Fentanyl Transdermal System CII
Dosage Form: transdermal system
Compare to: Duragesic®
Product Insert: download PDF
Patient Insert: download PDF
Product Markings
Each Dose* |
System
Size |
Fentanyl
Content |
FENTANYL TRANSDERMAL SYSTEM
25 mcg/hr |
10 cm2 |
2.5 mg |
FENTANYL TRANSDERMAL SYSTEM
50** mcg/hr |
20 cm2 |
5 mg |
FENTANYL TRANSDERMAL SYSTEM
75** mcg/hr |
30 cm2 |
7.5 mg |
FENTANYL TRANSDERMAL SYSTEM
100** mcg/hr |
40 cm2 |
10 mg |
* Nominal delivery rate per hour
** FOR USE ONLY IN OPIOID TOLERANT PATIENTS |
Indication and Boxed Warning
Fentanyl transdermal system is indicated in the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by lesser means such as acetaminophen-opioid combinations, nonsteroidal analgesics, or PRN dosing with short-acting opioids.
BECAUSE SERIOUS OR LIFE-THREATENING HYPOVENTILATION COULD OCCUR, FENTANYL TRANSDERMAL SYSTEM IS CONTRAINDICATED:
- In the management of acute or post-operative pain, including use in out-patient surgeries
- In the management of mild or intermittent pain responsive to PRN or non-opioid therapy
- In doses exceeding 25 mcg/hr at the initiation of opioid therapy
(See CONTRAINDICATIONS for further information.)
SAFETY OF FENTANYL TRANSDERMAL SYSTEM HAS NOT BEEN ESTABLISHED IN CHILDREN UNDER 2 YEARS OF AGE. FENTANYL TRANSDERMAL SYSTEM SHOULD BE ADMINISTERED TO CHILDREN ONLY IF THEY ARE OPIOID-TOLERANT AND AGE 2 YEARS OR OLDER (see PRECAUTIONS--Pediatric Use).
Fentanyl transdermal system is indicated for treatment of chronic pain (such as that of malignancy) that:
- Cannot be managed by lesser means such as acetaminophen-opioid combinations, non-steroidal analgesics, or PRN dosing with short-acting opioids and
- Requires continuous opioid administration
The 50, 75, and 100 mcg/hr dosages should ONLY be used in patients who are already on and are tolerant to opioid therapy.
Duragesic® is a registered Trademark of Janssen Pharmaceutica Products, L.P.