HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
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.
fentanyl citrate injection, USP CARPUJECT
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.
fentanyl citrate injection, USP CARPUJECT Quick Finder
Highlights
Boxed Warning
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF FENTANYL CITRATE INJECTION
Addiction, Abuse, and Misuse...
Did you find an answer to your question?
Yes
No
Indications and Usage
1 INDICATIONS AND USAGE
Fentanyl Citrate Injection is indicated for:
- •
- analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Fentanyl Citrate Injection should be administered only by persons specifically...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Fentanyl Citrate Injection, USP 50 mcg/mL (equivalent to 50 mcg/mL fentanyl base) is available as:
2 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™...
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
Fentanyl Citrate Injection is contraindicated in patients with:
- •
- Hypersensitivity to fentanyl (e.g., anaphylaxis) [see Adverse Reactions (6)]...
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse, and Misuse
Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance. As an opioid, Fentanyl...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection.
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Use of opioid...
Did you find an answer to your question?
Yes
No
Drug Abuse and Dependence
...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Fentanyl Citrate Injection contains fentanyl, a Schedule II controlled substance.
Did you find an answer to your question?
Yes
No
Overdosage
10 OVERDOSAGE
Clinical Presentation
Acute overdose with Fentanyl Citrate Injection can be manifested by respiratory depression,...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
Fentanyl Citrate Injection is a Schedule II controlled drug substance and is an opioid agonist. Fentanyl Citrate Injection, USP is a sterile, clear, colorless, non-pyrogenic, preservative free aqueous solution...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Fentanyl Citrate Injection is an opioid agonist, whose principal actions of therapeutic value are analgesia and...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Fentanyl Citrate Injection, USP, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is a preservative-free solution, supplied as follows:
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
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.