Carvedilol

Carvedilol is used to treat high blood pressure and heart failure. It is also used after a heart attack to improve the chance of survival if your heart is not pumping well. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Carvedilol works by blocking the action of certain natural substances in your body, such as epinephrine, on the heart and blood vessels. This effect lowers your heart rate, blood pressure, and strain on your heart. Carvedilol belongs to a class of drugs known as alpha and beta-blockers.

Carvedilol may also be used to treat a certain type of irregular heartbeat (atrial fibrillation).

Carvedilol is available under the following different brand names: Coreg, and Coreg CR.

Dosages of Carvedilol

Dosage Forms and Strengths

Capsule, extended-release

• 10 mg
• 20 mg
• 40 mg
• 80 mg

Tablet

• 3.125 mg
• 6.25 mg
• 40 mg
• 80 mg

Dosage Considerations – Should be Given as Follows:

Congestive Heart Failure

Immediate-release

• 3.125 mg orally every 12 hours for 2 weeks, then increased every 2 weeks as tolerated to 6.25 mg, 12.5 mg, or 25 mg orally twice daily
• Maximum recommended dosage (mild-to-moderate heart failure): less than 85 kg, 25 mg orally every 12 hours; greater than 85 kg: 50 mg orally twice daily
• Maximum recommended dosage (severe heart failure): 25 mg orally twice daily

Extended-release

• 10 mg/day orally; maintained for 1-2 weeks if tolerated; may be increased to 20 mg/day, 40 mg/day or 80 mg/day orally if necessary

Immediate-release:

• 6.25 mg orally twice daily initially; after 7-14 days, increased as tolerated, first to 12.5 mg orally twice daily and then to 25 mg orally twice daily

Extended-release:

• 20 mg/day orally; maintained for 1-2 weeks if tolerated; may be increased to 40 mg/day orally if necessary; not to exceed 80 mg/day orally

Immediate-release:

• 3.125-6.25 mg orally every 12 hours initially; after 3-10 days, increased as tolerated, first to 12.5 mg orally every 12 hours and then to 25 mg orally every 12 hours (target dosage)

Extended-release:

• 10-20 mg/day orally; increased every 3-10 days as tolerated up to 80 mg/day orally (target dosage)

• 25-50 mg orally twice daily

Renal impairment:

• No dosage adjustments are necessary

Hepatic impairment:

• Contraindicated in severe liver impairment

Pediatric:

• Safety and efficacy not established

• 3.125 mg twice daily: Administer 10 mg orally once/day
• 6.25 mg twice daily: Administer 20 mg orally once/day
• 12.5 mg twice daily: Administer 40 mg orally once/day
• 25 mg twice daily: Administer 80 mg orally once/day

• To be taken with food
• May break the capsule and sprinkle on a spoonful of applesauce; to be eaten immediately

Common side effects of carvedilol include:

• Dizziness
• Fatigue
• Low blood pressure (hypotension)
• Weight gain
• High blood sugar (hyperglycemia)
• Diarrhea
• Slow heart rate
• Nausea
• Cough
• Headache
• Atrioventricular block, edema
• Chest pain (angina)
• Hypercholesterolemia
• Hypertriglyceridemia
• Vomiting
• Indigestion
• Lightheadedness/fainting
• Runny nose

Other side effects of carvedilol include:

• High blood pressure (hypertension)
• Palpitations
• Insomnia
• Somnolence
• Skin rash
• Liver damage (hepatotoxicity)
• Impotence
• Bronchospasm
• Abnormal lung sounds (rales)
• Depression
• Decreased exercise tolerance
• Raynaud phenomenon
• Increased triglyceride levels and insulin resistance with decreased high-density lipoprotein (HDL) levels

Postmarketing side effects of carvedilol reported include:

• Blood and lymphatic system: Aplastic anemia
• Immune system: Hypersensitivity (e.g., severe allergic reactions [anaphylaxis], angioedema, hives) with Coreg and Coreg CR, including cases occurring after initiation of Coreg CR in patients previously treated with Coreg
• Kidneys and urinary tract: Urinary incontinence
• Respiratory system, thorax, and mediastinum: Interstitial pneumonitis
• Skin and subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication for diabetes, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe Interactions of carvedilol include:

• None.

Carvedilol has serious interactions with at least 34 different drugs.

Carvedilol has moderate interactions with at least 240 different drugs.

Carvedilol has mild interactions with at least 34 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains carvedilol. Do not take Coreg or Coreg CR if you are allergic to carvedilol or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol

Bronchial asthma, bronchospasm

Chronic obstructive pulmonary disease (COPD)

2°/3° AV block, sick sinus syndrome without permanent pacemaker, cardiogenic shock, severe bradycardia, decompensated heart failure requiring IV inotropic medication

Severe hepatic impairment

Effects of Drug Abuse

None.

Short-Term Effects

See "What Are Side Effects Associated with Using Carvedilol?"

Long-Term Effects

See "What Are Side Effects Associated with Using Carvedilol?"

Cautions

Use caution in anesthesia or surgery (myocardial depression), cerebrovascular insufficiency, diabetes mellitus, hyperthyroidism or thyrotoxicosis, liver disease, peripheral vascular disease (monitor for progression of arterial obstruction), compromised left ventricular function, heart failure, pheochromocytoma, and myasthenia gravis.

Avoid beta-blocker use in non-allergic bronchospasm (e.g., chronic bronchitis and emphysema); if deemed necessary, use with caution and at lowest effective dose.

Combined incidence of hypotension, syncope, or dizziness reported in elderly patients (older than 65 years) switched from highest dose of immediate-release carvedilol (25 mg every 12 hours) to extended-release carvedilol 80 mg/day.

When elderly patients are switched from higher doses of immediate-release carvedilol to extended-release carvedilol, a lower starting dose is recommended.

Sudden discontinuance can exacerbate angina and lead to myocardial infarction.

Increased risk of stroke after surgery.

Dosage should be reduced if bradycardia (HR less than 55 beats/min) develops.

May mask hypoglycemia or hyperthyroidism.

May worsen arterial insufficiency in patients with peripheral vascular disease.

Use caution in patients with mild to moderate hepatic impairment.

Heart failure patients may experience a worsening of renal function, especially during upward titration; dose reduction or temporary discontinuation may be necessary; may also need to adjust other medications.

Extended release: Separate any form of alcohol intake by at least 2 hours.

Elderly (liver function).

Intraoperative floppy iris syndrome observed during cataract surgery in some patients treated with alpha1-blocking agents.

Beta-blockers may cause induction or exacerbation of psoriasis.

Pregnancy and Lactation

Use carvedilol with caution during the first trimester of pregnancy if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. Only use carvedilol in LIFE-THREATENING emergencies during the second and third trimesters of pregnancy when no safer drug is available. There is positive evidence of human fetal risk.

It is unknown whether carvedilol is excreted in milk; it is not recommended for use while breastfeeding.