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Applies to codeine: oral solution, oral tablet
Oral route (Tablet)
Codeine sulfate exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing codeine sulfate, and monitor all patients regularly for the development of these behaviors or conditions.
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.
Serious, life-threatening, or fatal respiratory depression may occur with use of codeine sulfate. Monitor for respiratory depression, especially during initiation of codeine sulfate or following a dose increase.
Accidental ingestion of even one dose of codeine sulfate, especially by children, can result in a fatal overdose of codeine.
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Codeine sulfate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine sulfate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine
Prolonged use of codeine sulfate during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine sulfate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of codeine sulfate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking codeine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking codeine:
Symptoms of overdose
Some side effects of codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to codeine: compounding powder, injectable solution, oral solution, oral tablet
The most frequently observed adverse reactions include drowsiness lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Uncommon (0.1% to 1%): Bronchospasm, laryngospasm, respiratory depression
Frequency not reported: Respiratory arrest, dyspnea
Postmarketing reports: Deaths due to respiratory depression
Respiratory depression resulting in death has been reported in children who received codeine postoperatively following tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine. Death has also been reported in nursing infants exposed to high levels of morphine in breast milk due to their breastfeeding mother being an ultra-rapid metabolizer of codeine.
Uncommon (0.1% to 1%): Heartbeat irregularities, blood pressure changes, syncope
Frequency not reported: Flushing, hypotension, palpitations, circulatory depression, shock, cardiac arrest, circulatory depression, bradycardia, tachycardia, edema
Common (1% to 10%): Drowsiness, dizziness
Uncommon (0.1% to 1%): Headache, lightheadedness, feeling faint, paradoxical CNS stimulation (especially in children), disorientation, restlessness, shakiness, somnolence, weakness
Frequency not reported: Seizures
Frequency not reported: Fatigue, vertigo, malaise, hypothermia, fever, addiction, tolerance, dependence, withdrawal reactions upon discontinuation of chronically administered drug included diarrhea, sweating, vomiting, insomnia, agitation, tremor, body aches, gooseflesh, loss of appetite, nervousness or restlessness, runny nose, sneezing, shivering, stomach cramps, nausea, sleep disturbances, yawning, weakness, tachycardia, fever, irritability, mydriasis
Uncommon (0.1% to 1%): Itching, facial swelling, pruritus, urticaria, histamine release (hypotension, sweating, flushing of the face, tachycardia, breathlessness)
Frequency not reported: Allergic reactions including maculopapular rash
Common (1% to 10%): Constipation
Uncommon (0.1% to 1%): Dry mouth, loss of appetite, nausea, vomiting, paralytic ileus, toxic megacolon, anorexia, stomach cramps
Frequency not reported: Gastrointestinal distress, anorexia, diarrhea, pancreatitis
Frequency not reported: Biliary spasm
Uncommon (0.1% to 1%): Urinary retention or hesitance, ureteric spasm, reduced libido and/or potency
Uncommon (0.1% to 1%): Rash
Frequency not reported: Sweating, urticaria, pruritus
Uncommon (0.1% to 1%): Miosis, blurred or double vision
Frequency not reported: Visual disturbances
Uncommon (0.1% to 1%): Antidiuretic effect
Frequency not reported: Decreased libido or potency, erectile dysfunction, sexual dysfunction
Uncommon (0.1% to 1%): Euphoria, dysphoria, unusual dreams, hallucinations, insomnia, anxiety
Frequency not reported: Mood changes, restlessness, confusion, mental depression
Frequency not reported: Hyperglycemia, anorexia
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
June 26, 2020