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codeine sulfate
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 patients w/ inadequate tx alternatives; proper dosing and titration essential to decr. resp. depression risk
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance 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 patients 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; avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol; reserve concomitant use of opioid analgesics w/ benzodiazepines or other CNS depressants for patients w/ inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
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
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients 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 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
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
Adult Dosing .
Dosage forms: TAB: 15 mg, 30 mg, 60 mg
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
- [15-60 mg PO q4-6h prn]
- Max: 360 mg/24h; Info: use lowest effective dose, shortest effective tx duration; doses >60 mg rarely more effective or well-tolerated in opioid-naive patients; consider low start dose, titrate slowly in patients 65 yo or older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
cough (off-label)
- [15-30 mg PO q4-6h prn]
- Max: 120 mg/day; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [see below]
- CrCl 10-50: decr. usual dose by 25%, titrate slowly; CrCl <10: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: decr. usual start dose or frequency, amount not defined; Info: titrate slowly
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.