Fentanyl, Page 5

Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means.

Dose Selection

Doses must be individualized based upon the status of each patient and should be assessed at regular intervals after fentanyl transdermal system application. Reduced doses of fentanyl transdermal system are suggested for the elderly and other groups discussed in precautions.

Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression.

In selecting an initial fentanyl transdermal system dose, attention should be given to 1) the daily dose, potency, and characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist-antagonist), 2) the reliability of the relative potency estimates used to calculate the fentanyl transdermal system dose needed (potency estimates may vary with the route of administration), 3) the degree of opioid tolerance and 4) the general condition and medical status of the patient. Each patient should be maintained at the lowest dose providing acceptable pain control.

Initial Fentanyl Transdermal System Dose Selection

Overestimating the fentanyl transdermal system dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean elimination half-life of 17 hours of fentanyl transdermal system, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.

There has been no systematic evaluation of fentanyl transdermal system as an initial opioid analgesic in the management of chronic pain, since most patients in the clinical trials were converted to fentanyl transdermal system from other narcotics. The efficacy of fentanyl transdermal system 12 mcg/h as an initiating dose has not been determined. In addition, patients who are not opioid-tolerant have experienced hypoventilation and death during use of fentanyl transdermal system. Therefore, fentanyl transdermal system should be used only in patients who are opioid-tolerant.

To convert adult and pediatric patients from oral or parenteral opioids to fentanyl transdermal system use Table C:

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table C, use the following methodology:

  1. Calculate the previous 24-hour analgesic requirement.

  2. Convert this amount to the equianalgesic oral morphine dose using Table D.

  3. Table E displays the range of 24-hour oral morphine doses that are recommended for conversion to each fentanyl transdermal system dose. Use this table to find the calculated 24-hour morphine dose and the corresponding fentanyl transdermal system dose. Initiate fentanyl transdermal system treatment using the recommended dose and titrate patients upwards (no more frequently than every 3 days after the initial dose or than every 6 days thereafter) until analgesic efficacy is attained. The recommended starting dose when converting from other opioids to fentanyl transdermal system is likely too low for 50% of patients. This starting dose is recommended to minimize the potential for overdosing patients with the first dose. For delivery rates in excess of 100 mcg/h, multiple systems may be used.

Table C1 Dose Conversion Guidelines
Current Analgesic Daily Dosage(mg/d)
Oral morphine 60-134 135-224 225-314 315-404
IM/IV morphine 10-22 23-37 38-52 53-67
Oral oxycodone 30-67 67.5-112 112.5-157 157.5-202
IM/IV oxycodone 15-33 33.1-56 56.1-78 78.1-101
Oral codeine 150-447 448-747 748-1047 1048-1347
Oral hydromorphone 8-17 17.1-28 28.1-39 39.1-51
IV hydromorphone 1.5-3.4 3.5-5.6 5.7-7.9 8-10
IM meperidine 75-165 166-278 279-390 391-503
Oral methadone 20-44 45-74 75-104 105-134
IM methadone 10-22 23-37 38-52 53-67
Down arrow imageDown arrow imageDown arrow imageDown arrow image
Recommended fentanyl
transdermal system dose
25 mcg/h
50 mcg/h
75 mcg/h
100 mcg/h

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table C, use the conversion methodology outlined above with Table D.

1 Table C should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of table C for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible (seeDOSAGE AND ADMINISTRATION-Discontinuation of Fentanyl Transdermal System).

