PROCHLORPERAZINE MESILATE

M. injection followed by oral medication six hours later, if necessary. M. injection until oral treatment becomes possible.

Elderly:

Prochlorperazine should be used with caution in the elderly with psychotic disorders. Because elderly patients are susceptible to centrally acting drugs, lower initial dosage is recommended. Correct initial diagnosis of the disorder is important.

g. orthostatic hypotension with effects due to the primary disorder. Paediatric population Intramuscular prochlorperazine should not be used in children under 18 years. Method of administration Prochlorperazine injection is for administration by intramuscular injection.

Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders.

Not known (cannot be estimated from available data) Adverse effects:

System organ class Frequency Undesirable effects Blood and lymphatic system disorders Not known A mild leukopenia occurs in up to 30% of patients on prolonged high dosage. 4). Immune system disorders Not known Type I hypersensitivity reactions such as angioedema and urticaria Endocrine disorders Not known Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia; amenorrhoea; impotence Nervous system disorders Not known *Acute dystonia or dyskinesias, **Akathisia, ***Tardive dyskinesia, Insomnia and agitation may occur.

Eye disorders Not known Ocular changes and the development of a metallic greyish-mauve coloration of exposed skin have been noted in some individuals mainly females, who have received chlorpromazine continuously for long periods (four to eight years).

This could happen with prochlorperazine. Cardiac disorders Not known ECG changes include QT prolongation (as with other neuroleptics), ST depression, U-Wave and T-Wave changes. Cardiac arrhythmias, including ventricular arrhythmias and atrial arrhythmias, A-V block, ventricular tachycardia, which may result in ventricular fibrillation or 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. 4, above), as well as cases of unexplained sudden death, in patients receiving neuroleptic phenothiazines. Vascular disorders Not known Hypotension, usually postural, commonly occurs.

Elderly or volume depleted subjects are particularly susceptible; it is more likely to occur after intramuscular injection. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs.

Respiratory, thoracic and mediastinal disorders Not known Respiratory depression is possible in susceptible patients. Nasal stuffiness may occur. Gastrointestinal disorders Not known Dry mouth Hepatobiliary disorders Not known Jaundice, usually transient, occurs in a very small percentage of patients taking neuroleptics.

A premonitory sign may be sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstruction of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon.

4). 4); Skin rashes of various kinds may also be seen in patients treated with the drug. Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight. 6).

4). 4). * usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases. ** characteristically occurs after large initial doses. Parkinsonism is commoner in adults and the elderly.

It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism. Commonly just tremor. *** If this occurs, it is usually, but not necessarily, after prolonged or high dosage.

It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible. 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.

Prochlorperazine should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis or prostate hypertrophy. It should also be avoided in patients hypersensitive to phenothiazines or with a history of narrow angle glaucoma or agranulocytosis.

Close monitoring is required in patients with epilepsy or a history of seizures, as phenothiazines may lower the seizure threshold. As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended.

8), and requires immediate haematological investigation. It is imperative that treatment be discontinued in the event of unexplained fever, as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity).

Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brain disease are predisposing factors.

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. 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. The risk-benefit should be fully assessed before prochlorperazine treatment is commenced. g. g. 8). 5). In randomised clinical trials versus placebo performed in a population with 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. Prochlorperazine Injection should be used with caution with stroke risk factors.

As with all antipsychotic drugs, Prochlorperazine Injection 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.

Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight. 8). M. administration. It should be used with caution in the elderly, particularly during very hot or very cold weather because of the risk of hyper-, hypothermia.

The elderly are particularly susceptible to postural hypotension. Prochlorperazine Injection should be used cautiously in the elderly owing to their susceptibility to drugs acting on the central nervous system and a lower initial dosage is recommended.

There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use. g. orthostatic hypotension, with the effects due to the underlying disorder.

Increased Mortality in Elderly people with Dementia:

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Prochlorperazine is not licensed for the treatment of dementia-related behavioural disturbances. Cases of venous thromboembolism (VTE) 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 prochlorperazine and preventive measures undertaken.

Hyperglycaemia or intolerance to glucose had been reported in patients treated with antipsychotic phenothiazines. 8).

Excipients:

This medicine contains less than 1mmol sodium (23mg) per ml, that is to say essentially ‘sodium-free’. This medicine also contains the preservatives sodium sulphite (E221) and sodium metabisulphite (E223) which may rarely cause severe […]

1. 5mg/kg.