FENTANYL CITRATE lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical Inc.

INN (International Name):

FENTANYL CITRATE

Composition:

FENTANYL 200 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FENTANYL CITRATE- FENTANYL CITRATE LOZENGE
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ORAL
TRANSMUCOSAL FENTANYL CITRATE
(OTFC) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OTFC.
ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) LOZENGE, CII
INITIAL U.S. APPROVAL: 1968
WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; RISKS
FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS;
ADDICTION,
ABUSE, AND MISUSE; REMS; AND NEONATAL OPIOID WITHDRAWAL SYNDROME
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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RECENT MAJOR CHANGES
12/2016
12/2016
INDICATIONS AND USAGE
Oral Transmucosal Fentanyl Citrate (OTFC) is an opioid agonist
indicated for the management of breakthrough pain in
cancer patients 16 years of age and older who are already receiving
and who are tolerant to around-the-clock opioid
Serious, life-threatening, and/or fatal respiratory depression has
occurred. Monitor closely, especially upon
initiation or following a dose increase. Due to the risk of fatal
respiratory depression, OTFC is contraindicated in
opioid non-tolerant patients (1) and in management of acute or
postoperative pain, including
headache/migraines. (5.1)
Accidental ingestion of OTFC, especially by children, can result in a
fatal overdose of fentanyl. Keep out of
reach of children. Ensure proper storage and disposal. (2.7, 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 min