Duragesic Patch Defect Recall. Yet another Duragesic. A division of Ortho- Mc. Neil Janssen Pharmaceuticals named Pri. Cara voluntarily recalled two lots of 5. Duragesic. The recall was conducted . Food and Drug Administration). Potential leaks in the fentanyl reservoir were the reason for this latest recall. Defective Duragesic. The manufacturer of the Duragesic. Some of the fentanyl may have leaked into the pouches in which the patches were packaged. Deadly Risks Direct exposure to fentanyl can be extremely hazardous. Fentanyl is one of the strongest painkillers available . Fentanyl Transdermal official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.That's why 'microgram' doses are used rather than milligrams. A patient or a caregiver removing the packaging for a defective Duragesic. Soon thereafter, all lots of fentanyl- containing transdermal patches were recalled in the U. S. Each year, over a billion dollars in sales of Duragesic. Over four million prescriptions for Duragesic? If so, contact us to speak with a Duragesic. Let us help you win the compensation you need and deserve.
13, 2008 -- Certain prescription skin patches containing the painkiller fentanyl are being recalled because of possible overdose risk. The voluntary recall applies to the following products. FDA Video: Fentanyl (Duragesic) Patches Recalled. FDA MedWatch Safety Alert. Fentanyl transdermal system CII Patches. Johnson & Johnson Duragesic Fentanyl Patch Recall Lawsuit. Fentanyl Transdermal - FDA prescribing information, side effects and uses. Fentanyl Transdermal system is indicated for the management of pain in opioid- tolerant patients, severe enough to require daily, around- the- clock, long- term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid- tolerant are those who are taking, for one week or longer, at least 6. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended- release opioid formulations, reserve Fentanyl Transdermal system for use in patients for whom alternative treatment options (e. Fentanyl Transdermal Dosage and Administration. Initial Dosing. Fentanyl Transdermal system should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Due to the risk of respiratory depression, Fentanyl Transdermal system is only indicated for use in patients who are already opioid- tolerant. Discontinue or taper all other extended- release opioids when beginning Fentanyl Transdermal system therapy. As Fentanyl Transdermal system is only for use in opioid- tolerant patients, do not begin any patient on Fentanyl Transdermal system as the first opioid. Patients considered opioid- tolerant are those who are taking at least 6. Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse . Monitor patients closely for respiratory depression, especially within the first 2. Fentanyl Transdermal system when serum concentrations from the initial patch will peak . As such, it is preferable to underestimate a patient’s 2. In a Fentanyl Transdermal system clinical trial, patients were converted from their prior opioid to Fentanyl Transdermal system using Table 1 as a guide for the initial Fentanyl Transdermal system dose. Consider the following when using the information in Table 1: This is not a table of equianalgesic doses. The conversion doses in this table are only for the conversion from one of the listed oral or parenteral opioid analgesics to Fentanyl Transdermal system. The table cannot be used to convert from fentanyl to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose. To convert patients from oral or parenteral opioids to Fentanyl Transdermal system, use Table 1. Do not use Table 1 to convert from Fentanyl Transdermal system to other therapies because this conversion to Fentanyl Transdermal system is conservative and will overestimate the dose of the new agent. Table 1. 1: DOSE CONVERSION TO Fentanyl Transdermal SYSTEMCurrent Analgesic. Daily Dosage (mg/day)Oral morphine. Intramuscular or Intravenous morphine. Oral oxycodone. 30- 6. Oral codeine. 15. Oral hydromorphone. Intravenous hydromorphone. Intramuscular meperidine. Oral methadone. 20- 4. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Fentanyl Patch Recall. Are you taking Fentanyl? The FDA has not yet determined if the fatal Fentanyl overdose risks are the product of a drug defect or the incorrect use of this powerful narcotic. Overdosage of the new analgesic agent is possible . Calculate the previous 2. Convert this amount to the equianalgesic oral morphine dose using a reliable reference. Refer to Table 2 for the range of 2. Fentanyl Transdermal system dose. Use this table to find the calculated 2. Fentanyl Transdermal system dose. Initiate Fentanyl Transdermal system treatment using the recommended dose and titrate patients upwards (no more frequently than 3 days after the initial dose and every 6 days thereafter) until analgesic efficacy is attained. Do not use Table 2 to convert from Fentanyl Transdermal system to other therapies because this conversion to Fentanyl Transdermal system is conservative and will overestimate the dose of the new agent. Table 2. 