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 pts 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 pts 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 pts

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 pts 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 pts post-tonsillectomy and/or adenoidectomy and who were CYP2D6 ultra-rapid metabolizers; contraindicated in pts <12 yo and in pts <18 yo post-tonsillectomy and/or adenoidectomy; avoid use in pts 12-18 yo w/ risk factors that incr. sensitivity to resp. depressant effects of codeine

Neonatal Opioid Withdrawal Syndrome

use not recommended in pregnant pts; extended use in pregnant pts can lead to potentially life-threatening neonatal opioid withdrawal syndrome; advise pregnant pts of risks and ensure tx by neonatology experts avail. at delivery if extended opioid use required

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 pts <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