Posology : מינונים

4.2.   Posology and Method of Administration
Posology

Adults

A low initial dose is recommended, and this must be adjusted according to the patient’s response in order to determine the minimal effective dose (see section 5.2).

The dose recommendations for HALDOL solution for injection are presented in Table 1.
Table 1: Haloperidol dose recommendations for adults aged 18 years and above

Rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder when oral therapy is not appropriate •    5 mg intramuscularly.
•    May be repeated hourly until sufficient symptom control is achieved.
•    In the majority of patients, doses of up to 15 mg/day are sufficient. The maximum dose is 20 mg/day.
•       The continued use of HALDOL should be evaluated early in treatment (see section           4.4). Treatment with HALDOL solution for injection must be discontinued as soon as clinically indicated and, if further treatment is needed, oral haloperidol should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response.
Acute treatment of delirium when non-pharmacological treatments have failed •    1 to 10 mg intramuscularly.
•    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 mild to moderate chorea in Huntington’s disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate •    2 to 5 mg intramuscularly.
•    May be repeated hourly until sufficient symptom control is achieved or up to a maximum of 10 mg/day.
There are no clinical studies performed with Haldol Ampoules for this indication.

Single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated •    1 to 2 mg intramuscularly, at induction or 30 minutes before the end of anaesthesia.


Combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not tolerated
•    1 to 2 mg intramuscularly.


Treatment withdrawal
Gradual withdrawal of haloperidol is advisable (see section 4.4)

Special populations

Elderly
The recommended initial haloperidol dose in elderly patients is half the lowest adult dose.


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

The maximum dose 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 further doses administered and adjusted according to the patient’s response (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. Further doses may be administered and adjusted according to the patient’s response (see sections 4.4 and 5.2).

Paediatric population

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

Method of administration

HALDOL solution for injection is recommended for intramuscular use only (see section 4.4). For instructions on handling HALDOL solution for injection, see section 6.6.