Posology : מינונים

4.1   Posology and method of administration
Posology
The dosage of Oramorph® 20 mg/ml has to be adapted to the severity of pain and to the individual sensitivity of the patient.
The recommended range of the single and daily doses for children and adults is stated in the following table based on a single dose of 0.2 to 0.3 mg morphine sulphate/kg body weight.



Age                                            Single dose
(body weight)

Children under 3 years    contra indicated
Children 3-5 years        0.125-0.25 ml, i. e. 2-4 drops Oramorph® 20 mg/ml, corresponding (12.5 - 18 kg)            to 2.5-5 mg morphine sulphate, every 4-6 hours 

0.25-0.5 ml, i. e. 4-8 drops Oramorph® 20 mg/ml, corresponding to
Children 6-12 years
5-10 mg morphine sulphate, every 4-6 hours
(20 - 40 kg)

Adolescents 13-18         0.5-1.0 ml, i. e. 8-16 drops Oramorph® 20 mg/ml, corresponding to years / Adults            10-20 mg morphine sulphate, every 4-6 hours (40-50 kg)

Adults                    0.5-3 ml, i. e. 8-48 drops Oramorph® 20 mg/ml, corresponding to 10-60 mg morphine sulphate, every 4-6 hours


The dose is removed from the 20 ml bottle by counting the drops (1 drop = 1.25 mg morphine sulphate).
In case of decreasing effect the single doses can be repeated after 4-6 hours. The maximum daily doses should not exceed the single doses by more than 4- to 6-fold.
If higher daily doses are needed other appropriate dosage strengths have to be considered alternatively or in combination with Oramorph® 20 mg/ml.

When patients are transferred from other morphine preparations to Oramorph oral solution dosage titration may be appropriate.
A calibrated oral dosing pipette is supplied with this dosage form for accurate and convenient dose adjustment. The required dose may be added to a soft drink immediately prior to administration.
Morphine Sulphate is readily absorbed from the gastro-intestinal tract following oral administration. However, when Oramorph oral is used in place of parenteral morphine, a 50 % to 100 % increase in dosage is usually required in order to achieve the same level of analgesia.
Renal or hepatic impairment
In patients with impaired liver or kidney function and in those with suspected delayed gastrointestinal passage Oramorph® 20 mg/ml should be dosed with special caution.

Elderly patients
Elderly patients (usually 75 years and older) and patients with poor overall physical condition may be more sensitive to morphine. Therefore, the adjustment of dose has to be done more carefully and / or the dosage intervals have to be extended. As appropriate, lower dosage strengths have to be given instead.



Special recommendations concerning dose adjustment
For initial dose adjustment pharmaceutical forms with lower active ingredient content may be applied, possibly also in addition to an existing therapy with prolonged-release tablets.
In principle, the administered dose should be sufficiently high and at the same time the lowest dose needed for pain relief in the individual case should be aimed at.

For treatment of chronic pain dosing following a fixed time schedule is preferred.

In patients receiving another additional analgesic treatment (e. g. surgery, plexus blockage) the dose should be readjusted following the respective measure.

Method and duration of administration
The oral solution is administered with a sufficient quantity of liquid. The medication can be taken independently of meals.

The physician decides about the duration of the treatment in dependence on the pain.
By no means Oramorph® 20 mg/ml should be given longer than absolutely necessary. If prolonged analgesic treatment with Oramorph® 20 mg/ml appears necessary based on the nature and severity of the disease, careful and regular monitoring within short time intervals should be installed (if required by means of temporary suspension of the medication) to evaluate if and to what extent the therapeutic necessity persists. If needed, more suitable pharmaceutical forms should be applied instead. In case of chronic pain conditions, a fixed dosage regimen is preferred.

Discontinuation of therapy
Since the risk of occurrence of withdrawal symptoms is increased in case of abrupt discontinuation of therapy the dose should be reduced stepwise after termination of treatment.