Limitations on use
Jaundice, prostatic hypertrophy, predisposition to urinary retention, bladder neck stenosis, open or closed angle glaucoma, peptic ulcer with pyloroduodenal obstruction, lower respiratory tract diseases, suppression of bone marrow function, cardiovascular diseases (severe angina pectoris, arterial hypertension, decompensated chronic heart failure, atrial fibrillation), epilepsy, sleep apnea syndrome, Reye syndrome, pregnancy, lactation, older age.
Administration during pregnancy and lactation.
Contraindicated in pregnancy
Fetal category of action according to FDA – C. Breast-feeding should be stopped for the duration of treatment.
Side effects of the substance Prometazine
- Nervous system and sense organs: sedation, dizziness, drowsiness, restlessness, agitation, nightmares, increased nighttime apnea; rarely – disorientation, confusion, extrapyramidal disorders, increased seizure activity (in children); accommodation and vision disorders, tinnitus or ringing in the ears.
- Cardiovascular system and blood (hematopoiesis, hemostasis): orthostatic hypotension (in intravenous administration), hypertension, tachycardia or bradycardia; rarely – leukopenia, thrombocytopenia, agranulocytosis.
- Gastrointestinal system: anesthesia and dry mouth, nausea, vomiting, cholestasis, constipation.
- Respiratory system: dryness in the nose, pharynx.
- Urinary system: rarely – difficult or painful urination.
- Allergic reactions: urticaria, dermatitis, asthma.
- Others: increased sweating, photosensitization, pain (when administered intravenously).
It intensifies the effects of analgesics, hypnotics, tranquilizers, neuroleptics, anesthetics, local anesthetics, m-cholinoblockers, hypotensive agents (dose adjustment is required). Weakens the effect of amphetamine derivatives, m-cholinomimetics, anticholinesterase drugs, ephedrine, guanethidine, levodopa, dopamine. Barbiturates accelerate elimination and decrease activity. Beta-adrenoblockers increase (mutually) plasma concentrations (acute hypotension, arrhythmias, irreversible retinopathy, tardive dyskinesia are possible). It weakens the effect of bromocriptine and increases the serum concentration of prolactin. Tricyclic antidepressants and anticholinergic agents potentiate m-cholinoblocking activity, ethyl alcohol, clopheline, antiepileptic agents – CNS depression. MAO inhibitors (concomitant administration is not recommended) and phenothiazine derivatives increase the risk of hypotension and extrapyramidal disorders. Quinidine increases the possibility of cardiodepressive action.
Symptoms: facial hyperemia, dyspnea, dry mucous membranes, mydriasis, restlessness, motor hyperactivity, agitation, delirium (in children), extrapyramidal disorders, tremor, epileptiform seizures (rare), hypotension, respiratory depression, loss of consciousness.
Treatment: induction of vomiting, gastric lavage, administration of activated charcoal, saline laxatives (if oral), IV fluid administration; monitoring and maintenance of vital functions; symptomatic therapy: vasoconstrictors (for hypotension), oxygen (to maintain adequate oxygenation).
It is not recommended to use analeptics (may cause seizures) and epinephrine (may increase hypotension). If extrapyramidal reactions develop, anticholinergic agents used to treat parkinsonism, diphenhydramine or barbiturates are used. Dialysis is ineffective.