Sufiject®

Therapeutic Area:

Generic Name:

Sufentanil

Dosage Form:

Ampoule

Drug Dose

Therapeutic Indications:

Epidural analgesia (injection): For epidural administration as an analgesic combined with low-dose bupivacaine during labor and vaginal delivery.

Surgical analgesia (injection): Analgesic adjunct for the maintenance of balanced general anesthesia in patients who are intubated and ventilated.

Mechanism of Action:

Binds to opioid receptors throughout the CNS. Once receptor binding occurs, effects are exerted by opening K+ channels and inhibiting Ca++ channels. These mechanisms increase pain threshold, alter pain perception, inhibit ascending pain pathways; short-acting opioid; dose-related inhibition of catecholamine release (up to 30 mcg/kg) controls sympathetic response to surgical stress.

Method of Administration:

Hypersensitivity (eg, anaphylaxis) to sufentanil or any component of the formulation.

Notes

Hypersensitivity (eg, anaphylaxis) to sufentanil or any component of the formulation.

Interactions:

CYP3A4 Inducers (Strong): May decrease the serum concentration of SUFentanil. Management: If a strong CYP3A4 inducer is initiated in a patient on sufentanil, consider a sufentanil dose increase and monitor for decreased sufentanil effects and opioid withdrawal symptoms. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of SUFentanil. Management: If a strong CYP3A4 inhibitor is initiated in a patient on sufentanil, consider a sufentanil dose reduction and monitor for increased sufentanil effects and toxicities (eg, respiratory depression). Risk D: Consider therapy modification

Pregnancy and Lactation:

Sufentanil crosses the placenta, Opioids used as part of obstetric analgesia/anesthesia during labor and delivery may temporarily affect the fetal heart rate.

Sufentanil is present in breast milk, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Warning and Precaution:

  • Adrenocortical insufficiency: Use with caution in patients with adrenal insufficiency, including Addison disease. Long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis.
  • Bradyarrhythmias: Severe bradycardia may occur; use with caution in patients with bradyarrhythmias.
  • CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
  • Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute myocardial infarction), or drugs that may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration. Use injection with caution in patients with circulatory shock. Avoid use of sublingual tablets in patients with circulatory shock.
  • Respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur with use of sufentanil. Monitor for respiratory depression, especially during initiation of sufentanil or dose escalation. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Patients and caregivers should be educated on how to recognize respiratory depression and the importance of getting emergency assistance immediately in the event of known or suspected overdose.

Adverse Reactions:

Central nervous system: Headache (12%)

 Dermatologic: Pruritus (epidural administration with bupivacaine: 25%)

 Gastrointestinal: Nausea (29%)

Storage:

Store below 30ºC and protect from freezing.