COREG CR Extended-release tablet (2020)
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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, ...
2. Dosage and Administration
COREG CR is an extended-release capsule intended for once‑daily administration. Patients controlled with immediate‑release carvedilol tablets alone or in combination with other medications may be switched ...
3. Dosage Forms and Strengths
The hard gelatin capsules are filled with white to off-white microparticles and are available in the following strengths: 10 mg white and green capsule shell printed with GSLGK and "10 mg" 20 mg white ...
4. Contraindications
COREG CR is contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release ...
5. Warnings and Precautions
In clinical trials of COREG CR in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile ...
6. Adverse Reactions
Heart Failure The following information describes the safety experience in heart failure with immediate-release carvedilol. Carvedilol has been evaluated for safety in heart failure in more than 4,500 ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of COREG or COREG CR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...
7. Drug Interactions
7.1 CYP2D6 Inhibitors and Poor Metabolizers Interactions of carvedilol with potent inhibitors of CYP2D6 isoenzyme (such as quinidine, fluoxetine, paroxetine, and propafenone) have not been studied, but ...
8.1. Pregnancy
Risk Summary Available data regarding use of COREG CR in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother ...
8.2. Lactation
Risk Summary There are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. Carvedilol is present in the milk of lactating rats. ...
8.4. Pediatric Use
Effectiveness of carvedilol in patients younger than 18 years has not been established. In a double-blind trial, 161 children (mean age: 6 years; range: 2 months to 17 years; 45% younger than 2 years) ...
8.5. Geriatric Use
The initial clinical trials of COREG CR in subjects with hypertension, heart failure, and left ventricular dysfunction following myocardial infarction did not include sufficient numbers of subjects aged ...
10. Overdosage
Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized ...
11. Description
Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α<sub>1</sub>-blocking activity. It is (2<em>RS</em>) - 1- (9<em>H</em>-Carbazol-4-yloxy) - 3- [[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol ...
12.1. Mechanism of Action
Carvedilol is a racemic mixture in which nonselective β‑adrenoreceptor blocking activity is present in the S( - ) enantiomer and α<sub>1</sub>‑adrenergic blocking activity is present in both R( + ) and ...
12.2. Pharmacodynamics
Heart Failure and Left Ventricular Dysfunction following Myocardial Infarction The basis for the beneficial effects of carvedilol in patients with heart failure and in patients with left ventricular dysfunction ...
12.3. Pharmacokinetics
Absorption Carvedilol is rapidly and extensively absorbed following oral administration of immediate-release carvedilol tablets, with an absolute bioavailability of approximately 25% to 35% due to a significant ...
13.1. 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 m<sup>2</sup>) or in mice given up to 200 mg per kg per day (16 times the MRHD as mg ...
14. Clinical Studies
Support for the use of COREG CR extended-release capsules for the treatment of mild-to-severe heart failure and for patients with left ventricular dysfunction following myocardial infarction is based on ...
16.1. How Supplied
The hard gelatin capsules are available in the following strengths: 10 mg white and green capsule shell printed with GSLGK and "10 mg" 20 mg white and yellow capsule shell printed with GSMHV and "20 ...
16.2. Storage and Handling
Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light-resistant container.
17. Patient Counseling Information
Patients taking COREG CR should be advised of the following: Patients should not interrupt or discontinue using COREG CR without a physicians advice. Patients with heart failure should consult their physician ...