FENTANYL CITRATE injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Phlow Corp.

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Fentanyl Citrate Injection is indicated for: - analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. - use as a narcotic analgesic supplement in general or regional anesthesia. - administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. - use as an anesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is contraindicated in patients with: - Hypersensitivity to fentanyl (e.g., anaphylaxis) [See Adverse Reactions (6)] Table 2 includes clinically significant drug interactions with Fentanyl Citrate Injection. Table 2: Clinically Significant Drug Interactions with Fentanyl Citrate Injection The concomitant use of Fentanyl Citrate Injecti

Povzetek izdelek:

Fentanyl Citrate Injection, equivalent to 50 mcg (0.05 mg) fentanyl base per mL, is a preservative-free solution, supplied as follows: NDC 81565-205-02          2 mL Single Dose vials packaged in 25s PROTECT FROM LIGHT. Keep covered in carton until time of use. Store at 20˚‑25˚C (68˚‑77˚F), excursions permitted to 15˚‑30˚C (59˚‑86˚F) [See USP Controlled Room Temperature]. Contains no preservative. DISCARD ANY UNUSED CONTENTS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

FENTANYL CITRATE- FENTANYL CITRATE INJECTION
PHLOW CORP.
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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: RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY
DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM
CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FENTANYL CITRATE INJECTION EXPOSES USERS TO RISKS OF ADDICTION, ABUSE,
AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND
MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY,
ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
CONCOMITANT USE WITH CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN
RESULT IN A FATAL OVERDOSE OF FENTANYL. (5.3, 7, 12.3)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION,
RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE CONCOMITANT PRESCRIBING FOR USE
IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE; LIMIT DOSAGES
AND DURATIONS
TO THE MINIMUM REQUIRED; AND FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF
RESPIRATORY
DEPRESSION AND SEDATION. (5.4, 7)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 09/2022
INDICATIONS AND USAGE
Fentanyl Citrate Injection is indicated for: (1)
analgesic action of short duration during the anesthetic periods,
premedication, induction and
maintenance, and in the immediate postoperative period (recovery room)
as the need arises.
use as an opioid analgesic supplement in general or regional
anesthesia.
administration with a neuroleptic as an anesthetic p