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Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems - For Health Professionals
- Starting date:
- January 2, 2009
- Posting date:
- January 7, 2009
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Novopharm Limited, Ranbaxy Pharmaceuticals Canada Inc. and ratiopharm Inc.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Fentanyl Transdermal Systems
January 2, 2009
Dear Health Care Professional,
Subject: Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems
The manufacturers of Fentanyl Transdermal Systems (FTS), in collaboration with Health Canada wish to provide you with important information regarding changes to the Dose Conversion Guidelines (Table 1.1) and to the analgesic equivalency table: Opioid Analgesics: Parenteral/Oral/Rectal Equianalgesic Potency Conversion (Table 1.2) in the Dosage and Administration section of the Canadian Product Monographs for FTS. The Dose Conversion Guidelines are to be used to convert adult patients from their current oral or parenteral opioid therapy to the fentanyl transdermal patch. The analgesic equivalency table Opioid Analgesics: Parenteral/Oral/Rectal Equianalgesic Potency Conversion, may be used for adult patients taking opioids or doses not listed in Table 1.1, using the conversion methodology outlined for Table 1.1 with Table 1.2.
The revised Dose Conversion Guidelines and Opioid Analgesics: Parenteral/Oral/Rectal Equianalgesic Potency Conversion Table are attached for your reference and should be retained for future consultation. Changes have been highlighted for ease of reference.
Serious or life-threatening hypoventilation can result if appropriate conversions are not used.
Based on clinical experience in patients with chronic pain:
- The conversion from IM/IV morphine to the fentanyl transdermal patch has been revised to reflect a conversion ratio of 1:2 and 1:3 of parenteral morphine to oral morphine.
- The conversion from IV hydromorphone to the fentanyl transdermal patch has been revised to reflect a conversion ratio of 1:2 of parenteral hydromorphone to oral hydromorphone.
The use of fentanyl transdermal systems in opioid-naïve patients and in patients with acute or postoperative pain is contraindicated.
In addition, the analgesic equivalency table 1.2 has been revised to remove the data equating 10 mg parenteral morphine to 60 mg oral morphine derived from single or intermittent dosing studies. Data referring to IM/IV oxycodone and to IM meperidine have been removed from both Tables 1.1 and 1.2 as the former drug is not marketed in Canada as an Injectable, and the latter drug causes CNS toxicity if used by the parenteral route chronically.
Manufacturers of all fentanyl transdermal patches are working with Health Canada to include this safety information in the Dosage and Administration section in all Canadian Product Monographs for Fentanyl Transdermal Systems:
Duragesic® (fentanyl transdermal system)
RAN-fentanyl transdermal system
ratio-FENTANYL Transdermal System
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any serious or unexpected adverse reactions in patients receiving fentanyl transdermal systems should be reported to the manufacturers or Health Canada at the following addresses:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario L5N 2B8
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
Please contact the appropriate manufacturer with any questions or concerns.
Cobalt Pharmaceuticals Inc.
Ranbaxy Pharmaceuticals Canada Inc.
Johnson BL, Gross J. Chapter 8, Pharmacological Treatment of Cancer Pain in Handbook of Oncology Nursing, Jones & Bartlett Publishers, 1998. p.313-327
Ripamont, C, Pharmacology of Opioid Analgesia: Clinical Principles in Cancer Pain: Assessment and Management, edited by Bruera E and Portenoy RK. Cambridge University Press, 2003. p.124
Dosage conversion guidelines for fentanyl transdermal systems
|Current Analgesic||Daily Dosage (mg/d)|
|IM/IV morphineTable 1.1 footnote 2||30-66||67-90||91-111||112-134||135-157||158-179||180-202|
|IV hydromorphoneTable 1.1 footnote 3||4.0-8.4||8.5-11.4||11.5-14.4||14.5-16.5||16.6-19.5||19.6-22.5||22.6-25.5|
|Recommended Fentanyl Transdermal System (FTS) Dose||
Table 1.1 footnotes
- Table 1.1 footnote #
12 mcg/h dose is not included in this table because it generally should not be used as the initiating dose, except in the case of patients for whom clinical judgment deems it appropriate to start DURAGESIC and other FTS at less than 25 mcg/h; DURAGESIC and other FTS at any dose is contraindicated in opioid-naive patients (see CONTRAINDICATIONS).
- Table 1.1 footnote 1
Table 1.1 should not be used to convert from DURAGESIC and other FTS to other therapies because this conversion to DURAGESIC and other FTS is conservative. Use of Table 1.1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible (see DOSAGE AND ADMINISTRATION, Safe Use of Tables 1.1, 1.2, and 1.3).
- Table 1.1 footnote 2
Based on clinical experience in patients with chronic pain, the conversion ratio of 10 mg parenteral morphine is equal to approximately 20 – 30 mg oral morphine. In the table above, calculation is based on a 1:2 parenteral to oral dose ratio. For some patients, a 1:3 parenteral to oral dose ratio (10 mg parenteral morphine = 30 mg oral morphine) may be more appropriate.
IM/IV morphine (mg/d) at
1:3 parenteral to oral dose ratio
20-44 45-60 61-75 76-90 91-104 105 -119 120-134 Recommended FTS Dose 25
- Table 1.1 footnote 3
The conversion ratio of parenteral hydromorphone to oral hydromorphone of 1:2 is based on clinical experience in patients with chronic pain. Reference: Parenteral Drug Therapy Manual, Vancouver General Hospital, Pharmaceutical Sciences Clinical Services.
Opioid analgesics: parenteral/oral/rectal equianalgesic potency conversion
Equivalent Dose (mg)Table 1.2 footnote 2
(compared to morphine 10 mg IM)
|Duration of Action (hours)|
|Strong Opioid Agonists:|
|Morphine (repeated dosing)||10||20-30 Table 1.2 footnote 3||3-4|
|MethadoneTable 1.2 footnote 4||---||---||---|
|Weak Opioid Agonists:|
Table 1.2 footnotes
- Table 1.2 footnote 1
Foley K.M. Cancer, Principles and Practice of Oncology, 4th Ed., V.T. Devita, Jr., S. Hellman, S.A. Rosenberg (Ed.), J.B. Lippincott Co., Philadelphia: 1993. p. 2417-2448.
Foley K. M. The Treatment of Cancer Pain, New Engl. J. Med. 313(2): 84-95, 1985.
Aronoff G.M Evans, W.O., Evaluation and Treatment of Chronic Pain, 2nd Ed., G.M. Aronoff (Ed.), Williams and Wilkins, Baltimore, p. 359-368, 1992.
Cherny N.I,Portenoy, R.K., Textbook of Pain, 3rd Ed., P.D. Wall and R. Melzack (Eds.), Churchill Livingstone, London, p. 1437-1467, 1994
- Table 1.2 footnote 2
Most of these data were derived from single-dose, acute pain studies and should be considered an approximation for selection of doses when treating chronic pain.
- Table 1.2 footnote 3
The conversion ratio of 10 mg parenteral morphine = 20 – 30 mg oral morphine is based on clinical experience in patients with chronic pain.
Skaer TL. Practice Guidelines for Transdermal Opioids in Malignant Pain. Drugs: 64 (23) 2629 – 2638, 2004.
Berdine HJ, Nesbit SA. Equianalgesic Dosing of Opioids. Journal of Pain & Palliative Care Pharmacotherapy: 20 (4) 79 – 84, 2006.
- Table 1.2 footnote 4
Extremely variable equianalgesic dose. Patients should undergo personalized titration starting at an equivalent to 1/10 of the morphine dose.