Medicine guide

Carvedilol

3.125 mg · Tablet, Film Coated

  • Prescription only
  • alpha-Adrenergic Blocker
Active substance
Carvedilol
Made by
Dr. Reddy's Laboratories Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2018-12-05

What it is

alpha-Adrenergic Blocker

Used for
  • Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) Hypertension ( 1.3 )
The label’s usual adult dose

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.

Full directions ↓
Do not take it if

Carvedilol tablets are contraindicated in the following conditions:

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
119other products contain Carvedilol — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:

  • Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) Hypertension ( 1.3 )
  • 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 ≤ 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) ].

From the official label · 2018-12-05 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Half-life7–10 h
Mostly cleared after≈ 42.5 hfive half-lives — our arithmetic
How the body breaks it down

Carvedilol is extensively metabolized.

How it leaves the body

Less than 2% of the dose was excreted unchanged in the urine.

With food

When administered with food, the rate of absorption is slowed, as evidenced by a delay in the time to reach peak plasma levels, with no significant difference in extent of bioavailability.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2018-12-05

Do not take it if

  • 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.
  • 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)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Carvedilol tablets should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
  • Take with food.
  • Individualize dosages and monitor during up-titration.( 2 ) 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 )
  • 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 is 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 one 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 is 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) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Acute exacerbation of coronary artery disease upon cessation of therapy:
  • Do not abruptly discontinue.
  • ( 5.1 ) Bradycardia, hypotension, 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 )
  • 5.1 Cessation of Therapy Patients with coronary artery disease, who are being treated with carvedilol, 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 angina patients 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 is planned, the patients should be carefully observed and advised to limit physical activity to a minimum.
  • Carvedilol should be discontinued over 1 to 2 weeks whenever possible.
  • If the angina worsens or acute coronary insufficiency develops, it is recommended that carvedilol 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.
  • 5.2 Bradycardia In clinical trials, carvedilol caused bradycardia in about 2% of hypertensive patients, and 6.5% of myocardial infarction patients with left ventricular dysfunction.
  • If pulse rate drops below 55 beats/minute, the dosage should be reduced.
  • 5.3 Hypotension Postural hypotension occurred in 1.8% and syncope in 0.1% of hypertensive patients, primarily following the initial dose or at the time of dose increase and was a cause for discontinuation of therapy in 1% of patients.
  • In the CAPRICORN study of survivors of an acute myocardial infarction, hypotension or postural hypotension occurred in 20.2% of patients receiving carvedilol compared to 12.6% of placebo patients.
  • Syncope was reported in 3.9% and 1.9% of patients, respectively.
  • These events were a cause for discontinuation of therapy in 2.5% of patients receiving carvedilol, compared to 0.2% of placebo patients.
  • 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 (2.2 , 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 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.
  • 5.5 Non-allergic Bronchospasm Patients with bronchospastic disease (e.g., chronic bronchitis and emphysema) should, in general, not receive β-blockers.
  • Carvedilol may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents.
  • It is prudent, if carvedilol is used, to use
  • the smallest effective dose, so that inhibition of endogenous or exogenous β-agonists is minimized.
  • In clinical trials patients 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.
  • 5.6 Glycemic Control in Type 2 Diabetes In general, β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia.
  • Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels.
  • Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities.
  • Studies designed to examine the effects of carvedilol on glycemic control in patients with diabetes and heart failure have not been conducted.
  • In a study designed to examine the effects of carvedilol on glycemic control in a population with mild-to-moderate hypertension and well-controlled type 2 diabetes mellitus, carvedilol had no adverse effect on glycemic control, based on HbA1c measurement [see Clinical studies(14.4 ) ].
  • 5.7 Peripheral Vascular Disease β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
  • Caution should be exercised in such individuals.
  • 5.8 Deterioration of Renal Function Rarely, use of carvedilol in patients with heart failure has resulted in deterioration of renal function.
  • Patients at risk appear to be those with low blood pressure (systolic blood pressure <100 mm Hg), ischemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency.
  • Renal function has returned to baseline when carvedilol was stopped.
  • In patients with these risk factors it is recommended that renal function be monitored during up-titration of carvedilol and the drug discontinued or dosage reduced if worsening of renal function occurs.
  • 5.9 Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
  • 5.10 Thyrotoxicosis β-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia.
  • Abrupt withdrawal of β-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.
  • 5.11 Pheochromocytoma In patients with pheochromocytoma, an α-blocking agent should be initiated prior to the use of any β-blocking agent.
  • Although carvedilol has both α- and β-blocking pharmacologic activities, there has been no experience with its use in this condition.
