HALOPERIDOL Solution for injection Ref.[6854] Active ingredients: Haloperidol

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 Haloperidol 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 haloperidol should be evaluated early in treatment (see section 4.4). Treatment with haloperidol 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.

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

Method of administration

Haloperidol solution for injection is recommended for intramuscular administration only (see section 4.4). For instructions on handling haloperidol solution for injection, see section 6.6.

Symptoms and signs

The manifestations of haloperidol overdose are an exaggeration of the known pharmacological effects and adverse reactions. The most prominent symptoms are severe extrapyramidal reactions, hypotension and sedation. An extrapyramidal reaction is manifest by muscular rigidity and a generalised or localised tremor. Hypertension rather than hypotension is also possible.

In extreme cases, the patient would appear comatose with respiratory depression and hypotension that could be severe enough to produce a shock-like state. The risk of ventricular arrhythmias, possibly associated with QTc prolongation, must be considered.

Management

There is no specific antidote. Treatment is supportive. Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol (see section 5.2).

For comatose patients, a patent airway must be established by use of an oropharyngeal airway or endotracheal tube. Respiratory depression may necessitate artificial respiration.

It is recommended that ECG and vital signs be monitored, and that monitoring continues until the ECG is normal. Treatment of severe arrhythmias with appropriate anti-arrhythmic measures is recommended.

Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma or concentrated albumin and vasopressor agents, such as dopamine or noradrenaline. Adrenaline must not be used because it might cause profound hypotension in the presence of haloperidol.

In cases of severe extrapyramidal reactions, parenteral administration of an antiparkinson medicinal product is recommended.

Unopened: 3 years.

The product should be used immediately after opening.

Do not store above 25°C.

Store in the original carton in order to protect from light.

1ml & 2 ml clear One Point Cut (OPC) glass ampoules, glass type 1 Ph. Eur. borosilicate glass packed in cardboard cartons to contain 10x1ml ampoules and 10x2ml ampoules.

Not all pack sizes may be marketed.

For single use only.

If only part of the contents of an ampoule is used, the remaining solution should be discarded.

Do not use if the solution is cloudy, discoloured or if there are any particles present.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.