Coreg

GENERIC AVAILABLE: yes

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Coreg falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take Coreg exactly as prescribed.

Coreg comes in tablet form and is taken twice every day with food and a full glass of water.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Coreg at the same time.

• Store Coreg tablets at 20º to 25 º C (68 º to 77 ºF).
• Keep the tablets dry.
• Keep Coreg tablets and all medicines out of the reach of children.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Coreg or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Coreg. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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).

Carcinogenesis, Mutagenesis, Impairment of Fertility

In 2-year studies conducted in rats given carvedilol at doses up to 75 mg per kg per day (12 times the MRHD as mg per m2) or in mice given up to 200 mg per kg per day (16 times the MRHD as mg per m2), carvedilol had no carcinogenic effect.

Carvedilol was negative when tested in a battery of genotoxicity assays, including the Ames and the CHO/HGPRT assays for mutagenicity and the in vitro hamster micronucleus and in vivo human lymphocyte cell tests for clastogenicity.

In a combined fertility/developmental/post-natal toxicity study, rats were given carvedilol (12, 60, 300 mg per kg per day) orally by gavage for 2 weeks before mating and through mating, gestation, and weaning for females and for 62 days prior to and through mating for males. At a dosage of 300 mg per kg per day (greater than or equal to 50 times the MRHD as mg per m2) carvedilol was toxic to adult rats (sedation, reduced weight gain) and was associated with a reduced number of successful matings, prolonged mating time, fewer corpora lutea and implants per dam, fewer live pups per litter, and delays in physical growth/development. The no-effect level for overt toxicity and impairment of fertility was 60 mg per kg per day (10 times the MRHD as mg per m2).

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

100 Tablets

Rx only

Store below 30oC (86oF).

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.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland.

  10000000120631 Rev. 10/13

PRINCIPAL DISPLAY PANEL

NDC 0007-4140-20

Coreg®

CARVEDILOL TABLETS

6.25 mg

100 TILTAB® Tablets

Rx only

Store below 30oC (86oF).

Dispense in a tight, light-resistant container.

Protect from moisture.

Each Tiltab® tablet 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.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland.

  10000000120632 Rev. 10/13

PRINCIPAL DISPLAY PANEL

NDC 0007-4141-20

Coreg®

CARVEDILOL TABLETS

12.5 mg

100 TILTAB® Tablets

Rx only

Store below 30oC (86oF).

Dispense in a tight, light-resistant container.

Protect from moisture.

Each Tiltab® tablet 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.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland.

  10000000120633 Rev. 10/13

PRINCIPAL DISPLAY PANEL

NDC 0007-4142-20

Coreg®

CARVEDILOL TABLETS

25 mg

100 TILTAB® Tablets

Rx only

Store below 30oC (86oF).

Dispense in a tight, light-resistant container.

Protect from moisture.

Each Tiltab® tablet 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.

Manufactured for GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

  10000000120634 Rev. 10/13

Coreg  carvedilol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0007-4139 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (CARVEDILOL) CARVEDILOL 3.125 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSPOVIDONE (15 MPA.S AT 5%)   HYPROMELLOSES   LACTOSE, UNSPECIFIED FORM   MAGNESIUM STEARATE   POLYETHYLENE GLYCOLS   POLYSORBATE 80   POVIDONES   SUCROSE   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 6mm Flavor Imprint Code 39;SB Contains

Packaging # Item Code Package Description 1 NDC:0007-4139-20 100 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020297 06/03/1997

Coreg  carvedilol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0007-4140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (CARVEDILOL) CARVEDILOL 6.25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSPOVIDONE (15 MPA.S AT 5%)   HYPROMELLOSES   LACTOSE, UNSPECIFIED FORM   MAGNESIUM STEARATE   POLYETHYLENE GLYCOLS   POLYSORBATE 80   POVIDONES   SUCROSE   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 9mm Flavor Imprint Code 4140;SB Contains

Packaging # Item Code Package Description 1 NDC:0007-4140-20 100 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020297 06/03/1997

Coreg  carvedilol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0007-4141 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (CARVEDILOL) CARVEDILOL 12.5 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSPOVIDONE (15 MPA.S AT 5%)   HYPROMELLOSES   LACTOSE, UNSPECIFIED FORM   MAGNESIUM STEARATE   POLYETHYLENE GLYCOLS   POLYSORBATE 80   POVIDONES   SUCROSE   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 11mm Flavor Imprint Code 4141;SB Contains

Packaging # Item Code Package Description 1 NDC:0007-4141-20 100 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020297 06/03/1997

Coreg  carvedilol tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0007-4142 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (CARVEDILOL) CARVEDILOL 25 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSPOVIDONE (15 MPA.S AT 5%)   HYPROMELLOSES   LACTOSE, UNSPECIFIED FORM   MAGNESIUM STEARATE   POLYETHYLENE GLYCOLS   POLYSORBATE 80   POVIDONES   SUCROSE   TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL Size 14mm Flavor Imprint Code 4142;SB Contains

Packaging # Item Code Package Description 1 NDC:0007-4142-20 100 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020297 06/03/1997

Labeler - GlaxoSmithKline LLC (167380711)

Revised: 09/2017   GlaxoSmithKline LLC

You should not take Coreg 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).

Avoid drinking alcohol within 2 hours before or after taking extended-release 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.

If you are being treated for high blood pressure, keep using Coreg even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, and seizure (convulsions).

Coreg may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Coreg. You should especially avoid drinking alcohol within 2 hours before or after taking extended-release Coreg CR.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Usual Adult Dose for Angina Pectoris:

Immediate-release tablets:
Initial dose: 6.25 mg orally twice a day with food
Maintenance dose: 6.25 mg to 25 mg orally twice a day with food
Maximum dose: 50 mg per day

Usual Adult Dose for Congestive Heart Failure:

Immediate-release tablets:
Initial dose: 3.125 mg orally twice a day for 2 weeks. If tolerated, increase dosage to 6.25 mg orally twice a day.

Dosage should then be doubled every 2 weeks to the highest level tolerated by the patient.

Maximum dose: 50 mg orally twice a day in patients weighing 85 kg or greater and 25 mg orally twice a day in patients weighing 85 kg or less

Extended-release capsules:
Initial dose: 10 mg orally once a day for 2 weeks. If tolerated, increase dosage to 20 mg, 40 mg, and 80 mg over successive intervals of at least 2 weeks.

Usual Adult Dose for Hypertension:

Immediate-release tablets:
Initial dose: 6.25 mg orally twice a day with food
Maintenance dose: 6.25 mg to 25 mg orally twice a day with food
Maximum dose: 50 mg per day

Extended-release capsules:
Initial dose: 20 mg orally once a day for 7 to 14 days. If tolerated, may increase dosage to 40 mg orally once a day, then again to 80 mg orally once a day after 7 to 14 days.

Maximum dose: 80 mg per day

Usual Adult Dose for Left Ventricular Dysfunction:

Immediate-release tablets:
Initial dose: 6.25 mg orally twice a day (an initial dosage of 3.25 mg twice daily can be given to patients unable to tolerate the initial dosage).

Maintenance dose: If tolerated, the initial dosage may be titrated to 12.5 mg twice a day after 3 to 10 days to a target dose of 25 mg twice a day.

Extended-release capsules:
Initial dose: 20 mg orally once a day (an initial dosage of 10 mg once daily can be given to patients unable to tolerate the initial dosage). If tolerated, may increase dosage to 40 mg after 3 to 10 days, then again to 80 mg orally once a day.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 15.01.

Medical Disclaimer