Description
Carvedilol is used alone or together with other medicines 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. Lowering blood pressure may reduce the risk of stroke and heart attacks.
Carvedilol is also used to prevent further worsening of congestive heart failure. It is also 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.
This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.
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
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 carvedilol 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 carvedilol in the elderly.
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.
- Colchicine
- Mavorixafor
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Afatinib
- Albuterol
- Amiodarone
- Betrixaban
- Bupropion
- Capecitabine
- Carbamazepine
- Ceritinib
- Clonidine
- Cobicistat
- Crizotinib
- Dabigatran Etexilate
- Darunavir
- Desvenlafaxine
- Digoxin
- Diltiazem
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Duloxetine
- Epinephrine
- Escitalopram
- Fedratinib
- Fenoldopam
- Fexinidazole
- Fingolimod
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Formoterol
- Indacaterol
- Iobenguane I 123
- Iobenguane I 131
- Iohexol
- Lacosamide
- Lefamulin
- Levalbuterol
- Mavacamten
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.
- Acarbose
- Aceclofenac
- Acemetacin
- Albiglutide
- Alfuzosin
- Alogliptin
- Amtolmetin Guacil
- Aspirin
- Bromfenac
- Bufexamac
- Bunazosin
- Canagliflozin
- Celecoxib
- Chlorpropamide
- Choline Salicylate
- Cimetidine
- Clonixin
- Dapagliflozin
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyrone
- Dobutamine
- Doxazosin
- Droxicam
- Dulaglutide
- Empagliflozin
- Ertugliflozin
- Etodolac
- Etofenamate
- Etoricoxib
- Exenatide
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Flufenamic Acid
- Flurbiprofen
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
- Bradycardia (slow heartbeat) or
- Breathing or other lung problems (eg, bronchitis or emphysema) or
- Coronary artery disease or
- Diabetes or
- Edema (fluid retention or body swelling) or
- Heart or blood vessel disease or
- Hyperthyroidism (overactive thyroid) or
- Hypotension (low blood pressure) or
- Major surgery, scheduled or
- Peripheral vascular disease (blood circulation problem) or
- Pheochromocytoma (adrenal gland tumor)—Use with caution. May make these conditions worse.
- Asthma or
- AV block, second or third-degree or
- Bradycardia (slow heartbeat), severe (without a pacemaker) or
- Cardiogenic shock (shock caused by heart attack) or
- Heart failure, decompensated or
- Hypersensitivity reactions (eg, anaphylaxis, angioedema, Stevens-Johnson syndrome), history of or
- Liver disease, severe or
- Sick sinus syndrome (type of abnormal heart rhythm)—Should not be used in patients with these conditions.
- Diabetes or
- Hyperthyroidism (overactive thyroid) or
- Hypoglycemia (low blood sugar)—May cover up some of the symptoms of these diseases, including a fast heartbeat.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
- Patients who are fasting (eg, surgery, not eating regularly, vomiting)—May increase risk of hypoglycemia (low blood sugar).
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Your dose may need to be changed several times in order to find out what works best for you.
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 comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
You may take this medicine with food.
Swallow the extended-release capsule whole. Do not break, crush, or chew it.
If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of cold, soft food such as an applesauce. Stir this mixture well and swallow it without chewing.
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 (extended-release capsules):
- For heart failure:
- Adults—At first, 10 milligrams (mg) once a day for at least 2 weeks. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For hypertension:
- Adults—At first, 20 milligrams (mg) once a day for 7 to 14 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For left ventricular dysfunction after a heart attack:
- Adults—At first, 20 milligrams (mg) once a day for 3 to 10 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg once a day
- Children—Use and dose must be determined by your doctor.
- For heart failure:
- For oral dosage form (tablets):
- For congestive heart failure:
- Adults—At first, 3.125 milligrams (mg) 2 times a day for 2 weeks. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For high blood pressure (hypertension):
- Adults—At first, 6.25 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For left ventricular dysfunction after a heart attack:
- Adults—At first, 6.25 milligrams (mg) 2 times a day. Some patients may start at 3.125 mg two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 25 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For congestive heart failure:
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 important that your doctor check your progress at regular visits to make sure this medicine is working properly and to allow for changes in the dose.
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 are dizzy or not alert.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Sitting or lying down may help alleviate these unwanted effects.
Before having any kind of surgery (including dental surgery or cataract surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking this medicine or who had recently taken this medicine when they had cataract surgery.
For diabetic patients:
- This medicine may cause changes in blood sugar levels. Also, this medicine may cover up the symptoms of low blood sugar (including fast heartbeat) and increase the risk for serious or prolonged hypoglycemia (low blood sugar). Check with your doctor if you notice a change in your normal symptoms or a change in the results of your blood or urine sugar tests. Call your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.
This medicine may worsen the symptoms of heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort, dilated neck veins, irregular breathing or heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
For congestive heart failure patients:
- Check with your doctor if you have unexplained weight gain or increased trouble breathing. 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 doctor if you have dry eyes.
Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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
- Allergy
- chest pain, discomfort, tightness, or heaviness
- dizziness, lightheadedness, or fainting
- generalized swelling or swelling of the feet, ankles, or lower legs
- pain
- slow heartbeat
- trouble breathing
- weight gain
Less common
- Ankle, knee, or great toe joint pain
- anxiety
- arm, back, or jaw pain
- blood in the urine
- bloody, black or tarry stools
- chills
- cloudy urine
- cold sweats
- coma
- confusion
- cool pale skin
- cough
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- depression
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying position
- dry mouth
- fainting
- fast or irregular heartbeat
- 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
Incidence not known
- Blistering, peeling, or loosening of the skin
- diarrhea
- joint or muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots on the lips or in the mouth
- swollen or painful glands
- unusual tiredness or weakness
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:
More common
- Back pain
- diarrhea
- prickling or tingling sensation
- unusual tiredness or weakness
Less common
- 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
- stomach pain
- 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.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
