Carvedilol

Generic name: carvedilol tablets, USP · Brand names: Coreg (Waylis Therapeutics LLC)

Quick facts

Drug class

Carvedilol is an alpha- and beta-adrenergic blocking agent (a beta-blocker with alpha-blocking activity).

Section

Highlights, Indications and Usage

Source text (exact source wording)

Carvedilol is 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)

Rx or otc

Prescription (FDA-approved patient labeling accompanies label)

Forms and strengths

3.125 mg: white to off-white, round, biconvex, film-coated, debossed with 'Z' on one side and '1' on other side
6.25 mg: white to off-white, round, biconvex, beveled edge, film-coated, debossed with 'ZC40' on one side and plain on other side
12.5 mg: white to off-white, round, biconvex, beveled edge, film-coated, debossed with 'ZC41' on one side and plain on other side
25 mg: white to off-white, round, biconvex, beveled edge, film-coated, debossed with 'ZC42' on one side and plain on other side (BluePoint label)

Generic available

Value

Yes, generic label (BluePoint Laboratories, manufactured by Zydus Lifesciences Ltd). ANDA status not displayed in text read.

Source

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e68c9b18-e7fd-45f7-a8f5-1d815e32680b&type=display

Common use one line

Treats heart failure, improves survival after a heart attack with weak heart function, and treats high blood pressure.

What it is used for

Carvedilol treats mild-to-severe chronic heart failure, usually along with diuretics, ACE inhibitors and digitalis, to improve survival and cut hospital stays. It lowers the risk of cardiovascular death in stable people who survived a heart attack and have a left ventricular ejection fraction of 40% or less. It also treats essential high blood pressure, alone or with other medicines.

Section

1.1, 1.2, 1.3 Indications and Usage

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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) [seeClinical 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)].

How it works

Carvedilol blocks beta receptors (nonselective) and alpha-1 receptors. It has no intrinsic sympathomimetic activity. The label says the basis for its benefit in heart failure and after a heart attack is not established.

Section

12.1 Mechanism of Action; 12.2 Pharmacodynamics

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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. 12.2 Pharmacodynamics, Heart Failure: The basis for the beneficial effects of carvedilol tablets in heart failure is not established. Hypertension: The mechanism by which β-blockade produces an antihypertensive effect has not been established.

Dosage: adults

Take it with food. For heart failure, start at 3.125 mg twice a day for 2 weeks, then raise to 6.25, 12.5 and 25 mg twice a day at intervals of at least 2 weeks if tolerated. After a heart attack, start at 6.25 mg twice a day and raise after 3 to 10 days to 12.5 mg and then 25 mg twice a day. For high blood pressure, start at 6.25 mg twice a day and raise to 12.5 mg and then 25 mg twice a day after 7 to 14 days each; the total daily dose should not exceed 50 mg.

Section

2, 2.1, 2.2, 2.3 Dosage and Administration (selected sentences, joined in label order)

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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). 2.2 Left Ventricular Dysfunction following Myocardial Infarction: 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). 2.3 Hypertension: 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.

Dosage: children

Effectiveness in people under 18 years has not been established.

Section

8.4 Pediatric Use

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Effectiveness of carvedilol tablets in patients younger than 18 years has not been established.

Dosage adjustments

Drug interaction caps

Section

n/a

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Kidney

No specific kidney dose is given. In heart failure, kidney function should be monitored during dose increases in people at risk, and the dose reduced or stopped if it worsens.

Section

5.8 Deterioration of Renal Function

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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 less than 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.

Liver

Do not give to people with severe liver impairment.

Section

2.4 Hepatic Impairment

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Carvedilol tablets should not be given to patients with severe hepatic impairment [see Contraindications (4)].

Elderly

Apart from more dizziness in older people with high blood pressure (8.8% versus 6%), no overall differences in safety or effectiveness were seen. No separate dose is given for older adults.

Section

8.5 Geriatric Use

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Missed dose

Take a missed dose as soon as you remember, unless it is almost time for the next one. Then take the next dose at the usual time. Never take 2 doses at the same time.

