Carvedilol

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• CARVEDILOL DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACODYNAMICS
• PHARMACOKINETICS
• USE IN SPECIFIC POPULATIONS
• INDICATIONS & USAGE
• CARVEDILOL CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• DRUG INTERACTIONS
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• CARVEDILOL ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• DOSAGE FORMS & STRENGTHS
• HOW SUPPLIED
• INFORMATION FOR PATIENTS
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

CARVEDILOL DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

PHARMACOKINETICS

USE IN SPECIFIC POPULATIONS

INDICATIONS & USAGE

CARVEDILOL CONTRAINDICATIONS

• ●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.

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WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

CARVEDILOL ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

DOSAGE FORMS & STRENGTHS

HOW SUPPLIED

INFORMATION FOR PATIENTS

• ●To treat patients with high blood pressure (hypertension)

• ●To treat patients who had a heart attack that worsened how well the heart pumps

• ●To treat patients with certain types of heart failure

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• ●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.

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• ●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. You should not breastfeed while using COREG.

• ●Are scheduled for surgery and will be given anesthetic agents

• ●Are taking prescription or non-prescription 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.

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• ●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.

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• ●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.

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• ●Safely, throw away COREG that is out of date or no longer needed.

• ●Keep COREG and all medicines out of the reach of children.

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION