FENTANYL CITRATE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Akorn

INN (Διεθνής Όνομα):

FENTANYL CITRATE

Σύνθεση:

FENTANYL 50 ug in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 (6.2)] Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Fentanyl Citrate Injection in pregnant women are insufficient to inform a drug-associa

Περίληψη προϊόντος:

Fentanyl Citrate Injection, USP equivalent to 50 mcg fentanyl base per mL are available in single-dose glass containers as follows: Storage: Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light. AKORN Manufactured by: Akorn Lake Forest, IL 60045 AFCA0N Rev. 03/22

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

FENTANYL CITRATE- FENTANYL CITRATE INJECTION, SOLUTION
AKORN
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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: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; CYTOCHROME P450 3A4 INTERACTION; AND RISK 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)
INDICATIONS AND USAGE
Fentanyl Citrate Injection is an opioid agonist 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 premedication, for
the induction of anesthesia an