SERENACE Tablet Ref.[50297] Active ingredients: Haloperidol

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).

The dose recommendations for Serenace tablets 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 Serenace 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 Serenace should be evaluated early in treatment (see section 4.4).
• When switching from haloperidol intramuscular injection, Serenace 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.

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

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

The dose recommendations for Serenace tablets are presented in Table 4.

Table 2. 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 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 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 in divided doses (2 to 3 times a day).
• The need for continued treatment must be reassessed every 6 to 12 months.

The safety and efficacy of Serenace 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.

Method of administration

Serenace tablets are for oral use.

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.

Treatment

There is no specific antidote. Treatment is supportive. The efficacy of activated charcoal has not been established. 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.

3 years.

Do not store above 25°C.

Store in original container.

PVC/Aluminium blisters in packs of 30 or 100 tablets.

Not all pack sizes may be marketed.

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