The official health care professional site of Mylan Fentanyl Transdermal System (TDS). Find dosage and comparison information. Read Important Safety Information. 12, 25, 50, 75,100 micrograms/hour. Mezolar Matrix 37.5 microgram/hour transdermal patch - Summary of Product Characteristics (SPC) by Sandoz Limited. Fentanyl Transdermal Patch: learn about side effects, dosage, special precautions, and more on MedlinePlus. This Guidance should be used in conjunction with the Summary of Product Characteristics (SmPC) for the particular brand of fentanyl patch being used. Duragesic (Fentanyl Transdermal) Drug Information: Warnings and Precautions. Addiction, Abuse, And Misuse. DURAGESIC contains fentanyl, an opioidagonist and a. Schedule II controlled substance. ![]() The patch is fentanyl the strongest family of opiates we have.It will blow away oxycontin and percocet.The patch will take a little while to get in to your system. Learn about indications, dosage and how it is supplied for the drug Duragesic (Fentanyl Transdermal). Q: I was prescribed fentanyl patch (25) for excruciating back pain, but after reading all of the side effects from the included pamphlet, I am actually afraid to use it. I've been on a Fentanyl patch for the past 9 years. I went from 175mcg/hr down to 12.5 mcgs then 5 days ago I stopped cold turkey. I don't take any other drugs except. As an opioid, DURAGESIC exposes users to the. As. modified- release products such as DURAGESIC deliver the opioid over an extended. Although the risk of addiction in any individual is. DURAGESIC and in. Addiction can occur at recommended doses. Assess each patient's risk for opioid addiction, abuse. DURAGESIC, and monitor all patients receiving. DURAGESIC for the development of these behaviors or conditions. Risks are. increased in patients with a personal or family history of substance abuse. Patients at increased. DURAGESIC. but use in such patients necessitates intensive counseling about the risks and. DURAGESIC along with intensive monitoring for signs of addiction. Abuse or misuse of DURAGESIC by placing it in the mouth. Consider these risks when prescribing or dispensing DURAGESIC. Contact local state. Life- Threatening Respiratory Depression. Serious, life- threatening, or fatal respiratory. Respiratory depression from opioid use, if not immediately. Management of. respiratory depression may include close observation, supportive measures, and. While serious. life- threatening, or fatal respiratory depression can occur at any time during. DURAGESIC, the risk is greatest during the initiation of therapy or following. Closely monitor patients for respiratory depression when. DURAGESIC. To reduce the risk of respiratory depression, proper. DURAGESIC are essential . Overestimating the DURAGESIC dose when converting patients. Accidental exposure to DURAGESIC, especially in children. Accidental Exposure. A considerable amount of active fentanyl remains in. DURAGESIC even after use as directed. Death and other serious medical problems. DURAGESIC. Placing DURAGESIC in the. Improper disposal of. DURAGESIC in the trash has resulted in accidental exposures and deaths. Advise patients about strict adherence to the recommended. DURAGESIC . Neonatal opioid withdrawal syndrome, unlike. If opioid use is required for a prolonged period in a. Neonatal opioid withdrawal syndrome presents as. The onset, duration, and. Interactions With Central Nervous System Depressants. Hypotension, profound sedation, coma, respiratory. DURAGESIC is used concomitantly with. CNS) depressants (e. When considering the use of DURAGESIC in a patient taking. CNS depressant, assess the duration use of the CNS depressant and the. CNS. depression. Additionally, evaluate the patient's use of alcohol or illicit. CNS depression. If the decision to begin DURAGESIC is made. CNS depressant . Consider. Head Injuries And Increased Intracranial Pressure. Avoid use of DURAGESIC in patients who may be. CO2 retention such as. In addition, opioids may obscure. Monitor patients with brain. CO2 retention for. DURAGESIC, as DURAGESIC may reduce respiratory drive and CO2. Hypotensive Effects. DURAGESIC may cause severe hypotension including. There is an. increased risk in patients whose ability to maintain blood pressure has already. CNS depressant drugs (e. Monitor these patients for signs of hypotension. DURAGESIC. Interactions With CYP3. A4 Inhibitors And Inducers. Since the CYP3. A4 isoenzyme plays a major role in the. DURAGESIC, drugs that alter CYP3. A4 activity may cause changes in. The concomitant use of DURAGESIC with a CYP3. A4 inhibitors. (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin. Carefully. monitor patients receiving DURAGESIC and any CYP3. A4 inhibitor for signs of. CYP4. 