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SUFENTANIL CITRATE is a brand name for Sufentanil, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS........................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Patients who are hypersensitive to the active substance sufentanil or other opioid analgesics or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
, ileus of any type). , acute appendicitis or pancreatitis). Patients with mild pain that can be managed with other pain medications. Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus.
Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale. Patients with acute alcoholism, delirium tremens, and convulsive disorders. Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). Intravenous use in labour or before clamping of the cord during cesarean section is not recommended due to the possibility of respiratory depression in the newborn infant.
This is in contrast to the epidural use in labour, during which sufentanil in doses up to 30 mcg does not influence the condition of the mother or the newborn. As with other opiates administered epidurally, sufentanil should not be given to patients exhibiting the following: severe hemorrhage or shock; septicemia; local infection at the site of proposed puncture; disturbances in blood morphology and/or anticoagulant therapy or other concomitant drug therapy or medical conditions which could contraindicate the technique of epidural administration.
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Sufentanil Citrate Injection Page 5 of 42 Addiction, Abuse, and Misuse Sufentanil Citrate Injection poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient’s risk should be assessed prior to prescribing Sufentanil Citrate Injection, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). Sufentanil Citrate Injection should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of Sufentanil Citrate Injection. Infants exposed in-utero or through breast milk are at risk of life- threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of Sufentanil Citrate Injection or following a dose increase. Further, instruct patients of the hazards related to taking opioids including fatal overdose.
Accidental Exposure Accidental ingestion of even one dose of Sufentanil Citrate Injection, especially by children, can result in a fatal overdose of sufentanil (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of Sufentanil Citrate Injection during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS). Interaction with Alcohol The co-ingestion of alcohol with Sufentanil Citrate Injection should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
• Reserve concomitant prescribing of Sufentanil Citrate Injection 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. General Patients should be instructed not to give Sufentanil Citrate Injection (sufentanil) to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
Sufentanil Citrate Injection should Sufentanil Citrate Injection Page 6 of 42 be stored securely to avoid theft or misuse. Sufentanil Citrate Injection should only be prescribed by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Complete resuscitation equipment and opioid antagonist should be readily available whenever sufentanil is used. Vital signs should be monitored continuously in all patients receiving sufentanil. Patients should be cautioned not to consume alcohol while taking Sufentanil Citrate Injection as it may increase the chance of experiencing serious adverse events, including death.
Hyperalgesia that will not respond to a further dose increase of Sufentanil Citrate Injection can occur at particularly high doses. A sufentanil dose reduction or change in opioid may be required. […]