Coreg

DRUG DESCRIPTION

Carvedilol is a nonselective ?-adrenergic blocking agent with ?1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:

COREG® (carvedilol)  Structural Formula Illustration

COREG (carvedilol) is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 6.25 mg, 12.5 mg, and 25 mg tablets are TILTAB® tablets. Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sucrose, and titanium dioxide.

Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C24H26N2O4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).

What are the possible side effects of carvedilol (Coreg, Coreg CR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or uneven heartbeats;
  • feeling light-headed, fainting;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing...

Read All Potential Side Effects and See Pictures of Coreg »

What are the precautions when taking carvedilol (Coreg)?

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...

Read All Potential Precautions of Coreg »


Coreg Consumer (continued)

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.


Coreg Patient Information Including Side Effects

Brand Names: Coreg, Coreg CR

Generic Name: carvedilol (Pronunciation: KAR ve dil ole)

  • What is carvedilol (Coreg)?
  • What are the possible side effects of carvedilol (Coreg)?
  • What is the most important information I should know about carvedilol (Coreg)?
  • What should I discuss with my healthcare provider before taking carvedilol (Coreg)?
  • How should I take carvedilol (Coreg)?
  • What happens if I miss a dose (Coreg)?
  • What happens if I overdose (Coreg)?
  • What should I avoid while taking carvedilol (Coreg)?
  • What other drugs will affect carvedilol (Coreg)?
  • Where can I get more information?

What is carvedilol (Coreg)?

Carvedilol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Carvedilol is used to treat heart failure and hypertension (high blood pressure). It is also used to treat or prevent heart attack.

Carvedilol may also be used for other purposes not listed in this medication guide.

What are the possible side effects of carvedilol (Coreg)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or uneven heartbeats;
  • feeling light-headed, fainting;
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • depression; or
  • cold feeling in your hands and feet.

Less serious side effects may include:

  • decreased sex drive, impotence, or difficulty having an orgasm;
  • sleep problems (insomnia);
  • tired feeling; or
  • anxiety, nervousness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about carvedilol (Coreg)?

You should not take this medication if you are allergic to carvedilol, or if you have asthma, bronchitis, emphysema, severe liver disease, or a serious heart condition such as heart block, sick sinus syndrome, or slow heart rate (unless you have a pacemaker).

If you need to have any type of surgery, you may need to temporarily stop using carvedilol. Be sure the surgeon knows ahead of time that you are using carvedilol.

Do not stop taking carvedilol without first talking to your doctor. Stopping suddenly may make your condition worse.

Carvedilol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol within 2 hours before or after taking extended-release carvedilol (Coreg CR). Also avoid taking medicines or other products that might contain alcohol. Alcohol may cause the carvedilol in Coreg CR to be released too quickly into the body.

Carvedilol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

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