Adults:

• Schizophrenia: treatment of symptoms and prevention of relapse (oral and IM)
• Other psychoses, especially paranoid (oral and IM)
• Mania and hypomania(oral and IM)
• Mental or behavioural problems such as aggression, hyperactivity and self- mutilations in the mentally retarded and in patients with organic brain damage
• As an adjunct to short-term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behavior (oral and IM)
• Intractable hiccup (oral)
• Restlessness and agitation in the elderly (oral)
• Gilles de la Tourette syndrome and severe tics (oral)
• Nausea and vomiting (IM)

Children (Oral administration only):

• Childhood behavioral disorders especially when associated with hyperactivity and aggression
• Gilles de la Tourette syndrome
• Childhood schizophrenia

Butyrophenone drugs, Drugs used in tremor, tics & related disorder

Haloperidol blocks postsynaptic dopamine D1 and D2 receptors in the mesolimbic system and decreases the release of hypothalamic and hypophyseal hormones. It produces calmness and reduces aggressiveness with disappearance of hallucinations and delusions.

Oral Administration-

Adults: Schizophrenia, Psychoses, Mania and Hypomania, Mental or behavioral problems, Psychomotor agitation, Excitement, Violent or dangerously impulsive behavior, Organic brain damage.

Initial dosage:

• Moderate symptomatology 1.5-3.0 mg bd or tds.
• Severe symptomatology/resistant patients 3.0-5.0 mg bd or tds. The same starting doses may be employed in adolescents, who in certain cases, may require up to 30 mg or exceptionally up to 60 mg/day
• In resistant schizophrenics daily dosages up to 100 mg (or rarely up to 120 mg) may be necessary to achieve an optimal response.

Maintenance dosage:

• Once satisfactory control of symptoms has been achieved dosage, dosage should be gradually reduced to the lowest maintenance dose, often as low as 5 mg/day. Too rapid a dosage reduction should be avoided.
• Restlessness or agitation in elderly: Initial dose 1.5- 3.0 mg bd or tds titrated to attain an effective maintenance dose (1.5-5.0 mg daily)
• Gilles de la tourette syndrome/Severe tics/Intractable hiccup: Starting dose 1.5 mg tds adjusted according to response. A daily maintenance dose of 10 mg may be required in Gilles de la tourette syndrome.

Children:

• Childhood behavioural disorder/schizophrenia: Total daily maintenance dose of 0.025-0.05 mg/kg/day. Half the total dose should be given in the morning and the other half in the evening, up to a maximum of 10 mg daily. Not recommended for parenteral use in children.

Parenteral Administration-

Administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory. The maximum dose is 20 mg/day.

Dosage for all indications should be individually determined and is best initiated and titrated under close clinical supervision. To determine the initial dose consideration should be given to the patients age, severity of symptoms and previous response to other neuroleptics. The normal starting dose should be halved, followed by a gradual titration to achieve an optimal response.

Haloperidol has been reported to interfere with the anticoagulant properties of phenindione in an isolated case and the possibility should be kept in mind of a similar effect occurring when haloperidol is used with other anticoagulants. Haloperidol may antagonize the action of epinephrine and other sympathomimetic agents and reverse the blood pressure-lowering effects of adrenergic-blocking agents, such as guanethidine. Enhanced CNS effects may occur when haloperidol is used in combination with methyldopa. Haloperidol inhibits the metabolization of tricyclic antidepressants, thereby increasing plasma levels of these drugs. This may result in increased tricyclic antidepressant toxicity (anticholinergic effects, cardiovascular toxicity, lowering of seizure threshold). Haloperidol may impair the antiparkinson effects of levodopa. If an antiparkinson agent is used concomitantly with haloperidol, both drugs should not be discontinued simultaneously, since extrapyramidal symptoms may occur due to the slower excretion rate of haloperidol.

Comatose states; CNS depression; Parkinson’s disease; known hypersensitivity to haloperidol; lesions of the basal ganglia.

Extrapyramidal symptoms, acute dystonia, parkinsonian rigidity, tremor, oculogyric crises and laryngeal dystonia, confusional states or epileptic fits, depression, sedation, agitation, drowsiness, insomnia, headache, vertigo and apparent exacerbation of psychotic symptoms, nausea, loss of appetite, constipation and dyspepsia, dry mouth as well as excessive salivation, blurred vision, urinary retention have been reported.

There is no proven harmful effect in the first trimester, however there have been some reports of limb malfonnations, so the drug is best avoided if possible. The principal hazard in late pregnancy is extrapyramidal adverse effects in the neonate. The drug is excreted only in trace amounts and sedation or extrapyramidal rigidity in the neonate can occur but is rarely a problem.

Caution is advised in patients with liver disease, renal failure, epilepsy and conditions predisposing to epilepsy (e.g. alcohol withdrawal and brain damage) or convulsions. Haloperidol should only be used with great caution in patients with disturbed thyroid function.

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: severe extrapyramidal reactions, hypotension or sedation.The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state.

Store at 15-30° C.