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sufentanil citrate injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
sufentanil citrate injection, USP Quick Finder
Highlights
Boxed Warning
WARNING:SERIOUS AND LIFE-THREATENING RISKS FROM USE OF SUFENTANIL CITRATE INJECTION
...
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Indications and Usage
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Sufentanil Citrate Injection should be administered only by persons specifically...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Sufentanil Citrate Injection, USP 50 mcg/mL (equivalent to 50 mcg/mL sufentanil base).
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Contraindications
4 CONTRAINDICATIONS
Sufentanil Citrate Injection is contraindicated in patients with:
- •
- Hypersensitivity to sufentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance. As an opioid,...
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Drug Interactions
7 DRUG INTERACTIONS
Table 3 includes clinically significant drug interactions with Sufentanil Citrate Injection.
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Use of opioid...
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Drug Abuse and Dependence
...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Sufentanil Citrate Injection contains sufentanil, a Schedule II controlled substance.
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Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Sufentanil Citrate Injection can be manifested by respiratory depression,...
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Description
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...
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Clinical Pharmacology
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...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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Clinical Studies
14 CLINICAL STUDIES
Epidural Use in Labor and Delivery
Epidural sufentanil was tested in 340 patients in two (one single-center and one...
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How Supplied/Storage and Handling
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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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.