  • Therefore, caution should be taken in the administration of carvedilol to patients suspected of having pheochromocytoma.
  • 5.12 Prinzmetal's Variant Angina Agents with non-selective β-blocking activity may provoke chest pain in patients with Prinzmetal's variant angina.
  • There has been no clinical experience with carvedilol in these patients although the α-blocking activity may prevent such symptoms.
  • However, caution should be taken in the administration of carvedilol to patients suspected of having Prinzmetal's variant angina.
  • 5.13 Risk of Anaphylactic Reaction While taking β-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic.
  • Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
  • 5.14 Intraoperative Floppy Iris Syndrome Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (carvedilol is an alpha/beta blocker).
  • This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions.
  • The patient’s ophthalmologist should be prepared for possible modifications to the surgical technique, such as utilization of iris hooks, iris dilator rings, or viscoelastic substances.
  • There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Pregnancy Category C.
  • Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg/kg/day (50 times the maximum recommended human dose [MRHD] as mg/m 2 ) and in rabbits at doses of 75 mg/kg/day (25 times the MRHD as mg/m 2 ).
  • In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg/kg/day (50 times the MRHD as mg/m 2 ), which was accompanied by an elevation in the frequency of fetuses with delayed skeletal development (missing or stunted 13th rib).
  • In rats the no-observed-effect level for developmental toxicity was 60 mg/kg/day (10 times the MRHD as mg/m 2 ); in rabbits it was 15 mg/kg/day (5 times the MRHD as mg/m 2 ).
  • There are no adequate and well-controlled studies in pregnant women.
  • Carvedilol tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • It is not known whether this drug is excreted in human milk.
  • Studies in rats have shown that carvedilol and/or its metabolites (as well as other β-blockers) cross the placental barrier and are excreted in breast milk.
  • There was increased mortality at one week post-partum in neonates from rats treated with 60 mg/kg/day (10 times the MRHD as mg/m 2 ) and above during the last trimester through day 22 of lactation.
  • Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from β-blockers, especially bradycardia, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • The effects of other α- and β-blocking agents have included perinatal and neonatal distress.
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Pregnancy Category C.
  • Studies performed in pregnant rats and rabbits given carvedilol revealed increased post-implantation loss in rats at doses of 300 mg/kg/day (50 times the maximum recommended human dose [MRHD] as mg/m 2 ) and in rabbits at doses of 75 mg/kg/day (25 times the MRHD as mg/m 2 ).
  • In the rats, there was also a decrease in fetal body weight at the maternally toxic dose of 300 mg/kg/day (50 times the MRHD as mg/m 2 ), which was accompanied by an elevation in the frequency of fetuses with delayed skeletal development (missing or stunted 13th rib).
  • In rats the no-observed-effect level for developmental toxicity was 60 mg/kg/day (10 times the MRHD as mg/m 2 ); in rabbits it was 15 mg/kg/day (5 times the MRHD as mg/m 2 ).
  • There are no adequate and well-controlled studies in pregnant women.
  • Carvedilol tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk.
  • Studies in rats have shown that carvedilol and/or its metabolites (as well as other β-blockers) cross the placental barrier and are excreted in breast milk.
  • There was increased mortality at one week post-partum in neonates from rats treated with 60 mg/kg/day (10 times the MRHD as mg/m 2 ) and above during the last trimester through day 22 of lactation.
  • Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from β-blockers, especially bradycardia, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • The effects of other α- and β-blocking agents have included perinatal and neonatal distress.
  • 8.4 Pediatric Use Effectiveness of carvedilol in patients younger than 18 years of age has not been established.
  • In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction <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 4-6 heart beats per minute, indicative of ß-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 patients treated with carvedilol and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).
  • 8.5 Geriatric Use Of the 975 myocardial infarction patients randomized to carvedilol in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older.
  • Of the 2,065 hypertensive patients in US clinical trials of efficacy or safety who were treated with carvedilol, 21% (436) were 65 years of age or older.
  • Of 3,722 patients receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older.
  • With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see Figure 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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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 )
  • 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 both agents with β-blocking properties 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 agents with β-blocking properties may potentiate blood-pressure- and heart-rate-lowering effects.
  • When concomitant treatment with agents with β-blocking properties and clonidine is to be terminated, the β-blocking agent 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 patients suffering from chronic vascular rejection.
  • In about 30% of patients, 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 patients.
  • 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 Digoxin 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 C max [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 properties of carvedilol 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 tablets are co-administered with diltiazem.
  • As with other agents with β-blocking properties, if carvedilol is to be 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 Agents with β-blocking properties 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 phosphate extended release capsules is to be continued perioperatively, particular care should be taken when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used [see Overdosage (10) ].

