•
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)
•
Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction. ( 7.6)
•
Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure. ( 7.7)
•
Insulin and oral hypoglycemics action may be enhanced. ( 7.8)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2017
CLOSE
FULL PRESCRIBING INFORMATION: CONTENTS*
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
2.5 Geriatric Use
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 Major Surgery
5.10 Thyrotoxicosis
5.11 Pheochromocytoma
5.12 Prinzmetal’s Variant Angina
5.13 Risk of Anaphylactic Reaction
5.14 Intraoperative Floppy Iris Syndrome
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 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 Amiodarone
7.7 Calcium Channel Blockers
7.8 Insulin or Oral Hypoglycemics
7.9 Proton Pump Inhibitors
7.10 Anesthesia
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
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
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
1.1 Heart Failure
COREG CR 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)].
1.2 Left Ventricular Dysfunction following Myocardial
