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Codeine

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.

Cardiovascular

Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics).

Gastrointestinal

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.

Genitourinary

Oliguria, urinary retention, antidiuretic effect has been reported (common to narcotic analgesics).

Allergic

Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema.

Other

Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness.

Promethazine

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.

Cardiovascular

Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic

Dermatitis, photosensitivity, urticaria.

Hematologic

Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal

Dry mouth, nausea, vomiting, jaundice.

Respiratory

Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal) (see WARNINGSPromethazine; Respiratory Depression).

Other

Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (see WARNINGSPromethazine; Neuroleptic Malignant Syndrome).

Paradoxical Reactions

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

Controlled Substance

Promethazine HCl and Codeine Phosphate Oral Solution is a Schedule V Controlled Substance.

Abuse

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.

Dependence

Psychological dependence, physical dependence, and tolerance are known to occur with codeine.