Brand Name
Coreg
Generic Name
Carvedilol
View Brand Information FDA approval date: September 05, 2007
Classification: alpha-Adrenergic Blocker
Form: Tablet, Capsule
What is Coreg (Carvedilol)?
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure.
Approved To Treat
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Brand Information
Coreg (Carvedilol)
1DOSAGE AND ADMINISTRATION
COREG should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
1.1Heart Failure
DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG, it is recommended that fluid retention be minimized. The recommended starting dose of COREG is 3.125 mg twice daily for 2 weeks. If tolerated, patients may have their dose increased to 6.25, 12.5, and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs.).
Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. During these periods, patients should avoid situations such as driving or hazardous tasks, where symptoms could result in injury. Vasodilatory symptoms often do not require treatment, but it may be useful to separate the time of dosing of COREG from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor. The dose of COREG should not be increased until symptoms of worsening heart failure or vasodilation have been stabilized.
Fluid retention (with or without transient worsening heart failure symptoms) should be treated by an increase in the dose of diuretics.
The dose of COREG should be reduced if patients experience bradycardia (heart rate less than 55 beats per minute).
Episodes of dizziness or fluid retention during initiation of COREG can generally be managed without discontinuation of treatment and do not preclude subsequent successful titration of, or a favorable response to, carvedilol.
1.2Left Ventricular Dysfunction following Myocardial Infarction
DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION.
Treatment with COREG may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that COREG be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.
1.3Hypertension
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of COREG is 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure 1 hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of COREG is seen within 7 to 14 days. Total daily dose should not exceed 50 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
1.4Hepatic Impairment
COREG should not be given to patients with severe hepatic impairment
2DOSAGE FORMS AND STRENGTHS
The white, oval, film‑coated tablets are available in the following strengths:
- 3.125 mg – engraved with "39" and "WP"
- 6.25 mg – engraved with "4140" and "WP"
- 12.5 mg – engraved with "4141" and "WP"
- 25 mg – engraved with "4142" and "WP"
3CONTRAINDICATIONS
COREG is contraindicated in the following conditions:
- Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of COREG.
- Second- or third-degree AV block.
- Sick sinus syndrome.
- Severe bradycardia (unless a permanent pacemaker is in place).
- Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating COREG.
- Patients with severe hepatic impairment.
- Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol.
4OVERDOSAGE
Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur.
The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions. The following agents may be administered:
For excessive bradycardia: Atropine, 2 mg IV.
To support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg per hour; sympathomimetics (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect.
If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy- resistant bradycardia, pacemaker therapy should be performed. For bronchospasm, β- sympathomimetics (as aerosol or IV) or aminophylline IV should be given. In the event of seizures, slow IV injection of diazepam or clonazepam is recommended.
NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7- to 10-hour half-life of carvedilol.
Cases of overdosage with COREG alone or in combination with other drugs have been reported. Quantities ingested in some cases exceeded 1,000 milligrams. Symptoms experienced included low blood pressure and heart rate. Standard supportive treatment was provided and individuals recovered.
5DESCRIPTION
Carvedilol is a nonselective β-adrenergic blocking agent with α1-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 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).
6HOW SUPPLIED/STORAGE AND HANDLING
The white, oval, film‑coated tablets are available in the following strengths:
- 3.125 mg – engraved with "39" and "WP"
- 6.25 mg – engraved with "4140" and "WP"
- 12.5 mg – engraved with "4141" and "WP"
- 25 mg – engraved with "4142" and "WP"
The 6.25-mg, 12.5-mg, and 25-mg tablets are TILTAB tablets.
- 3.125 mg bottles of 100: NDC 80725-139-20
- 6.25 mg bottles of 100: NDC 80725-140-20
- 12.5 mg bottles of 100: NDC 80725-141-20
- 25 mg bottles of 100: NDC 80725 142-20
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients taking COREG should be advised of the following:
- Patients should take COREG with food.
- Patients should not interrupt or discontinue using COREG without a physician's advice.
- Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.
- Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur.
- If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks.
- Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted.
- Inform patients or caregivers that there is a risk of hypoglycemia when COREG is given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia
- Contact lens wearers may experience decreased lacrimation.
COREG, COREG CR, and TILTAB are trademarks used under license by Waylis Therapeutics LLC
The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to Waylis Therapeutics LLC. The maker of this brand is not affiliated with and does not endorse Waylis Therapeutics LLC or its products.
8PATIENT INFORMATION COREG (Co-REG) (carvedilol) tablets
Read the Patient Information that comes with COREG before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about COREG, ask your doctor or pharmacist.
