Each tablet contains Carvedilol 3.125mg/6.25mg /12.5mg.
In treatment of congestive heart failure (CHF), essential hypertension,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).
Carvedilolis a racemic mixture in which nonselective β-adrenoceptor blocking activity is present in the S(-) enantiomer and α1-adrenergic blocking activity is present in both R (+) and S (-) enantiomers at equal potency. It does not have any intrinsic sympathomimetic activity.
Heart failure: To be started at 3.125mg 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. 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. 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.
Carvedilolis contraindicated in Bronchial asthma or related bronchospastic conditions, Second-or third-degree AV block, Sick sinus syndrome, Severe bradycardia, Cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy, Severe hepatic impairment and Hypersensitivity
Acute exacerbation of coronary artery disease can occur upon cessation of therapy sonot to discontinue abruptly. If bradycardia, hypotension, worsening heart failure/fluid retention occurs reduce the dose as needed. Avoid β-blocker, if deemed necessary, use with caution and at lowest effective dose. In diabetes monitor glucose as β-blockers may mask symptoms of hypoglycemia or worsen hyperglycemia.
Pregnancy category C.There are no adequate and well-controlled studies in pregnant women,it is not known whether this drug is excreted in human milk. Safety and effectiveness of Carvedilol inpediatric patients has not been established.
CYP P450 2D6 enzyme inhibitors may increase R- enantiomers of carvedilol and rifampin may decrease carvedilol levels. Close monitoring is recommended at the time of administration with Hypotensive agents, Cyclosporine or digoxin. Concomitant use with digitalis glycosides and β-blockerscan increase therisk of bradycardia. Amiodarone may increase carvedilol levels resulting in further slowing of the heart rate or cardiac conduction.Insulin and oral hypoglycemic action may be enhanced. Verapamil- or diltiazem-type calcium channel blockers may affect ECG and/or blood pressure.
The most common adverse events are dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia and weight gain.