Carvedilol
Tablet, Film Coated · Oral
Uses
1. INDICATIONS AND USAGE . Carvedilol tablets are 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) 1.1 Heart Failure Carvedilol tablets are 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 Infarction Carvedilol tablets are 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 less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2 )] 1.3 Hypertension Carvedilol tablets are 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 )].
Dosage and administration
2. 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 and then 25 mg twice daily over intervals of 1 to 2 weeks. ( 2.3 ) Carvedilol 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 Carvedilol tablets, it is recommended that fluid retention be minimized. The recommended starting dose of Carvedilol tablets are 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 successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated. A maximum dose of 50 mg twice daily has been administered to patients with mild-to-moderate heart failure weighing over 85 kg (187 lbs). Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. During these periods, patients should avoid situations such as driving or hazardous tasks, where symptoms could result in injury. Vasodilatory symptoms often do not require treatment, but it may be useful to separate the time of dosing of Carvedilol tablets from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor. The dose of Carvedilol tablets should not be increased until symptoms of worsening heart failure or vasodilation have been stabilized. Fluid retention (with or without transient worsening heart failure symptoms) should be treated by an increase in the dose of diuretics. The dose of Carvedilol tablets should be reduced if patients experience bradycardia (heart rate less than 55 beats per minute). Episodes of dizziness or fluid retention during initiation of Carvedilol tablets can generally be managed without discontinuation of treatment and do not preclude subsequent successful titration of, or a favorable response to, carvedilol. 2.2 Left Ventricular Dysfunction following Myocardial Infarction DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with carvedilol tablets may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that carvedilol tablets be started at 6.25 mg twice daily and increased after 3 to 10 days, based on tolerability, to 12.5 mg twice daily, then again to the target dose of 25 mg twice daily. A lower starting dose may be used (3.125 mg twice daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction. 2.3 Hypertension DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol tablets are 6.25 mg twice daily. If this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 12.5 mg twice daily if needed, based on trough blood pressure, again using standing systolic pressure 1 hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 25 mg twice daily if tolerated and needed. The full antihypertensive effect of carvedilol tablets are seen within 7 to 14 days. Total daily dose should not exceed 50 mg. Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action. 2.4 Hepatic Impairment Carvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications ( 4 )].
Dosage forms and strengths
3. DOSAGE FORMS AND STRENGTHS Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg ( 3 ) The white to off-white, round, film-coated tablets are available in the following strengths: 3.125 mg– debossed with Z and 1, 6.25 mg–debossed with ZC40, 12.5 mg–debossed with ZC41 and 25 mg–debossed with ZC42.
Contraindications
4. 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 any component of this medication or other medications containing carvedilol ( 4 ) Carvedilol tablets are contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets. 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 carvedilol tablets. 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.
Warnings and precautions
5. 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: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.6 ) 5.1 Cessation of Therapy Patients with coronary artery disease, who are being treated with carvedilol tablets, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with angina following the abrupt discontinuation of therapy with β-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris. As with other β-blockers, when discontinuation of carvedilol tablets are planned, the patients should be carefully observed and advised to limit physical activity to a minimum. Carvedilol tablets should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that carvedilol tablets be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with carvedilol abruptly even in patients treated only for hypertension or heart failure. 5.2 Bradycardia In clinical trials, carvedilol tablets caused bradycardia in about 2% of hypertensive subjects, 9% of subjects with heart failure, and 6.5% of subjects with myocardial infarction and left ventricular dysfunction. If pulse rate drops below 55 beats per minute, the dosage should be reduced. 