Haloperidol Tablets Bp 1.5mg
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1. Trade Name of the Medicinal Product
Haloperidol Tablets BP 1.5 mg
2. Qualitative and Quantitative Composition
Each tablet contains 1.5 mg of Haloperidol BP
3. Pharmaceutical Form
Tablet
Clinical Particulars
4.1 Therapeutic Indications
The tablets are indicated for the treatment of psychotic disorders - schizophrenia, mania and hypomania, especially paranoid psychoses. Mental or behavioural problems such as aggression, hyperactivity and self-mutilation in the mentally retarded. Moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Gilles de la Tourette syndrome and severe tics. Intractable hiccup, childhood behaviour disorders, especially when associated with hyperactivity and aggression. Restlessness and agitation in the elderly.
4.2 Posology and Method of Administration
Route of administration oral.
There is a considerable variation from patient to patient in the response to treatment and the dosage required. As with all antipsychotics, dosage should be individualised according to the needs and response of each patient.
To determine the initial dosage, consideration should be given to the patients age, severity of symptoms and previous responses to other antipsychotic therapy. Oral dosage may be given in single or divided doses. Administration twice daily is sufficient in most cases.
Adults: Dosage ranges from as little as 1.5 mg to 20 mg daily, depending on the characteristics, severity of symptoms and response of each individual patient. It may be necessary to increase the dosage gradually to obtain maximum control of symptoms.
Severely disturbed or resistant patients may require up to 30 mg daily.
Once a satisfactory therapeutic response has been achieved, dosage should be reduced gradually to the lowest effective maintenance level which is often as low as 3 to 10 mg daily, dependent on the characteristics and response of each individual patient.
Gilles de la Tourette syndrome, severe tics, intractable hiccup: starting dose 1.5 mg three times daily adjusted according to response. A daily maintenance dose of 10 mg may be required in Gilles de la Tourette syndrome.
Once a satisfactory therapeutic response has been achieved dosage should be reduced gradually to the lowest effective maintenance level which, for most patients, is 4 mg daily.
Elderly: Half the recommended adult starting dose may be sufficient for therapeutic response in the elderly. The maximum maintenance dose will generally be lower for debilitated or geriatric patients who may be more sensitive to haloperidol.
Children: 25 to 50 Micrograms (0.025 mg to 0.05 mg) per kg body weight per day to a maximum of 10 mg, although adolescents may require up to 30 mg daily.
4.3 Contra-indications
Comatose states, patients with Parkinson’s disease or a sensitivity to haloperidol and use during lactation.
4.4 Special Warnings and Precautions for Use
Liver disease, renal failure, phaeochromocytoma, conditions predisposing to epilepsy (eg. alcohol withdrawal or brain damage). May be given to epileptics, but usual anticonvulsant therapy should be continued.
Use cautiously in thyrotoxic patients and those with arteriosclerosis who may have occult or manifest lesions of the basal ganglia. Such patients may be more prone to develop extrapyramidal symptoms.
Administer with care to patients with severe cardiovascular disorders, because of the possibility of transient hypotension. Should hypotension occur and a vasopressor be required, adrenaline should not be used since haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur.
4.5 Interactions with other Medicaments and other forms of Interaction
Haloperidol may potentiate the central nervous system depression produced by other CNS-depressant drugs including alcohol, hypnotics, sedatives or strong analgesics.
Concurrent use of fluoxetine may lead to an increased plasma concentration of haloperidol.
Enhanced CNS effects (sedation, mental disturbances) have been reported with the combined use of methyldopa and haloperidol.
Severe neuromuscular symptoms with impairment of consciousness and fever have been reported with combined use of lithium and haloperidol. A causal relationship has not been established, however, patients receiving such combined therapy should be carefully observed for early evidence of neurological toxicity and treatment should be discontinued if such signs appear.
Haloperidol may antagonise the action of adrenaline and other sympathominetic agents and reverses the blood pressure lowering effects of adrenergic-blocking agents such as guanethidine. Haloperidol may impair the metabolism of tricyclic antidepressants (clinical significance unknown) and the antiparkinsonian effects of levodopa.
The dosage of anticonvulsants may need to be increased to take account of the lowered seizure threshold. Co-administration of haloperidol with carbamazepine may lead to reduced plasma concentrations of haloperidol; in some cases, an increase in efficacy may occur, possibly as a result of the central action of carbamazepine.
Concurrent use of rifampicin may lead to reduced plasma-haloperidol levels.
4.6 Pregnancy and Lactation
The safety of haloperidol in pregnancy has not been established. No well controlled studies of haloperidol use in pregnant women have been conducted. Two cases of foetal limb malformation have been reported following maternal use of haloperidol combined with other drugs during the first trimester. No causal relationship has been established. Use of haloperidol during pregnancy requires that the anticipated benefit be weighed against the possible hazards to mother and foetus.
Lactation: Haloperidol has been detected in breast milk. If use of haloperidol is considered essential, breast feeding should be discontinued.
4.7 Effects on Ability to Drive and Use Machines
Haloperidol may impair alertness, especially at the start of treatment. These effects may be potentiated by alcohol. Patients should be warned of the risks of sedation and advised not to drive or operate machinery during treatment, until their susceptibility is known.
4.8 Undesirable Effects
Extrapyramidal symptoms such as Parkinson-like symptoms, akinesia, akathisia, dyskinesia, dystonia may develop during haloperidol treatment. Very rarely dystonia has been reported to produce laryngeal/pharyngeal spasm associated with gagging, cyanosis, respiratory distress and asphyxia. Such symptoms may be promptly controlled by parenteral administration of a shortacting barbiturate, an antihistamine or an antiparkinsonian drug.