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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.
  • Gastric lavage or pharmacologically induced emesis may be used shortly after ingestion.
  • The following agents may be administered:
  • for excessive bradycardia:
  • a tropine, 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/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.

Quoted from the official label, section “Overdosage”.

Use in children

  • Effectiveness of carvedilol in patients younger than 18 years of age has not been established.
  • In a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [NYHA class II-IV, left ventricular ejection fraction <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 4-6 heart beats per minute, indicative of ß-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 patients treated with carvedilol and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%).

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Of the 975 myocardial infarction patients randomized to carvedilol in the CAPRICORN trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older.
  • Of the 2,065 hypertensive patients in US clinical trials of efficacy or safety who were treated with carvedilol, 21% (436) were 65 years of age or older.
  • Of 3,722 patients receiving carvedilol tablets in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older.
  • With the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see Figure 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • Most common adverse events ( 6.1 ):
  • 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 Dr.
  • Reddy’s Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • 6.1 Clinical Studies Experience Carvedilol tablets have been evaluated for safety in patients with left ventricular dysfunction following myocardial infarction and in hypertensive patients.
  • The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients 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).
  • Left Ventricular Dysfunction Following Myocardial Infarction :
  • Carvedilol tablets have been evaluated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 patients who received carvedilol tablets and 980 who received placebo.
  • Approximately 75% of the patients received carvedilol tablets for at least 6 months and 53% received carvedilol tablets for at least 12 months.
  • Patients were treated for an average of 12.9 months and 12.8 months with carvedilol tablets and placebo, respectively.
  • The following adverse events were reported with a frequency of >1% but ≤3% and more frequently with carvedilol tablets:
  • Flu syndrome, cerebrovascular accident, peripheral vascular disorder, hypotonia, depression, gastrointestinal pain, arthritis, and gout.
  • The overall rates of discontinuations due to adverse events were similar in both groups of patients.
  • In this database, the only cause of discontinuation >1%, and occurring more often on carvedilol was hypotension (1.5% on carvedilol, 0.2% on placebo).
  • Hypertension :
  • Carvedilol has been evaluated for safety in hypertension in more than 2,193 patients in US clinical trials and in 2,976 patients in international clinical trials.
  • Approximately 36% of the total treated population received carvedilol tablets for at least 6 months.
  • Most adverse events reported during therapy with carvedilol tablets were of mild to moderate severity.
  • In US controlled clinical trials directly comparing carvedilol tablets in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of patients receiving carvedilol tablets discontinued for adverse events versus 5.2% of placebo patients.
  • Although there was no overall difference in discontinuation rates, discontinuations were more common in the carvedilol group for postural hypotension (1% versus 0).
  • The overall incidence of adverse events in US placebo-controlled trials increased with increasing dose of carvedilol tablets.
  • For individual adverse events this could only be distinguished for dizziness, which increased in frequency from 2% to 5% as total daily dose increased from 6.25 mg to 50 mg.
  • Table 2 shows adverse events in US placebo-controlled clinical trials for hypertension that occurred with an incidence of ≥1% regardless of causality, and that were more frequent in drug-treated patients than placebo-treated patients.
  • Table 2.
  • Adverse Events (%) Occurring in US Placebo-Controlled Hypertension Trials (Incidence ≥1%, Regardless of Causality)* Shown are events with rate >1% rounded to nearest integer.
  • Carvedilol Tablets Placebo (n = 1,142) (n = 462) Cardiovascular Bradycardia 2 — Postural hypotension 2 — Peripheral Edema 1 — Central Nervous System Dizziness 6 5 Insomnia 2 1 Gastrointestinal Diarrhea 2 1 Hematologic Thrombocytopenia 1 — Metabolic Hypertriglyceridemia 1 — Dyspnea and fatigue were also reported in these studies, but the rates were equal or greater in patients who received placebo.
  • The following adverse events not described above were reported as possibly or probably related to carvedilol tablets in worldwide open or controlled trials with carvedilol in patients with hypertension.
  • Incidence >0.1% to ≤ 1% Cardiovascular: Peripheral ischemia, tachycardia.
  • Central and Peripheral Nervous System: Hypokinesia.
  • Gastrointestinal:
  • Bilirubinemia, increased hepatic enzymes (0.2% of hypertension patients were discontinued from therapy because of increases in hepatic enzymes) [see Adverse Reactions (6.2) ].
