Sufentanil

What it is used for

Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:

• 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.

Sufentanil Citrate Injection is indicated for epidural administration:

• as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.

Side effects, and when to stop

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, Abuse, and Misuse
• Life-Threatening Respiratory Depression
• Skeletal Muscle Rigidity and Skeletal Muscle Movement
• Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions ( 5.5 )
• Severe Cardiovascular Depression
• Serotonin Syndrome
• Gastrointestinal Adverse Reactions
• Seizures

Who should not take it

Sufentanil Citrate Injection is contraindicated in patients with:

• Hypersensitivity to sufentanil (e.g., anaphylaxis)

Other medicines and interactions

Table 3 includes clinically significant drug interactions with Sufentanil Citrate Injection.

Storing it

Storage: Store at 20° to 25°C (68° to 77°F). Protect from light.

U.S. Patent No. 3,998,834 MAY 1995, SEPTEMBER 1995

AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045

SFA0N Rev. 10/19