HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)

Tillgänglig från:

Hospira, Inc.

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Fentanyl Citrate Injection is indicated for: Fentanyl Citrate Injection is contraindicated in patients with: Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, fentanyl administration to pregnant rats during organogenesis was embryocidal at doses within the range of the human recommended dosing. No evidence of malformations was noted in animal studies completed to date [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, resp

Produktsammanfattning:

Fentanyl Citrate Injection, USP, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is a preservative-free solution, supplied as follows: NDC 0409-1276-32 Carton of 10 2 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 100 mcg/2 mL (50 mcg/mL) Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included. Instructions for Use of the Syringe Systems Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02. Carpuject™ Single-dose cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02. PROTECT FROM LIGHT. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FENTANYL CITRATE- FENTANYL CITRATE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENTANYL CITRATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENTANYL CITRATE
INJECTION.
FENTANYL CITRATE INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE, CII
INITIAL U.S. APPROVAL: 1968
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE ​OF FENTANYL
​CITRATE
INJECTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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RECENT MAJOR CHANGES
Boxed Warning
7/2023​
Warnings and Precautions (5.1, 5.3, 5.7)
7/2023​
INDICATIONS AND USAGE
Fentanyl Citrate Injection is an opioid agonist indicated for: (1)
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DOSAGE AND ADMINISTRATION
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FENTANYL CITRATE INJECTION EXPOSES USERS TO RISKS OF OPIOID ADDICTION,
ABUSE, AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S
RISK PRIOR TO
PRESCRIBING AND REASSESS ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF
THESE
BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH USE
FENTANYL CITRATE INJECTION, ESPECIALLY DURING INITIATION OR FOLLOWING
A DOSAGE
INCREASE. TO REDUCE THE RISK OF RESPIRATORY DEPRESSION, PROPER DOSING
AND TITRATION
​OF ​FENTANYL CITRATE INJECTION ARE ESSENTIAL. (5.2)
CONCOMITANT USE OF FENTANYL CITRATE INJECTION WITH BENZODIAZEPINES
AND/OR OTHER
CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY
RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT
PRESCRIBING OF FENTANYL CITRATE INJECTION AND BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS
ARE
INADEQUATE. (5.3, 7)
THE CONCOMITANT USE OF FENTANYL CITRATE INJECTION WITH ALL CYTOCHROME
P450 3A4
INHIBITORS MAY ​​RESULT IN AN INCREASE IN FENTANYL PLASMA
CONCENTRATIONS, WHICH COULD
INCREASE OR PROLONG ADVERSE ​​REACTIONS AND MAY CAUSE POTENTIALLY
FATAL RESPIRATORY
DEPRESSION. IN AD