5.3 Hypotension In clinical trials of primarily mild-to-moderate heart failure, hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of subjects receiving carvedilol tablets compared with 3.6% and 2.5% of placebo subjects, respectively. The risk for these events was highest during the first 30 days of dosing, corresponding to the up-titration period and was a cause for discontinuation of therapy in 0.7% of subjects receiving carvedilol tablets, compared with 0.4% of placebo subjects. In a long-term, placebo-controlled trial in severe heart failure (COPERNICUS), hypotension and postural hypotension occurred in 15.1% and syncope in 2.9% of heart failure subjects receiving carvedilol tablets compared with 8.7% and 2.3% of placebo subjects, respectively. These events were a cause for discontinuation of therapy in 1.1% of subjects receiving carvedilol tablets, compared with 0.8% of placebo subjects. Postural hypotension occurred in 1.8% and syncope in 0.1% of hypertensive subjects, primarily following the initial dose or at the time of dose increase and was a cause for discontinuation of therapy in 1% of subjects. In the CAPRICORN trial of survivors of an acute myocardial infarction, hypotension or postural hypotension occurred in 20.2% of subjects receiving carvedilol tablets compared with 12.6% of placebo subjects. Syncope was reported in 3.9% and 1.9% of subjects, respectively. These events were a cause for discontinuation of therapy in 2.5% of subjects receiving carvedilol tablets, compared with 0.2% of placebo subjects. Starting with a low dose, administration with food, and gradual up-titration should decrease the likelihood of syncope or excessive hypotension [ see Dosage and Administration ( 2.1 , 2.2 , 2.3 )] . During initiation of therapy, the patient should be cautioned to avoid situations such as driving or hazardous tasks, where injury could result should syncope occur. 5.4 Heart Failure/Fluid Retention Worsening heart failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, diuretics should be increased and the carvedilol dose should not be advanced until clinical stability resumes [ see Dosage and Administration (2) ]. Occasionally it is necessary to lower the carvedilol dose or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of, or a favorable response to, carvedilol. In a placebo-controlled trial of subjects with severe heart failure, worsening heart failure during the first 3 months was reported to a similar degree with carvedilol and with placebo. When treatment was maintained beyond 3 months, worsening heart failure was reported less frequently in subjects treated with carvedilol than with placebo. Worsening heart failure observed during long-term therapy is more likely to be related to the patients’ underlying disease than to treatment with carvedilol. 5.5 Non-allergic Bronchospasm Patients with bronchospastic disease (e.g., chronic bronchitis, emphysema) should, in general, not receive β-blockers. Carvedilol tablets may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents. It is prudent, if carvedilol tablets are used, to use the smallest effective dose, so that inhibition of endogenous or exogenous β-agonists is minimized. In clinical trials of subjects with heart failure, subjects with bronchospastic disease were enrolled if they did not require oral or inhaled medication to treat their bronchospastic disease. In such patients, it is recommended that carvedilol be used with caution. The dosing recommendations should be followed closely and the dose should be lowered if any evidence of bronchospasm is observed during up-titration.
Side effects
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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies 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 another drug and may not reflect the rates observed in practice. Carvedilol tablets have been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction and in hypertensive subjects. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the subjects in the clinical trials. Adverse events reported for each of these patient populations are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks). Heart Failure Carvedilol tablets have been evaluated for safety in heart failure in more than 4,500 subjects worldwide of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total treated population in placebo-controlled clinical trials received Carvedilol tablets for at least 6 months and 30% received Carvedilol tablets for at least 12 months. In the COMET trial, 1,511 subjects with mild-to-moderate heart failure were treated with Carvedilol tablets for up to 5.9 years (mean: 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared Carvedilol tablets in daily doses up to 100 mg (n = 765) with placebo (n = 437), and in a multinational clinical trial in severe heart failure (COPERNICUS) that compared Carvedilol tablets in daily doses up to 50 mg (n = 1,156) with placebo (n = 1,133), discontinuation rates for adverse experiences were similar in carvedilol and placebo subjects. In placebo-controlled clinical trials, the only cause of discontinuation greater than 1% and occurring more often on carvedilol was dizziness (1.3% on carvedilol, 0.6% on placebo in the COPERNICUS trial). Table 1 shows adverse events reported in subjects with mild-to-moderate heart failure enrolled in US placebo-controlled clinical trials, and with severe heart failure enrolled in the COPERNICUS trial. Shown are adverse events that occurred more frequently in drug-treated subjects than placebo-treated subjects with an incidence of greater than 3% in subjects treated with carvedilol regardless of causality. Median trial medication exposure was 6.3 months for both carvedilol and placebo subjects in the trials of mild-to-moderate heart failure, and 10.4 months in the trial of subjects with severe heart failure. The adverse event profile of Carvedilol tablets observed in the long-term COMET trial was generally similar to that observed in the US Heart Failure Trials. Table 1 Adverse Events (%) Occurring More Frequently with Carvedilol tablets than with Placebo in Subjects with Mild-to-Moderate Heart Failure (HF) Enrolled in US Heart Failure Trials or in Subjects with Severe Heart Failure in the COPERNICUS Trial (Incidence >3% in Subjects Treated with Carvedilol, Regardless of Causality) Mild-to-Moderate HF Severe HF Body System/ Adverse Event Carvedilol (n = 765) Placebo (n = 437) Carvedilol (n = 1,156) Placebo (n = 1,133) Body as a Whole Asthenia Fatigue Digoxin level increased Edema generalized Edema dependent 7 24 5 5 4 7 22 4 3 2 11 — 2 6 — 9 — 1 5 — Cardiovascular Bradycardia Hypotension Syncope Angina pectoris 9 9 3 2 1 3 3 3 10 14 8 6 3 8 5 4 Central Nervous System Dizziness Headache 32 8 19 7 24 5 17 3 Gastrointestinal Diarrhea Nausea Vomiting 12 9 6 6 5 4 5 4 1 3 3 2 Metabolic Hyperglycemia Weight increase BUN increased NPN increased Hypercholesterolemia Edema peripheral 12 10 6 6 4 2 8 7 5 5 3 1 5 12 — — 1 7 3 11 — — 1 6 Musculoskeletal Arthralgia 6 5 1 1 Respiratory Cough increased Rales 8 4 9 4 5 4 4 2 Vision Vision abnormal 5 2 — — Cardiac failure and dyspnea were also reported in these trials, but the rates were equal or greater in subjects who received placebo. The following adverse events were reported with a frequency of greater than 1% but less than or equal to 3% and more frequently with carvedilol in either the US placebo-controlled trials in subjects with mild-to-moderate heart failure or in subjects with severe heart failure in the COPERNICUS trial. Incidence greater than 1% to less than or equal to 3% Body as a Whole Allergy, malaise, hypovolemia, fever, leg edema. Cardiovascular Fluid overload, postural hypotension, aggravated angina pectoris, AV block, palpitation, hypertension. Central and Peripheral Nervous System Hypesthesia, vertigo, paresthesia. Gastrointestinal Melena, periodontitis. Liver and Biliary System SGPT increased, SGOT increased. Metabolic and Nutritional Hyperuricemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, glycosuria, hypervolemia, diabetes mellitus, GGT increased, weight loss, hyperkalemia, creatinine increased. Musculoskeletal Muscle cramps. Platelet, Bleeding, and Clotting Prothrombin decreased, purpura, thrombocytopenia. Psychiatric Somnolence. Reproductive, male Impotence. Special Senses Blurred vision. Urinary System Renal insufficiency, albuminuria, hematuria.
Drug interactions
7. 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. ( 7.4 ) 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 ) 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 these drugs would be expected to increase blood levels of the R(+) enantiomer of carvedilol [see Clinical Pharmacology (12.3) ]. Retrospective analysis of side effects in clinical trials showed that poor 2D6 metabolizers had a higher rate of dizziness during up-titration, presumably resulting from vasodilating effects of the higher concentrations of the α-blocking R(+) enantiomer. 7.2 Hypotensive Agents Patients taking a β-blocker and a drug that can deplete catecholamines (e.g., reserpine and monoamine oxidase inhibitors) should be observed closely for signs of hypotension and/or severe bradycardia. Concomitant administration of clonidine with a β-blocker may cause hypotension and bradycardia. When concomitant treatment with a β-blocker and clonidine is to be terminated, the β-blocker should be discontinued first. Clonidine therapy can then be discontinued several days later by gradually decreasing the dosage. 7.3 Cyclosporine Modest increases in mean trough cyclosporine concentrations were observed following initiation of carvedilol treatment in 21 renal transplant subjects suffering from chronic vascular rejection. In about 30% of subjects, the dose of cyclosporine had to be reduced in order to maintain cyclosporine concentrations within the therapeutic range, while in the remainder no adjustment was needed. On the average for the group, the dose of cyclosporine was reduced about 20% in these subjects. Due to wide interindividual variability in the dose adjustment required, it is recommended that cyclosporine concentrations be monitored closely after initiation of carvedilol therapy and that the dose of cyclosporine be adjusted as appropriate. 7.4 Digitalis Glycosides Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing carvedilol tablets [see Clinical Pharmacology (12.5) ]. 7.5 Inducers/Inhibitors of Hepatic Metabolism Rifampin reduced plasma concentrations of carvedilol by about 70% [see Clinical Pharmacology ( 12.5 )] . Cimetidine increased AUC by about 30% but caused no change in Cmax [see Clinical Pharmacology ( 12.5 ) ]. 