  • Psychiatric:
  • Nervousness, sleep disorder, aggravated depression, impaired concentration, abnormal thinking, paroniria, emotional lability.
  • Respiratory System: Asthma [see Contraindications (4) ].
  • Reproductive, male: Decreased libido.
  • Skin and Appendages:
  • Pruritus, rash erythematous, rash maculopapular, rash psoriaform, photosensitivity reaction.
  • Special Senses: Tinnitus.
  • Urinary System: Micturition frequency increased.
  • Autonomic Nervous System: Dry mouth, sweating increased.
  • Metabolic and Nutritional: Hypokalemia, hypertriglyceridemia.
  • Hematologic: Anemia, leukopenia.
  • The following events were reported in ≤0.1% of patients and are potentially important:
  • Complete AV block, bundle branch block, myocardial ischemia, cerebrovascular disorder, convulsions, migraine, neuralgia, paresis, anaphylactoid reaction, alopecia, exfoliative dermatitis, amnesia, GI hemorrhage, bronchospasm, pulmonary edema, decreased hearing, respiratory alkalosis, increased BUN, decreased HDL, pancytopenia, and atypical lymphocytes.
  • 6.2 Laboratory Abnormalities Reversible elevations in serum transaminases (ALT or AST) have been observed during treatment with carvedilol tablets.
  • Rates of transaminase elevations (2- to 3-times the upper limit of normal) observed during controlled clinical trials have generally been similar between patients treated with carvedilol tablets and those treated with placebo.
  • However, transaminase elevations, confirmed by rechallenge, have been observed with carvedilol tablets.
  • In a long-term, placebo-controlled trial in severe heart failure, patients treated with carvedilol tablets had lower values for hepatic transaminases than patients treated with placebo, possibly because improvements in cardiac function induced by carvedilol led to less hepatic congestion and/or improved hepatic blood flow.
  • Carvedilol tablets have not been associated with clinically significant changes in serum potassium, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
  • No clinically relevant changes were noted in fasting serum glucose in hypertensive patients.
  • 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of carvedilol.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Blood and Lymphatic System Disorders: Aplastic anemia.
  • Immune System Disorders:
  • Hypersensitivity (e.g., anaphylactic reactions, angioedema, urticaria).
  • Renal and Urinary Disorders: Urinary incontinence.
  • Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonitis.
  • Skin and Subcutaneous Tissue Disorders:
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • See FDA-Approved Patient Labeling (17.2)
  • 17.1 Patient Advice 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 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.
  • Diabetic patients should report any changes in blood sugar levels to their physician.
  • Contact lens wearers may experience decreased lacrimation.
  • 17.2 FDA-Approved Patient Labeling Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.
  • Rx Only Manufactured by: Dr.
  • Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA Revised:
  • 0811 FDA-Approved Patient Labeling PHARMACIST-DETACH FROM HERE ------------------------------------------------------------------------------------------------------------ PATIENT INFORMATION CARVEDILOL TABLETS USP Read the Patient Information that comes with carvedilol tablets before you start taking it and each time
  • you get a refill.
  • There may be new information.
  • This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • If you have any questions about carvedilol tablets, ask your doctor or pharmacist.
  • What is carvedilol? Carvedilol is a prescription medicine that belongs to a group of medicines called "beta-blockers".
  • Carvedilol is used, often with other medicines, for the following conditions:
  • To treat patients who had a heart attack that worsened how well the heart pumps To treat patients with high blood pressure (hypertension) Carvedilol tablets are not approved for use in
  • children under 18 years of age.
  • Who should not take carvedilol tablets?
  • Do not take carvedilol tablets
  • if you:
  • Have severe heart failure and are hospitalized in the intensive care unit or require certain intravenous medications that help support circulation (inotropic medications) Are prone to asthma or other breathing problems Have a slow heartbeat or a heart that skips a beat (irregular heartbeat) Have liver problems Are allergic to any of the ingredients in carvedilol tablets.
  • The active ingredient is carvedilol.
  • See the end of this leaflet for a list of all the ingredients in carvedilol tablets.
  • What should I tell my doctor before taking carvedilol tablets? Tell your doctor about all of your medical conditions, including
  • if you:
  • Have asthma or other lung problems (such as bronchitis or emphysema) Have problems with blood flow in your feet and legs (peripheral vascular disease) carvedilol tablets can make some of your symptoms worse.
  • Have diabetes Have thyroid problems Have a condition called pheochromocytoma Have had severe allergic reactions Are pregnant or trying to become pregnant.
  • It is not known if carvedilol tablets are safe for your unborn baby.
  • You and your doctor should talk about the best way to control your high blood pressure during pregnancy.
