pramipexole dihydrochloride monohydrate: clinical use

Prescribing considerations

• Assess renal function because clearance is predominantly renal and formulation suitability changes with impairment.
• Counsel patients and carers about impulse-control disorders, sudden sleep onset, hallucinations, mania and delirium.
• Use particular caution with psychotic disorders or severe cardiovascular disease.
• For restless legs syndrome, review for augmentation: earlier onset, greater severity or spread to other limbs.
• Avoid abrupt withdrawal in Parkinson’s disease because neuroleptic malignant syndrome and dopamine agonist withdrawal syndrome may occur.

Contraindications and cautions

• Hypersensitivity to pramipexole or a formulation excipient.

Monitoring

• Renal function and treatment tolerability
• Blood pressure, particularly early in treatment
• Daytime somnolence and sudden sleep episodes
• Impulse-control and other behavioural changes
• Hallucinations, psychosis, mania or delirium
• Visual symptoms; arrange ophthalmic assessment when indicated
• Dyskinesia when combined with levodopa
• Restless legs augmentation
• Withdrawal symptoms during supervised reduction

Clinical pharmacology

A full dopamine agonist with high selectivity for D2-family receptors and preferential D3 affinity. Oral bioavailability exceeds 90%, metabolism is limited, protein binding is low and most absorbed pramipexole is eliminated unchanged by the kidneys.

Formulation and product differences

• The selected immediate-release product is licensed for Parkinson’s disease and restless legs syndrome; the selected prolonged-release product is licensed only for Parkinson’s disease.
• The selected immediate-release tablet is scored for equal division.
• Prolonged-release tablets must remain whole. Tablet-like remnants may appear in stools; reassess clinical response if this is reported.
• Switching between release formulations should be directed and reviewed by the prescriber.

Modified-release tablet

Route: Oral

Strengths: 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.10 mg, 2.62 mg, 3.15 mg