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Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Codeine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g.,non-opioid analgesics or opioid combination products]:
• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Use in Pregnancy and Lactation
Codeine has been prescribed and used over the counter during pregnancy as
it is considered a safer option to other opiates. It is also is prescribed for obstetric purposes.
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The most frequently observed adverse reactions with codeine administration include;
Shortness of breath
Sweating and constipation.
Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain, and pruritis.
DOSAGE AND ADMINISTRATION
• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient
response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse
• Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy
and following dosage increases with Codeine Sulfate Oral Solution and adjust the dosage accordingly.
WARNINGS AND PRECAUTIONS
Risk of Accidental Overdose and Death due to Medication Errors
Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg
and mL when prescribing, dispensing, and administering Codeine Sulfate Oral Solution. Ensure that the dose is
communicated clearly and dispensed accurately. Always use the enclosed calibrated oral syringe or measuring cup when
administering Codeine Sulfate Oral Solution to ensure the dose is measured and administered accurately.
Addiction, Abuse, and Misuse
Codeine Sulfate Oral Solution contains codeine, a Schedule II controlled substance. As an opioid, Codeine Sulfate Oral
Solution exposes users to the risks of addiction, abuse, and misuse.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Codeine
Sulfate Oral Solution. Addiction can occur at recommended dosages and if the drug is misused or abused.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as
recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and
death. Management of respiratory depression may include close observation, supportive measures, and use of opioid
antagonists, depending on the patient’s clinical status [see Overdosage. Carbon dioxide (CO2) retention from opioidinduced respiratory depression can exacerbate the sedating effects of opioids.
Acute overdose with Codeine Sulfate Oral Solution can be manifested by respiratory depression, somnolence progressing
to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary
edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis
rather than miosis may be seen with hypoxia in overdose situations.
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or
controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the
management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced