Posology : מינונים

4.2    Posology and method of administration

Treatment initiation and dose titration must be carried out under close clinical supervision.
Posology

The individual dose will depend on both the severity of the symptoms and the current oral haloperidol dose. Patients must always be maintained on the lowest effective dose.

As the initial dose of haloperidol decanoate is based on a multiple of the daily oral haloperidol dose, specific guidance on switching from other antipsychotics cannot be provided (see section 5.1).

Adults aged 18 years and above

Table 1: Haloperidol decanoate dose recommendations for adults aged 18 years and above 


Haldol decanoas_100mg/ml_PI_01-2023
Transition from oral haloperidol
•    A haloperidol decanoate dose of 10 to 15 times the previous daily dose of oral haloperidol is recommended.
•    Based on this conversion, the haloperidol decanoate dose will be 25 to150 mg for most patients.

Continuation of treatment
•    It is recommended to adjust the haloperidol decanoate dose by up to 50 mg every 4 weeks (based on individual patient response) until an optimal therapeutic effect is obtained.
•    The most effective dose is expected to range between 50 and 200 mg.
•    It is recommended to assess the individual benefit-risk when considering doses above 200 mg every 4 weeks.
•    A maximum dose of 300 mg every 4 weeks must not be exceeded because the safety concerns outweigh the clinical benefits of treatment.

Dosing interval
•    Usually 4 weeks between injections.
•    Adjustment of the dosing interval may be required (based on individual patient response).

Supplementation with non-decanoate haloperidol
•    Supplementation with non-decanoate haloperidol may be considered during transition to HALDOL Decanoas, dose adjustment or episodes of exacerbation of psychotic symptoms (based on individual patient response).
•    The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 20 mg/day.


Special populations
Elderly

Table 2: Haloperidol decanoate dose recommendations for elderly patients 
Transition from oral haloperidol
•    A low haloperidol decanoate dose of 12.5 to 25 mg is recommended.

Continuation of treatment
•    It is recommended only to adjust the haloperidol decanoate dose if required (based on individual patient response) until an optimal therapeutic effect is obtained.
•    The most effective dose is expected to range between 25 and 75 mg.
•    Doses above 75 mg every 4 weeks should only be considered in patients who have tolerated higher doses and after reassessment of the patient’s individual benefit-risk profile.

Dosing interval
•    Usually 4 weeks between injections.
•    Adjustment of the dosing interval may be required (based on individual patient response).

Supplementation with non-decanoate haloperidol
•    Supplementation with non-decanoate haloperidol may be considered during transition to HALDOL Decanoas, dose adjustment or episodes of exacerbation of psychotic symptoms (based on individual patient response).
•    The combined total dose of haloperidol from both formulations must not exceed the corresponding maximum oral haloperidol dose of 5 mg/day or the previously administered oral haloperidol dose in patients who have received long-term treatment with oral haloperidol.


Haldol decanoas_100mg/ml_PI_ 01-2023
Renal impairment
The influence of renal impairment on the pharmacokinetics of haloperidol has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with renal impairment.
However, patients with severe renal impairment may require a lower initial dose, with subsequent adjustments at smaller increments and at longer intervals than in patients without renal impairment (see section 5.2).

Hepatic impairment

The influence of hepatic impairment on the pharmacokinetics of haloperidol has not been evaluated.
Since haloperidol is extensively metabolised in the liver, it is recommended to halve the initial dose, and adjust the dose with smaller increments and at longer intervals than in patients without hepatic impairment (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of HALDOL Decanoas in children and adolescents below 18 years of age have not been established. No data are available.

Method of administration

HALDOL Decanoas is for intramuscular use only and must not be administered intravenously. It is administered as a deep intramuscular injection in the gluteal region. It is recommended to alternate between the two gluteal muscles. As the administration of volumes greater than 3 ml is uncomfortable for the patient, such large volumes are not recommended. For instructions on handling HALDOL Decanoas, see section 6.6.