Carvedilol

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CARVEDILOL – ORAL

(car-VEDD-ih-lol)

COMMON BRAND NAME(S): Coreg

WARNING: Do not stop using this drug without first consulting your doctor. Your condition may become worse when the drug is suddenly stopped, especially if you have chest pain (angina) or heart disease (e.g., coronary artery disease, ischemic heart disease, heart failure, high blood pressure). If your doctor decides you should no longer use this drug, you must gradually decrease your dose according to your doctor’s instructions.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Seek immediate medical attention if you develop: worsening chest pain, tightness/pressure in the chest, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, or fast/irregular heartbeat.

USES: This medication is an alpha and beta blocker used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This drug works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This effect lowers heart rate, blood pressure, and strain on the heart.

HOW TO USE: See also Warning section.

Read the Patient Information Leaflet provided by your pharmacist before you start using carvedilol and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with food, usually twice daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose should be gradually decreased.

For the treatment of high blood pressure, it may take 1 to 2 weeks before you get the full benefit of this drug. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Tell your doctor if your condition worsens (e.g., your routine blood pressure readings increase).

SIDE EFFECTS: See also Warning and Precautions sections.

Dizziness, lightheadedness, drowsiness, diarrhea, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. The risk of dizziness is highest within 1 hour after you take your dose. Dizziness is most common when you first start using this drug or any time your doctor increases your dose.

This drug may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: very slow heartbeat, severe dizziness, fainting, unusual weakness, new or increased shortness of breath, sudden weight gain, swelling hands/ankles/feet, increased thirst/urination, numbness/tingling of the hands/feet, bluish fingers/toes.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, mental/mood changes (e.g., depression, nervousness), seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking carvedilol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to other beta blockers (e.g., propranolol); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: asthma, certain types of heart rhythm problems (sinus bradycardia, sick sinus syndrome, second- or third-degree atrioventricular block), severe heart failure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, serious reaction/allergy needing treatment with epinephrine, other breathing problems (e.g., bronchitis, emphysema), other heart problems (e.g., Prinzmetal’s variant angina), diabetes, overactive thyroid disease (hyperthyroidism), kidney disease, blood circulation problems (e.g., Raynaud’s disease, peripheral vascular disease), a certain type of tumor (pheochromocytoma), mental/mood disorders (e.g., depression), a certain muscle disease (myasthenia gravis).

Before having surgery (including cataract eye surgery), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy or cause you to faint. This is most likely to occur within 1 hour after taking your dose or any time your doctor increases your dose. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of a low blood sugar level, such as dizziness and sweating, are unaffected by this drug. This product also may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst, hunger, and urination. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in older adults because they may be more sensitive to its effects, especially dizziness and lightheadedness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: calcium channel blockers (e.g., diltiazem, verapamil), cyclosporine, digoxin, drugs affecting liver enzymes that remove carvedilol from your body (such as cimetidine, certain heart medications including amiodarone/quinidine/propafenone, rifamycins including rifabutin, certain SSRI antidepressants including fluoxetine/paroxetine), drugs for diabetes (e.g., insulin, sulfonylureas such as glipizide/glyburide), epinephrine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), other drugs to treat high blood pressure (e.g., clonidine, hydralazine, methyldopa, reserpine), theophylline.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about using these products safely.

This medication may interfere with certain medical/laboratory tests (including cardiovascular stress testing using arbutamine), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat, severe dizziness, fainting, slow/shallow breathing, seizures.

NOTES: Do not share this medication with others.

Talk with your doctor about making changes to your lifestyle that may increase the effectiveness of this medication (e.g., stress reduction programs, exercise, and dietary changes).

Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Learn how to monitor your own blood pressure and pulse at home, and share the results with your doctor.

Laboratory and/or medical tests (e.g., kidney function test, liver function test) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised March 2011 Copyright(c) 2011 First DataBank, Inc.