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acetaminophen/ caffeine/ dihydrocodeine
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
Schedule III 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 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 dihydrocodeine 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 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
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: CAP: 320.5 mg/30 mg/16 mg; TAB: 325 mg/30 mg/16 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, moderate-mod. severe
- [2 caps/tabs PO q4h prn]
- Max: 2 tabs/4h; 10 caps or tabs/24h, 5 doses/24h; 4 g/day acetaminophen from all sources; Info: use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo or older; taper dose by 25-50% q2-4 days to D/C if long-term use
renal dosing
- [adjust dose amount]
- renal impairment: decr. usual dose, amount not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.