Central Nervous System
CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions.
Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).
Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported.
Oliguria, urinary retention, antidiuretic effect has been reported (common to narcotic analgesics).
Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.
Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.
Central Nervous System
Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.
Increased or decreased blood pressure, tachycardia, bradycardia, faintness.
Dermatitis, photosensitivity, urticaria.
Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Dry mouth, nausea, vomiting, jaundice.
Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal) (see WARNINGS – Promethazine; Respiratory Depression).
Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGS – Promethazine; Neuroleptic Malignant Syndrome).
Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium and agitated behavior have also been reported in some of these patients.
Drug Abuse And Dependence
Promethazine HCl and Codeine Phosphate Oral Solution is a Schedule V Controlled Substance.
Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence.
Psychological dependence, physical dependence, and tolerance are known to occur with codeine.