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Codeine
Aka: Codeine, Tylenol #3, Acetaminophen with Codeine, Tylenol with codeine
- Indications
- Analgesic (low efficacy and potential for adverse effects)
- Cough Suppressant (often abused, and other agents are preferred)
- Contraindications
- Breastfeeding women
- All children under age 12 years old
- Children ages 12 to 18 years old with additional risks
- Tonsillectomy or adenoidectomy
- Obesity
- Sleep Apnea
- References
- FDA Drug Safety Communication (4-20-2017)
- https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
- Preparations: Codeine 30 with Acetaminophen 300 tablets
- Dose: 1-2 tablets orally every 4-6 hours
- Avoid due to low efficacy and increased toxicity risk
- Preparations: Acetaminophen with Codeine Elixir (not recommended)
- Risk of Opioid induced respiratory depression and other Overdose adverse effects (especially in children)
- Deaths in children have occurred with codeine Analgesics following Tonsillectomy and adenoidectomy
- Resulted in FDA black box warning in 2013
- (2013) Presc Lett 20(4): 21
- FDA Drug Safety Communication
- http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm
- Components
- Acetaminophen (120 mg/5ml Elixir)
- Codeine (12 mg/5ml Elixir)
- Dosing
- Age 3 to 6 years: 5 ml/dose every 4 hours prn
- Age 7 to 12 years: 10 ml/dose every 4 hours prn
- Efficacy
- Acetaminophen is a safe and effective Analgesic
- Codeine is no more effective than standard NSAIDs
- Naprosyn is as effective in post-operative pain
- Ouellette (1986) Curr Ther Res 39(5):839 [PubMed]
- Busquets (1988) Curr Ther Res 43(2):311 [PubMed]
- Codeine offers no significant benefit to Tylenol
- Zhang (1996) J Clin Pharm Ther 21(4):261 [PubMed]
- Adding Codeine to Tylenol increases adverse effects
- Jochimsem (1978) J Am Geriatr Soc 26(11):521 [PubMed]
- Codeine 60 mg equivalent to Aspirin 650 mg
- Precautions
- Weak Analgesic, with abuse potential and risk of death in ultrarapid CYP2D6 metabolizers
- Other agents are preferred: NSAIDs, Acetaminophen, short acting Morphine, Hydrocodone, Oxycodone
- Non-responders to Codeine: 10% of patients
- Lack endogenous enzyme to convert to Morphine
- Risk of Opioid induced respiratory depression and other Overdose adverse effects (especially in children)
- Associated with CYP2D6 ultrarapid metabolization (fast metabolizers) found in 5-30% (depending on ethnicity)
- Deaths in children have occurred with codeine Analgesics following Tonsillectomy and adenoidectomy
- Deaths likely related to ultrarapid metabolizers with underlying airway disorders (e.g. Sleep Apnea)
- Resulted in FDA black box warning in 2013
- AAP recommends no use of Codeine products under age 18 years old
- FDA Drug Safety Communication
- http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm