What is the amount of codeine in over-the-counter (OTC) medications?

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From the FDA Drug Label

Drug Facts Active Ingredients Purpose (in each teaspoonful (5 mL)) Codeine Phosphate USP 10 mg ................... Antitussive

  • The amount of codeine in one teaspoonful (5 mL) is 10 mg.
  • For adults and children 12 years of age and over, the dose is 2 tsp (10 mL) every 4 hours, which contains 20 mg of codeine.
  • For children 6 to under 12 years of age, the dose is 1 tsp (5 mL) every 4 hours, which contains 10 mg of codeine 1.

From the Research

Codeine is not available over-the-counter in many countries, including the United States, due to its potential for abuse and dependence, and when available, it typically contains 8-15 mg of codeine per dose, often combined with other medications like acetaminophen or ibuprofen. In countries where low-dose codeine products are available without prescription, these combination products usually limit codeine to help prevent misuse while providing pain relief 2. Codeine works by binding to opioid receptors in the brain and is converted by the liver into morphine, which produces its pain-relieving effects, however, this conversion varies significantly between individuals based on genetics, making dosing unpredictable 3. Some studies have shown that acetaminophen plus codeine is effective in pain control, at least in certain patient populations, such as polytrauma patients, and may represent a valid alternative to NSAIDs, especially in patients with a documented haemorrhage or with a high hemorrhagic risk 4. However, due to safety concerns, especially for children, respiratory depression risks, and addiction potential, many health authorities have restricted codeine access, requiring a prescription for any codeine-containing product regardless of dosage 5. Key points to consider when prescribing codeine include:

  • The potential for abuse and dependence
  • The risk of respiratory depression, especially in children
  • The potential for addiction
  • The need for careful dosing and monitoring, especially in patients with a history of substance abuse or respiratory problems
  • The availability of alternative pain relief options, such as NSAIDs or other opioids, which may be safer and more effective in certain patient populations. It's also important to note that the use of codeine in combination with other medications, such as acetaminophen, may help to limit the potential for misuse and provide effective pain relief, while minimizing the risk of adverse effects 6. Overall, the use of codeine should be carefully considered and monitored, taking into account the individual patient's needs and risk factors, as well as the potential benefits and risks of treatment.

References

Research

Purchasing Over The Counter (OTC) Medicinal Products Containing Codeine - Easy Access, Advertising, Misuse and Perceptions of Medicinal Risk.

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques, 2018

Research

Acetaminophen plus codeine compared to ketorolac in polytrauma patients.

European review for medical and pharmacological sciences, 2010

Research

Combination analgesics.

The American journal of medicine, 1984

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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