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FDA新药信息
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Ionsys Iontophoretic Transdermal System Generic Name: fentanyl Date of Approval: May 23, 2006 Company: ALZA Corporation Treatment for: Acute Postoperative Pain -------------------------------------------------------------------------------- The US Food and Drug Administration (FDA) has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-activated analgesic system. Ionsys is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Ionsys is the first and only product to incorporate the proprietary E-TRANS(R) iontophoretic transdermal drug delivery system developed by ALZA. E-TRANS utilizes iontophoresis -- a process in which a low-intensity electric field, which is generally imperceptible to the patient, is used to rapidly transport fentanyl across the skin and into the circulatory system of the body. Ionsys securely adheres to the upper outer arm or chest, and provides patients an on-demand dose of fentanyl. Fentanyl is an opioid analgesic that has been used in the management of pain for more than 40 years. Ionsys is indicated for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia during hospitalization. Patients should be titrated to an acceptable level of analgesia before initiating treatment with Ionsys. Ionsys is not intended for home use and is, therefore, inappropriate for use in patients once they have been discharged from the hospital. It is not recommended for patients under the age of 18 years (see WARNINGS and PRECAUTIONS section of the full prescribing information). Unlike other methods of administering pain medications after surgery such as intravenous patient-controlled analgesia (IV PCA) pumps, which tether patients to an IV pole and equipment, Ionsys is compact, self-contained and needle-free. When pain medication is needed, the patient double-clicks the dosing button, which delivers a pre-programmed, 40mcg dose of fentanyl through the skin. Each dose is delivered over a 10-minute period. Patients should be titrated to comfort before initiating Ionsys. Ionsys should be applied to intact, non-irritated and non-irradiated skin on the chest or upper outer arm. Patients must have access to supplemental analgesia. Important Safety Information Ionsys should only be used for the treatment of hospitalized patients. Treatment with Ionsys should be discontinued before patients are discharged from the hospital. Treatment with fentanyl, the active component of Ionsys, may result in potentially life-threatening respiratory depression and death. To avoid potential overdosing, only the patient should activate Ionsys dosing. Inappropriate use of Ionsys leading to ingestion or contact with mucous membranes or unintended exposure to the fentanyl hydrogel could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with the fingers or mouth. Ionsys contains fentanyl, a potent opioid agonist and a Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Ionsys in situations where the Health Care Professional is concerned about an increased risk of misuse, abuse or diversion. After the maximum dosage administration, a significant amount of fentanyl remains in the device. Ionsys should always be kept out of reach of children. Ionsys is contraindicated in patients with known hypersensitivity to fentanyl, cetylpyridinium chloride, (e.g. Cepacol) or any components of the Ionsys system. Ionsys should be prescribed only by persons knowledgeable in the administration of potent opioids, and in the management of patients receiving potent opioids for treatment of pain. Patients treated with Ionsys should be under the supervision of medical personnel with expertise in the detection and management of hypoventilation, including airway management and the use of opioid antagonists. Since serum fentanyl concentrations decline gradually after system removal, patients who have experienced serious adverse events, including overdose, will require continued monitoring after removal of Ionsys. To avoid potential overdosing, only the patient should activate Ionsys. More than one Ionsys system should not be applied to a patient at the same time. If the fentanyl hydrogel becomes separated from the Ionsys system, contact can be harmful to humans and animals. If this happens during system removal use gloves or tweezers to remove the hydrogel from the skin and properly dispose of in accordance with state and federal regulations for controlled substances. The skin area that had been in contact with the hydrogel should be thoroughly flushed with water. Do not use soap, alcohol or other solvents to remove the hydrogel as they may enhance the drug's ability to penetrate the skin. In the event that the Ionsys system falls off, ensure that the entire Ionsys system (i.e. with hydrogel) is collected and properly disposed of. Prior to discharge from the hospital, medical personnel must remove the Ionsys system and dispose of it properly (see DOSAGE AND ADMINISTRATION, Disposal section of the full prescribing information). The most common (greater than 10%) adverse events reported in 2,114 patients treated with Ionsys 40mcg/dose including 3 Placebo-Controlled Trials and 4 Active Comparator Trials vs. IV PCA morphine, regardless of relationship to study medication, were nausea, vomiting, application site reaction- erythema, fever and headache. |
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2楼2006-06-03 15:44:43