TABLE Da EQUIANALGESIC POTENCY CONVERSION

Name
Equianalgesic
IMb,c
Dose (mg)
PO
¹Table D should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of table D for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible (seeDOSAGE AND ADMINISTRATION–Discontinuation of Fentanyl Transdermal System).
a All IM and PO doses in this chart are considered equivalent to 10 mg of IM morphine in analgesic effect. IM denotes intramuscular, PO oral, and PR rectal.
b Based on single-dose studies in which an intramuscular dose of each drug listed was compared with morphine to establish the relative potency. Oral doses are those recommended when changing from parenteral to an oral route. Reference: Foley, K.M. (1985) The treatment of cancer pain. NEJM 313(2):84-95.
c Although controlled studies are not available, in clinical practice it is customary to consider the doses of opioid given IM, IV, or subcutaneously to be equivalent. There may be some differences in pharmacokinetic parameters such as Cmax and Tmax.
d The conversion ratio of 10 mg parenteral morphine = 30 mg oral morphine is based on clinical experience in patients with chronic pain. The conversion ratio of 10 mg parenteral morphine = 60 mg oral morphine is based on a potency study in acute pain. Reference: Ashburn and Lipman (1993) Management of pain in the cancer patient.
Anesth Analg 76:402-416.
Morphine 10 60 (30)d
Hydromorphone (Dilaudid®) 1.5 7.5
Methadone (Dolophine®) 10 20
Oxycodone 15 30
Levorphanol (Levo-Dromoran®) 2 4
Oxymorphone (Numorphan®) 1 10 (PR)
Meperidine (Demerol®) 75
Codeine 130 200
TABLE E¹ RECOMMENDED INITIAL FENTANYL TRANSDERMAL SYSTEM DOSE BASED UPON DAILY ORAL MORPHINE DOSE
Oral 24-hour
Morphine
(mg/day)
Fentanyl Transdermal System
Dose
(mcg/h)
60-134² 25
135-224 50
225-314 75
315-404 100
405-494 125
495-584 150
585-674 175
675-764 200
765-854 225
855-944 250
945-1034 275
1035-1124 300

NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to fentanyl transdermal system.

1Table E should not be used to convert from fentanyl transdermal system to other therapies because this conversion to fentanyl transdermal system is conservative. Use of table E for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible (seeDOSAGE AND ADMINISTRATION Discontinuation of Fentanyl Transdermal System).

The majority of patients are adequately maintained with fentanyl transdermal system administered every 72 hours. Some patients may not achieve adequate analgesia using this dosing interval and may require systems to be applied every 48 hours rather than every 72 hours. An increase in the fentanyl transdermal system dose should be evaluated before changing dosing intervals in order to maintain patients on a 72-hour regimen. Dosing intervals less than every 72 hours were not studied in children and adolescents and are not recommended.

Because of the increase in serum fentanyl concentration over the first 24 hours following initial system application, the initial evaluation of the maximum analgesic effect of fentanyl transdermal system cannot be made before 24 hours of wearing. The initial fentanyl transdermal system dose may be increased after 3 days (see DOSAGE AND ADMINISTRATION – Dose Titration).

During the initial application of fentanyl transdermal system, patients should use short-acting analgesics as needed until analgesic efficacy with fentanyl transdermal system is attained. Thereafter, some patients still may require periodic supplemental doses of other short-acting analgesics for “breakthrough” pain.

Dose Titration

The recommended initial fentanyl transdermal system dose based upon the daily oral morphine dose is conservative, and 50% of patients are likely to require a dose increase after initial application of fentanyl transdermal system. The initial fentanyl transdermal system dose may be increased after 3 days based on the daily dose of supplemental opioid analgesics required by the patient in the second or third day of the initial application.

Physicians are advised that it may take up to 6 days after increasing the dose of fentanyl transdermal system for the patient to reach equilibrium on the new dose (see graph in CLINICAL PHARMACOLOGY). Therefore, patients should wear a higher dose through two applications before any further increase in dosage is made on the basis of the average daily use of a supplemental analgesic.

Appropriate dose increments should be based on the daily dose of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12.5 mcg/h increase in fentanyl transdermal system dose. Fentanyl transdermal system -12 delivers 12.5 mcg/h of fentanyl.

Discontinuation of fentanyl transdermal system

To convert patients to another opioid, remove fentanyl transdermal system and titrate the dose of the new analgesic based upon the patient’s report of pain until adequate analgesia has been attained. Upon system removal, 17 hours or more are required for a 50% decrease in serum fentanyl concentrations. Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and shivering) are possible in some patients after conversion or dose adjustment. For patients requiring discontinuation of opioids, a gradual downward titration is recommended since it is not known at what dose level the opioid may be discontinued with producing the signs and symptoms of abrupt withdrawal.

Tables, C, D, and E should not be used to convert from fentanyl transdermal system to other therapies. Because the conversion to fentanyl transdermal system is conservative, use of tables C, D and E for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible.

HOW SUPPLIED

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.

Fentanyl Transdermal System Dose
(mcg/h)
System Size
(cm 2 )
Fentanyl Content
(mg)
Fentanyl Transdermal System-25 10 2.5
Fentanyl Transdermal System-50 20 5

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