CHLORPROMAZINE HYDROCHLORIDE

Posology For oral administration only. Dosage should be low to begin with and gradually increased under close supervision until the optimum dosage within the recommended range is reached. Individual response and dosage requirements may vary greatly.

Dosage for schizophrenia, other psychoses, mania, hypomania, anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour Adults: Initially 25mg three times daily or 75mg at bedtime increasing daily by 25mg to an effective maintenance dose.

This maintenance dose is usually 70 to 300mg daily, but may be up to 1g daily in some patients.

Children under 1 year:

Not recommended unless the need is life saving. 5mg/Kg bodyweight every 4 - 6 hours to a maximum recommended dose of 40mg daily. Children 6 - 12 years: 1/3 to 1/2 the adult dose up to a maximum recommended dose of 75 mg daily.

Elderly or disabled patients:

Start with 1/3 to 1/2 the usual adult dose with a more gradual increase in dosage.

Dosage for Intractable Hiccup Adults: 25 - 50mg tds or qds Children:

Not recommended/ no information available. Dosage for Vomiting and Nausea of Terminal Illness Adults: 10 - 25mg every 4 - 6 hours Children under 1 year: Do not use unless need is life saving. 5mg/Kg every 4 - 6 hours. Maximum daily dosage should not exceed 40 mg.

5mg/Kg every 4 - 6 hours. Maximum daily dosage should not exceed 75mg.

Elderly or disabled patients:

Initially 1/3 to 1/2 the adult dose. The clinician should then use his clinical judgement to obtain control.

4) Parkinsonism (more common in adults and the elderly. 4), ST depression, U- Wave and T- Wave changes. Cardiac arrhythmias, including Ventricular arrhythmia and atrial arrhythmias, a-v block, Ventricular fibrillation Ventricular tachycardia Torsade de pointes Cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage.

Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose. 6) Reproductive system and breast disorders Priapism General disorders and administration site conditions Temperature regulation disorder including hypothermia Insomnia Agitation Pallor 1may be seen without evidence of clinical disease 2particularly at the start of treatment 3particularly during long term treatment; may occur after the neuroleptic is withdrawn and resolve after reintroduction of treatment or if the dose is increased.

4linked to anticholinergic effects 5in the anterior segment of the eye caused by accumulation of the drug but generally without any impact on sight 6A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development of jaundice.

Chlorpromazine jaundice has the biochemical and other characteristics of obstructive (cholestatic) jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon.

Liver injury, sometimes fatal, has been reported rarely in patients treated with chlorpromazine. 4). 7The development of a metallic greyish-mauve coloration of exposed skin, the cornea, retina and conjunctiva has been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (four to eight years) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Blood disorders All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the latter.

As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. 8) and requires immediate haematological investigation. Neuroleptic malignant syndrome: treatment must be interrupted in the event of unexplained hyperpyrexia since this can be one of the signs of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity).

Signs of autonomic instability, such as hyperhydrosis and irregular blood pressure, can precede the onset of hyperthermia and as such constitute premonitory signs of this syndrome. While this neuroleptic-related effect can be of idiosyncratic origin, certain risk factors such as dehydration and brain damage would seem to indicate a predisposition.

Chlorpromazine should be avoided in patients with, hypothyroidism, phaeochromocytoma, myasthenia gravis and prostate hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma or agranulocytosis.

Withdrawal Acute withdrawal symptoms, including nausea, vomiting and insomnia, have very rarely been reported following the abrupt cessation of high doses of neuroleptics. Relapse may also occur, and the emergence of extrapyramidal reactions has been reported.

Therefore, gradual withdrawal is advisable. In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time. QT prolongation Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death).

e. drug induced) QT prolongation. 8). 5) With the exception of emergencies, it is recommended that the initial work up of patients receiving a neuroleptic should include an ECG. Except under exceptional circumstances, this drug must not be administered to patients with Parkinson's disease.

5). 8). Cases of venous thromboembolism (VTE), sometimes fatal have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with chlorpromazine and preventative measures undertaken.

Stroke:

In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed.

The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Chlorpromazine should be used with caution in patients with stroke risk factors.

Elderly Patients with Dementia:

Elderly patients with dementia-related psychosis treated with antipsychotics drugs are at an increased risk of death. 7 times the risk of death in placebo-treated patients. 6% in the placebo group. , heart failure, sudden death) or infectious (eg.

, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

As with all antipsychotic drugs, chlorpromazine should not be used alone where depression is predominant. However, it may be combined with antidepressant therapy to treat those conditions in which depression and psychosis coexist. Chlorpromazine is not licensed for the treatment of dementia-related behavioural disturbances.

Because of the risk of photosensitisation, patients should be advised to […]

1. • Comatose states • Severe CNS depression • History of blood dyscrasias including bone marrow depression and agranulocytosis. 6) • Citalopram and escitalopram