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Fentanyl transdermal system 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 systems (fentanyl transdermal system) may be a particular target for abuse and diversion.
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 such as non-steroidal analgesics, opioid combination products, or immediate-release opioids
Fentanyl transdermal system 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 fentanyl transdermal system 25 mcg/hr. 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, 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 concentrations generally occur between 20 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 fentanyl transdermal system 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 fentanyl transdermal system 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
The 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 2 years of age or older
(see PRECAUTIONS - Pediatric Use).
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. Overestimating the fentanyl transdermal system dose when converting patients from another opioid medication can result in fatal overdose with the first dose (see
DOSAGE AND ADMINISTRATION - Initial Fentanyl Transdermal System Dose Selection). Due to the mean half-life of approximately 20 to 27 hours, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.
Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing fentanyl transdermal system 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.
Fentanyl transdermal system is intended for transdermal use (on intact skin) only. Do not use a fentanyl transdermal system if the pouch seal is broken or the system is cut, damaged, or changed in any way.
Avoid exposing the fentanyl transdermal system 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 fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the fentanyl transdermal system dose should be adjusted if necessary.
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FENTANYL SUMMARY
Fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours.
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 such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.
Fentanyl transdermal system 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 fentanyl transdermal system 25 mcg/hr (see
DOSAGE AND ADMINISTRATION). 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 result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., prn), for the management of post-operative or acute pain, or in patients who are not opioid-tolerant or who require opioid analgesia for a short period of time (see
BOX WARNING
CONTRAINDICATIONS
).
An evaluation of the appropriateness and adequacy of treating with immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.
Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. 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 at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
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NEWS HIGHLIGHTSMedia Articles Related to Fentanyl
Addicts Try to Avoid Deadly Fentanyl, But Many Tragically Fail
Source: MedicineNet codeine Specialty [2017.06.16]
Title: Addicts Try to Avoid Deadly Fentanyl, But Many Tragically Fail
Category: Health News
Created: 6/16/2017 12:00:00 AM
Last Editorial Review: 6/16/2017 12:00:00 AM
Published Studies Related to Fentanyl
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 Fentanyl
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.
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.
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.
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.
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl [Completed]
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after
epidural injection. The objective of this investigation was to compare the analgesic effect
of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.
DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.
METHODS: 29 patients were divided into two groups. During the postoperative period, in the
presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in
saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n
= 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl
intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL
epidural 0. 25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity
was evaluated by numerical scale and plasma concentrations of Fentanyl were measured
simultaneously.
Reports of Suspected Fentanyl Side Effects
Product Quality Issue (194),
Inadequate Analgesia (108),
Toxicity TO Various Agents (108),
Respiratory Arrest (84),
Cardiac Arrest (84),
Drug Administration Error (70),
Wrong Technique in Drug Usage Process (69),
Dyspnoea (64),
Pain (62),
Nausea (59), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Fentanyl has an overall score of 7. The effectiveness score is 6 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
| | Fentanyl review by 47 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Chronic pain due to neck injury and surgeries |
| Dosage & duration: | | 100 mcg and 25 mcg patches (dosage frequency: every 72 hours) for the period of 4 years |
| Other conditions: | | GERD,Arthritis,HBP,Depression,Anxiety,VentricularTachycardia |
| Other drugs taken: | | Elavil,,Zanaflex,Morphine Sulfate,Metoprolol,Digoxin,Lisinopril,Nitroglycerin,Aspirin,Multivitamin. | | |
Reported Results |
| Benefits: | | Pain reduction at a controlled rate over 72 hours |
| Side effects: | | Local irritation due to the adhesive,dry mouth,mild constipation,mild memory loss,slowed motor responses |
| Comments: | | Medication delivered by 2 topical patches of 100 and 25 mcg.patches changed every 72 hours.They were used in conjunction with 15 mgs of MSIR as needed up to twice daily for breakthrough pain.I was also prescribed 8 mgs.of Zanaflex at bedtime along with Elavil to treat the depression commonly associated with Chronic health conditions. |
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| | Fentanyl review by 38 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Chronic Regional Pain Syndrome |
| Dosage & duration: | | 25mg Patch taken 1 patch per day for the period of 6 months |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Alleviated pain in the affected area of the arm. Reduced all other symptoms also of Chronic Regional Pain Syndrome. Allowed me to get a good noghts sleep without waking and needing to shower due to excessive sweating which is symptomatic of the condition. |
| Side effects: | | Side effects were chronic constipation, for which I was prescribed Lactulose, headaches which would last for days, disturbed sleep patterns, vivid dreaming. The inability to concentrate for even moderate periods of time, dry mouth and sluggishness. |
| Comments: | | The patches were prescribed following a consulatation with the local pain clinic and unsuccessful nerve blocks performed by both the pain clinic and the fracture consultant. After 6 months of side effects I decided to stop using the patches as I felt that the relief in pain was not matched by the quality of life provided by the use of the drug |
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Page last updated: 2017-06-16
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