
• Fenoldopam
• Fenoterol
• Fentanyl
• Formoterol
• Hexoprenaline
• Isoetharine
• Levalbuterol
• Metaproterenol
• Pirbuterol
• Procaterol
• Reproterol
• Rimiterol
• Ritodrine
• Salmeterol
• Terbutaline
• Tretoquinol
• Tulobuterol
• Verapamil

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:

• Allergic reaction, severe (that involved facial swelling and/or difficulty breathing), history of or
• Asthma or
• Related bronchospastic conditions, other—May cause a greater reaction to substances that aggravate these conditions and less of a response to the treatment of the reaction.

• Angina (severe chest pain)—May provoke chest pain.

• Bronchial conditions, nonallergic or
• Bronchitis, chronic or
• Edema (fluid retention or body swelling) or
• Emphysema—May aggravate these conditions.

• Bradycardia (unusually slow heartbeat) or other heart rate problems or
• Heart or blood vessel disease—May make problems resulting from these conditions worse.

• Low blood sugar (hypoglycemia)—May aggravate low blood sugar (hypoglycemia) levels caused by insulin and may delay recovery of blood sugar levels; in patients with diabetes and heart failure, carvedilol may further increase blood sugar levels; in addition, if your diabetes medicine causes your blood sugar to be too low, carvedilol may cover up some of the symptoms (fast heartbeat).

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of the medicine from the body.

• Overactive thyroid—May cover up symptoms of this condition, such as a fast heartbeat; suddenly stopping carvedilol may provoke symptoms of this condition.

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Proper Use

Take this medicine exactly as directed. This medicine works best if you take it at the same time each day; however, do not take more of this medicine and do not take it more often than your doctor ordered. Do not miss any doses.

Take this medicine with food.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

Swallow the extended-release capsule whole. Do not crush, break, or chew it .

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):
  • Congestive heart failure:
    • Adults—3.125 milligrams (mg) two times a day, taken with food. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .
  • Hypertension:
    • Adults—6.25 milligrams (mg) two times a day, taken with food. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .
  • Left ventricular dysfunction after a heart attack:
    • Adults—6.25 milligrams (mg) two times a day, taken with food. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .

• For oral dosage form (extended-release capsules):
  • Heart failure:
    • Adults—At first, 10 milligrams (mg) once a day for two weeks. Then, your doctor may increase your dose up to 80 mg once a day, if needed.
    • Children—Use and dose must be determined by your doctor .
  • Hypertension:
    • Adults—At first, 20 milligrams (mg) once a day for 7 to 14 days. Then, your doctor may increase your dose up to 80 mg once a day, if needed.
    • Children—Use and dose must be determined by your doctor .
  • Left ventricular dysfunction after a heart attack:
    • Adults—At first, 20 milligrams (mg) once a day for 3 to 10 days. Then, your doctor may increase your dose up to 80 mg once a day, if needed.
    • 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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Precautions

It is important that your doctor check your progress at regular visits. This is to make sure the medicine is working for you and to allow the dosage to be changed if needed.

Do not take other medicines unless they have been discussed with your doctor.

This medicine may cause dizziness, lightheadedness, or fainting. 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 experience these effects.

Dizziness, lightheadedness, or fainting can also occur when standing quickly. Sitting or lying down may help alleviate these effects.

Check with your doctor if you become dizzy or if you faint. Your dosage may need to be adjusted.

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

For diabetic patients:

• This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of hypoglycemia (low blood sugar), such as a rapid pulse rate. Check with your physician if you experience these problems or if you notice a change in the results of your blood or urine sugar tests .

For congestive heart failure patients:

• Check with your physician if you experience weight gain or increased shortness of breath. These may be signs of a worsening of your condition.

For patients who wear contact lenses:

• Carvedilol may cause your eyes to form tears less than they do normally. Check with your physician if you experience dry eyes.

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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:

• Allergy
• Chest pain, discomfort, tightness, or heaviness
• Dizziness, lightheadedness, or fainting
• Generalized swelling or swelling of the feet, ankles or lower legs
• Pain
• Shortness of breath
• Slow heartbeat
• Weight gain

• Ankle, knee, or great toe joint pain
• Anxiety
• Arm, back or jaw pain
• Blood in urine
• Bloody, black or tarry stools
• Chills
• Cloudy urine
• Cold sweats
• Coma
• Confusion
• Convulsions
• Cool pale skin
• Cough
• Dark urine
• Decreased appetite
• Decreased frequency or amount of urine
• Depression
• Difficult breathing
• Dizziness, faintness, or lightheadedness when getting up from a lying position suddenly
• Dry mouth
• Fainting
• Fast or irregular heartbeat
• Fatigue
• Fever
• Flu-like symptoms
• Flushed, dry skin
• Fruit-like breath odor
• Headache, sudden and severe
• Inability to speak
• Increased blood pressure
• Increased hunger
• Increased thirst
• Increased urination
• Itching
• Joint stiffness or swelling
• Large amount of cholesterol in the blood
• Loss of appetite
• Loss of consciousness
• Lower back, side, or stomach pain
• Mental depression
• Muscle pain or cramps
• Nervousness
• Nightmares
• Noisy, rattling breathing
• Numbness or tingling in the hands, feet, or lips
• Pinpoint red or purple spots on the skin
• Pounding in the ears
• Pounding, slow heartbeat
• Rapid breathing
• Seizures
• Shakiness
• Slurred speech
• Stomachache
• Sweating
• Swelling of the fingers or hands
• Temporary blindness
• Tenderness on the upper right side of the body
• Trouble with breathing even at rest
• Unexplained weight loss
• Unusual bleeding or bruising
• Weakness in the arm and/or leg on one side of the body, sudden and severe
• Weakness or heaviness of the legs
• Yellow eyes or skin

• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen or painful glands
• Wheezing

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:

• Back pain
• Diarrhea
• Prickling or tingling sensation
• Unusual tiredness or weakness

• Abdominal pain
• Bleeding gums
• Blurred vision
• Burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feelings
• Changes in vision
• Cold hands and feet
• Decreased interest in sexual intercourse
• Decreased tearing
• Difficulty with moving
• Feeling of constant movement of self or surroundings
• General feeling of discomfort or illness
• Headache
• Inability to have or keep an erection
• Increased sweating
• Joint or muscle pain
• Lack or loss of strength
• Loose teeth
• Loss of sexual ability, desire, or performance
• Loss of strength or energy
• Muscle aches, stiffness, or weakness
• Nausea
• Persistent breath odor or bad taste in your mouth
• Redness and swelling of the gums
• Sensation of spinning
• Sleepiness or unusual drowsiness
• Sore throat
• Stuffy or runny nose
• Sugar in the urine
• Trouble sleeping
• Unusual weak feeling
• Vomiting
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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