Coreg

Generic name: carvedilol
Brand names: Coreg, Coreg CR
Drug class: Non-cardioselective beta blockers

Medically reviewed by  A Ras MD.

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.

Description

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).

 Mechanism of Action

COREG is a racemic mixture in which nonselective β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α1-adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. COREG has no intrinsic sympathomimetic activity.

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 “What are the ingredients in Coreg?” for a list of all the ingredients in Coreg.

What should I tell my healthcare provider 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.
• Do not stop taking Coreg and do not change the amount of Coreg you take without talking to your doctor.
• 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
• 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.

General information about the safe and effective use of 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.

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.

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: 3.125mg, 6.25mg, 12.5mg, 25mg.

Label

PRINCIPAL DISPLAY PANEL

• NDC 0007-4139-20
• COREG
• (carvedilol) Tablets
• 3.125 mg
• Rx only
• 100 Tablets
• Store below 30oC (86oF).
• Do not accept if membrane seal under cap is missing or broken.
• Dispense in a tight, light-resistant container.
• Protect from moisture. Each tablet contains carvedilol, 3.125 mg.
• Dosage: See accompanying prescribing information.
• Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
• Trademark is owned by or licensed to the GSK group of companies.
• Manufactured for GlaxoSmithKline
• Research Triangle Park, NC 27709
• Made in India
• ©2017 GSK or licensor.

LB014100 Rev. 2/18

PRINCIPAL DISPLAY PANEL

• NDC 0007-4140-20
• COREG
• (carvedilol) Tablets
• 6.25 mg
• Rx only
• 100 TILTAB Tablets
• Store below 30oC (86oF).
• Do not accept if membrane seal under cap is missing or broken.
• Dispense in a tight, light-resistant container.
• Protect from moisture. Each TILTABtablet contains carvedilol, 6.25 mg.
• Dosage: See accompanying prescribing information.
• Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
• Trademarks are owned by or licensed to the GSK group of companies.
• Manufactured for GlaxoSmithKline
• Research Triangle Park, NC 27709
• Made in India
• ©2017 GSK or licensor.

LB014200 Rev. 2/18

PRINCIPAL DISPLAY PANEL

• NDC 0007-4141-20
• COREG
• (carvedilol) Tablets
• 12.5 mg
• Rx only
• 100 TILTAB Tablets
• Store below 30oC (86oF).
• Do not accept if membrane seal under cap is missing or broken.
• Dispense in a tight, light-resistant container.
• Protect from moisture. Each TILTABtablet contains carvedilol, 12.5 mg.
• Dosage: See accompanying prescribing information.
• Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
• Trademarks are owned by or licensed to the GSK group of companies.
• Manufactured for GlaxoSmithKline
• Research Triangle Park, NC 27709
• Made in India
• ©2017 GSK or licensor.

LB013900 Rev. 2/18