Section

Patient Information (FDA-approved patient labeling)

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Overdose

Too much carvedilol can cause very low blood pressure, slow heartbeat, heart failure, shock and cardiac arrest, plus breathing problems, vomiting, fainting and seizures. Call poison control: 1-800-222-1222 (RxDiff rule) or your doctor right away.

Section

10 OVERDOSAGE (partial copy); Patient Information

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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. 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. [Patient Information:] If you take too much carvedilol tablets, call your doctor or poison control center right away.

Storage

Store at room temperature, 20°C to 25°C (68°F to 77°F). Protect from moisture. Keep in a tight, light-resistant container. This is the BluePoint label; other makers' labels can differ.

Section

16 HOW SUPPLIED/STORAGE AND HANDLING

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Boxed warning

NONE (no boxed warning in the label text read)

Contraindications

Do not use with asthma or similar breathing-tube spasm conditions.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol tablets.

Do not use with second- or third-degree AV block.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Second- or third-degree AV block.

Do not use with sick sinus syndrome.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Sick sinus syndrome.

Do not use with severe slow heartbeat unless a permanent pacemaker is in place.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Severe bradycardia (unless a permanent pacemaker is in place).

Do not use in cardiogenic shock or decompensated heart failure needing IV inotropic therapy.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Do not use with severe liver impairment.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Patients with severe hepatic impairment.

Do not use after a serious allergic reaction to carvedilol or any ingredient.

Section

4 CONTRAINDICATIONS

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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

Do not stop suddenly. Abrupt stopping of beta-blockers has caused worse angina, heart attack and dangerous rhythms. When planned, stopping should take 1 to 2 weeks when possible.

Heading

5.1 Cessation of Therapy

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

It can slow the heartbeat (about 2% with high blood pressure, 9% with heart failure, 6.5% after heart attack). The dose is reduced if the pulse falls below 55 beats per minute.

Heading

5.2 Bradycardia

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

It can lower blood pressure and cause fainting, mainly at the start or when the dose goes up. Avoid driving or hazardous tasks at that time.

Heading

5.3 Hypotension

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Heart failure or fluid retention can worsen while the dose is being raised. Diuretics are increased and the dose is not raised until stable.

Heading

5.4 Heart Failure/Fluid Retention

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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)].

People with chronic bronchitis or emphysema should generally not take beta-blockers.

Heading

5.5 Non-allergic Bronchospasm

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Patients with bronchospastic disease (e.g., chronic bronchitis, emphysema) should, in general, not receive β-blockers.

It can hide early signs of low blood sugar such as fast heartbeat, especially in people with diabetes or who are fasting.

Heading

5.6 Effects on Blood Sugar

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery not eating regularly or are vomiting).

It can hide signs of an overactive thyroid, and stopping suddenly may worsen it.

Heading

5.10 Thyrotoxicosis

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Tell your eye surgeon you take it before cataract surgery; a floppy iris problem has been seen with alpha blockers.

Heading

5.14 Intraoperative Floppy Iris Syndrome

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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).

Pregnancy and breastfeeding

There is not enough data in pregnant women to know the risks. Beta blockers in the third trimester may cause low blood pressure, slow heartbeat, low blood sugar and breathing problems in the newborn. There are no data on breast milk in humans; it is present in rat milk.

Section

8.1 Pregnancy; 8.2 Lactation

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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]. 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.

Side effects

Common

In heart failure and after a heart attack (10% or more): dizziness, fatigue, low blood pressure, diarrhea, high blood sugar, weakness, slow heartbeat and weight gain. In high blood pressure (5% or more): dizziness.

Threshold

Highlights: Heart failure and left ventricular dysfunction following myocardial infarction (≥10%); Hypertension (≥5%)

Section

Highlights, Adverse Reactions

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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

Less common

In the heart failure trials dizziness was 32% on carvedilol versus 19% on placebo in mild-to-moderate heart failure, and 24% versus 17% in severe heart failure. In the high blood pressure trials dizziness was 6% versus 5%, and insomnia 2% versus 1%. Other table figures are in the source text.