50 inducers, such as rifampin, carbamazepine, and. If co- administration is necessary, caution is advised. DURAGESIC treatment in patients currently taking, or. CYP3. A4 inhibitors or inducers. Evaluate these patients at. Warn patients to avoid. DURAGESIC to avoid the risk of potential overdose and death. Cardiac Disease. DURAGESIC may produce bradycardia. Monitor patients with. DURAGESIC. Hepatic Impairment. A clinical pharmacology study with DURAGESIC in patients. Because of the long half- life of fentanyl when administered as. DURAGESIC and hepatic metabolism of fentanyl, avoid use of DURAGESIC in. Insufficient information exists to. DURAGESIC in patients. Therefore, to avoid starting patients with mild. DURAGESIC. Closely monitor for signs of sedation and. Because of the long. DURAGESIC, avoid the use of. DURAGESIC in patients with severe renal impairment. Insufficient information. DURAGESIC in. patients with impaired renal function. Therefore, to avoid starting patients. DURAGESIC. Closely monitor for signs of sedation. DURAGESIC may cause increases in the serum amylase. Avoidance Of Withdrawal. Avoid the use of mixed agonist/antagonist (i. DURAGESIC. In these patients, mixed. Driving And Operating Machinery. Strong opioid analgesics impair the mental or physical. Warn patients not to drive or operate. DURAGESIC. Patient Counseling Information. Advise the patient to read the FDA- approved patient labeling (Medication Guide and Instructions for Use). Addiction, Abuse, And Misuse. Inform patients that the use of DURAGESIC, even when. Instruct. patients not to share DURAGESIC with others and to take steps to protect. DURAGESIC from theft or misuse. Life- Threatening Respiratory Depression. Inform patients of the risk of life- threatening. DURAGESIC or when the dose is increased, and that it can occur even at. Advise patients how to. Accidental Exposure. Inform patients to keep DURAGESIC in a secure place out. Instruct patients to contact their healthcare provider if they. Instruct patients to: avoid strenuous exertion that can increase body. DURAGESIC application site and. Driving Or Operating Heavy Machinery. DURAGESIC may impair mental and/or physical ability. Instruct patients to refrain from any potentially. DURAGESIC or when their dose is being adjusted. Pregnancy. Advise women of childbearing potential who become, or are. DURAGESIC. Additive Effects Of Alcohol And Other CNS Depressants. Instruct patients not to use alcohol or other CNS. To properly dispose of a used patch, instruct. Unused patches should be removed. Instruct patients to dispose of any patches remaining. Nonclinical Toxicology. Carcinogenesis, Mutagenesis, And Impairment Of Fertility. Carcinogenesis. In a two- year carcinogenicity study conducted in rats. In the. male fertility study, male rats were treated with fentanyl (0, 0. In the female fertility study, female rats were. Analysis of fertility parameters in both studies. In a separate study, a single daily bolus dose of fentanyl. Use In Specific Populations. Pregnancy. Clinical Considerations. Fetal/neonatal Adverse Reactions. Prolonged use of opioid analgesics during pregnancy for. Observe newborns. DURAGESIC should be used during. The potential effects of fentanyl on embryo- fetal. Published. literature reports that administration of fentanyl (0, 1. There was no clear evidence of teratogenicity noted. Pregnant female New Zealand White rabbits were treated. Fentanyl produced a slight decrease in the body weight of. Transient neonatal muscular. The potential effects of fentanyl on prenatal and. Female Wistar rats were treated. Fentanyl treatment (0. Both the mid- dose and high- dose of fentanyl animals. The. mid- dose and the high- dose are 0. DURAGESIC is not for use in women during and. Opioid analgesics can prolong labor through actions. However, this effect is not consistent and may be offset by an. Nursing Mothers. Fentanyl is excreted in human milk; therefore, DURAGESIC. Pediatric Use. The safety of DURAGESIC was evaluated in three open- label. Starting doses of 2. Initiation of DURAGESIC therapy in pediatric. The safety and effectiveness of DURAGESIC in children. To guard against excessive exposure to DURAGESIC by young. DURAGESIC. application and disposal instructions . Other reported clinical experience has not. In. general, dose selection for an elderly patient should be cautious, usually. Data from intravenous studies with fentanyl suggest that. A study conducted with the DURAGESIC patch in elderly. A clinical pharmacology study with. DURAGESIC in patients with cirrhosis has shown that systemic fentanyl exposure. Because there is in- vitro and in- vivo evidence of. DURAGESIC, hepatic impairment. DURAGESIC. A clinical pharmacology study with. Avoid the use of DURAGESIC in patients with severe renal impairment. FENTANYL Transdermal System. WARNING: ADDICTION, ABUSE, and MISUSE; LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P4. A4 INTERACTION, and EXPOSURE TO HEATSee full prescribing information for complete boxed warning. Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. Serious, life- threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl. Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life- threatening if not recognized and treated. 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. Initiation of CYP 3. A4 inhibitors (or discontinuation of CYP 3. A4 inducers) can result in a fatal overdose of fentanyl from fentanyl transdermal system. Avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Temperature dependent increases in fentanyl release from the system may result in overdose and death. Fentanyl transdermal system patches are for transdermal use, only. Proper handling and disposal of fentanyl transdermal system is necessary in order to prevent serious adverse outcomes, including death, associated with accidental secondary exposure to fentanyl transdermal system. Contraindications. Fentanyl transdermal system is contraindicated in the following patients and situations due to the risk of fatal respiratory depression. Severe hypersensitivity reactions, including anaphylaxis have been observed with fentanyl transdermal system. 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 (i. Use in Elderly, Cachectic, and Debilitated Patients Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting, or altered clearance. Therefore, monitor these patients closely, particularly when initiating therapy with fentanyl transdermal system and when given in conjunction with other drugs that depress respiration. Chronic Pulmonary Disease Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre- existing respiratory depression for respiratory depression, particularly when initiating therapy with fentanyl transdermal system, as in these patients, even usual therapeutic doses of fentanyl transdermal system may decrease respiratory drive to the point of apnea. 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 as fentanyl transdermal system may reduce respiratory drive and CO2 retention can further increase intracranial pressure. Opioids may obscure the clinical course of patients with head injury. 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 (i. Monitor these patients for signs of hypotension after initiating or titrating the dose of fentanyl transdermal system. 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. Avoid use of fentanyl transdermal system in patients with severe hepatic impairment. To avoid starting patients with mild to moderate hepatic impairment on too high of a dose, start with one half of the usual dosage of fentanyl transdermal system. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase. Renal Impairment Avoid the use of fentanyl transdermal system in patients with severe renal impairment. To avoid starting patients with mild to moderate renal impairment on too high of a dose, start with one half of the usual dosage of fentanyl transdermal system. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase. Use in Pancreatic/Biliary Tract Disease Fentanyl transdermal system may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis for worsened symptoms. Fentanyl transdermal system may cause increases in the serum amylase concentration. Avoidance of Withdrawal. Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and shivering) are possible in some patients after conversion to another opioid or when decreasing or discontinuing fentanyl transdermal system. Gradual reduction of the dose of fentanyl transdermal system is recommended. Driving and Operating Machinery Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of the fentanyl transdermal system. Adverse Reactions Most common adverse reactions (. Drug Interactions Mixed agonist/antagonist and partial agonist opioid analgesics: Avoid use with fentanyl transdermal system because they may reduce analgesic effect of fentanyl transdermal system or precipitate withdrawal symptoms. Avoid use of fentanyl transdermal system in the patient who would require the concomitant administration of a monoamine oxidase (MAO) inhibitor, or within 1. MAO inhibitors has been reported with opioid analgesics. Use In Specific Populations Pregnancy: Based on animal data, may cause fetal harm. Nursing Mothers: Breast- feeding is not advised in mothers treated with fentanyl transdermal system. Pediatric Use: Safety and efficacy in pediatric patients below the age of 2 years have not been established. To guard against accidental ingestion by children, use caution when choosing the application site for fentanyl transdermal system. Geriatric Use: Administer fentanyl transdermal system with caution, and in reduced dosages in elderly patients. Hepatic or Renal Impairment: Administer fentanyl transdermal system with caution. Monitor for signs of fentanyl toxicity and reduce dosage, if necessary. Click here for full Prescribing Information, including Boxed WARNING, Instructions for Use and Medication Guide.
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