Linked Life Data

OPANA ER (Tablet, Film Coated, Extended Release)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1299

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
OPANA ER (Tablet, Film Coated, Extended Release)
dailymed-instance:dosage
OPANA ER Tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER Tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone. Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone. OPANA ER is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine and other opioids. OPANA ER, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. OPANA ER tablets are to be swallowed whole, and are not to be broken, chewed, crushed or dissolved. Taking broken, chewed, crushed or dissolved OPANA ER tablets leads to the rapid release and absorption of a potentially fatal dose of oxymorphone. While symmetric (same dose AM and PM), around-the-clock, every 12 hours dosing is appropriate for the majority of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to their pain pattern. It is usually appropriate to treat a patient with only one extended-release opioid for around-the-clock therapy. Selection of patients for treatment with OPANA ER should be governed by the same principles that apply to the use of other extended-release opioid analgesics . As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Physicians should individualize treatment in every case , using non-opioid analgesics, prn opioids and/or combination products, and chronic opioid therapy in a progressiveplan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring . In the selection of the initial dose of OPANA ER, attention should be given to the following: The following dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient. OPANA ER should be administered on an empty stomach, at least one hour prior to or two hours after eating.<br/>Initiation of Therapy:<br/>Opioid-Na��ve Patients: It is suggested that patients who are not opioid-experienced being initiated on chronic around-the-clock opioid therapy be started with OPANA ER 5 mg every 12 hours. Thereafter, it is recommended that the dose be individually titrated, preferably at increments of 5-10 mg every 12 hours every 3-7 days, to a level that provides adequate analgesia and minimizes side effects under the close supervision of the prescribing physician .<br/>Opioid-Experienced Patients:<br/>Individualization of Dose: Once therapy is initiated, pain relief and other opioid effects should be frequently assessed. In clinical practice, titration of the total daily OPANA ER dose should be based upon the amount of supplemental opioid utilization, severity of the patient's pain, and the patient's ability to tolerate the opioid. Patients should be titrated to generally mild or no pain with the regular use of no more than two doses of supplemental analgesia, i.e.���rescue,���per 24 hours. If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this adjustment leads to inadequate analgesia, a supplemental dose of OPANA, another immediate-release opioid, or a non-opioid analgesic may be administered. Dose adjustments should be made to obtain an appropriate balance between pain relief and opioid-related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is achieved, the events should be treated aggressively. Once adverse events are under control, upward titration should continue to an acceptable level of pain control. During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient and the caregiver/family. Patients and caregivers/family members should be advised of the potential side effects.<br/>Patients with Hepatic Impairment: Patients with mild hepatic impairment should be started with the lowest dose and titrated slowly while carefully monitoring side effects. OPANA ER is contraindicated in patients with moderate and severe hepatic dysfunction .<br/>Patients with Renal Impairment: There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal impairment, respectively . Accordingly, in patients with creatinine clearance rate less than 50 mL/min, OPANA ER should be started with the lowest dose and titrated slowly while carefully monitoring side effects.<br/>Use with CNS Depressants: OPANA ER, like all opioid analgesics, should be started at 1/3 to 1/2 of the usual dose in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma mayresult. No specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate .<br/>Geriatrics: The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in young subjects . In general, caution should be exercised in the selection of the starting dose of OPANA ER for an elderly patient usually starting at the low end of the dosing range and slowly titrating to adequate analgesia.<br/>Maintenance of Therapy and Supplemental Analgesia: The intent of the titration period is to establish a patient-specific every 12 hours dose that will maintain adequate analgesia with acceptable side effects for as long as pain relief is necessary. During titration and before a stable dose is achieved, OPANA or other immediate-release medications can be used as supplemental analgesia between dosings. Should pain recur, the dose can be incrementally increased to re-establish pain control. The method of therapy adjustment outlined above should be employed to re-establish pain control. During chronic therapy with OPANA ER, the continued need for around-the-clock opioid therapy should be reassessed periodically.<br/>Cessation of Therapy: When the patient no longer requires therapy with OPANA ER tablets, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient .
dailymed-instance:activeIng...
dailymed-instance:activeMoi...
dailymed-instance:inactiveI...
dailymed-instance:genericMe...
Oxymorphone Hydrochloride
dailymed-instance:fullName
OPANA ER (Tablet, Film Coated, Extended Release)
dailymed-instance:indicatio...
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended for use as a prn analgesic. OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.
dailymed-instance:represent...
dailymed-instance:routeOfAd...
dailymed-instance:name
OPANA ER