Promazine Hydrochloride Rosemont warnings
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, coronary insufficiency or cardiac disease.
3. Respiratory depression may occur in patients with severe respiratory disease.
4. Promazine Hydrochloride Rosemont 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 Hydrochloride Rosemont, 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. Neuroleptic therapy should be withdrawn if dyskinesia develops.
8. Care should be exercised if Promazine Hydrochloride Rosemont 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 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 Hydrochloride Rosemont 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 Hydrochloride Rosemont may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, Promazine Hydrochloride Rosemont should be used with caution in susceptible individuals (with hypoklaemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Concomitant treatment with other antipsychotics should be avoided.
19. Concomitant use of Promazine Hydrochloride Rosemont with other neuroleptics should be avoided.
20. 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 Hydrochloride Rosemont 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 Hydrochloride Rosemont is not licensed for the treatment of dementia-related behavioural disturbances.
Excipients in the Formulation
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 Hydrochloride Rosemont Syrup contains liquid glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.
Promazine Hydrochloride Rosemont Syrup contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
What should I discuss with my healthcare provider before taking Promazine Hydrochloride Rosemont?
All products:
- If you are allergic to Promazine Hydrochloride Rosemont; any part of Promazine Hydrochloride Rosemont; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you are very sleepy.
- If you have recently drunk a lot of alcohol or taken a big amount of drugs that may slow your actions like phenobarbital or some pain drugs like oxycodone.
- If you have an adrenal gland tumor called pheochromocytoma.
- If you are taking or will be taking another drug like this one.
- If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
- If you are pregnant or may be pregnant. Do not use Promazine Hydrochloride Rosemont in the first 3 months of pregnancy.
- If you are breast-feeding. Do not breast-feed while you take Promazine Hydrochloride Rosemont.
- If the patient is a child. This medicine is not approved for use in children.
Liquid (syrup):
- If you have bone marrow disease.
- If you have rare hereditary health problems like glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase deficiency.
This is not a list of all drugs or health problems that interact with Promazine Hydrochloride Rosemont.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Promazine Hydrochloride Rosemont with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Promazine Hydrochloride Rosemont precautions
Hepatic and renal impairment, CV disease, Parkinson's disease, epilepsy, depression, myasthenia gravis, paralytic ileus, prostatic hypertrophy, severe resp disease, blood dyscrasias and history of jaundice. Elderly. Photosensitization may occur in higher doses. May impair ability to drive and operate machines. Regular eye examinations are recommended for patients on long term treatment. Pregnancy, lactation.
References
- DrugBank. "promazine". http://www.drugbank.ca/drugs/DB00420 (accessed September 17, 2018).
- MeSH. "Dopamine Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
