Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Fentanyl can be abused in a manner similar to other opioids, legal or illicit. This should be considered when prescribing or dispensing fentanyl transdermal system in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Fentanyl transdermal system has been reported as being abused by other methods and routes of administration. Concerns about abuse, addiction and diversion should not prevent the proper management of pain.
However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Healthcare professionals should contact their state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Serious or life-threatening hypoventilation may occur at any time during the use of fentanyl transdermal system especially during the initial 24 to 72 hours following initiation of therapy and following increases in dose. Because significant amounts of fentanyl continue to be absorbed from the skin for 17 hours or more after the patch is removed, hypoventilation may persist beyond the removal of fentanyl transdermal system. Consequently, patients with hypoventilation should be carefully observed for degree of sedation and their respiratory rate monitored until respiration has stabilized.
The use of concomitant CNS active drugs requires special patient care and observation. Respiratory depression is the chief hazard of opioid agonists, including fentanyl the active ingredient in fentanyl transdermal system.
Respiratory depression is more likely to occur in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
This makes overdoses involving drugs with sedative properties and opioids especially dangerous. Fentanyl transdermal system should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
In such patients, even usual therapeutic doses of fentanyl transdermal system may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose. Because potent opioids can cause serious or life-threatening hypoventilation, fentanyl transdermal system should be administered with caution to patients with pre-existing medical conditions predisposing them to hypoventilation.
In such patients, normal analgesic doses of opioids may further decrease respiratory drive to the point of respiratory failure. Fentanyl transdermal system should not be used in patients who may be particularly susceptible to the intracranial effects of CO 2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma. Opioids may obscure the clinical course of patients with head injury.
Fentanyl transdermal system should be used with caution in patients with brain tumors. The concomitant use of fentanyl transdermal system with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers e. When such combined therapy is contemplated, the dose of one or both agents should be significantly reduced.
Fentanyl may be expected to have additive CNS depressant effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.
Fentanyl transdermal system should not be used to initiate opioid therapy in patients who are not opioid-tolerant. Patients, family members and caregivers should be instructed to keep patches new and used out of the reach of children and others for whom fentanyl transdermal system was not prescribed.
A considerable amount of active fentanyl remains in fentanyl transdermal system even after use as directed. Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression that could result in death. Fentanyl may produce bradycardia. Fentanyl should be administered with caution to patients with bradyarrhythmias. Insufficient information exists to make recommendations regarding the use of fentanyl transdermal system in patients with impaired renal or hepatic function.
Fentanyl transdermal system may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
Opioids like fentanyl transdermal system may cause increases in the serum amylase concentration. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
Strong opioid analgesics impair the mental or physical abilities required for the performance of potentially dangerous tasks, such as driving a car or operating machinery. Patients who have been given fentanyl transdermal system should not drive or operate dangerous machinery unless they are tolerant to the effects of the drug. Patients and their caregivers should be provided with a Medication Guide each time fentanyl transdermal system is dispensed because new information may be available.
Patients receiving fentanyl transdermal systems should be given the following instructions by the physician:. The concomitant use of transdermal fentanyl with all CYP3A4 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 fatal respiratory depression.
Central Nervous System Depressants The concomitant use of fentanyl transdermal system with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers e. MAO Inhibitors Fentanyl transdermal system is not recommended for use in patients who have received MAOI within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments. In the male fertility study, male rats were treated with fentanyl 0, 0. In the female fertility study, female rats were treated with fentanyl 0, 0.
Analysis of fertility parameters in both studies indicated that an intravenous dose of fentanyl up to 0. In a separate study, a single daily bolus dose of fentanyl was shown to impair fertility in rats when given in intravenous doses of 0.
Teratogenic Effects. Pregnancy Category C No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported. The potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models.
In contrast, the intravenous administration of fentanyl 0, 0. There was no clear evidence of teratogenicity noted. Pregnant female New Zealand White rabbits were treated with fentanyl 0, 0. Fentanyl produced a slight decrease in the body weight of the live fetuses at the high dose, which may be attributed to maternal toxicity.
Under the conditions of the assay, there was no evidence for fentanyl induced adverse effects on embryo-fetal development at doses up to 0. There are no adequate and well-controlled studies in pregnant women. Fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants.
Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl.
Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. The potential effects of fentanyl on prenatal and postnatal development were examined in the rat model.
Female Wistar rats were treated with 0, 0. Fentanyl treatment 0. Both the mid-dose and high-dose of fentanyl animals demonstrated alterations in some physical landmarks of development delayed incisor eruption and eye opening and transient behavioral development decreased locomotor activity at day 28 which recovered by day The mid-dose and the high-dose are 0.
