Each Haloperidol 5 mg tablet contains:
active ingredient: haloperidol – 5 mg
For a full list of excipients, see section List of excipients.
Products
Haloperidol, 5 mg tablets
Drug formTablets
ATC categoryNeurology. Psychiatry
ATC subcategoryNeuroleptics
Brand nameHaloperidol
Generic nameHaloperidol
Leaflet in Georgian: Haloperidol 5 mg tablets
Qualitative and quantitative composition
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 Pharmacokinetic properties).
The dose recommendations for Haloperidol tablets are presented in Table 1.
Table 1: Haloperidol dose recommendations for adults aged 18 years and above
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Treatment of schizophrenia and schizoaffective disorder • 2 to 10 mg/day orally, as a single dose or in 2 divided doses. Patients with firstepisode 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. |
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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. |
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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 Haloperidol tablets should be evaluated early in treatment (see section Special warnings and precautions for use). |
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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 Haloperidol tablets should be evaluated early in treatment (see section Special warnings and precautions for use). • When switching from haloperidol intramuscular injection, Haloperidol tablets orally should be initiated at a 1:1 dose conversion rate followed by dose adjustment according to clinical response. |
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Treatment of persistent aggression and psychotic symptoms in patients with moderate to severe Alzheimer’s dementia and vascular dementia when nonpharmacological 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 |
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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. |
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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. |
Haloperidol oral solution should be used for single doses of less than 1 mg that cannot be achieved with haloperidol tablets
Treatment withdrawal
Gradual withdrawal of haloperidol is advisable (see section Special warnings and precautions for use).
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 Pharmacokinetic properties).
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 Special warnings and precautions for use and Pharmacokinetic properties).
Paediatric population
The dose recommendations for Haloperidol tablets are presented in Table 2.
Table 2: Haloperidol dose recommendations for paediatric population
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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. |
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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. |
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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 Haloperidol 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
Haloperidol tablets are for oral use.
Pharmacological properties Pharmacodynamic properties
Pharmacotherapeutic group: psycholeptics; antipsychotics; butyrophenone derivatives.
ATC code: N05AD01.
Pharmaceutical particulars
List of excipients
Haloperidol 5 mg tablets
microcrystalline cellulose
calcium phosphate dibasic
maize (corn) starch
lactose monohydrate
povidone
sodium starch glycolate
magnesium stearate.
For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134425/1736329537406.pdf