7.6 Amiodarone Amiodarone, and its metabolite desethyl amiodarone, inhibitors of CYP2C9, and P-glycoprotein, increased concentrations of the S(-) -enantiomer of carvedilol by at least 2 fold [see Clinical Pharmacology (12.5) ]. The concomitant administration of amiodarone or other CYP2C9 inhibitors such as fluconazole with carvedilol may enhance the β-blocking activity, resulting in further slowing of the heart rate or cardiac conduction. Patients should be observed for signs of bradycardia or heart block, particularly when one agent is added to pre-existing treatment with the other. 7.7 Calcium Channel Blockers Conduction disturbance (rarely with hemodynamic compromise) has been observed when carvedilol tablet is co-administered with diltiazem. As with other β-blockers, if carvedilol tablet is administered with calcium channel blockers of the verapamil or diltiazem type, it is recommended that ECG and blood pressure be monitored. 7.8 Insulin or Oral Hypoglycemics β-blockers may enhance the blood-sugar-reducing effect of insulin and oral hypoglycemics. Therefore, in patients taking insulin or oral hypoglycemics, regular monitoring of blood glucose is recommended [see Warnings and Precautions (5.6) ]. 7.9 Anesthesia If treatment with carvedilol is to be continued perioperatively, particular care should be taken when anesthetic agents that depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used [see Overdosage (10) ].
Use in specific populations
8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see Data] . Oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (MRHD). In addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the MRHD [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/ or Embryo/ Fetal Risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/ Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. Data Animal Data: Studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m 2 ) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the MRHD as mg per m 2 ). In the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD as mg per m 2 ), accompanied by an increased incidence of fetuses with delayed skeletal development. In rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the MRHD as mg per m 2 ); in rabbits, it was 15 mg per kg per day (5 times the MRHD as mg per m 2 . In a pre- and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200mg per kg per day (approximately 32 times the MRHD as mg per m 2 ), and pup mortality and delays in physical growth / development were observed at 60 mg per kg per day (10 times the MRHD as mg per m 2 ) in the absence of maternal toxicity. The no-effect level was 12 mg per kg per day (2 times the MRHD as mg per m 2 ). Carvedilol was present in fetal rat tissue. 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carvedilol and any potential adverse effects on the breastfed infant from carvedilol or from the underlying maternal condition. 8.4 Pediatric Use Effectiveness of carvedilol tablets 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) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol. These dose levels produced placebo-corrected heart rate reduction of 4 to 6 heart beats per minute, indicative of β-blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes. Adverse reactions in this trial that occurred in greater than 10% of subjects treated with carvedilol and at twice the rate of placebo-treated subjects included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%). 8.5 Geriatric Use Of the 765 subjects with heart failure randomized to carvedilol in US clinical trials, 31% (235) were aged 65 years or older, and 7.3% (56) were aged 75 years or older. Of the 1,156 subjects randomized to carvedilol in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were aged 65 years or older, and 15% (174) were aged 75 years or older. Of 3,025 subjects receiving carvedilol in heart failure trials worldwide, 42% were aged 65 years or older. Of the 975 subjects with myocardial infarction randomized to carvedilol tablets in the CAPRICORN trial, 48% (468) were aged 65 years or older, and 11% (111) were aged 75 years or older.
Pregnancy
8.1 Pregnancy Risk Summary Available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. The use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see Data] . Oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (MRHD). In addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the MRHD [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/ or Embryo/ Fetal Risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/ Neonatal Adverse Reactions: Neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. Data Animal Data: Studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per m 2 ) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the MRHD as mg per m 2 ). In the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD as mg per m 2 ), accompanied by an increased incidence of fetuses with delayed skeletal development. In rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the MRHD as mg per m 2 ); in rabbits, it was 15 mg per kg per day (5 times the MRHD as mg per m 2 . In a pre- and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200mg per kg per day (approximately 32 times the MRHD as mg per m 2 ), and pup mortality and delays in physical growth / development were observed at 60 mg per kg per day (10 times the MRHD as mg per m 2 ) in the absence of maternal toxicity. The no-effect level was 12 mg per kg per day (2 times the MRHD as mg per m 2 ). Carvedilol was present in fetal rat tissue.
Pediatric use
8.4 Pediatric Use Effectiveness of carvedilol tablets 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) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (LV), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an LV] who were receiving standard background treatment were randomized to placebo or to 2 dose levels of carvedilol. These dose levels produced placebo-corrected heart rate reduction of 4 to 6 heart beats per minute, indicative of β-blockade activity. Exposure appeared to be lower in pediatric subjects than adults. After 8 months of follow-up, there was no significant effect of treatment on clinical outcomes. Adverse reactions in this trial that occurred in greater than 10% of subjects treated with carvedilol and at twice the rate of placebo-treated subjects included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).
Geriatric use
8.5 Geriatric Use Of the 765 subjects with heart failure randomized to carvedilol in US clinical trials, 31% (235) were aged 65 years or older, and 7.3% (56) were aged 75 years or older. Of the 1,156 subjects randomized to carvedilol in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were aged 65 years or older, and 15% (174) were aged 75 years or older. Of 3,025 subjects receiving carvedilol in heart failure trials worldwide, 42% were aged 65 years or older. Of the 975 subjects with myocardial infarction randomized to carvedilol tablets in the CAPRICORN trial, 48% (468) were aged 65 years or older, and 11% (111) were aged 75 years or older. Of the 2,065 hypertensive subjects in US clinical trials of efficacy or safety who were treated with carvedilol tablets, 21% (436) were aged 65 years or older. Of 3,722 subjects receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were aged 65 years or older. With the exception of dizziness in hypertensive subjects (incidence 8.8% in the elderly versus 6% in younger subjects), no overall differences in the safety or effectiveness (see Figures 2 and 4 ) were observed between the older subjects and younger subjects in each of these populations. Similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Overdosage
10. OVERDOSAGE Overdosage may cause severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, and cardiac arrest. Respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures may also occur. The patient should be placed in a supine position and, where necessary, kept under observation and treated under intensive-care conditions. The following agents may be administered: For excessive bradycardia: Atropine, 2 mg IV. To support cardiovascular function: Glucagon, 5 to 10 mg IV rapidly over 30 seconds, followed by a continuous infusion of 5 mg per hour; sympathomimetics (dobutamine, isoprenaline, adrenaline) at doses according to body weight and effect. If peripheral vasodilation dominates, it may be necessary to administer adrenaline or noradrenaline with continuous monitoring of circulatory conditions. For therapy-resistant bradycardia, pacemaker therapy should be performed. For bronchospasm, β-sympathomimetics (as aerosol or IV) or aminophylline IV should be given. In the event of seizures, slow IV injection of diazepam or clonazepam is recommended. NOTE: In the event of severe intoxication where there are symptoms of shock, treatment with antidotes must be continued for a sufficiently long period of time consistent with the 7- to 10-hour half-life of carvedilol. Cases of overdosage with carvedilol tablets alone or in combination with other drugs have been reported. Quantities ingested in some cases exceeded 1,000 milligrams. Symptoms experienced included low blood pressure and heart rate. Standard supportive treatment was provided and individuals recovered.
Description
11. DESCRIPTION Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure: Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24 H 26 N 2 O 4 . It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3. structured formula for carvedilol
Mechanism of action
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 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol has no intrinsic sympathomimetic activity.
How supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Carvedilol Tablets USP, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with 'Z' on one side and '1' on other side and are supplied as follows: NDC-68001-153-00 in bottles of 100 tablets NDC-68001-153-03 in bottles of 500 tablets Carvedilol Tablets USP, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC40' on one side and plain on other side and are supplied as follows: NDC-68001-154-00 in bottles of 100 tablets NDC-68001-154-03 in bottles of 500 tablets Carvedilol Tablets USP, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC41' on one side and plain on other side and are supplied as follows: NDC-68001-151-00 in bottles of 100 tablets NDC-68001-151-03 in bottles of 500 tablets Carvedilol Tablets USP, 25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC42' on one side and plain on other side and are supplied as follows: NDC-68001-152-00 in bottles of 100 tablets NDC-68001-152-03 in bottles of 500 tablets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
Patient information
17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking carvedilol tablets should be advised of the following: Patients should take carvedilol tablets with food. Patients should not interrupt or discontinue using carvedilol tablets without a physician’s advice. Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur. If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks. Patients should consult a physician if they experience dizziness or faintness in case the dosage should be adjusted. Inform patients or caregivers that there is a risk of hypoglycemia when carvedilol tablets are given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions (5.6 )] Contact lens wearers may experience decreased lacrimation. The brands listed are registered trademark of their respective owner.
Label text from the FDA structured product label by BluePoint Laboratories (revised Mar 9, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Carvedilol in 168 products
Carvedilol NDC products (168)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-6742 | Carvedilol 6.25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1067 | Carvedilol 12.5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1062 | Carvedilol 3.125 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1069 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2079 | Carvedilol 12.5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2119 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-2175 | Carvedilol 6.25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4171 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4898 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5726 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6865 | Carvedilol 6.25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6878 | Carvedilol 12.5 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-6949 | Carvedilol 3.125 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7786 | Carvedilol 6.25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7849 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7850 | Carvedilol 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7890 | Carvedilol 3.125 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 72888-501 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Advagen Pharma Limited | ANDA |
| 72888-499 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Advagen Pharma Limited | ANDA |
| 72888-500 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Advagen Pharma Limited | ANDA |
| 72888-502 | Carvedilol 25 mg/1 Tablet, Film Coated | Advagen Pharma Limited | ANDA |
| 72888-037 | Carvedilol 25 mg/1 Tablet, Film Coated | Advagen Pharma Ltd | ANDA |
| 72888-036 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Advagen Pharma Ltd | ANDA |
| 72888-035 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Advagen Pharma Ltd | ANDA |
| 72888-034 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Advagen Pharma Ltd | ANDA |
| 68084-854 | Carvedilol 6.25 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 71610-062 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-063 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-067 | Carvedilol 25 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-066 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-132 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 65862-145 | Carvedilol 25 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-144 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-143 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-142 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 68001-151 | Carvedilol 12.5 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-152 | Carvedilol 25 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-153 | Carvedilol 3.125 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 68001-154 | Carvedilol 6.25 mg/1 Tablet, Film Coated | BluePoint Laboratories | ANDA |
| 63629-4070 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1623 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1545 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1533 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2474 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2101 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2033 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2026 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-4060 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1463 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2023 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1937 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1813 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0273 | Carvedilol 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1128 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1407 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1457 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 55154-2649 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2648 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2641 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2640 | Carvedilol 25 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-0973 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0879 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0336 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1616 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-653 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-372 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-663 | Carvedilol 25 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-664 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 55111-253 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-252 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-254 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 55111-255 | Carvedilol 25 mg/1 Tablet, Film Coated | Dr. Reddy's Laboratories Limited | ANDA |
| 68462-165 | Carvedilol 25 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-164 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-163 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-162 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-042 | Carvedilol 25 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-040 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-039 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-041 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 0904-7305 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7306 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7307 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7308 | Carvedilol 25 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 58657-753 | Carvedilol 25 mg/1 Tablet, Film Coated | Method Pharmaceuticals, LLC | ANDA |
| 58657-751 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Method Pharmaceuticals, LLC | ANDA |
| 58657-750 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Method Pharmaceuticals, LLC | ANDA |
