HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use coreg safely and effectively. See full prescribing information for coreg.
coreg (carvedilol) tablet for oral use
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
Contraindications (4)
April 2008
INDICATIONS AND 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)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosage and monitor during up-titration. (2)
Heart failure: Start at 3.125 mg twice daily and increase to 6.25, 12.5, and then 25 mg twice daily over intervals of at least 2 weeks. Maintain lower doses if higher doses are not tolerated. (2.1)
Left ventricular dysfunction following myocardial infarction: Start at 6.25 mg twice daily and increase to 12.5 mg then 25 mg twice daily after intervals of 3 to 10 days. A lower starting dose or slower titration may be used. (2.2)
Hypertension: Start at 6.25 mg twice daily and increase if needed for blood pressure control to 12.5 mg then 25 mg twice daily over intervals of 1 to 2 weeks. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125, 6.25, 12.5, 25 mg (3)
CONTRAINDICATIONS
Bronchial asthma or related bronchospastic conditions (4)
Second- or third-degree AV block (4)
Sick sinus syndrome (4)
Severe bradycardia (unless permanent pacemaker in place) (4)
Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. (4)
Severe hepatic impairment (2.4, 4)
History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol, any of the components of COREG, or to COREG CR (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.1)
Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed. (5.2, 5.3, 5.4)
Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid β-blockers. (4) However, if deemed necessary, use with caution and at lowest effective dose. (5.5)
Diabetes: Monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia. (5.6)
ADVERSE REACTIONS
Most common adverse events (6.1):
Heart failure and left ventricular dysfunction following myocardial infarction (≥10%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase
Hypertension (≥5%): Dizziness
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
CYP P450 2D6 enzyme inhibitors may increase and rifampin may decrease carvedilol levels. (7.1, 7.5)
Hypotensive agents (e.g., reserpine, MAO inhibitors, clonidine) may increase the risk of hypotension and/or severe bradycardia. (7.2)
Cyclosporine or digoxin levels may increase. (7.3, 7.4)
Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. (7.4)
Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. (7.6)
Insulin and oral hypoglycemics action may be enhanced. (7.7)
Revised: July 2008
CRG:16PI
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 08/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Heart Failure
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
1.3 Hypertension
2 DOSAGE AND ADMINISTRATION
2.1 Heart Failure
2.2 Left Ventricular Dysfunction Following Myocardial Infarction
2.3 Hypertension
2.4 Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Cessation of Therapy
5.2 Bradycardia
5.3 Hypotension
5.4 Heart Failure/Fluid Retention
5.5 Non-allergic Bronchospasm
5.6 Glycemic Control in Type 2 Diabetes
5.7 Peripheral Vascular Disease
5.8 Deterioration of Renal Function
5.9 Anesthesia and Major Surgery
5.10 Thyrotoxicosis
5.11 Pheochromocytoma
5.12 Prinzmetal’s Variant Angina
5.13 Risk of Anaphylactic Reaction
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Laboratory Abnormalities
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 CYP2D6 Inhibitors and Poor Metabolizers
7.2 Hypotensive Agents
7.3 Cyclosporine
7.4 Digitalis Glycosides
7.5 Inducers/Inhibitors of Hepatic Metabolism
7.6 Calcium Channel Blockers
7.7 Insulin or Oral Hypoglycemics
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Specific Populations
12.5 Drug-Drug Interactions
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Heart Failure
14.2 Left Ventricular Dysfunction Following Myocardial Infarction
14.3 Hypertension
14.4 Hypertension With Type 2 Diabetes Mellitus
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Patient Advice
17.2 FDA-Approved Patient Labeling
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 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) and Clinical Studies (14.1)].
1.2 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 ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 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)].
2 DOSAGE AND ADMINISTRATION
COREG should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
2.1 Heart 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 succe
