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DURAGESIC ® contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC ® ) may be a particular target for abuse and diversion.
DURAGESIC® 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 such as non-steroidal analgesics, opioid combination products, or immediate-release opioids
DURAGESIC ® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC ® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated:
- in patients who are not opioid-tolerant
- in the management of acute pain or in patients who require opioid analgesia for a short period of time
- in the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
- in the management of mild pain
- in the management of intermittent pain (e.g., use on an as needed basis [prn])
(See CONTRAINDICATIONS for further information.)
Since the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers should be aware that serious or life threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.
The concomitant use of DURAGESIC® with all cytochrome P450 3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving DURAGESIC ® and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see CLINICAL PHARMACOLOGY – Drug Interactions, WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION and for further information).
The safety of DURAGESIC® has not been established in children under 2 years of age. DURAGESIC® should be administered to children only if they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS - Pediatric Use ).
DURAGESIC® 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. Overestimating the DURAGESIC ® 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 DURAGESIC ® , patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.
DURAGESIC ® can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing DURAGESIC ® in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.
Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
DURAGESIC ® patches are intended for transdermal use (on intact skin) only. Do not use a DURAGESIC ® patch if the seal is broken or the patch is cut, damaged or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal.
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, saunas, hot tubs, and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death. Patients wearing DURAGESIC® systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the DURAGESIC® dose should be adjusted if necessary.
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NEWS HIGHLIGHTS
Published Studies Related to Duragesic (Fentanyl Transdermal)
Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses
determined from oral morphine rescue doses in the treatment of breakthrough
cancer pain. [2015]
evaluate the efficacy and safety of sublingual fentanyl tablet... CONCLUSIONS: Patients treated with strong opioid analgesics at fixed intervals
Effect of intravenous fentanyl given prior to the end of surgery on emergence
agitation in pediatric patients. [2013]
CONCLUSION: Administration of intravenous fentanyl 1 microg/kg 15 minutes prior
Desflurane/fentanyl compared with sevoflurane/fentanyl on awakening and quality
of recovery in outpatient surgery using a laryngeal mask airway: a randomized,
double-blinded controlled trial. [2013]
anesthetic regimen inclusive of opioids... CONCLUSIONS: Desflurane retains faster awakening properties than does sevoflurane
Clinical effects of intrathecal fentanyl on shoulder tip pain in laparoscopic
total extraperitoneal inguinal hernia repair under spinal anaesthesia: a
double-blind, prospective, randomized controlled trial. [2013]
anaesthesia... CONCLUSIONS: Addition of intrathecal fentanyl to local anaesthetic can relieve
A double-blinded randomized evaluation of alfentanil and morphine vs fentanyl:
analgesia and sleep trial (DREAMFAST). [2013]
interference... CONCLUSIONS: Despite better early postoperative analgesia, pain-related sleep
Clinical Trials Related to Duragesic (Fentanyl Transdermal)
Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients [Recruiting]
Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the
patient. The pain associated with the procedure is not caused by the insertion of the scope
but from inflating of the colon in order to do the inspection. It has been shown that
colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients
feel discomfort during the procedure. Factors predicting a painful colonoscopy are
female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy
(Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are
associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or
analgesia are achieved by administering a benzodiazepine or a combination of a
benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine
(Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol
as monotherapy did not significantly decrease pain intensity or endoscopist's evaluation of
colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most
commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely
increases the cost of procedure; drug administration, need for pulse oximetry monitoring and
the need for follow-up after the procedure make colonoscopy sometimes expensive and
troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor
makes patients forget it (Elphick et al. 2009).
Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal
sublingual formulation of fentanyl has been developed to further improve the management of
pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed
under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by
the body through the mucous membrane. After administration of buccal fentanyl maximum plasma
drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl
concentrations versus time following buccal and sublingual administration are very similar
(Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under
the tongue at the deepest part. Sublingual administration is an easy and non-invasive
method of pain treatment for the patient coming to colonoscopy done as an office based
procedure. Other advantages compared to invasive methods are improved comfort of patients
and no need for intravenous access because of pain relief. Before, it has been used in the
management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be
effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al.
2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia [Recruiting]
Hypotension is frequently encountered after induction of general anesthesia. It can be
pronounced in elderly patients and can require administration of vasopressor agents
including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged
episodes, can contribute to an increase in morbidity and mortality in the postoperative
period as suggested by some former studies. The investigators hypothesize that fentanyl can
contribute to the decrease in blood pressure (BP) that is seen after induction of general
anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the
sympathetic nervous system.
