II. Indications
-
Opioid Analgesic
- Low efficacy and potential for significant adverse effects
-
Cough Suppressant (Antitussive)
- Often abused (other agents are preferred)
III. 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)
IV. 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
V. 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
- 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
VI. 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
- Adding Codeine to Tylenol increases adverse effects
- Codeine 60 mg equivalent to Aspirin 650 mg
VII. 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
VIII. Resources
- Codeine Tablet (DailyMed)
- Acetaminophen with Codeine (DailyMed)
Images: Related links to external sites (from Bing)
Related Studies
| codeine (on 2/23/2022 at Medicaid.Gov Survey of pharmacy drug pricing) | ||
| CODEINE SULFATE 15 MG TABLET | Generic | $0.69 each |
| CODEINE SULFATE 30 MG TABLET | Generic | $0.68 each |
| CODEINE-GUAIFEN 10-100 MG/5 ML | Generic OTC | $0.02 per ml |