Posology : מינונים

4.2      Posology and method of administration
Posology

Adults

A low initial dose is recommended, which subsequently may be adjusted according to the patient’s response. Patients must always be maintained on the minimal effective dose (see section 5.2).

Tablets:
The dose recommendations for HALDOL tablets are presented in Table 1.

Oral solution:
The dose recommendations for HALDOL oral solution are presented in Table 1.
Table 1: Haloperidol dose recommendations for adults aged 18 years and above 
Treatment of schizophrenia and schizoaffective disorder
•    2 to 10 mg/day orally, as a single dose or in 2 divided doses. Patients with first-episode schizophrenia generally respond to 2 to 4 mg/day, whereas patients with multiple-episode schizophrenia may need doses up to 10 mg /day.
•    Adjustments to the dose may be made every 1 to 7 days.
•    Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit-risk should be assessed when considering doses above 10 mg/day.
•    The maximum dose is 20 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.

Acute treatment of delirium when non-pharmacological treatments have failed •    1 to 10 mg/day orally, as a single dose or in 2 to 3 divided doses.
•    Treatment should be started at the lowest possible dose, and the dose should be adjusted in increments at 2- to 4-hour intervals if agitation continues, up to a maximum of 10 mg/day.



Treatment of moderate to severe manic episodes associated with bipolar I disorder •    2 to 10 mg/day orally, as a single dose or in 2 divided doses.
•    Adjustments to the dose may be made every 1 to 3 days.
•    Doses above 10 mg/day have not demonstrated superior efficacy to lower doses in the majority of patients and may cause an increased incidence of extrapyramidal symptoms. The individual benefit-risk should be assessed when considering doses above 10 mg/day.
•    The maximum dose is 15 mg/day because safety concerns outweigh the clinical benefits of treatment at higher doses.
•    The continued use of HALDOL should be evaluated early in treatment (see section 4.4).

Treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder
•     5 to 10 mg orally, repeated after 12 hours if necessary to a maximum of 20 mg/day.
•     The continued use of HALDOL should be evaluated early in treatment (see section 4.4).
•     When switching from haloperidol intramuscular injection, HALDOL orally should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response.

Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others
•     0.5 to 5 mg/day orally, as a single dose or in 2 divided doses.
•     Adjustments to the dose may be made every 1 to 3 days.
•     The need for continued treatment must be reassessed after no more than 6 weeks.

Treatment of tic disorders, including Tourette’s syndrome, in patients with severe impairment after educational, psychological and other pharmacological treatments have failed •      0.5 to 5 mg/day orally, as a single dose or in 2 divided doses.
•      Adjustments to the dose may be made every 1 to 7 days.
•      The need for continued treatment must be reassessed every 6 to 12 months.

Treatment of mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated
•     2 to 10 mg/day orally, as a single dose or in 2 divided doses.
•     Adjustments to the dose may be made every 1 to 3 days.

HALDOL oral solution should be used for single doses of less than 1 mg that cannot be achieved with HALDOL tablets.

Oral solution:
HALDOL oral solution in a dropper container is intended to be used for single doses up to 2 mg haloperidol (equivalent to 20 drops).

The number of drops or quantity (ml) required to achieve a given single dose using HALDOL 2 mg/ml oral solution is presented in Table 2.

Table 2: Conversion table for HALDOL oral solution (2 mg/ml)
 mg haloperidol     Number of drops of HALDOL
(dropper container)
0.1 mg                 1 drop
0.2 mg                2 drops
0.3 mg                3 drops
0.4 mg                     4 drops
0.5 mg                     5 drops
1 mg                      10 drops
2 mg                      20 drops
5 mg                          -
10 mg                          -
15 mg                          -
20 mg                          -
Treatment withdrawal

Gradual withdrawal of haloperidol is advisable (see section 4.4)

Missed dose
If patients miss a dose, it is recommended that they take the next dose as usual, and do not take a double dose.

Special populations

Elderly
Clinical studies with oral haloperidol in the treatment of tic disorders, including Tourette’s syndrome, did not include patients aged 65 years and above.
The following initial haloperidol doses are recommended in elderly patients: • Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when non-pharmacological treatments have failed and when there is a risk of harm to self or others – 0.5 mg/day.
• All other indications – half the lowest adult dose.

The haloperidol dose may be adjusted according to the patient’s response. Careful and gradual dose up-titration in elderly patients is recommended.

The maximum dose in elderly patients is 5 mg/day.

Doses above 5 mg/day should only be considered in patients who have tolerated higher doses and after reassessment of the patient’s individual benefit-risk profile.

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

Tablets:
The dose recommendations for HALDOL tablets are presented in Table 3.

Oral solution:

The dose recommendations for HALDOL oral solution are presented in Table 3.
Table 3: Haloperidol dose recommendations for paediatric population

Treatment of schizophrenia in adolescents aged 13 to 17 years when other pharmacological treatments have failed or are not tolerated
•     The recommended dose is 0.5 to 3 mg/day, administered orally, preferably in divided doses (2 to 3 times a day).
•     It is recommended to assess the individual benefit-risk when considering doses above 3 mg/day.
•     The maximum recommended dose is 5 mg/day.
•     The treatment duration must be individually evaluated.

Treatment of persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have failed or are not tolerated
•     The recommended doses are 0.5 to 3 mg/day in children aged 6 to 11 years and 0.5 to 5 mg/day in adolescents aged 12 to 17 years, administered orally, preferably in divided doses (2 to 3 times a day).
•     The need for continued treatment must be reassessed after 6 weeks.
Treatment of tic disorders, including Tourette’s syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational, psychological and other pharmacological treatments have failed
•     The recommended doses are 0.5 to 3 mg/day in children and adolescents aged 10 to 17 years, administered orally, preferably in divided doses (2 to 3 times a day).
•     The need for continued treatment must be reassessed every 6 to 12 months.


Tablets:
The safety and efficacy of HALDOL tablets in children below the ages defined in the indications have not been established. Data are not available for children aged less than 3 years.

Oral solution:

The safety and efficacy of HALDOL oral solution in children below the ages defined in the indications have not been established. Data are not available for children aged less than 3 years 
Method of administration

Tablets:
HALDOL tablets are for oral use.

Oral solution:

HALDOL oral solution is for oral use. It may be mixed with water to facilitate dose administration, but it must not be mixed with any other liquid. The diluted solution must be taken immediately.