1: RECOMMENDED INITIAL Fentanyl Transdermal SYSTEM DOSE BASED UPON DAILY ORAL MORPHINE DOSEOral 2. Morphine (mg/day)Fentanyl Transdermal System. Dose (mcg/hour)6. NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to Fentanyl Transdermal system. Table 2 should not be used to convert from Fentanyl Transdermal system to other therapies because this conversion to Fentanyl Transdermal system is conservative. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible . In patients with mild to moderate hepatic impairment, 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 . In patients with mild to moderate renal impairment, 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 . Continually reevaluate patients receiving Fentanyl Transdermal system to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics. The dosing interval for Fentanyl Transdermal system is 7. Do not increase the Fentanyl Transdermal system dose for the first time until at least 3 days after the initial application. Titrate the dose based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application. It may take up to 6 days for fentanyl levels to reach equilibrium on a new dose . Therefore, evaluate patients for further titration after no less than two 3- day applications before any further increase in dosage is made. Base dosage increments on the daily dosage of supplementary opioids, using the ratio of 4. Fentanyl Transdermal system dose. If unacceptable opioid- related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid- related adverse reactions. A small proportion of adult patients may not achieve adequate analgesia using a 7. An increase in the Fentanyl Transdermal system dose should be evaluated before changing dosing intervals in order to maintain patients on a 7. Dosing intervals less than every 7. Administration of Fentanyl Transdermal System. Fentanyl Transdermal system patches are for transdermal use, only. Proper handling of Fentanyl Transdermal system is necessary in order to prevent serious adverse outcomes, including death, associated with accidental secondary exposure to Fentanyl Transdermal system. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of Fentanyl Transdermal system application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application. Patients should apply Fentanyl Transdermal system immediately upon removal from the sealed package. The patch must not be altered (e. Fentanyl Transdermal system should not be used if the blister seal is broken or if the patch is cut or damaged. The transdermal system is pressed firmly in place with the palm of the hand for 3. Each Fentanyl Transdermal system patch may be worn continuously for 7. The next patch is applied to a different skin site after removal of the previous transdermal system. If problems with adhesion of the Fentanyl Transdermal system patch occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing. If the patch falls off before 7. A new patch may be applied to a different skin site. Patients (or caregivers who apply Fentanyl Transdermal system) should wash their hands immediately with soap and water after applying Fentanyl Transdermal system. Contact with unwashed or unclothed application sites can result in secondary exposure to Fentanyl Transdermal system and should be avoided. Examples of accidental exposure include transfer of a Fentanyl Transdermal system patch from an adult’s body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver’s skin to the medication in the patch while applying or removing the patch. Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom Fentanyl Transdermal system was not prescribed. Avoidance of Heat. Instruct patients to 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, sunbathing, hot baths, saunas, hot tubs, and heated water beds, while wearing the system . Upon system removal, 1. Withdrawal symptoms are possible in some patients after conversion or dose adjustment . It is not known at what dose level Fentanyl Transdermal system may be discontinued without producing the signs and symptoms of opioid withdrawal. Dosage Forms and Strengths. Fentanyl Transdermal system is available as: Fentanyl Transdermal System 1. Fentanyl Transdermal System 2. Fentanyl Transdermal System 5. Fentanyl Transdermal System 7. Fentanyl Transdermal System 1. This lowest dosage is designated as 1. Contraindications.
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