Sufentanil Citrate Injection CII

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Sufentanil Citrate Injection

Anesthetics
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Generic Name and Formulations:

Sufentanil citrate 50mcg/mL; soln for IV or epidural inj.

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Indications for Sufentanil Citrate Injection:

For IV administration: as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated; as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. For epidural administration: as an analgesic combined with low dose bupivacaine during labor and vaginal delivery.

Adult:

Should be administered only by trained persons in IV and epidural anesthetics and management of respiratory effects in an adequate facility. Have an opioid antagonist and other resuscitative measures available. Individualize. Titrate to lowest effective dose. For IV use: Give by slow inj or infusion. Adjunct to general anesthesia: up to 8mcg/kg; see full labeling. Primary anesthetic for induction and maintenance of anesthesia: ≥8mcg/kg; see full labeling. For epidural use (labor & delivery): give by slow inj; 10–15mcg with 10mL bupivacaine 0.125% with or without epinephrine (sufentanil and bupivacaine should be mixed together before administration); may repeat twice (for a total of three doses) at not less than one-hour intervals until delivery. Elderly, debilitated: reduce dose. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children:

<12yrs: Induction and maintenance of anesthesia in cardiovascular surgery: 10–25mcg/kg with 100% oxygen; supplemental doses of up to 25–50mcg may be needed for maintenance (see full labeling). Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Warnings/Precautions:

Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor closely. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Shock; monitor for hypotension after initiation or dose titrations. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Monitor vital signs routinely. Epidural: confirm proper placement of needle/catheter; unintentional intravascular or intrathecal administration may cause potential risks (see full labeling). Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: IV inj or larger epidural doses not recommended. Nursing mothers: monitor infants.

Interactions:

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. Cardiovascular depression with nitrous oxide and high-dose fentanyl. High pancuronium doses during sufentanil-oxygen anesthesia may increase heart rate. Concomitant calcium channel blockers or β-blockers with other muscle relaxants: greater incidence of bradycardia and hypotension. May increase serum amylase.

Pharmacological Class:

Opioid agonist.

Adverse Reactions:

Apnea, skeletal muscle rigidity, bradycardia (may be severe); respiratory depression, severe hypotension, syncope.

Note:

Formerly known under the brand name Sufenta.

How Supplied:

Contact supplier.