Mylan Technologies has expanded its US transdermal patch facility, doubling capacity as part of a global investment of more than $600m ( Fentanyl Transdermal official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more. Is the Watson patch a gel reservoir? Perhaps that is the difference? I have had the Sandoz and the Mylan adhesive patches and find they both work about the. Based in West Virginia, Mylan Pharmaceuticals is the maker of a generic form of the fentanyl drug known as the fentanyl transdermal system. Delivering pain medication. Mylan Pharmaceutical's Xulane is the first generic contraceptive transdermal patch to hit the market, marking another milestone for the delivery technology. What form(s) does this medication come in? Mylan Fentanyl Patch is a skin patch that gradually delivers fentanyl through the skin into the bloodstream for 72 hours. Daily. Med - FENTANYL- fentanyl patch. Addiction, Abuse, and Misuse. Estradiol Transdermal Patch: learn about side effects, dosage, special precautions, and more on MedlinePlus. Mylan strives to design, develop and manufacture high quality, innovative transdermal drug-delivery patches that deliver medication through the skin. A study conducted with the fentanyl transdermal system patch in elderly patients. For questions about Fentanyl Transdermal System, call Mylan. 02407477 Mylan-Nitro Patch 0.8 Transdermal System About this Medication. How does this medication work? What will it do for me? Fentanyl Transdermal System contains fentanyl, an opioid agonist and a Schedule II controlled substance. As an opioid, Fentanyl Transdermal System exposes users to the risks of addiction, abuse, and misuse . As modified- release products such as Fentanyl Transdermal System deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of fentanyl present. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Fentanyl Transdermal System and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Fentanyl Transdermal System, and monitor all patients receiving Fentanyl Transdermal System for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e. The potential for these risks should not, however, prevent the prescribing of Fentanyl Transdermal System for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified- release opioid formulations such as Fentanyl Transdermal System, but use in such patients necessitates intensive counseling about the risks and proper use of Fentanyl Transdermal System along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of Fentanyl Transdermal System by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose, and death . Consider these risks when prescribing or dispensing Fentanyl Transdermal System. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Life- Threatening Respiratory Depression. Serious, life- threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status . Carbon dioxide (CO2) retention from opioid- induced respiratory depression can exacerbate the sedating effects of opioids. Fentanyl Transdermal System is indicated only in opioid tolerant patients because of the risk for respiratory depression and death. While serious, life- threatening, or fatal respiratory depression can occur at any time during the use of Fentanyl Transdermal System, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with Fentanyl Transdermal System. To reduce the risk of respiratory depression, proper dosing and titration of Fentanyl Transdermal System are essential . Overestimating the Fentanyl Transdermal System dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to Fentanyl Transdermal System, especially in children, can result in respiratory depression and death due to an overdose of fentanyl. Accidental Exposure. A considerable amount of active fentanyl remains in Fentanyl Transdermal System even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to Fentanyl Transdermal System. Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression that can result in death. Placing Fentanyl Transdermal System in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death. Improper disposal of Fentanyl Transdermal System in the trash has resulted in accidental exposures and deaths. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure to Fentanyl Transdermal System . Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life- threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Interactions with Central Nervous System Depressants Hypotension, profound sedation, coma, respiratory depression, and death may result if Fentanyl Transdermal System is used concomitantly with alcohol or other central nervous system (CNS) depressants (e. When considering the use of Fentanyl Transdermal System in a patient taking a CNS depressant, assess the duration use of the CNS depressant and the patient's response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient's use of alcohol or illicit drugs that cause CNS depression. If the decision to begin Fentanyl Transdermal System is made, reduce the starting dose, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant . Monitor such patients closely, particularly when initiating and titrating Fentanyl Transdermal System and when Fentanyl Transdermal System is given concomitantly with other drugs that depress respiration . Consider the use of alternative non- opioid analgesics in these patients if possible. Head Injuries and Increased Intracranial Pressure. Avoid use of Fentanyl Transdermal System in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma . In addition, opioids may obscure the clinical course of patients with head injury. Monitor patients with brain tumors who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with Fentanyl Transdermal System, as Fentanyl Transdermal System may reduce respiratory drive and CO2 retention can further increase intracranial pressure. Hypotensive Effects. Fentanyl Transdermal System may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e. Monitor these patients for signs of hypotension after initiating or titrating the dose of Fentanyl Transdermal System. Interactions with CYP3. A4 Inhibitors and Inducers Since the CYP3. A4 isoenzyme plays a major role in the metabolism of Fentanyl Transdermal System, drugs that alter CYP3. A4 activity may cause changes in clearance of fentanyl which could lead to changes in fentanyl plasma concentrations. The concomitant use of Fentanyl Transdermal System with a CYP3. A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, 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. Carefully monitor patients receiving Fentanyl Transdermal System and any CYP3. A4 inhibitor for signs of sedation and respiratory depression for an extended period of time, and make dosage adjustments as needed. CYP4. 50 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of fentanyl and, therefore, may cause increased clearance of the drug which could lead to a decrease in fentanyl plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to fentanyl. If co- administration is necessary, caution is advised when initiating Fentanyl Transdermal System treatment in patients currently taking, or discontinuing, CYP3. A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved . A clinical pharmacology study conducted in healthy adult subjects has shown that the application of heat over the Fentanyl Transdermal System increased fentanyl exposure . Monitor patients wearing Fentanyl Transdermal System systems who develop fever closely for opioid side effects and reduce the Fentanyl Transdermal System dose if necessary. Warn patients to avoid strenuous exertion that leads to increased core body temperature while wearing Fentanyl Transdermal System to avoid the risk of potential overdose and death. Cardiac Disease. Fentanyl Transdermal System may produce bradycardia. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with Fentanyl Transdermal System. Hepatic Impairment.
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