What is COREG?
COREG is a prescription medicine that belongs to a group of medicines called "beta- blockers". COREG is used, often with other medicines, for the following conditions:
- to treat patients with certain types of heart failure
- to treat patients who had a heart attack that worsened how well the heart pumps
- to treat patients with high blood pressure (hypertension)
COREG is not approved for use in children under 18 years of age.
Who should not take COREG?
Do not take COREG if you:
- have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications).
- are prone to asthma or other breathing problems.
- have a slow heartbeat or a heart that skips a beat (irregular heartbeat).
- have liver problems.
- are allergic to any of the ingredients in COREG. The active ingredient is carvedilol. See the end of this leaflet for a list of all the ingredients in COREG.
What should I tell my doctor before taking COREG?
Tell your doctor about all of your medical conditions, including if you:
- have asthma or other lung problems (such as bronchitis or emphysema).
- have problems with blood flow in your feet and legs (peripheral vascular disease). COREG can make some of your symptoms worse.
- have diabetes.
- have thyroid problems.
- have a condition called pheochromocytoma.
- have had severe allergic reactions.
- are pregnant or trying to become pregnant. It is not known if COREG is safe for your unborn baby. You and your doctor should talk about the best way to control your high blood pressure during pregnancy.
- are breastfeeding. It is not known if COREG passes into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking COREG.
- are scheduled for surgery and will be given anesthetic agents.
- are scheduled for cataract surgery and have taken or are currently taking COREG.
- are taking prescription or over-the-counter medicines, vitamins, and herbal supplements. COREG and certain other medicines can affect each other and cause serious side effects. COREG may affect the way other medicines work. Also, other medicines may affect how well COREG works.
Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.
How should I take COREG?
It is important for you to take your medicine every day as directed by your doctor. If you stop taking COREG suddenly, you could have chest pain and/or a heart attack. If your doctor decides that you should stop taking COREG, your doctor may slowly lower your dose over a period of time before stopping it completely.
- Take COREG exactly as prescribed. Your doctor will tell you how many tablets to take and how often. In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
- Tell your doctor if you gain weight or have trouble breathing while taking COREG.
- Take COREG with food.
- If you miss a dose of COREG, take your dose as soon as you remember, unless it is time to take your next dose. Take your next dose at the usual time. Do not take 2 doses at the same time.
- If you take too much COREG, call your doctor or poison control center right away.
What should I avoid while taking COREG?
- COREG can cause you to feel dizzy, tired, or faint. Do not drive a car, use machinery, or do anything that needs you to be alert if you have these symptoms.
What are possible side effects of COREG?
- Low blood pressure (which may cause dizziness or fainting when you stand up).
If these happen, sit or lie down right away and tell your doctor. - Tiredness. If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
- Slow heartbeat.
- Changes in your blood sugar. If you have diabetes, tell your doctor if you have any changes in your blood sugar levels.
- COREG may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
- COREG may mask the symptoms of hyperthyroidism (overactive thyroid).
- Worsening of severe allergic reactions.
- Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on COREG. These reactions can be life-threatening.
Other side effects of COREG include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome if you wear contact lenses.
Call your doctor if you have any side effects that bother you or don't go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store COREG?
- Store COREG at less than 86°F (30°C). Keep the tablets dry.
- Safely, throw away COREG that is out of date or no longer needed.
- Keep COREG and all medicines out of the reach of children.
General Information about COREG
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use COREG for a condition for which it was not prescribed. Do not give COREG to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about COREG. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about COREG that is written for healthcare professionals.
What are the ingredients in COREG?
Active Ingredient: carvedilol.
Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sucrose, and titanium dioxide.
Carvedilol tablets come in the following strengths: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg.
What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels. COREG can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure may lower your chance of having a stroke or heart attack.
COREG is a trademark used under license by Waylis Therapeutics LLC.
Manufactured for
Waylis Therapeutics LLC
Wixom, MI 48393
October 2023
9PRINCIPAL DISPLAY PANEL - 3.125 mg Tablet Bottle Label
NDC 80725-139-20
Waylis
COREG
3.125 mg
Rx only
10PRINCIPAL DISPLAY PANEL - 6.25 mg Tablet Bottle Label
NDC 80725-140-20
Waylis
COREG
6.25 mg
Rx only
11PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Bottle Label
NDC 80725-141-20
Waylis
COREG
12.5 mg
Rx only
12PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 80725-142-20
Waylis
COREG
25 mg
Rx only
