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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: ADDICTION, ABUSE, AND MISUSE
See full prescribing information for complete boxed warning.
Sufentanil Citrate Injection exposes users...
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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...
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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
Prolonged 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
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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 Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.