ELDEPRYL

What it is

Eldepryl is a tablet containing 5 mg selegiline hydrochloride. Selegiline is an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria, and inhibits MAO by acting as a 'suicide' substrate for the enzyme.

Approved indications

— Treatment of patients with Parkinson's disease, used as monotherapy in the early phases of the disease or as adjunctive therapy with levodopa.

Dosing overview

Selegiline is administered as monotherapy in the early phase of Parkinson's disease or as adjunctive therapy with levodopa, with an initial dose of 5 mg taken at breakfast and lunch. There is no evidence that additional benefit will be obtained from the administration of higher doses. After two to three days of adjunctive therapy, an attempt may be made to reduce the dose of levodopa (10–30%) if levodopa-related adverse reactions occur, and further reductions of levodopa may be possible during continued selegiline therapy.

Key safety warnings

The recommended dose of 10 mg per day should not be exceeded because of the risks associated with non-selective inhibition of MAO, including 'cheese reactions'. In higher doses (above 20 mg per day), the selectivity of selegiline starts to diminish, resulting in increased inhibition of MAO-A, and the possibility of a hypertensive reaction has to be taken into account after ingestion of food or drugs rich in various exogenous amines. Serious, sometimes fatal reactions have been reported in patients receiving selective serotonin reuptake inhibitors (SSRIs) in combination with selegiline, including agitation, ataxia, cold sweats, hypertension, mania and 'serotonergic reaction'. It is recommended to avoid the combination of selegiline and SSRIs. Selegiline should be given cautiously to patients with labile hypertension, cardiac arrhythmias, severe angina pectoris or psychosis as selegiline may exacerbate these conditions. Parkinson's disease patients treated with dopamine agonists and other dopaminergic treatments such as selegiline have been reported as exhibiting impulse control disorders and compulsions like pathological gambling, increased libido, hypersexuality, binge eating, shopping and different kinds of compulsive or repetitive activities.

Contraindications

Known hypersensitivity to selegiline or any other components of the formulation is contraindicated. Pethidine is contraindicated in combination with selegiline because of reports of serious, sometimes fatal reactions, and agitation, delirium, irritability, hyperpyrexia, restlessness, rigidity, stupor and sweating have been reported with the concomitant use. Selegiline should not be used in combination with serotonin noradrenaline reuptake inhibitors, tricyclic antidepressants, sympathomimetics or monoamine oxidase inhibitors. Selegiline should not be used in patients with active duodenal or gastric ulcer.

PBS listing

Eldepryl 5 mg tablets are listed on the PBS with 2 items, restricted access, at an ex-manufacturer price of A$37.49.

Regulatory history

Eldepryl 5 mg tablets were first registered on the ARTG on 18 January 1994.