entacapone/levodopa/carbidopa (Rx)

Brand and Other Names:Stalevo
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Dosing & Uses

AdultPediatricGeriatric

Dosing Forms & Strength

levodopa/carbidopa/entacapone

tablet

  • 50mg/12.5mg/200mg
  • 75mg/18.75mg/200mg
  • 100mg/25mg/200mg
  • 125mg/31.25mg/200mg
  • 150mg/37.5mg/200mg
  • 200mg/50mg/200mg

Parkinson Disease

Substitute an equal levodopa dose with Stalevo as patient's dose at transfer

Maintenance: Titrate as necessary

Carbidopa should be 70-100 mg/day; not to exceed 200 mg/day

Not to exceed 8 tablets/day divided q4-8hr while awake

Food increases levodopa absorption

Monitor hepatic, hematopoietic, cardiovascular, renal function

Safety & efficacy not established

Parkinson Disease

Substitute an equal levodopa dose with Stalevo as patient's dose at transfer

Maintenance: Titrate as necessary

Carbidopa should be 70-100 mg/day; not to exceed 200 mg/day

Not to exceed 8 tablets/day divided q4-8hr while awake

Food increases levodopa absorption

Monitor hepatic, hematopoietic, cardiovascular, renal function

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Interactions

Interaction Checker

and entacapone/levodopa/carbidopa

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Entacapone

            • Dyskinesia (25%)
            • Nausea (14%)
            • Diarrhea (10%)
            • Hyperkinesia (10%)
            • Urine discoloration (10%)

            1-10%

            Entacapone

            • Hypokinesia (9%), dizziness (8%), Fatigue (6%), hallucinations (1-4%), anxiety (2%), somnolence (2%), asthenia (2%), agitation (1%)
            • Increased sweating (2%)
            • Purpura (2%)
            • Abdominal pain (8%), constipation (6%), vomiting (4%), dry mouth (3%), dyspepsia (2%), flatulence (2%), taste perversion (1%), gastritis (1%)
            • Back pain (4%)
            • Dyspnea (3%)
            • Bacterial infection (1%)

            Frequency Not Defined

            Levodopa/Carbodopa

            • Edema
            • Agitation, anxiety, ataxia, bruxism, confusion, daytime somnolence decreased attention span, dyskinesia, dystonia, euphoria, insomnia, fainting, fatigue, increased trembling of hands, insouciance, malaise, memory loss, nightmares, nervousness, restlessness, trismus, vivid dreams
            • Alopecia, hot flushes, increased &/or dark perspiration, skin eruptions
            • Abdominal pain & discomfort, burning feeling in tongue, constipation, diarrhea, dysgeusia, dry mouth, dysphagia, hiccups, meteorism, sialorrhea, nausea, weight loss
            • Muscular spasms, muscular cramp
            • Hematuria, dark urine, incontinence, priapism, urine retention
            • Blurred vision, diplopia, dilated pupil, oculogyric problems

            Entacapone

            • Postural hypotension
            • Insomnia
            • Confusion
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            Warnings

            Contradindications

            Hypersensitivity

            Concurrency with nonselective MAOIs (discontinue 2 weeks before starting treatment)

            Narrow angle glaucoma

            Undiagnosed skin lesions, history of melanoma

            Cautions

            Hepatic disease, severe cardiovascular/pulmonary disease, bronchial asthma, renal/endocrine disease, open-angle glaucoma

            Age >75 yr

            History/active psychoses, history of MI or peptic ulcer

            Residual atrial, nodal, ventricular arrhythmias

            Risk of uncontrollable sexual, gambling or other urges

            May be linked to higher melanoma risk in patient with Parkinson disease

            May cause NMS if reduced abruptly or discontinued

            Risk of syncope

            Risk of developing prostate cancer

            Diarrhea may occur and be associated entacapone; may cause weight loss, dehydration, and hypokalemia; if severe, may be a sign of drug-induced microscopic colitis

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk; use caution

            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

            Levodopa: Crosses blood-brain barrier & converts to dopamine

            Carbidopa: Inhibits decarboxylation or breakdown of peripheral levodopa

            Entacapone: Selective & reversible inhibitor of COMT

            Pharmacokinetics

            Absorption

            • levodopa: rapid
            • carbidopa: slightly slower than levodopa/entacapone
            • entacapone: rapid

            Peak plasma time

            • levodopa: 0.6-2.4 hr
            • carbidopa: 2.5-3.4 hr
            • entacapone: 1-1.2 hr

            Half Life

            • levodopa: 1.7 hr
            • carbidopa: 1.6-2 hr
            • entacapone: 0.8-1 hr

            Protein Bound

            • levodopa: 10-30%
            • carbidopa: 36%
            • entacapone: 98%

            Metabolites

            • levodopa: dopamine, homovanillic acid
            • carbidopa: alpha-methyl-3-methoxy-4-hydroxyphenyl propionic acid & alpha-methyl-3,4-dihydroxyphenylpropionic acid
            • entacapone: cis-isomer

            Elimination

            • levodopa: urine: 80-85%
            • carbidopa: 30% unchanged in urine
            • entacapone: Urine (10%); feces (90%)
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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