Generic Medicine Info
May be taken with or without food.
Coma, compromised respiratory function, at risk for respiratory failure (e.g. COPD, sleep apnoea), lower respiratory tract symptoms, including asthma, bronchiectasis, bronchitis; CNS depression of any cause. Children <2 years; children with symptoms suggestive of Reye's syndrome or hepatic disease. SC and intra-arterial administration. Concurrent use with or within 14 days of stopping MAOI.
Special Precautions
Patient with bone marrow depression; cerebrovascular disease, CV disease (e.g. severe coronary artery disease), narrow-angle glaucoma, hypovolaemia, decreased gastrointestinal motility, xerostomia, visual problems, bladder neck obstruction, pyloroduodenal obstruction, stenosing peptic ulcer, prostatic hypertrophy, urinary retention, Reye's syndrome, myasthenia gravis, Parkinson's disease; epilepsy, history of seizures, head trauma, brain damage, alcoholism. Patient subjected to heat exposure, strenuous exercise, dehydration. Avoid extravasation (IV inj). Renal and hepatic impairment. Children ≥2 years. Pregnancy and lactation. Patient Counselling This drug may cause marked drowsiness, dizziness, disorientation, or confusion; if affected, do not drive or operate machinery. Avoid prolonged exposure to sunlight. Monitoring Parameters Monitor mental status and CNS effects; signs and symptoms of tissue injury with IV administration.
Adverse Reactions
Significant: Anticholinergic effects (e.g. blurred vision, xerostomia, constipation, urinary retention), CNS depression, extrapyramidal symptoms, including akathisia, tardive dyskinesia, pseudoparkinsonism and acute dystonic reactions; orthostatic hypotension, leucopenia and agranulocytosis, cholestatic jaundice, photosensitivity, impaired core body temperature regulation; lowered seizure threshold. Blood and lymphatic system disorders: Thrombocytopenia. Rarely, haemolytic anaemia. Cardiac disorders: Palpitation, bradycardia, tachycardia. Gastrointestinal disorders: Gastric irritation, nausea, vomiting. General disorders and administration site conditions: Tiredness; inj site reactions (e.g. burning sensation, pain, erythema, swelling, phlebitis). Hepatobiliary disorders: Rarely, jaundice. Immune system disorders: Rarely, anaphylaxis. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Muscle spasms, tic-like movements of head and face. Nervous system disorders: Dizziness, headache, restlessness, incoordination, paradoxical hyperexcitability (in children). Psychiatric disorders: Drowsiness, disorientation, confusion, nightmares, hallucination. Respiratory, thoracic and mediastinal disorders: Asthma, nasal congestion. Skin and subcutaneous tissue disorders: Urticaria, rash, pruritus, dermatitis. Vascular disorders: Hypotension.
Potentially Fatal: Arrhythmias, respiratory depression (in children), apnoea, neuroleptic malignant syndrome (NMS); severe tissue injury, including gangrene (inj).
Drug Interactions
May enhance the action of any anticholinergic agent, TCA, sedative or hypnotic. May increase and prolong the sedative effects of other CNS depressants such as barbiturates, general anaesthetics, narcotic analgesics, tranquilisers. May mask the warning signs of ototoxicity caused by salicylates. May cause lowered seizure threshold with narcotics and local anaesthetics. May reverse the vasopressor effects of epinephrine.
CIMS Class
Antiemetics / Antihistamines & Antiallergics / Antivertigo Drugs
ATC Classification
D04AA10 - promethazine ; Belongs to the class of topical antihistamines used in the treatment of pruritus.
R06AD02 - promethazine ; Belongs to the class of phenothiazine derivatives used as systemic antihistamines.
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