COREG carvedilol

Get an overview of COREG (carvedilol tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in COREG can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as COREG.

Drug Basics

Brand Name: COREG

Generic Name: CARVEDILOL

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2020-01-13

indications & usage

COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of:

  • mild to severe chronic heart failure (1.1)
  • left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
  • hypertension (1.3)

heart failure

COREG is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)].

left ventricular dysfunction following myocardial infarction

COREG is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].

hypertension

COREG is indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].

patient 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.
  • Diabetic patients should report any changes in blood sugar levels to their physician.
  • Contact lens wearers may experience decreased lacrimation.

COREG, COREG CR, and TILTAB are trademarks owned by or licensed to the GSK group of companies.

The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured for

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies or its licensor.

CRG:25PI

PHARMACIST‑DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

-------------------------------------------------------------------------------------------------------------

PATIENT 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.
  • 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, 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 owned by or licensed to the GSK group of companies.

Manufactured for

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies or its licensor.

September 2017

CRG:7PIL

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
coreg spl graphic 06.jpg

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
coreg spl graphic 07.jpg

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
coreg spl graphic 08.jpg

PRINCIPAL DISPLAY PANEL

NDC 0007-4142-20

COREG

(carvedilol) Tablets

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, 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.

  •  LB014000 Rev. 2/18

coreg spl graphic 09.jpg

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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