Drug reference

Co-beneldopa

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 455, 456

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Parkinson’s disease ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: Initially 50 mg 3–4 times a day, then increased in steps of 100 mg daily, dose to be increased once or twice weekly according to response; maintenance 400–800 mg daily in divided doses ▶Elderly: Initially 50 mg 1–2 times a day, then increased in steps of 50 mg daily, dose to be increased every 3–4 days according to response Parkinson’s disease (in advanced disease) ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: Initially 100 mg 3 times a day, then increased in steps of 100 mg daily, dose to be increased once or Nervous system twice weekly according to response; maintenance 400–800 mg daily in divided doses Parkinson’s disease (patients not taking levodopa/dopa- decarboxylase inhibitor therapy) ▶BY MOUTH USING MODIFIED-RELEASE MEDICINES ▶Adult: Initially 1 capsule 3 times a day; maximum 6 capsules per day Parkinson’s disease (patients transferring from immediate-release levodopa/dopa-decarboxylase inhibitor preparations) ▶BY MOUTH USING MODIFIED-RELEASE MEDICINES ▶Adult: Initially 1 capsule substituted for every 100 mg of levodopa and given at same dosage frequency, increased every 2–3 days according to response; average increase of 50% needed over previous levodopa dose and titration may take up to 4 weeks, supplementary dose of immediate-release Madopar ® may be needed with ﬁrst morning dose; if response still poor to total daily dose of Madopar ® CR plus Madopar ® corresponding to 1.2 g levodopa—consider alternative therapy. DOSE EQUIVALENCE AND CONVERSION ▶Dose is expressed as levodopa.

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Cautions

Cushing’s syndrome. diabetes mellitus. endocrine disorders. history of convulsions. history of myocardial infarction with residual arrhythmia. history of peptic ulcer. hyperthyroidism. osteomalacia. phaeochromocytoma. psychiatric illness (avoid if severe and discontinue if deterioration). severe cardiovascular disease. severe pulmonary disease. susceptibility to angle-closure glaucoma

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Prescribing And Dispensing Information

Co- beneldopa is a mixture of benserazide hydrochloride and levodopa in mass proportions corresponding to 1 part of benserazide and 4 parts of levodopa. When transferring patients from another levodopa/dopa-decarboxylase inhibitor preparation, the previous preparation should be discontinued 12 hours before (although interval can be shorter). When switching from modiﬁed-release levodopa to dispersible co-beneldopa, reduce dose by approximately 30%. When administered as an adjunct to other antiparkinsonian drugs, once therapeutic effect apparent, the other drugs may be reduced or withdrawn.

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Safety

Important Safety Information

IMPULSE CONTROL DISORDERS Treatment with levodopa is associated with impulse control disorders, including pathological gambling, binge eating, and hypersexuality. Patients and their carers should be informed about the risk of impulse control disorders. See Parkinson’s disease p. 429.

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Interactions

→Appendix 1: levodopa

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Side Effects

▶Common or very common Anxiety. appetite decreased. arrhythmia. depression. diarrhoea. hallucination. movement disorders. nausea. parkinsonism. postural hypotension. sleep disorders. taste altered. vomiting ▶Rare or very rare Leucopenia ▶Frequency not known Aggression. compulsions. confusion . delusions. dopamine dysregulation syndrome. drowsiness. eating disorders. euphoric mood. ﬂushing. gastrointestinal haemorrhage. haemolytic anaemia. hyperhidrosis. oral disorders. pathological gambling. psychosis. sexual dysfunction. skin reactions. thrombocytopenia. tongue discolouration. tooth discolouration. urine discolouration

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Pregnancy

Caution in pregnancy—toxicity has occurred in animal studies.

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Breast Feeding

May suppress lactation; present in milk—avoid.

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Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in decompensated hepatic function.

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Renal Impairment

Use with caution. l EFFECT ON LABORATORY TESTS False positive tests for urinary ketones have been reported.