  • Are breastfeeding.
  • It is not known if carvedilol tablets passes into your breast milk.
  • You should not breastfeed while using carvedilol tablets.
  • Are scheduled for surgery and will be given anesthetic agents Are scheduled for cataract surgery and have taken or are currently taking carvedilol.
  • Are taking prescription or non-prescription medicines, vitamins, and herbal supplements.
  • Carvedilol tablets and certain other medicines can affect each other and cause serious side effects.
  • Carvedilol tablets may affect the way other medicines work.
  • Also, other medicines may affect how well Carvedilol tablet works Keep a list of all the medicines
  • you take.
  • Show this list to your doctor and pharmacist before you start a new medicine.
  • How should I take carvedilol tablets? It is important for you to take your medicine every day as directed by your doctor.
  • If you stop taking carvedilol tablets suddenly, you could have chest pain and/or a heart attack.
  • If your doctor decides that you should stop taking carvedilol tablets, your doctor may slowly lower your dose over a period of time before stopping it completely.
  • Take carvedilol tablets exactly as prescribed.
  • Your doctor will tell you how many tablets to take and how often.
  • In order to minimize possible side effects, your doctor might begin with a low dose and then slowly increase the dose.
  • Do not stop taking carvedilol tablets and do not change the amount of carvedilol tablets
  • you take without talking to your doctor.
  • Tell your doctor
  • if you gain weight or have trouble breathing while taking carvedilol tablets.
  • Take carvedilol tablets with food.
  • If you miss a dose of carvedilol tablets, take your dose as soon as you remember, unless it is time to take your next dose.
  • Take your next dose at the usual time.
  • Do not take 2 doses at the same time.
  • If you take too much carvedilol tablets, call your doctor or poison control center right away.
  • What should I
  • avoid while taking carvedilol tablets? Carvedilol tablets can cause you to feel dizzy, tired, or faint.
  • Do not drive a car, use machinery, or do anything that needs you to be alert
  • if you have these symptoms.
  • What are possible side effects of carvedilol tablets? Low blood pressure (which may cause dizziness or fainting when you stand up).
  • If these happen, sit or lie down right away and tell your doctor.
  • Tiredness.
  • If you feel tired or dizzy you should not drive, use machinery, or do anything that needs you to be alert.
  • Slow heart beat Changes in your blood sugar.
  • If you have diabetes, tell your doctor
  • if you have any changes in your blood sugar levels.
  • Carvedilol tablets may hide some of the symptoms of low blood sugar, especially a fast heartbeat.
  • Carvedilol tablets may mask the symptoms of hyperthyroidism (overactive thyroid).
  • Worsening of severe allergic reactions.
  • Rare but serious allergic reactions (including hives or swelling of the face, lips, tongue and/or throat that may cause difficulty breathing or swallowing) have happened in patients who were on carvedilol tablets.
  • These reactions can be life-threating.
  • Other side effects of carvedilol tablets include shortness of breath, weight gain, diarrhea, and fewer tears or dry eyes that become bothersome
  • if you wear contact lenses.
  • Call your doctor if you have any side effects that bother you or don't go away.
  • How should I store carvedilol tablets? Store carvedilol tablets at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
  • Keep the tablets dry.
  • Safely, throw away carvedilol tablets that is out of date or no longer needed.
  • Keep carvedilol tablets and all medicines out of the reach of children.
  • General Information About Carvedilol Tablets Medicines are sometimes prescribed for conditions other than those described in patient information leaflets.
  • Do not use carvedilol tablets for a condition for which it was not prescribed.
  • Do not give carvedilol tablets to other people, even if they have the same symptoms
  • you have.
  • It may harm them.
  • This leaflet summarizes the most important information about carvedilol tablets.
  • If you would like more formation, talk with your doctor.
  • You can ask your doctor or pharmacist for information about carvedilol tablets that is written for healthcare professionals.
  • You can also find out more about carvedilol tablets by calling 1-888-375-3784.
  • This call is free.
  • What are the ingredients in carvedilol? Active Ingredient:
  • Carvedilol USP Inactive Ingredients:
  • colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide.
  • Carvedilol tablets USP come in the following strengths:
  • 3.125 mg, 6.25 mg, 12.5 mg, 25 mg What is high blood pressure (hypertension)? Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests.
  • You have high blood pressure when the force is too much.
  • High blood pressure makes the heart work harder to pump blood through the body and causes damage to blood vessels.
  • Carvedilol tablets can help your blood vessels relax so your blood pressure is lower.
  • Medicines that lower blood pressure may lower your chance of having a stroke or heart attack.
  • To reorder additional Patient Information Sheets contact Dr.
  • Reddy’s Customer Service at 1-866-733-3952.
  • Rx Only Manufactured by: Dr.
  • Reddy's Laboratories Limited Bachepalli – 502 325 INDIA Revised: 0811

