Select a medication above to begin.
acetaminophen/ codeine
generic
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate assoc. risks; reserve opioid analgesics for pts w/ inadequate tx alternatives; proper dosing and titration essential to decr. resp. depression risk
Medication Error Risk
ensure accuracy when prescribing, dispensing, and administering acetaminophen/codeine oral solution; dosing errors due to confusion between mg and mL, and other codeine-containing oral products of different concentrations can result in accidental overdose and death
Addiction, Abuse, and Misuse
Schedule III (tablet) or Schedule V (oral solution) controlled substance combination containing an opioid agonist w/ risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all pts for misuse, abuse, and addiction
Respiratory Depression
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
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; reserve concomitant use for pts w/ inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
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
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel pts and/or caregivers w/ each Rx on serious risks, safe use, and importance of reading medication guide
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
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
Hepatotoxicity
acetaminophen assoc. w/ acute liver failure incl. cases of liver transplant and death; most liver injury assoc. w/ acetaminophen doses >4000 mg per day and >1 acetaminophen-containing product
Adult Dosing .
Dosage forms: TAB: 300 mg/15 mg, 300 mg/30 mg, 300 mg/60 mg; SOL: 120 mg/12 mg per 5 mL
Special Note
- [prescribing info]
- Info: consider prescribing naloxone if risk of opioid overdose or accidental ingestion
pain, mild-moderate
- [15-60 mg codeine PO q4-6h prn]
- Max: 360 mg/day codeine; 4 g/day acetaminophen from all sources; Info: use lowest effective dose, shortest effective tx duration; codeine doses >60 mg rarely more effective or well-tolerated in opioid-naive pts; consider low start dose, titrate slowly in pts 65 yo or older; taper dose by 25-50% q2-4 days to D/C if long-term use
cough (off-label)
- [12-30 mg codeine PO q4-6h prn]
- Max: 120 mg/day codeine; 4 g/day acetaminophen from all sources; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to D/C if long-term use
renal dosing
- [see below]
- CrCl 10-50: consider decr. usual dose and/or frequency; CrCl <10: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: consider decr. usual dose
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.