carvedilol (Rx)

Brand and Other Names:Coreg, Coreg CR
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, extended release

  • 10mg
  • 20mg
  • 40mg
  • 80mg

tablet

  • 3.125mg
  • 6.25mg
  • 12.5mg
  • 25mg
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Congestive Heart Failure

Immediate release

  • 3.125 mg PO q12hr for 2 weeks, then increased every 2 weeks as tolerated to 6.25 mg, 12.5 mg, or 25 mg PO twice daily
  • Maximum recommended dosage (mild-to-moderate heart failure): <85 kg, 25 mg PO q12hr; >85 kg: 50 mg PO twice daily
  • Maximum recommended dosage (severe heart failure): 25 mg PO twice daily

Extended release

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

Hypertension

Immediate release: 6.25 mg PO twice daily initially; after 7-14 days, increased as tolerated, first to 12.5 mg PO twice daily and then to 25 mg PO twice daily

Extended release: 20 mg/day PO; maintained for 1-2 weeks if tolerated; may be increased to 40 mg/day PO if necessary; not to exceed 80 mg/day PO

Left Ventricular Dysfunction Following Myocardial Infarction

Immediate release: 3.125-6.25 mg PO q12hr initially; after 3-10 days, increased as tolerated, first to 12.5 mg PO q12hr and then to 25 mg PO q12hr (target dosage)

Extended release: 10-20 mg/day PO; increased every 3-10 days as tolerated up to 80 mg/day PO (target dosage)

Angina pectoris

25-50 mg PO twice daily

Dosing Modifications

Renal impairment: No dosage adjustments necessary

Hepatic impairment: Contraindicated in severe liver impairment

Conversion to Extended Release Form

3.125 mg twice daily: Administer 10 mg PO qDay

6.25 mg twice daily: Administer 20 mg PO qDay

12.5 mg twice daily: Administer 40 mg PO qDay

25 mg twice daily: Administer 80 mg PO qDay

Administration

To be taken with food

May break capsule and sprinkle on spoonful of applesauce; to be eaten immediately

Safety and efficacy not established

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Interactions

Interaction Checker

and carvedilol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (2-32%)

            Fatigue (4-24%)

            Hypotension (9-20%)

            Weight gain (10-12%)

            Hyperglycemia (5-12%)

            Diarrhea (1-12%)

            1-10% (selected)

            Bradycardia (2-10%)

            Nausea (2-9%)

            Cough (5-8%)

            Headache (5-8%)

            Atrioventricular block, edema (1-7%)

            Angina (1-6%)

            Hpercholesterolemia (1-4%)

            Hypertriglyceredemia (1%)

            Vomiting (1-6%)

            Dyspnea (>3%)

            Syncope (3%)

            Rhinitis (2%)

            Frequency Not Defined (selected)

            Hypertension

            Palpitations

            Insomnia

            Somnolence

            Skin rash

            Hepatotoxicity

            Impotence

            Bronchospasm

            Rales

            Depression

            Decreased exercise tolerance

            Raynaud phenomenon

            Increased triglyceride levels and insulin resistance with decreased high-density lipoprotein (HDL) levels

            Postmarketing Reports

            Blood and lymphatic system: Aplastic anemia

            Immune system: Hypersensitivity (eg, anaphylactic reactions, angioedema, urticaria) 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

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            Warnings

            Contraindications

            History of serious hypersensitivity reaction (eg, 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

            Cautions

            Use cautioin 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 (>65 years) switched from highest dose of immediate-release carvedilol (25 mg q12hr) 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 <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

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            Pregnancy & Lactation

            Pregnancy

            Available data in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes; there are risks to mother and fetus associated with poorly controlled hypertension in pregnancy; the use of beta blockers during third trimester of pregnancy may increase risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in neonates; in animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses; observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly

            Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

            Lactation

            There are no data on presence of carvedilol in human milk, effects on breastfed infant, or on milk production; drug is present in the milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Nonselective beta-adrenergic and alpha1-adrenergic blocking agent with no intrinsic activity for use in congestive heart failure and hypertension

            Absorption

            Bioavailability: 25-35% (immediate release)

            Onset (antihypertensive): Initial response, 1 hr; peak response, 1-2 hr

            Duration: 24 hr

            Peak plasma time: 5 hr

            Distribution

            Protein bound: >98%

            Vd: 115-132 L

            Metabolism

            Metabolized by CYP2D6 and CYP2C9 and, to a lesser extent, by CYP3A4, 2C19, 1A2, and 2E1

            Metabolites: 4'-Hydroxyphenyl metabolite is approximately 13 times more potent than carvedilol for beta blockade

            Elimination

            Half-life: 7-10 hr

            Dialyzable: HD, no

            Excretion: Feces (60%), urine (16%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.