Fentanyl Citrate (Page 7 of 7)
12.3 Pharmacokinetics
Fentanyl Citrate Injection is administered by the intravenous or intramuscular route. The pharmacokinetics of fentanyl can be described as a three-compartment model.
Distribution
Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system. It accumulates in skeletal muscle and fat, and is released slowly into the blood. The volume of distribution for fentanyl is 4 L/kg. It has a distribution time of 1.7 minutes and redistribution time of 13 minutes.
Elimination
The terminal elimination half-life is 219 minutes.
Fentanyl, which is primarily transformed in the liver, demonstrates a high first pass clearance and releases approximately 75% of an intravenous dose in urine, mostly as metabolites with less than 10% representing the unchanged drug. Approximately 9% of the dose is recovered in the feces, primarily as metabolites.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Long-term studies in animals to evaluate the carcinogenic potential of fentanyl citrate injection have not been conducted.
Mutagenesis
Studies in animals to evaluate the mutagenic potential of fentanyl have not been conducted.
Impairment of Fertility
Decreased pregnancy rates occurred in a multigenerational study in which pregnant rats were treated subcutaneously during the first 21 days of pregnancy with 160 mcg/kg to 1250 mcg/kg fentanyl (0.26 times to 2 times a human dose of 100 mcg/kg based on body surface area).
Studies in animals to characterize the effect of fentanyl on male fertility have not been conducted.
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:
Unit of Sale | Total Strength/Total Volume (Concentration) |
---|---|
NDC 0409-1276-32 Carton of 102 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.]

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
LAB-0829-7.0
PRINCIPAL DISPLAY PANEL — 2 mL Cartridge Label
2 mL Single-use Carpuject™
Sterile Cartridge Unit with Luer Lock
NDC 0409-1276-03
Fentanyl Citrate Injection, USP
100 mcg Fentanyl / 2 mL
(50 mcg/mL)
CII
For Intravenous or Intramuscular Use
PROTECT FROM LIGHT.
Rx only
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Hospira
PAA144187
LOT #####AA EXP DMMMYYYY
PRINCIPAL DISPLAY PANEL — 2 mL Cartridge Carton
NDC 0409-1276-32
Contains 10 of NDC 0409-1276-03
Rx only
2 mL Single-dose
10 Carpuject™
Sterile Cartridge Units
with Luer Lock
Needle not included
SLIM-PAK™
Tamper Detection Package
Fentanyl
Citrate
Injection,
USP
100 mcg Fentanyl / 2 mL
(50 mcg/mL)
CII
For Intravenous or
Intramuscular Use
Carpuject Cartridges are to be used ONLY with Carpuject Holders.
Hospira
FENTANYL CITRATE fentanyl citrate injection, solution | |||||||||||||||||
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Labeler — Hospira, Inc. (141588017) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Hospira, Inc. | 030606222 | ANALYSIS (0409-1276), LABEL (0409-1276), MANUFACTURE (0409-1276), PACK (0409-1276) |
Revised: 09/2023 Hospira, Inc.
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