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sufentanil citrate injection, USP
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sufentanil citrate injection, USP Quick Finder
WARNING:SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION
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1 INDICATIONS AND USAGE
Sufentanil Citrate Injection is indicated for intravenous administration in adults and pediatric patients:
- •
- as an analgesic adjunct in the maintenance of balanced general...
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Sufentanil Citrate Injection should be administered only by persons specifically...
3 DOSAGE FORMS AND STRENGTHS
Sufentanil Citrate Injection, USP 50 mcg/mL (equivalent to 50 mcg/mL sufentanil base).
4 CONTRAINDICATIONS
Sufentanil Citrate Injection is contraindicated in patients with:
- •
- Hypersensitivity to sufentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2...
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance. As an opioid,...
7 DRUG INTERACTIONS
Table 3 includes clinically significant drug interactions with Sufentanil Citrate Injection.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Use of opioid...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance.
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Sufentanil Citrate Injection can be manifested by respiratory depression,...
11 DESCRIPTION
Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Sufentanil is an opioid agonist. When used in balanced general anesthesia, sufentanil has been reported to be as...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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14 CLINICAL STUDIES
Epidural Use in Labor and Delivery
Epidural sufentanil was tested in 340 patients in two (one single-center and one...
16 HOW SUPPLIED/STORAGE AND HANDLING
Sufentanil Citrate Injection, USP equivalent to 50 mcg/mL sufentanil is supplied in the following single-dose containers:
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