|Stemetil should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided in patients known to be 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.Patients receiving phenothiazines over a prolonged period require regular and careful surveillance with particular attention to potential for inducing eye changes, liver dysfunction, myocardial conduction effects, particularly if other concurrently administered drugs also have potential effects on these systems.As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8 Undesirable effects), 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.Treatment involves the immediate cessation of neuroleptic therapy and symptomatic management as appropriate.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 extrapyrimidal 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 If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time.As with all antipsychotic drugs, Stemetil should not be used alone where depression is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.To prevent skin sensitisation in those frequently handling preparations of phenothiazines, the greatest care must be taken to avoid contact of the drug with the skin (see section 4.8 Undesirable effects).It should be used with caution in the elderly, particularly during very hot or very cold weather (risk of hyper-, hypothermia).The elderly are particularly susceptible to postural hypotension.Stemetil should be used cautiously in the elderly owing to their susceptibility to drugs acting on the central nervous system and a lower initial doseage is recommended. There is an increased risk of drug-induced Parkinsonism, dyskinesia, akathisia, dystonia, particularly after prolonged use. These are likely to be particularly severe in children. Care should also be taken not to confuse the adverse effects of Stemetil, e.g. orthostatic hypotension, with the effects due to the underlying disorder.Prolonged administration of any phenothiazine may result in persistent or tardive dyskinesias, particularly in the elderly.Phenothiazines should only be used with great caution in patients with coronary insufficiency, cardiovascular disorders which may predispose to prolongation of the QT interval.As with other neuroleptics, very rare cases of QT-interval prolongation have been reported with Stemetil.Cases of QT prolongation, possibly dose related have been reported with neuroleptic drugs. This effect can increase the risk of serious ventricular disorders such as torsades de pointes. As a precaution before administration of Prochlorperazine, it is recommended if possible, to eliminate the risk factors for cardiac rhythm disturbances:|
Except in emergencies, it is recommended that an ECG be performed as part of the initial evaluation of patients due to receive treatment with a neuroleptic drug.There have been isolated reports of sudden death with phenothiazines with possible causes of a cardiac origin.Avoid concomitant prescription of other antipsychotics.Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.Hyperglycaemia or intolerance to glucose has been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes who are started on Stemetil, should get appropriate gylcaemic monitoring during treatment (see section 4.8 Undesirable Effects).Stroke: In randomized 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. Stemetil should be used with caution in patients with stroke risk factors.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. Stemetil 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 Stemetil and preventative measures undertaken.
|• ||Brachycardia <55 beats/minute
|• ||Congenital or acquired QT prolongation
|• || Ongoing treatments with drugs which can result in brachycardia (<55 beats/minute), hypokalemia, slowed intracardiac conduction, QT prolongation (see section 4.5 interactions).