promethazine/ codeine

Addiction, Abuse, and Misuse

Schedule V controlled substance combination containing an opioid agonist w/ risk of addiction, abuse, and misuse, which can lead to overdose and death; reserve for use in adult patients w/ adequate assessment of cough etiology for whom benefits of cough suppression outweigh risks; assess opioid abuse or addiction risk prior to prescribing; prescribe for shortest duration consistent w/ tx goals and only refill after reevaluation of need for continued tx; regularly reassess all patients for misuse, abuse, and addiction

Respiratory Depression

serious, life-threatening, or fatal cases may occur; monitor for resp. depression, esp. during tx initiation or in high risk patients

Accidental Ingestion

accidental ingestion of even one dose, esp. by children, can result in fatal codeine overdose

Risks from Concomitant Use w/ Benzodiazepines, CNS Depressants

concomitant opioid use w/ benzodiazepines or other CNS depressants, incl. alcohol, may result in profound sedation, resp. depression, coma, and death; avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

Ultra-Rapid Metabolism of Codeine and Other Respiratory Depression Risk in Children

resp. depression and death have occurred in children; most cases occurred in patients post-tonsillectomy and/or adenoidectomy and who were CYP2D6 ultra-rapid metabolizers; contraindicated in patients <12 yo and in patients <18 yo post-tonsillectomy and/or adenoidectomy; avoid use in patients 12-18 yo w/ risk factors that incr. sensitivity to resp. depressant effects of codeine

Neonatal Opioid Withdrawal Syndrome

use not recommended in pregnant patients; advise pregnant patients w/ extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts avail. at delivery

Promethazine and Respiratory Depression in Children

serious, life-threatening, or fatal cases may occur even w/ recommended use, esp. during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; children are particularly sensitive to additive resp. depressant effects when promethazine combined w/ other resp. depressants incl. codeine; contraindicated in patients <12 yo

Medication Error Risk

ensure accuracy when prescribing, dispensing, and administering; dosing errors can result in accidental overdose and death; always use accurate mL measuring device when measuring and administering

CYP450 Interactions

concomitant use or D/C of concomitant CYP450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors are complex requiring careful consideration of the effects on codeine and its active metabolite, morphine; avoid concomitant use w/ CYP3A4 inducers, CYP3A4 inhibitors, or CYP2D6 inhibitors