Promethazine should not be taken if there is:
- Coma or other types of profound CNS depression;
- concomitant use of MAO inhibitors and a period of 14 days after completion of their administration;
- closed angle glaucoma;
- alcohol intoxication, acute intoxication with sleeping pills, opioid analgesics;
- sleep apnea syndrome;
- episodic vomiting in children of unspecified genesis;
- lactation period;
- Children under 2 months of age (for parenteral administration);
- Children under 6 years of age (for oral administration);
- hypersensitivity to promethazine, other phenothiazine derivatives or any other component of the drug.
Caution should be exercised when prescribing the drug in acute and chronic respiratory diseases (because of suppression of the cough reflex), open-angle glaucoma, bone marrow suppression, cardiovascular diseases, liver and kidney function disorders, peptic ulcer with pyloroduodenal obstruction, bladder neck stenosis and/or prostatic hypertrophy, predisposition to urinary retention, epilepsy, Reye syndrome, and elderly patients. There are no clinical data on administration of Promethazine during pregnancy, therefore its use is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be stopped because of the risk of extrapyramidal disorders in the child. Caution should be exercised when prescribing the drug in elderly patients. Prometazine should be prescribed with caution in children because it makes it difficult to diagnose the underlying disease. Symptoms of undiagnosed encephalopathy and Reye syndrome may be mistaken for side effects of Promethazine.
CNS effects: sedation, drowsiness, nightmares, increased nighttime apnea, visual disturbances, anxiety, psychomotor agitation, dizziness, confusion, disorientation; after high doses, extrapyramidal disorders, increased seizure activity (in children).
Cardiovascular system: possible BP decrease, tachycardia, bradycardia.
Digestive system: nausea, vomiting, constipation, dry mouth, nose, throat, anesthesia of the oral mucosa, cholestasis are possible.
Blood system: rare – thrombocytopenia and/or leukopenia, agranulocytosis.
Dermatological reactions: skin rash and/or photosensitization are possible.
Sensory organs: tinnitus or ringing in the ears, accommodation paresis, visual impairment.
Allergic reactions: urticaria, dermatitis, photosensitization, bronchospasm.
Other: increased sweating, difficulty or painful urination.
Description of the drug “Prometazine” on this page is a simplified and amended version of the official instructions for use. Before purchasing and using the drug, you should consult a physician and read the manufacturer’s approved leaflet.