| 58657-752 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Method Pharmaceuticals, LLC | ANDA |
| 0615-8387 | Carvedilol 3.125 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8388 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8389 | Carvedilol 12.5 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8390 | Carvedilol 25 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-713 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-029 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-030 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-033 | Carvedilol 25 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-034 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-943 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-397 | Carvedilol 25 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 68071-3138 | Carvedilol 3.125 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5311 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3970 | Carvedilol 3.125 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-5275 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4956 | Carvedilol 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4816 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4600 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2230 | Carvedilol 12.5 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2773 | Carvedilol 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2780 | Carvedilol 6.25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-833 | Carvedilol 6.25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-537 | Carvedilol 12.5 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-440 | Carvedilol 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-431 | Carvedilol 6.25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-411 | Carvedilol 3.125 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-125 | Carvedilol 12.5 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-126 | Carvedilol 3.125 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-129 | Carvedilol 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8252 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8231 | Carvedilol 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7539 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-9789 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals,Inc. | ANDA |
| 68788-9265 | Carvedilol 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals,Inc. | ANDA |
| 82804-138 | Carvedilol 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-183 | Carvedilol 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-191 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-225 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 82804-270 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-409 | Carvedilol 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-946 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-941 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-570 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-447 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-424 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-131 | Carvedilol 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 42708-181 | Carvedilol 3.125 mg/1 Tablet, Film Coated | QPharma Inc | ANDA |
| 42708-072 | Carvedilol 3.125 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 82009-125 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-126 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-127 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-128 | Carvedilol 25 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 67296-2298 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 67296-1901 | Carvedilol 25 mg/1 Tablet, Film Coated | RedPharm Drug, Inc | ANDA |
| 67296-1899 | Carvedilol 25 mg/1 Tablet, Film Coated | RedPharm Drug, Inc | ANDA |
| 70518-2389 | Carvedilol 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4389 | Carvedilol 12.5 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1826 | Carvedilol 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-1377 | Carvedilol 3.125 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0356 | Carvedilol 12.5 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0840 | Carvedilol 6.25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0426 | Carvedilol 6.25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 60760-582 | Carvedilol 6.25 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-494 | Carvedilol 12.5 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 0093-0051 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-0135 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-7295 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-7296 | Carvedilol 25 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 76385-111 | Carvedilol 6.25 mg/1 Tablet, Film Coated | UNICHEM PHARMACEUTICALS (USA), INC. | ANDA |
| 76385-113 | Carvedilol 25 mg/1 Tablet, Film Coated | UNICHEM PHARMACEUTICALS (USA), INC. | ANDA |
| 76385-112 | Carvedilol 12.5 mg/1 Tablet, Film Coated | UNICHEM PHARMACEUTICALS (USA), INC. | ANDA |
| 76385-110 | Carvedilol 3.125 mg/1 Tablet, Film Coated | UNICHEM PHARMACEUTICALS (USA), INC. | ANDA |
| 65841-616 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 65841-619 | Carvedilol 25 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 65841-618 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 65841-617 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 68382-095 | Carvedilol 25 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-094 | Carvedilol 12.5 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-093 | Carvedilol 6.25 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-092 | Carvedilol 3.125 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
Carvedilol recalls
- D-0594-2025 Aug 27, 2025 · Class II · Ongoing
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - D-0588-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - D-0577-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0578-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0579-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. - D-0587-2025 Aug 20, 2025 · Class II · Ongoing
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm - D-0448-2025 Jun 4, 2025 · Class II · Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0449-2025 Jun 4, 2025 · Class II · Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0450-2025 Jun 4, 2025 · Class II · Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0451-2025 Jun 4, 2025 · Class II · Ongoing
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit - D-0336-2025 Apr 16, 2025 · Class II · Ongoing
CGMP Deviations - D-0216-2025 Feb 12, 2025 · Class II · Ongoing
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. - D-0215-2025 Feb 12, 2025 · Class II · Ongoing
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. - D-0263-2022 Dec 1, 2021 · Class III · Terminated
Failed Impurities/Degradation Specifications - D-0753-2021 Aug 25, 2021 · Class II · Terminated
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle - D-1273-2019 May 15, 2019 · Class II · Terminated
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg - D-1242-2019 May 1, 2019 · Class III · Terminated
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets…
Frequently asked questions
What is Carvedilol used for?
1. INDICATIONS AND USAGE . Carvedilol tablets are 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) 1.1 Heart Failure Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of…
What are the side effects of Carvedilol?
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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or… See the full label for the complete list.
Who makes Carvedilol?
Carvedilol is listed by 36 labelers in the FDA NDC directory, including A-S Medication Solutions, Advagen Pharma Limited, Advagen Pharma Ltd, American Health Packaging.
Has Carvedilol been recalled?
The FDA enforcement database lists 17 recalls for Carvedilol, most recently D-0594-2025 (class ii): CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm