The Duragesic (fentanyl transdermal system) patch is a powerful opioid pain medication for moderate to severe chronic pain. Manufactured by Janssen Pharmaceutica Products, L.P., the chemical name of fentanyl is N-Phenyl-N-(1-2-phenylethyl-4-piperidyl) propanamide. The active component of the system is fentanyl. Less than 0.2 mL of alcohol is also released from the system during use. The molecular weight of fentanyl base is 336.5, and the chemical structural formula is C 22 H 28 N 2 O.
Duragesic is a DEA Schedule II narcotic and prescriptions require a DEA Order Form.
Street names for fentanyl include apache, china girl, china white, dance fever, friend, goodfella, jackpot, murder 8, TNT, and Tango and Cash.
With an analgesic potency of about 80 times that of morphine, fentanyl was introduced in the pharmacological world when it was first synthesized in Belgium in the late 1950s. A few years later, it was introduced into medical practice as an intravenous anesthetic under the trade name of Sublimaze. Thereafter, a number of ultra-short acting analgesics and potent analgesics were introduced. Today, fentanyls are widely used for anesthesia and analgesia. Duragesic is a fentanyl transdermal patch used in chronic pain management, and Actiq is a solid formulation of fentanyl citrate on a stick (like a lollipop) that dissolves slowly in the mouth for transmucosal absorption. Actiq is intended for opiate-tolerant individuals and is effective in treating breakthrough pain in cancer patients.
The illicit use of pharmaceutical fentanyls first appeared in the mid-1970s and remains a problem today. Illicit fentanyls are most commonly used by intravenous administration, but like heroin, they may also be smoked or snorted.
To date, over 12 different analogues of fentanyl have been produced secretly and identified in U.S. drug traffic. The biological effects of the fentanyls are comparable to those of heroin, with the exception that the fentanyls may be hundreds of times more potent.
Duragesic is a powerful narcotic painkiller for serious pain. It is generally only prescribed for long-lasting relief from intense, persistent and chronic pain. The Duragesic patch should only be used when less potent medicines have proved ineffective and pain needs to be controlled 24/7.
Duragesic patches are a transdermal system providing 72 hours of continuous systemic delivery of this potent opioid analgesic.
Duragesic is available in 4 color-coded patch strengths: 25 mg, 50 mg, 75 mg, and 100 mcg/hour. As with all pure opioid agonists, there is no analgesic ceiling effect with fentanyl, thus there are no dose-limiting adverse effects, and dosages can be gradually increased until adequate pain relief is achieved.
Duragesic should never be used in the following situations:
*where the right dosage hasn’t been established in advance – for instance, after an operation or an accident.
*for mild or intermittent pain that responds to other medications.
*in children under 12 or teenagers who weigh less than 110 pounds.
Fentanyl’s primary effect is on the central nervous system; its primary therapeutic effects are analgesia and sedation. Other effects of fentanyl may include mood changes, euphoria, dysphoria, or drowsiness. Fentanyl depresses the respiratory centers and the cough reflex and constricts the pupils. Nausea, vomiting, and postural syncope may also occur although more commonly in ambulatory patients.
Typical side effects of Duragesic therapy include abdominal pain, anxiety, confusion, constipation, depression, diarrhea, dizziness, dry mouth, euphoria, hallucinations, headache, impaired or interrupted breathing, indigestion, itching, anorexia, nausea, agitation, shortness of breath, sleepiness, sweating, urinary retention, vomiting, and weakness.
The following contraindications can cause serious or life-threatening hypoventilation if Duragesic is used:
· For acute or post-operative pain
· For mild or intermittent pain responsive to PRN (take as needed) or non–opioid therapy
· In doses exceeding 25 µg/hour at the initiation of opioid therapy
*To ensure controlled drug delivery, do not cut or damage the Duragesic patch.
*Heat can increase the release of fentanyl from the Duragesic patch, increasing breathing difficulties and other side effects. Do not expose the patch to heating pads, electric blankets, heated water beds, heat lamps, saunas, hot tubs, or other external sources of heat. Alert your doctor if you develop a high fever (104 degrees Fahrenheit or more).
*Duragesic can impair your reactions. Do not drive or operate dangerous machinery until you know how this drug affects you.
*Duragesic’s tendency to reduce respiration can be especially dangerous if your breathing is impaired by chronic pulmonary disease.
*Duragesic is not recommended for people with head injuries and other conditions that increase pressure on the brain.
*If you have an irregular heartbeat, Duragesic can make the problem worse.
*Use Duragesic with caution if you have kidney or liver disease.
*This medicine should be used with caution by patients with a known allergy to morphine, codeine, or acetaminophen products.
It is very important to check with your physician before combining Duragesic with the following:
*Antifungal medications such as Diflucan, Nizoral, and Sporanox
*HIV drugs classified as protease inhibitors, including Agenerase, Crixivan, Fortovase, Invirase, Kaletra, Norvir, and Viracept
*Macrolide antibiotics such as erythromycin, Biaxin, and Zithromax
Drugs that may decrease the effects of Duragesic:
Fentanyl is a central nervous system depressant and intensifies the effects of alcohol. Do not drink alcohol while taking this medication.
When wearing a Duragesic patch, check with your doctor before taking any other central nervous system (CNS) depressant drugs. The combined effect can lead to difficulty breathing, hypotension, and possibly coma.
Drugs in this category include the following:
*Antipsychotic drugs such as Compazine, Mellaril, Stelazine, and Thorazine
*Muscle relaxants such as Flexeril, Robaxin, and Skelaxin
*Narcotic painkillers such as Demerol, Percodan, OxyContin, and Vicodin
*Sleep aids such as Ambien, Halcion, and Sonata
*Sleep-inducing antihistamines such as Benadryl and Phenergan
*Tranquilizers such as Ativan, Librium, Valium, and Xanax
Users are susceptible to an overdose if they take too much transdermal fentanyl, or combine it with excessive amounts of another narcotic. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing and drowsiness so severe the person is unresponsive. Other signs of an overdose include cold, clammy skin; low blood pressure; pinpoint pupils of eyes; and slow heartbeat. If this occurs, get emergency help right away.
As a Schedule II controlled substance, fentanyl can produce drug dependence similar to that produced by morphine. Fentanyl has the potential for abuse, often leading to physical and psychological dependence, but may be a necessary evil to control chronic pain. Your doctor will have to take these factors into account before prescribing this drug.
Tolerance is when ever increasing doses are required to produce the same degree of analgesia. Tolerance is initially manifested by a decreased duration of analgesic effect, followed by decreases in the intensity of analgesia. Tolerance develops over days, weeks, or months. The rate of tolerance varies among patients.
According to the FDA, addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm.
When patients no longer require Duragesic, they must work with their physician to set a gradual taper schedule to avoid acute withdrawal.
After the patch is removed, it takes 17 hours or more for a 50 percent decrease in serum fentanyl concentrations. If you are planning to discontinue use of Duragesic, a gradual dosage decrease is recommended since it is not known what dose level the drug may be discontinued without producing the signs and symptoms of abrupt withdrawal.
Do not stop taking Duragesic without first checking with your doctor. Regular use will produce physical dependency in a few weeks which can lead to severe withdrawal if use is suddenly stopped. This can generally be avoided by reducing the dose gradually over a period of time before stopping treatment completely.
If during withdrawal, you experience any of the following symptoms, contact your physician:
Anxiety, body aches, diarrhea; rapid heartbeat, fever, runny nose or sneezing, chills, sweating, yawning, anorexia, nausea or vomiting,; nervousness, irritability, shivering or trembling, stomach cramps, insomnia, and weakness.
After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it.
Duragesic may cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal also may be precipitated by the administration of drugs with opioid antagonist activity, such as naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine).
Due to the fact that Duragesic is only prescribed for long-term, severe pain problems, patients must taper down slowly under a knowledgeable physician’s care, or, enter a detox center for 24/7 treatment. With a moderate to severe addiction from relatively long term use, an in patient detox in a hospital or medical supervised setting is highly recommended for its multi- disciplinary approach. Dependence resulting from even a few weeks of regular use can usually be handled under a physician’s supervision with minimal discomfort. Treatment will ultimately depend on the degree of addiction.
However a person chooses to free themselves from the clutches of a drug, there is one constant everyone needs and that is support. Narcotics Anonymous remains a successful choice for many addicts, with world-wide availability. The “information age” has produced numerous on line support forums, popular with many recovering addicts, useful to some addicts as their sole means of support and for others, as adjunct therapy. Drug addiction is treatable, with help out there for everyone.