Section

6.1 Clinical Studies Experience, Tables 1 and 2 (partial copy)

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Table 1 (mild-to-moderate HF carvedilol n = 765 vs placebo n = 437; severe HF carvedilol n = 1,156 vs placebo n = 1,133), %: Dizziness 32 vs 19; 24 vs 17. Fatigue 24 vs 22. Hypotension 9 vs 3; 14 vs 8. Bradycardia 9 vs 1; 10 vs 3. Diarrhea 12 vs 6; 5 vs 3. Hyperglycemia 12 vs 8; 5 vs 3. Headache 8 vs 7; 5 vs 3. Nausea 9 vs 5; 4 vs 3. Table 2 (hypertension, carvedilol n = 1,142 vs placebo n = 462), %: Dizziness 6 vs 5; Insomnia 2 vs 1; Bradycardia 2 vs —; Postural hypotension 2 vs —; Diarrhea 2 vs 1.

Serious

Serious reports include severe allergic reactions, a severe drop in blood cells (aplastic anemia), lung inflammation and severe skin reactions. Stopping suddenly can cause worse angina, heart attack and dangerous rhythms.

Label source text (exact source wording)

6.2 Postmarketing Experience: Blood and Lymphatic System Disorders: Aplastic anemia. Immune System Disorders: Hypersensitivity (e.g., anaphylactic reactions, angioedema, urticaria). Respiratory, Thoracic, and Mediastinal Disorders: Interstitial pneumonitis. Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. [5.1] 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.

Medlineplus source text (exact source wording)

not retrieved (MedlinePlus not opened in this run)

Led to discontinuation

In the severe heart failure trial, dizziness was the only reason for stopping above 1% and more common on carvedilol (1.3% versus 0.6%). In high blood pressure trials, 4.9% stopped on carvedilol versus 5.2% on placebo.

Section

6.1 Clinical Studies Experience

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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). [Heart Failure] In US controlled clinical trials directly comparing carvedilol tablets in doses up to 50 mg (n = 1,142) with placebo (n = 462), 4.9% of subjects receiving carvedilol tablets discontinued for adverse events versus 5.2% of placebo subjects. [Hypertension]

Interactions

Drugs

Not studied, but these drugs would be expected to raise carvedilol levels.

Name

CYP2D6 inhibitors (quinidine, fluoxetine, paroxetine, propafenone)

Section

7.1

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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

Watch closely for low blood pressure and very slow heartbeat. Clonidine with a beta-blocker may cause both.

Name

Reserpine, MAO inhibitors, clonidine

Section

7.2

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Cyclosporine levels should be monitored closely when carvedilol starts.

Name

Cyclosporine

Section

7.3

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

it is recommended that cyclosporine concentrations be monitored closely after initiation of carvedilol therapy and that the dose of cyclosporine be adjusted as appropriate.

Both slow the heart; digoxin levels rise about 15%, so more monitoring is advised.

Name

Digoxin / digitalis glycosides

Section

7.4

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Rifampin lowers carvedilol levels by about 70%. Cimetidine raises exposure by about 30%.

Name

Rifampin and cimetidine

Section

7.5

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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

May further slow the heart rate or conduction. Watch for slow heartbeat or heart block.

Name

Amiodarone and other CYP2C9 inhibitors (e.g., fluconazole)

Section

7.6

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

ECG and blood pressure should be monitored.

Name

Verapamil- or diltiazem-type calcium channel blockers

Section

7.7

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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.

Blood sugar lowering may be stronger. Check glucose regularly.

Name

Insulin and oral hypoglycemics

Section

7.8

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

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

Food and alcohol

Take with food to slow absorption and reduce dizziness on standing.

Name

Food

Section

2 Dosage and Administration

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

Carvedilol should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.

