carbidopa monohydrate + entacapone + levodopa: clinical use

Prescribing considerations

• Initiation, tube placement and individual pump adjustment should involve a neurological specialist service.
• Consider a temporary nasoduodenal or nasojejunal trial before permanent access when clinically appropriate.
• Assess the patient’s and carer’s ability to operate the system safely and arrange support where needed.
• Review cardiovascular, pulmonary, hepatic, renal, endocrine, psychiatric, gastrointestinal, ophthalmic and seizure history.
• Avoid abrupt withdrawal and arrange alternative dopaminergic treatment if delivery is interrupted.
• Consider sodium content in patients requiring sodium restriction.

Contraindications and cautions

• Hypersensitivity to an active substance or excipient
• Narrow-angle glaucoma
• Severe heart failure or severe cardiac arrhythmia
• Acute stroke
• Severe hepatic impairment
• Concurrent non-selective MAO inhibitor or selective MAO-A inhibitor treatment
• Phaeochromocytoma, hyperthyroidism or Cushing’s syndrome
• Previous neuroleptic malignant syndrome or non-traumatic rhabdomyolysis
• Suspected undiagnosed skin lesions or history of melanoma

Monitoring

• Motor response, dyskinesia and unexplained loss of effect
• Tube position, patency, stoma condition and procedure-related complications
• Mental state, suicidality, hallucinations and impulse-control disorders
• Somnolence and sudden sleep episodes
• Weight, appetite and persistent diarrhoea
• Peripheral neuropathy symptoms and risk factors before treatment and periodically
• Periodic hepatic, renal, haematological and cardiovascular assessment
• Skin examination for new or changing pigmented lesions
• INR when used with warfarin

Clinical pharmacology

Levodopa is a dopamine precursor; carbidopa inhibits peripheral dopa decarboxylase, and entacapone reversibly inhibits peripheral COMT. Together they increase and prolong levodopa availability, while direct intestinal delivery reduces within-person fluctuation in plasma levodopa concentrations.

Formulation and product differences

• An opaque yellow to yellowish-red intestinal gel supplied in single-use cartridges.
• Designed specifically for the Crono LECIG pump and intestinal administration; it is not an oral formulation.
• Long-term delivery requires specialist enteral access, while a temporary nasointestinal tube may be used for assessment.

Gel

Route: Cutaneous

Strengths: 20 mg/mL + 5 mg/mL + 20 mg/mL