Fentanyl readily passes across the placenta to the fetus; therefore, fentanyl transdermal system is not recommended for analgesia during labor and delivery. Fentanyl is excreted in human milk; therefore, fentanyl transdermal system is not recommended for use in nursing women because of the possibility of effects in their infants. The safety of fentanyl transdermal system was evaluated in three open-label trials in pediatric patients with chronic pain, 2 years of age through 18 years of age.
Fentanyl transdermal system was not studied in children under 2 years of age. Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life. Various adverse events were reported; a causal relationship to fentanyl transdermal system was not always determined.
The frequencies presented here reflect the actual frequency of each adverse effect in patients who received fentanyl transdermal system. There has been no attempt to correct for a placebo effect, concomitant use of other opioids, or to subtract the frequencies reported by placebo-treated patients in controlled trials. In the pediatric population, the safety of fentanyl transdermal system has been evaluated in patients with chronic pain 2 to 18 years of age.
Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months. There was no apparent pediatric-specific risk associated with fentanyl transdermal system use in children as young as 2 years old when used as directed. The following adverse reactions have been reported in association with the use of fentanyl transdermal system and not reported in the pre-marketing adverse reactions section above: Body as a Whole: edema Cardiovascular: tachycardia Metabolic and Nutritional: weight loss Special Senses: blurred vision Urogenital: decreased libido, anorgasmia, ejaculatory difficulty.
Fentanyl transdermal system contains a high concentration of fentanyl, a potent Schedule II opioid agonist. Schedule II opioid substances, which include hydromorphone, methadone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Fentanyl, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.
Since fentanyl transdermal system may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Fentanyl transdermal systems are intended for transdermal use to be applied on the skin only. The manifestations of fentanyl overdosage are an extension of its pharmacologic actions with the most serious significant effect being hypoventilation.
For the management of hypoventilation, immediate countermeasures include removing the fentanyl transdermal system and physically or verbally stimulating the patient. These actions can be followed by administration of a specific narcotic antagonist such as naloxone. The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after system removal; repeated administration of naloxone may be necessary. Reversal of the narcotic effect may result in acute onset of pain and the release of catecholamines.
Always ensure a patent airway is established and maintained, administer oxygen and assist or control respiration as indicated and use an oropharyngeal airway or endotracheal tube if necessary. Adequate body temperature and fluid intake should be maintained.
If severe or persistent hypotension occurs, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy. The fentanyl transdermal system should not be used if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
Each fentanyl transdermal system may be worn continuously for 72 hours. The next patch should be applied to a different skin site after removal of the previous transdermal system. If problems with adhesion of the fentanyl transdermal system occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlaid with a transparent adhesive film dressing e. 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. Respiratory depression is the chief hazard in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. 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 oral hydromorphone daily, or an equianalgesic dose of another opioid.
Safety of fentanyl transdermal system has not been established in children under 2 years of age. With all opioids, the safety of patients using the products is dependent on healthcare practitioners prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.
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In no particular order:. Fentanyl patches are extremely potent. Opioid conversions are never perfect, but conservatively, a total daily dose of oral morphine mg is approximately equivalent to fentanyl 25 mcg patch. Lost or missing patches should scare you. Fentanyl as mentioned above, is extremely potent.
Take a lost or missing patch very seriously. Flushing of used patches is recommended per ISMP. Fentanyl patches are meant for chronic pain. You are not helping patients relieve their acute pain. With an onset of action that takes hours to days once applied, a patient can be in pain for a long period of time before the drug begins having an effect.
Delayed withdrawal. Fentanyl patches basically create a deposit of drug being slowly absorbed through the skin. I remember a case where a patient was on a chronic higher dose mcg and the patch was discontinued in the ED without any follow up or supplemental opioids. Long story short, they ended up having withdrawal symptoms, but not until hours after they were discharged. Remember slow onset as well as slow elimination and offset. Drug diversion.
These cases even go to the point of diverters removing used patches from dementia patients. How do you convert Fentanyl patch to oral oxymorphone? Do you get high off Fentanyl mg patch? Can you take the Fentanyl patch off after 2 days? Its said scrotal transdermal absobtion rates are higher than elsewhere on the body is it safe to apply Fentanyl 50mcg per hr patch to scrotum of opoid-tollerant male?
How strong is a 2. Does the Fentanyl patch really work to relieve back pain? Where on your skin can you put a Fentanyl patch?
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