This study will be the first one to examine the effect of fentanyl administration on blood
pressure in elderly patients with induction of general anesthesia prior to the start of
surgery. If the study shows that fentanyl contributes to hypotension during this period, it
may lead to a change in practice and better patient outcomes and mortality rates.
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain [Recruiting]
This study will investigate the influence of intra-operative use of remifentanil versus
fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via
sternotomy. Secondary quantitative sensory testing is performed to determine thermal and
electrical detection and pain threshold and the difference in pain variability scoring.
Postoperative pain scores, analgesic use, genetic variances and costs are measured.
Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl Patches in Healthy Adults [Recruiting]
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare
fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)
fentanyl skin patches in healthy adults.
Breakthrough Dyspnea Fentanyl Study in Cancer Patients [Completed]
The goal of this clinical research study is to learn if fentanyl given under the skin can
reduce shortness of breath in cancer patients. Researchers also want to learn if it can
help to improve your physical function. In this study, fentanyl will be compared to a
placebo.
Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients
with their shortness of breath as well.
A placebo is not a drug. It looks like the study drug but is not designed to treat any
disease or illness. It is designed to be compared with a study drug to learn if the study
drug has any real effect.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Duragesic has an overall score of 5.50. The effectiveness score is 7 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Duragesic review by 53 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | cancer/constant pain |
| Dosage & duration: | | 50ncg/h patch (3-day patch cycle) (dosage frequency: 3 days) for the period of still taking |
| Other conditions: | | cancer within lung, spinal column, arteries, etc. |
| Other drugs taken: | | oxycodone | | |
Reported Results |
| Benefits: | | Having a constant level of pain relief by transdermal absorbpion. |
| Side effects: | | After 6-16 hours I became quite sleepy and tired. After a couple of hours of sleep, I awoke feeling as I usually do first thing in the morning. A couple of hours later the sleepiness returned. |
| Comments: | | Apply the patch every 3 days. |
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| | Duragesic review by care giver of 52 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Cancer related pain |
| Dosage & duration: | | ?? (dosage frequency: 3 days) for the period of 5 days |
| Other conditions: | | Cancer of the Esophagus |
| Other drugs taken: | | Famatodine | | |
Reported Results |
| Benefits: | | The Fentanyl patch helped some with pain, however, the patient was still in considerable pain. |
| Side effects: | | On the 4th day on the medication the patient who had been very responsive and alert was groggy, not alert and fell several times in attempts to go to the bathroom, something he had no problem with proir to the medication. In attempting to assist the patient, it was evident that his heart was beating rapidly and he was in a cold sweat. He died on the 5th day on the medication. |
| Comments: | | The patient was suffering from cancer of the esophagus, which was in an advanced state at the time of diagnosis. The patient was to begin treatment for cancer the day following his death. He had received a feeding tube through his stomach and was sent home from the hospital with a perscription for Fentanyl patches for pain. He had previously been taking a much milder medication. The patient rapidly deteriorated and died within 6 days of receiving the feeding tube and within 5 days of beginning the Fentanyl patch for pain. |
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| | Duragesic review by care giver of 52 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Cancer related pain |
| Dosage & duration: | | ?? (dosage frequency: 3 days) for the period of 5 days |
| Other conditions: | | Cancer of the Esophagus |
| Other drugs taken: | | Famatodine | | |
Reported Results |
| Benefits: | | The Fentanyl patch helped some with pain, however, the patient was still in considerable pain. |
| Side effects: | | On the 4th day on the medication the patient who had been very responsive and alert was groggy, not alert and fell several times in attempts to go to the bathroom, something he had no problem with proir to the medication. In attempting to assist the patient, it was evident that his heart was beating rapidly and he was in a cold sweat. He died on the 5th day on the medication. |
| Comments: | | The patient was suffering from cancer of the esophagus, which was in an advanced state at the time of diagnosis. The patient was to begin treatment for cancer the day following his death. He had received a feeding tube through his stomach and was sent home from the hospital with a perscription for Fentanyl patches for pain. He had previously been taking a much milder medication. The patient rapidly deteriorated and died within 6 days of receiving the feeding tube and within 5 days of beginning the Fentanyl patch for pain. |
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