DUROGESIC TRANSDERMAL SYSTEM 25 mcghr

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fentanyl

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

N02AB03

Dosage:

4.2 mg

Pharmaceutical form:

PATCH

Composition:

Fentanyl 4.2 mg

Administration route:

TRANSDERMAL

Prescription type:

Prescription Only

Manufactured by:

JANSSEN PHARMACEUTICA NV

Authorization status:

ACTIVE

Authorization date:

1995-07-29

Patient Information leaflet

NAME OF THE MEDICINAL PRODUCT 
TRADE NAME 
DUROGESIC
®

INTERNATIONAL NON PROPRIETARY NAME 
FENTANYL 

CHEMICAL NAME 
N-PHENYL-N-(1-(2-PHENYLETHYL)-4-PIPERDINYL) PROPANAMIDE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
DUROGESIC®  

Fentanyl Content 

Dosage 
Patch Size 
in Patch 

(mcg/h) 
(cm
2
) 
(mg) 
DUROGESIC®  
12 
5.25 
2.1 
DUROGESIC®  
25 
10.5 
4.2 
DUROGESIC®  
50 
21.0 
8.4 
DUROGESIC®  
75 
31.5 
12.6 
DUROGESIC®  
100 
42.0 
16.8 
The lowest dose is designated as 12 mcg/h (however, the actual dosage is 12.5 mcg/h) to distinguish it from a 125 
mcg/h dosage that could be prescribed by using multiple
patches. 
FOR EXCIPIENTS, SEE LIST OF EXCIPIENTS 

PHARMACEUTICAL FORM 
Transdermal patch providing continuous systemic delivery of fentanyl, a potent opioid 
analgesic, for 72 hours. 
              Matrix Formulation: 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
DUROGESIC
®
  is  indicated  in  the  management  of  chronic  pain  and  intractable  pain 
requiring  opioid  analgesia  that  requires  continuous  opioid  administration  for  an 
extended period of time in opioid-tolerant children age 2 years and
older and in adults. 
POSOLOGY AND METHOD OF ADMINISTRATION 
DUROGESIC
®
 doses should be individualized based upon the status of the patient and 
should  be  assessed  at  regular  intervals  after  application.  The  patches  are  designed  to 
deliver  approximately  12,  25,  50,  75,  and  100  mcg/h  fentanyl  to  the  systemic 
circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day (see Qualitative 
and Quantitative Composition), respectively. 

_Initial Dosage Selection _
The  appropriate  initiating  dose  of  DUROGESIC
®
  should  be  based  on  the  p

Summary of Product characteristics

1
PRODUCT NAME
DUROGESIC
®
(Fentanyl Transdermal System)
DOSAGE FORMS AND STRENGTHS
DUROGESIC
®
patches are for transdermal use only.
Transdermal patch providing continuous systemic delivery of fentanyl,
a potent opioid
analgesic, for 72 hours.
DUROGESIC
®
Dosage (mcg/h)
Patch Size
(cm
2
)
Fentanyl Content
in Patch (mg)
DUROGESIC
®
12
1
5.25
2.1
DUROGESIC
®
25
10.5
4.2
DUROGESIC
®
50
21.0
8.4
DUROGESIC
®
75
31.5
12.6
DUROGESIC
®
100
42.0
16.8
1
The lowest dose is designated as 12 mcg/h (however, the actual dosage
is 12.5 mcg/h) to
distinguish it from a 125 mcg/h dosage that could be prescribed by
using multiple patches.
Not all presentations may be available locally.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
DUROGESIC
®
is indicated in the management of chronic pain and intractable pain
requiring opioid analgesia that requires continuous opioid
administration for an
extended period of time in opioid-tolerant children age 2 years and
older and in adults.
DOSAGE AND ADMINISTRATION
DUROGESIC
®
doses should be individualized based upon the status of the patient
and
should be assessed at regular intervals after application. The lowest
effective dose
should be used. The patches are designed to deliver approximately 12,
25, 50, 75, and
100 mcg/hour fentanyl to the systemic circulation, which represent
about 0.3, 0.6, 1.2,
1.8, and 2.4 mg per day (see
_Dosage Forms and Strengths_
), respectively.
INITIAL DOSAGE SELECTION
The appropriate initiating dose of DUROGESIC
®
should be based on the patient’s
current opioid use. It is recommended that DUROGESIC
®
be used in patients who have
2
demonstrated opioid tolerance. Other factors to be considered are the
current general
condition and medical status of the patient, including body size, age,
and extent of
debilitation as well as degree of opioid tolerance.
DOSAGE – ADULTS
_ _
_OPIOID-TOLERANT PATIENTS_
To convert
opioid-tolerant patients from oral or parenteral opioids to DUROGESIC
®
,
refer to
_Equianalgesic potency convers