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PROMAZINE is a brand name for Promazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As an adjunct to non-pharmacological interventions in the short-term management of moderate to severe agitation and restlessness where there is a risk of harm to the individual or to others.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For oral administration only. Dosage varies with the individual and the purpose for which the drug is used, so the following dosages are only for general guidance with regard to possible effectiveness and good tolerance. Initial dosages should be low, with increments at frequent, regular intervals until the desired response is obtained.
Dosage intervals are usually six to eight hours, but in some patients a single bedtime dose may be sufficient. The lowest effective dose should be used. The commencement and increase of dosage should be performed under close supervision.
Agitation and restlessness Adults: 100mg to 200mg, up to four times daily. Elderly: 25 mg initially, up to 50 mg four times daily The lowest effective dose for the shortest period possible should be used.
Paediatric population Children:
Promazine is not recommended for children
Promazine is a member of the phenothiazine group of drugs and the size effects associated with that group have been noted. System Organ Class Blood and lymphatic system disorders Sensitivity reactions including agranulocytosis, leucopenia, haemolytic anaemia.
Psychiatric disorders Apathy, confusional state. Some individuals may be susceptible to the drug in low dosage and show paradoxical effects of excitement, agitation or insomnia and other minor side effects. 4). Nervous system disorders Drowsiness, dizziness, headache, sedation, epileptic fits, extrapyramidal symptoms (dystonia, tremor, tardive dyskinesia and akathisia), neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction, altered consciousness) may occur with any neuroleptic.
Eye disorders Blurred vision, precipitation of glaucoma, corneal and lens opacities and purplish pigmentation of the skin, cornea, conjunctiva and retina. Cardiac disorders Tachycardia, cardiovascular effects include hypotension. Phenothiazines can produce ECG changes with prolongation of QT interval and T-wave changes, ventricular arrhythmias (VF, VT (rare)), sudden unexplained death, cardiac arrest and Torsades de pointes have been reported.
Respiratory, thoracic and mediastinal disorders Nasal stuffiness Gastrointestinal disorders Gastrointestinal disturbances, dry mouth, constipation. Hepatobiliary disorders Transient abnormalities of liver function tests may occur without jaundice.
Rarely - obstructive jaundice associated with stasis in biliary canaliculi. Treatment should then be withdrawn and not given again. Skin and subcutaneous tissue disorder Sensitivity reactions including allergic skin reactions, rashes, photosensitisation and contact sensitization.
Renal and urinary disorders Urinary hesitancy or retention when due to enlarged prostate. Reproductive system and breast disorders Menstrual disturbances, galactorrhoea, gynaecomastia, impotence. General disorders and administration site conditions Hypothermia, hyperpyrexia.
1. Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Therefore, gradual withdrawal is advisable. 2. Phenothiazine should only be used with great caution in patients with a history of jaundice or with existent liver dysfunction, or blood dyscrasias, (perform blood counts if unexplained infection or fever occurs) coronary insufficiency or cardiac disease.
3. Respiratory depression may occur in patients with severe respiratory disease. 4. Promazine should be used with caution in patients with renal failure. 5. Patients receiving phenothiazines over a prolonged period require regular and careful surveillance with particular attention to potential for inducing eye changes (corneal and lens opacities and purplish pigmentation of the skin, cornea, conjunctiva and retina), effects on haemopoiesis, liver dysfunction, myocardial conduction effects, particularly if other concurrently administered drugs also have potential effects on these systems.
6. Use of phenothiazines at high (relative or absolute) doses may induce extrapyramidal side effects, dyskinesia, akathisia, dystonia. These are likely to be particularly severe in children. Caution should be exercised in patients with Parkinson’s disease.
Anti-parkinson agents should not be prescribed routinely because of the risk of aggravating anticholinergic side effects of Promazine, of precipitating toxic-confusional states or of impairing its therapeutic efficacy. They should be given only as required.
7. Prolonged administration of phenothiazines may result in persistent or tardive dyskinesias particularly in the elderly. The risk of tardive dyskinesia and the likelihood of irreversibility are believed to increase as the duration of therapy and total cumulative dose increase.
Use in patients hypersensitive to the active ingredient or other phenothiazines. Use in patients in coma or CNS depression Use in patients with bone marrow depression Use in patients with phaeochromocytoma Use during lactation Do not use during pregnancy, especially during the first three months, unless there are compelling reasons.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Promazine in United Kingdom.
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6). Investigations Weight gain The elderly are particularly susceptible to side effects of Promazine, especially to the sedative, hypotensive and temperature regulation effects. This may be dose related. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown 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.
Neuroleptic therapy should be withdrawn if dyskinesia develops. 8. Care should be exercised if Promazine is used for the treatment of patients with cerebral arteriosclerosis, coronary heart disease or other conditions in which a fall in blood pressure might be undesirable.
9. Caution should be observed with patients suffering from epilepsy or conditions predisposing to epilepsy. 10. Personal or family history of narrow angle glaucoma. 11. Phenothiazines may impair body temperature regulation. Caution should be observed in very hot or very cold weather.
12. Hypothyroidism. 13. Myasthenia gravis. 14. Phaeochromocytoma. 15. Prostatic hypertrophy. 16. Antipsychotic drugs may increase prolactin secretion. 17. An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics.
The mechanism for this increased risk is not known. Promazine should be used with caution in patients with risk factors for stroke. 18. As with other drugs belonging to the therapeutic class of antipsychotics, promazine may cause QT prolongation.
Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.
5). 19. Concomitant use of promazine with other neuroleptics should be avoided. 20. Photosensitisation may occur, particularly at higher doses. Patients should be advised to avoid direct sunlight. 21. The elderly are particularly susceptible to the side effects of promazine, particularly hypotension, sedation and temperature regulation effects.
22. 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 Promazine and preventive measures undertaken.
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. Promazine is not licensed for the treatment of dementia-related behavioural disturbances. Excipient Warnings This medicine contains: • Propylene Glycol (E1520).
6mg propylene glycol in each 5ml. • Methyl Hydroxybenzoate (E218), Ethyl Hydroxybenzoate (E214) and Propyl Hydroxybenzoate (E216). May cause allergic reactions (possibly delayed). • Liquid Glucose. 3g liquid glucose in each 5ml. This should be taken into account in patients with diabetes mellitus.
Patients with rare glucose-galactose malabsorption should not take this medicine. May be harmful to the teeth. • Sucrose. 8g sucrose in each 5ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
May be harmful to the teeth.