The occurrence and severity of most extrapyramidal symptoms are generally, but not always, dose related. Extrapyramidal reactions have on occasions been reported during treatment at relatively low dose levels in both children and adults. Administration of antiParkinsonian drugs may be required for control of such reactions.
In common with other antipsychotics haloperidol has been associated with persistent tardive dyskinesia. Tardive dyskinesia may develop in some patients on long term therapy or may develop after drug therapy has been discontinued. The risk is reported to be greater in elderly patients on high dose therapy. Characteristic symptoms are rhythmical involuntary movements of the tongue, face, mouth or jaw sometimes accompanied by involuntary movements of the extremities. They may persist for many months or even years and while they gradually disappear in some patients, they appear to be permanent in others. Gradual reduction of dosage to reveal persisting dyskinesia has been suggested, so that treatment may be stopped if necessary, anti-parkinson agents have proved of little value in this syndrome.
In schizophrenia, the response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months.
Some degree of sedation may occur particularly with higher doses and at the start of treatment. The elderly appear more susceptible. At low doses in susceptible (especially non-psychotic) individuals, haloperidol may cause unpleasant subjective feelings of being mentally dulled or slowed down, dizziness, headaches or paradoxical effects of excitement, agitation or insomnia.
Other adverse effects reported include gastrointestinal symptoms, nausea, loss appetite, dyspepsia, autonomic effects such as blurring of vision and infrequently, tachycardia. Dose-related hypotension is uncommon, but can occur, particularly in the elderly or after parenteral administration.
Impairment of sexual function, including erection and ejaculation; oedema; blood dyscrasias, including agranulocytosis and transient leucopenia; skin reactions including exfolitative dermatitis, erythema multiforme and photosensitisation and jaundice are rarely reported. Transient abnormalities of liver function may occur in the absence of jaundice.
Impairment of body temperature could occur at high doses. In common with other antipsychotics, hormonal effects include hyperprolactinaemia which could cause galactorrhoea, gynaecomastia and oligo or amenorrhoea. Abrupt discontinuation of high doses of antipsychotics has very rarely resulted in acute withdrawal symptoms, including nausea, vomiting and insomnia. Gradual withdrawal is advisable.
Rare cases of sudden and unexplained death have been reported in psychiatric patients receiving treatment with antipsychotics including haloperidol. The nature of the evidence makes it impossible to determine the contributory role, if any, of the drug. In common with other antipsychotics, haloperidol has been associated with rare cases of neuroleptic malignant syndrome (NMS), an idiosyncratic response characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and coma. Signs of autonomic dysfunction such as tachycardia, labile arterial pressure and sweating may precede the onset of hyperthermia, acting as early warning signs. Recovery usually occurs within five to seven days of antipsychotic withdrawal. Affected patients should be carefully monitored.
4.9 Overdose
Intensification of the known pharmacological and adverse effects may occur. The most prominent would be severe extrapyramidal symptoms, hypotension or sedation. The patient may appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. Extra-pyramidal reactions may include muscular weakness or rigidity and a generalised or localised tremor. With accidental overdosage hypothermia, bradycardia, sinus arrhythmia and hypertension have been reported in young children.
No specific antidote has been identified.
In the event of overdosage the stomach should be emptied by aspiration and lavage.
Emetics should not be used. Establishment of a patent airway and artificial ventilation may be needed. Hypotension may be counteracted by placing the patient in the head-down position and by use of a plasma expander and careful use of a vasopressor agent such as noradrenaline. Adrenaline should not be used. Severe extrapyramidal reactions should be treated with parenteral antihistamines or antiparkinsonian drugs. The relatively long plasma elimination half-life of haloperidol should be considered.
Pharmacological Properties
5.1 Pharmacodynamic Properties
Haloperidol is a butyrophenone with actions and uses similar to those of the phenothaizine, chlorpromazine.
5.2 Pharmacokinetic Properties
Haloperidol is readily absorbed from the gastro-intestinal tract. It is metabolised in the liver and is excreted in the urine and faeces; there is evidence of enterohepatic recycling. Owing to the first-pass effect of metabolism in the liver, plasma concentrations following oral administration are lower than those following intramuscular administration. Moreover, there is wide intersubject variation in plasma concentrations of haloperidol, but in practice, no simple correlation has been found between plasma concentrations of haloperidol and its therapeutic effect. Paths of metabolism of haloperidol include oxidative ^-dealkylation. Haloperidol has been reported to have a plasma half-life ranging from 13 to nearly 40 hours. Haloperidol is very extensively bound to plasma proteins. It is widely distributed in the body and crosses the blood brain barrier.
5.3 Preclinical Safety Data
There are no additional data of relevance to the prescriber.
Pharmaceutical Particulars
|
List of Excipients | |
|
Lactose |
BP |
|
Maize Starch |
BP |
|
Sucrose |
BP |
|
Purified Water |
BP |
|
Maize Starch |
BP |
|
Talc |
BP |
|
Magnesium Stearate |
BP |
6.2
Incompatibilities
None known.
6.3 Shelf Life
36 months
6.4 Special Precautions for Storage
Keep well closed. Store in a dry place below 25°C.
6.5 Nature and Contents of Container
Amber glass bottles with bakelite caps, polypropylene containers with polyethylene caps (with optional use of polyethylene ullage filler) and high density polyethylene (HDPE) containers with polyethylene snap closures in packs of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180 and 500.
6.6 Instruction for Use/Handling
Not applicable
Administrative Data
7. Marketing Authorisation Holder
Generics [UK] Limited Station Close Potters Bar Herts EN6 1TL
8. Marketing Authorisation Number
PL 04569/0028
9. Date of First Authorisation/Renewal of Authorisation
14 February 1984 / 1 December 1998
10. Date of (Partial) Revision of the Text
June 1998
POM