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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: Agitation and restlessness in the elderly Short-term adjunctive management of psychomotor agitation
Verbatim from this product's MHRA label. Tap a section to expand.
To be taken orally.
ADULTS:
For psychomotor agitation, 100-200mg four times daily ELDERLY: For agitation and restlessness, 25-50mg four times daily. These tablets are not recommended for use in children.
Promazine exhibits side effects associated with phenothiazines in general including; nasal congestion, drowsiness, apathy, agitation, excitement, convulsions and insomnia, dizziness, headache, gastrointestinal disturbances, hypothermia.
Promazine may induce extrapyramidal side effects including dystonia, tremor, tardive dyskinesia and akathisia. Antimuscarinic symptoms include: dry mouth, constipation, micturition difficulties and blurred vision. Cardiovascular symptoms include: hypotension.
Cardiac effects such as QT-interval prolongation, Torsade de Pointes, ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia, and cardiac arrest have been reported rarely. Cases of sudden unexplained death have also occurred.
These are class effects of neuroleptics. Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- frequency unknown. Sensitivity reactions such as agranulocytosis, leucopenia, allergic skin reactions, rashes.
Photosensitisation and contact sensitisation. Corneal and lens opacities and purplish pigmentation of the skin, cornea, conjunctiva, and retina. Confusional states and epileptic fits can occur. Haemolytic anaemia and jaundice (including cholestatic jaundice).
Endocrine effects such as menstrual disturbances, galactorrhoea, gynaecomastia, impotence and weight gain. Hypotension and interference with temperature regulation are dose-related side effects and are liable to cause dangerous falls and hypothermia or hyperthermia in the elderly.
Neuroleptic malignant syndrome (hyperthermia, fluctuating levels of consciousness, muscular rigidity, and autonomic dysfunction with pallor, tachycardia, labile blood pressure, sweating and urinary incontinence) is a rare but potentially fatal side effect of some drugs.
Promazine should be used only with great caution in the following conditions; history of jaundice, blood dyscrasias (perform blood counts if unexplained infection or fever develops), renal and hepatic impairment, respiratory disease, Parkinsonism, epilepsy, hypothyroidism, depression, myasthenia gravis, prostatic hypertrophy, personal or a family history of angle-closure glaucoma.
As with other neuroleptics, caution is advised in patients with cardiovascular diseases and patients with a family history of QT prolongation. 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 As photosensitisation may occur with higher dosages, patients should avoid direct sunlight.
In patients with Parkinson’s disease the anticholinergic side effects of promazine may be aggravated by anti-parkinsonian agents. Concomitant use of promazine with other neuroleptics should be avoided. 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. The elderly are particularly susceptible to the side effects of promazine especially sedation, hypotensive and temperature regulation effects.
Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse. An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics.
• Known sensitivity to phenothiazines or to any of the excipients • Comatose states • CNS depression • Phaeochromocytoma
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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If this occurs, antipsychotics should be discontinued. 6) - frequency is not known. 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.
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The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Promazine should be used with caution in patients with risk factors for stroke. Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.