Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE
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.
This product contains hydroxybenzoate esters. These are known to cause urticaria, delayed type reactions such as contact dermatitis and rarely an immediate reaction with urticaria and bronchospasm.
Promazine Syrup contains liquid glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.
Promazine Syrup contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The concomitant administration of this product with other medication such as central nervous system depressants (including alcohol and anaesthetics) or antihypertensives, opioids, anticholinergic or dopaminergic drugs may result in accentuation of their effects, while potentiation of action may also occur with monoamine oxidase inhibitors, antidepressants and analgesics. Promazine may impair the effects of anticonvulsants. Promazine may affect the control of diabetes and possibly antagonises the hypoglycaemic effect of sulfonylureas. Undesirable anticholinergic effects can be enhanced by anti-parkinson or other anticholinergic drugs.
The concomitant administration of this product with myelosuppressive drugs (carbamazepine, co-trimoxazole, chloramphenicol, sulphonamides, pyralizone analgesics (e.g. azapropazone), penicillamine and cytotoxics) increases the risk of toxicity.
Lithium administration will result in an increased risk of extrapyramidal effects and the possibility of neurotoxicity.
Coadministration of phenothiazines with metoclopramide or tetrabenazine increases the risk of extrapyramidal effects.
An increase in plasma concentration of antipsychotic drugs may occur if taken with ritonavir.
There is an increased risk of convulsions when promazine is coadministered with tramadol
Antipsychotic drugs antagonize the pressor effects of sympathomimetics.
The effects of antipsychotic drugs may be enhanced by cimetidine and reduced by memantine.
Antacids and kaolin may reduce absorption of phenothiazines.
Caution should be used when using antipsychotics with reboxetine.
Sotalol administration will result in an increased risk of ventricular arrhythmia.
Concomitant use of promazine with drugs known to prolong the QT interval may increase the risk of ventricular arrhythmias, including torsade de pointes. Therefore concomitant use of these products is not recommended. Examples include certain antiarrhythmics, such as those of Class 1A (such as quinidine, disopyramide and procainamide) and Class III (such as amiodarone, sotalol and dofetilide), certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV), tricyclic antidepressants (such as amitriptyline), certain tetracyclic antidepressants (such as maprotiline), other neuroleptics (e.g. phenothiazines, pimozide, sertindole and haloperidol), certain antihistamines (such as terfenadine), cisapride, bretylium and certain antimalarials such as quinine and mefloquine. This list is not comprehensive.
Concurrent use of drugs causing electrolyte imbalance is not recommended. Diuretics, in particular those causing hypokalemia, should be avoided but, if necessary, potassium-sparing diuretics are preferred.
Do not use during pregnancy, especially during the first three months, unless there are compelling reasons. There is insufficient evidence of the safety of Promazine in human pregnancy nor is there evidence from animal studies that it is free from hazard.
Promazine should not be used during lactation.
Neonates exposed to antipsychotics (including Promazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Phenothiazines may impair alertness and induce drowsiness especially at the start of treatment. Alcohol and many other drugs (see section 4.5) may enhance these effects and impair the ability to drive.
Persons taking these drugs should not drive or operate machinery unless the drug has been shown not to interfere with physical or mental ability.
Promazine is a member of the phenothiazine group of drugs and the size effects associated with that group have been noted.
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. Withdrawal symptoms, including nausea, vomiting, sweating, insomnia, recurrence of psychotic symptoms and involuntary movement disorders have been noted (see Section 4.4).
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.
Pregnancy, puerperium and perinatal conditions:
Not known: Drug withdrawal syndrome neonatal (see 4.6).
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.
None known.
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