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Dose and formulations

Directions For Administration

The dispersible tablets can be dispersed in water or orange squash (not orange juice) or swallowed whole. Nervous system

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Dispersible tablet CAUTIONARY AND ADVISORY LABELS 10, 14, 21 ▶Madopar (Roche Products Ltd) Benserazide (as Benserazide hydrochloride) 12.5 mg, Levodopa 50 mg Madopar 50mg/12.5mg dispersible tablets sugar-free | 100 tablet P £5.90 DT = £5.90 Benserazide (as Benserazide hydrochloride) 25 mg, Levodopa 100 mg Madopar 100mg/25mg dispersible tablets sugar-free | 100 tablet P £10.45 DT = £10.45 Modified-release capsule CAUTIONARY AND ADVISORY LABELS 5, 10, 14, 25 ▶Madopar CR (Roche Products Ltd) Benserazide (as Benserazide hydrochloride) 25 mg, Levodopa 100 mg Madopar CR capsules | 100 capsule P £12.77 DT = £12.77 Capsule CAUTIONARY AND ADVISORY LABELS 10, 14, 21 ▶Co-beneldopa (Non-proprietary) Benserazide (as Benserazide hydrochloride) 12.5 mg, Levodopa 50 mg Co-beneldopa 12.5mg/50mg capsules | 100 capsule P £4.96 DT = £4.96 Benserazide (as Benserazide hydrochloride) 50 mg, Levodopa 200 mg Co-beneldopa 50mg/200mg capsules | 100 capsule P s DT = £11.78 ▶Madopar (Roche Products Ltd) Benserazide (as Benserazide hydrochloride) 12.5 mg, Levodopa 50 mg Madopar 50mg/12.5mg capsules | 100 capsule P £4.96 DT = £4.96 Benserazide (as Benserazide hydrochloride) 25 mg, Levodopa 100 mg Madopar 100mg/25mg capsules | 100 capsule P £6.91 DT = £6.91 Benserazide (as Benserazide hydrochloride) 50 mg, Levodopa 200 mg Madopar 200mg/50mg capsules | 100 capsule P £11.78 DT = £11.78

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Clinical care

Treatment Cessation

Avoid abrupt withdrawal (risk of neuroleptic malignant syndrome and rhabdomyolysis).

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Patient And Carer Advice

Patients or carers should be given advice on how to administer co-beneldopa dispersible tablets. Dopamine dysregulation syndrome Manufacturer advises patients and their carers should be informed of the risk of developing dopamine dysregulation syndrome; addiction- like symptoms should be reported. Driving and skilled tasks Sudden onset of sleep Excessive daytime sleepiness and sudden onset of sleep can occur with co-beneldopa. Patients starting treatment with these drugs should be warned of the risk and of the need to exercise caution when driving or operating machinery. Those who have experienced excessive sedation or sudden onset of sleep should refrain from driving or operating machines until these effects have stopped occurring. Management of excessive daytime sleepiness should focus on the identiﬁcation of an underlying cause, such as depression or concomitant medication. Patients should be counselled on improving sleep behaviour.

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Dose text by age group

Elderly

Initially 50 mg 1–2 times a day, then increased

First-line fragment. Read the complete Indications and Dose section above.

PDF page 455

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Co-beneldopa

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 455, 456

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 455

Cautions

PDF page 455

Prescribing And Dispensing Information

PDF page 456

Safety

Important Safety Information

PDF page 455

Interactions

→Appendix 1: levodopa

PDF page 455

Side Effects

PDF page 455

Pregnancy

Caution in pregnancy—toxicity has occurred in animal studies.

PDF page 455

Breast Feeding

May suppress lactation; present in milk—avoid.

PDF page 455

Hepatic Impairment

Manufacturer advises caution in mild to moderate impairment; avoid in decompensated hepatic function.

PDF page 455

Renal Impairment

Use with caution. l EFFECT ON LABORATORY TESTS False positive tests for urinary ketones have been reported.

PDF pages 455, 456

Dose and formulations

Directions For Administration

The dispersible tablets can be dispersed in water or orange squash (not orange juice) or swallowed whole. Nervous system

PDF page 456

Medicinal Forms

PDF page 456

Clinical care

Treatment Cessation

Avoid abrupt withdrawal (risk of neuroleptic malignant syndrome and rhabdomyolysis).

PDF page 456

Patient And Carer Advice

PDF page 456

Dose text by age group

Elderly

Initially 50 mg 1–2 times a day, then increased

First-line fragment. Read the complete Indications and Dose section above.

PDF page 455

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.