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS The round, film coated tablets are available in the following strengths:
  • 3.125 mg– yellow colored, debossed with R and 252, 6.25 mg– white colored, debossed with R and 253, 12.5 mg– white colored, debossed with R and 254, and 25 mg– white colored, debossed with R and 255.
  • Tablets: 3.125, 6.25, 12.5, 25 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Carvedilol tablets USP 3.125 mg are yellow, round, film coated tablets debossed with 'R' on one side and '252' on other side and are supplied in bottles of 30, 100, 500, 1000 and unit dosage packages of 100 (10 × 10).
  • Bottles of 30 NDC 55111-252-30 Bottles of 100 NDC 55111-252-01 Bottles of 500 NDC 55111-252-05 Bottles of 1000 NDC 55111-252-10 Unit dose packages of 100 (10 ×10) NDC 55111-252-78 Carvedilol tablets USP 6.25 mg are white, round, film coated tablets debossed with 'R' on one side and '253' on other side and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 × 10).
  • Bottles of 30 NDC 55111-253-30 Bottles of 100 NDC 55111-253-01 Bottles of 500 NDC 55111-253-05 Bottles of 1000 NDC 55111-253-10 Unit dose packages of 100 (10 ×10) NDC 55111-253-78 Carvedilol tablets USP 12.5 mg are white, round, film coated tablets debossed with 'R' on one side and '254' on other side and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 × 10).
  • Bottles of 30 NDC 55111-254-30 Bottles of 100 NDC 55111-254-01 Bottles of 500 NDC 55111-254-05 Bottles of 1000 NDC 55111-254-10 Unit dose packages of 100 (10 ×10) NDC 55111-254-78 Carvedilol tablets USP 25 mg are white, round, film coated tablets debossed with 'R' on one side and '255' on other side and are supplied in bottles of 30, 100, 500, 1000 and unit-dose packages of 100 (10 × 10).
  • Bottles of 30 NDC 55111-255-30 Bottles of 100 NDC 55111-255-01 Bottles of 500 NDC 55111-255-05 Bottles of 1000 NDC 55111-255-10 Unit dose packages of 100 (10 ×10) NDC 55111-255-78
  • Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
  • Protect from moisture.
  • Dispense in a tight, light-resistant container.

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Carvedilol USP 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 USP is a racemic mixture with the following structure:
  • Carvedilol tablets USP are film-coated tablets containing 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol.
  • Carvedilol tablets USP 3.125 mg are yellow in color and 6.25 mg, 12.5 mg and 25 mg tablets are white in color.
  • Inactive ingredients consist of colloidal silicon dioxide, crospovidone, hypromellose 2910-5cP, lactose monohydrate, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone, synthetic yellow iron oxide and titanium dioxide.
  • Carvedilol USP is a white to off-white 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).
  • Carvedilol Tablets meet USP Dissolution Test 2. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (30)

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Made byDr. Reddy's Laboratories Limited
Active substanceCarvedilol
Used inHeart, blood pressure and circulation
Strength3.125 mg
FormTablet, Film Coated
RouteOral
Packs100 TABLET, FILM COATED in 1 BOTTLE · 500 TABLET, FILM COATED in 1 BOTTLE
NDC55111-252

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

116 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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