Generic name: fentanyl 12.5ug in 1h
Dosage form: patch, transdermal system
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Important Dosage and Administration Instructions
DURAGESIC should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Due to the risk of respiratory depression, DURAGESIC is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning DURAGESIC therapy. As DURAGESIC is only for use in opioid-tolerant patients, do not begin any patient on DURAGESIC as the first opioid [see Indications and Usage (1)].
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
- Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with DURAGESIC when serum concentrations from the initial patch will peak [see Warnings and Precautions (5.2)].
Do not initiate treatment with DURAGESIC in opioid nontolerant patients [see Contraindications (4)].
The recommended starting dose when converting from other opioids to DURAGESIC is intended to minimize the potential for overdosing patients with the first dose.
Discontinue all other around-the-clock opioid drugs when DURAGESIC therapy is initiated.
While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient's 24-hour fentanyl requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour fentanyl requirements which could result in adverse reactions. In a DURAGESIC clinical trial, patients were converted from their prior opioid to DURAGESIC using Table 1 as a guide for the initial DURAGESIC dose.
Consider the following when using the information in Table 1:
- This is not a table of equianalgesic doses.
- The conversion doses in this table are only for the conversion from one of the listed oral or parenteral opioid analgesics to DURAGESIC.
- The table cannot be used to convert from DURAGESIC to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.
To convert patients from oral or parenteral opioids to DURAGESIC, use Table 1. Do not use Table 1 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.
|Current Analgesic||Daily Dosage (mg/day)|
|Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the conversion methodology outlined above with Table 2.|
|Intramuscular or Intravenous morphine||10–22||23–37||38–52||53–67|
|Recommended DURAGESIC Dose||25 mcg/hour||50 mcg/hour||75 mcg/hour||100 mcg/hour|
Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the following methodology:
- Calculate the previous 24-hour analgesic requirement.
- Convert this amount to the equianalgesic oral morphine dose using a reliable reference.
Refer to Table 2 for the range of 24-hour oral morphine doses that are recommended for conversion to each DURAGESIC dose. Use this table to find the calculated 24-hour morphine dose and the corresponding DURAGESIC dose. Initiate DURAGESIC treatment using the recommended dose and titrate patients upwards (no more frequently than 3 days after the initial dose and every 6 days thereafter) until analgesic efficacy is attained.
- Do not use Table 2 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.
|Oral 24-hour Morphine
|NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to DURAGESIC.|
For delivery rates in excess of 100 mcg/hour, multiple systems may be used.
Titration and Maintenance of Therapy
Individually titrate DURAGESIC to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DURAGESIC to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.
Patients who experience breakthrough pain may require a dosage adjustment of DURAGESIC, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DURAGESIC dosage.
The dosing interval for DURAGESIC is 72 hours. Do not increase the DURAGESIC dose for the first time until at least 3 days after the initial application. Titrate the dose based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.
It may take up to 6 days for fentanyl levels to reach equilibrium on a new dose [see Clinical Pharmacology (12.3)]. Therefore, evaluate patients for further titration after no less than two 3-day applications before any further increase in dosage is made.
Base dosage increments on the daily dosage of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12 mcg/hour increase in DURAGESIC dose.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
A small proportion of adult patients may not achieve adequate analgesia using a 72-hour dosing interval and may require systems to be applied at 48 hours rather than at 72 hours, only if adequate pain control cannot be achieved using a 72-hour regimen. An increase in the DURAGESIC 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.
Dosage Modifications in Patients with Hepatic Impairment
Avoid the use of DURAGESIC in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of respiratory and central nervous system depression, including at each dosage increase [see Warnings and Precautions (5.15), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Dosage Modifications in Patients with Renal Impairment
Avoid the use of DURAGESIC in patients with severe renal impairment. In patients with mild to moderate renal impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of respiratory and central nervous system depression, including at each dosage increase [see Warnings and Precautions (5.16), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Administration of DURAGESIC
DURAGESIC PATCHES ARE FOR TRANSDERMAL USE ONLY.
Proper handling of DURAGESIC is necessary in order to prevent serious adverse outcomes, including death, associated with accidental secondary exposure to DURAGESIC [see Warnings and Precautions (5.3)].
Application and Handling Instructions
- Patients should apply DURAGESIC to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of DURAGESIC application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.
- Patients should apply DURAGESIC immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application. DURAGESIC should not be used if the pouch seal is broken or if the patch is cut or damaged.
- The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.
- Each DURAGESIC patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system.
- If problems with adhesion of the DURAGESIC patch occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing.
- If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site.
- Patients (or caregivers who apply DURAGESIC) should wash their hands immediately with soap and water after applying DURAGESIC.
- Contact with unwashed or unclothed application sites can result in secondary exposure to DURAGESIC and should be avoided. Examples of accidental exposure include transfer of a DURAGESIC patch from an adult's body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver's skin to the medication in the patch while applying or removing the patch.
- Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom DURAGESIC was not prescribed.
Avoidance of Heat
Instruct patients to avoid exposing the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds, while wearing the system [see Warnings and Precautions (5.6)].
Failure to properly dispose of DURAGESIC has resulted in accidental exposures and deaths, including deaths of children [see Warnings and Precautions (5.3)].
Instruct patients to dispose of used patches immediately upon removal by folding the adhesive side of the patch to itself, then flushing down the toilet.
Instruct patients to remove unused patches from their pouches, remove the protective liners, fold the patches so that the adhesive side of the patch adheres to itself, and to immediately flush the patches down the toilet.
Instruct patients to dispose of any patches remaining from a prescription as soon as they are no longer needed.
Discontinuation of DURAGESIC
Significant amounts of fentanyl continue to be absorbed from the skin for 24 hours or more after the patch is removed [see Clinical Pharmacology (12.3)].
To convert patients to another opioid, remove DURAGESIC 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. Withdrawal symptoms are possible in some patients after conversion or dose adjustment [see Warnings and Precautions (5.19)].
Do not use Tables 1 and 2 to convert from DURAGESIC to other therapies to avoid overestimating the dose of the new agent resulting in overdose of the new analgesic and possibly death.
When discontinuing DURAGESIC and not converting to another opioid, use a gradual downward titration, such as a 50% dosage reduction every 6 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue DURAGESIC [see Warnings and Precautions (5.19), Drug Abuse and Dependence (9.3)]. It is not known at what dose level DURAGESIC may be discontinued without producing the signs and symptoms of opioid withdrawal.
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