FENTANYL- fentanyl patch, extended release 
DirectRX

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FENTANYL

WARNINGS AND PRECAUTIONS SECTION

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


DOSAGE FORMS & STRENGTHS SECTION

CONTRAINDICATIONS SECTION

WARNINGS AND PRECAUTIONS SECTION

ADVERSE REACTIONS SECTION

DRUG INTERACTIONS SECTION

USE IN SPECIFIC POPULATIONS SECTION

DRUG ABUSE AND DEPENDENCE SECTION

OVERDOSAGE SECTION

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION

NONCLINICAL TOXICOLOGY SECTION

CLINICAL STUDIES SECTION

Fentanyl transdermal system as therapy for pain due to cancer has been studied in 153 patients. In this patient population, fentanyl transdermal system has been administered in doses of 25 mcg/h to 600 mcg/h. Individual patients have used fentanyl transdermal system continuously for up to 866 days. At one month after initiation of fentanyl transdermal system therapy, patients generally reported lower pain intensity scores as compared to a prestudy analgesic regimen of oral morphine.

The duration of fentanyl transdermal system use varied in cancer patients; 56% of patients used fentanyl transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used fentanyl transdermal system for more than 1 year.

In the pediatric population, the safety of fentanyl transdermal system has been evaluated in 289 patients with chronic pain 2 to 18 years of age. The duration of fentanyl transdermal system use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16 to 30 days; 16% for 31 to 60 days; and 17% for at least 61 days. Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months.

SPL MEDGUIDE SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

603

FENTANYL 
fentanyl patch, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-603(NDC:60505-7007)
Route of AdministrationTRANSDERMALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FENTANYL (UNII: UF599785JZ) (FENTANYL - UNII:UF599785JZ) FENTANYL50 ug  in 1 h
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-603-0572 h in 1 PATCH; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07744901/01/2015
Labeler - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320repack(61919-603)

Revised: 1/2020
Document Id: 9c940e14-e190-1bba-e053-2a95a90a5599
Set id: 51ed4fe8-61fd-499d-abf3-d363f4c096e4
Version: 3
Effective Time: 20200120
 
DirectRX