Name

Alcohol / grapefruit

Section

n/a

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Other

not applicable

Name

Liverpool HIV/HEP checkers

Section

n/a

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

not applicable: label interaction section lists no antiviral drugs

Patient tips

Label

Take it with food. Dizziness or lightheadedness may occur in the first hour after a dose, especially at the start or after a dose increase, so avoid driving or hazardous tasks then. Do not stop suddenly if you have coronary artery disease. Follow the missed-dose steps.

Section

2.1; 5.1; Patient Information (partly read)

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Source text (exact source wording)

[17] Patients should take carvedilol tablets with food. [2.1] 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. [5.1] Patients with coronary artery disease, who are being treated with carvedilol tablets, should be advised against abrupt discontinuation of therapy. [Patient Information] 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.

Alternatives

Class source

Label Highlights: 'Carvedilol is an alpha-/beta-adrenergic blocking agent'. openFDA not checked.

Note

No recommendation made.

Frequently asked questions

Question

What is carvedilol used for?

Answer

It treats mild-to-severe chronic heart failure, lowers the risk of cardiovascular death in stable people who survived a heart attack with a weak heart (ejection fraction 40% or less), and treats essential high blood pressure.

Source section

1 Indications and Usage

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

Should I take it with food?

Answer

Yes. The label says to take it with food to slow absorption and reduce dizziness on standing.

Source section

2 Dosage and Administration

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

What if I miss a dose?

Answer

Take it as soon as you remember, unless it is time for your next dose. Then take the next dose at the usual time. Do not take 2 doses at the same time.

Source section

Patient Information

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

What are the most common side effects?

Answer

Source section

Highlights; 6.1

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

Can I stop it suddenly?

Answer

No. Abrupt stopping has caused worse angina, heart attack and dangerous rhythms. When stopping is planned it should be done over 1 to 2 weeks when possible.

Source section

5.1

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

What should I not combine with it?

Answer

Tell your prescriber about clonidine, reserpine, MAO inhibitors, digoxin, cyclosporine, amiodarone, verapamil- or diltiazem-type medicines, rifampin, insulin and diabetes pills. Do not use it with asthma or certain heart-rhythm problems.

Source section

4; 7

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

Is it safe in pregnancy or breastfeeding?

Answer

There is not enough data in pregnant women. Beta blockers late in pregnancy may cause low blood pressure, slow heartbeat, low blood sugar and breathing problems in the newborn. There are no human milk data.

Source section

8.1; 8.2

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Question

Who should not take carvedilol?

Answer

People with asthma or related breathing-tube spasm, second- or third-degree AV block, sick sinus syndrome, severe slow heartbeat without a pacemaker, cardiogenic shock or decompensated heart failure needing IV inotropic therapy, severe liver impairment, or a serious allergic reaction to carvedilol.

Source section

4 Contraindications

Source

BluePoint carvedilol tablets label (e68c9b18-e7fd-45f7-a8f5-1d815e32680b)

Sources

DailyMed printer-friendly label, BluePoint Laboratories (carvedilol tablets)
Set id: e68c9b18-e7fd-45f7-a8f5-1d815e32680b · Label effective or revised date: Revised: 2/2026 (Highlights); Rev.: 02/26 (end of section 17) · Dailymed version date: Mar 10, 2026 (DailyMed list publish date) · Fetched at: 2026-11-03 · Sections used: Highlights, 1, 2, 3, 4, 5, 6.1, 6.2, 7, 8.1, 8.2, 8.4, 8.5, 10, 12.1, 12.2, 16, 17, Patient Information
DailyMed printer-friendly label, Coreg brand (Waylis)
Set id: 07c619c6-4a0c-445e-94fa-664a54f68a39 · Label effective or revised date: Revised: 10/2023 (Highlights) · Dailymed version date: 7/2026 (version line) · Fetched at: 2026-11-03 · Sections used: Revised date only
DailyMed SPL list (carvedilol), pages 1-2
Set id: n/a · Label effective or revised date: n/a · Fetched at: 2026-11-03 · Sections used: labeler and set ID list

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug