Treatment of motor fluctuations ("on-off" phenomena) in patients with Parkinson's disease

Active Ingredient: Apomorphine

Indication for Apomorphine

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Apomorphine is indicated for the treatment of motor fluctuations (‘on-off’ phenomena) in patients with Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication.

For this indication, competent medicine agencies globally authorize below treatments:

Incremental dosing schedules according to the patient's response within the range of 3-100 mg

For:

Route of admnistration

Subcutaneous

Defined daily dose

3 - 100 mg

Dosage regimen

From 0.3 To 10 mg 10 time(s) per day every day

Detailed description

Determination of the threshold dose

The appropriate dose for each patient is established by incremental dosing schedules.

The following schedule is suggested:

1 mg of apomorphine HCl (0.1 ml), that is approximately 15-20 micrograms/kg, may be injected subcutaneously during a hypokinetic, or ‘off’ period and the patient is observed over 30 minutes for a motor response.

If no response, or an inadequate response, is obtained a second dose of 2 mg of apomorphine HCl (0.2 ml) is injected subcutaneously and the patient observed for an adequate response for a further 30 minutes.

The dosage may be increased by incremental injections with at least a forty minute interval between succeeding injections, until a satisfactory motor response is obtained.

Establishment of treatment

Once the appropriate dose is determined a single subcutaneous injection may be given into the lower abdomen or outer thigh at the first signs of an ‘off’ episode. It cannot be excluded that absorption may differ with different injection sites within a single individual. Accordingly, the patient should then be observed for the next hour to assess the quality of their response to treatment. Alterations in dosage may be made according to the patient’s response.

The optimal dosage of apomorphine hydrochloride varies between individuals but, once established, remains relatively constant for each patient.

Precautions on continuing treatment

The daily dose of apomorphine varies widely between patients, typically within the range of 3-30 mg, given as 1-10 injections and sometimes as many as 12 separate injections per day.

It is recommended that the total daily dose of apomorphine HCl should not exceed 100mg and that individual bolus injections should not exceed 10 mg.

In clinical studies it has usually been possible to make some reduction in the dose of levodopa; this effect varies considerably between patients and needs to be carefully managed by an experienced physician.

Once treatment has been established domperidone therapy may be gradually reduced in some patients but successfully eliminated only in a few, without any vomiting or hypotension.

Active ingredient

Apomorphine

Apomorphine is a direct stimulant of dopamine receptors and while possessing both D1 and D2 receptor agonist properties does not share transport or metabolic pathways with levodopa. Its actions on parkinsonian motor disability are likely to be mediated at post-synaptic receptor sites.

Read more about Apomorphine

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