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
advise pregnant pts w/ extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts avail. at delivery
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 opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, mild-moderate
- [tablet form]
- Dose: 300 mg/15 mg-900 mg/60 mg PO q4-6h prn; Start: 300 mg/30 mg-600 mg/60 mg PO q4h 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 total daily dose by no more than 10-25% q2-4wk to D/C if long-term use
- [solution form]
- Dose: individualize dose PO q4-6h prn; Start: 360 mg/36 mg PO q4h 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 total daily dose by no more than 10-25% q2-4wk 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.