OPANA- oxymorphone hydrochloride tablet
Endo Pharmaceuticals Inc
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use OPANA® safely and effectively. See full prescribing information for OPANA®.OPANA® oxymorphone hydrochloride) tablets for Oral Use, CII
OPANA opens clients to dangers of dependence, misuse, and abuse, which can prompt overdose and passing. Survey patient’s hazard before recommending and screen normally for these practices and conditions.To guarantee that the advantages of narcotic analgesics exceed the dangers of compulsion, misuse, and abuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these items.Genuine, hazardous, or lethal respiratory gloom may happen. Screen intently, particularly upon inception or following a portion increment.Unplanned ingestion of OPANA, particularly by youngsters, can bring about a deadly overdose of oxymorphone.Drawn out utilization of OPANA during pregnancy can bring about neonatal narcotic withdrawal disorder, which might be dangerous if not perceived and treated. Whenever delayed narcotic use is required in a pregnant lady, inform the patient regarding the danger of neonatal narcotic withdrawal disorder and guarantee that proper treatment will be accessible.Train patients not to devour liquor or any item containing liquor while taking OPANA on the grounds that co-ingestion can bring about deadly plasma oxymorphone levels.Associative utilization of narcotics with benzodiazepines or other focal sensory system (CNS) depressants, including liquor, may bring about significant sedation, respiratory gloom, trance state, and demise. Hold accompanying endorsing for use in patients for whom elective treatment choices are insufficient; limit doses and spans to the base required; and pursue patients for signs and manifestations of respiratory gloom and sedation.
INDICATIONS AND USAGE
OPANA is a narcotic agonist showed for the administration of intense torment sufficiently extreme to require a narcotic pain relieving and for which elective medicines are lacking.Constraints of Use In light of the dangers of fixation, misuse, and abuse with narcotics, even at prescribed portions, hold OPANA for use in patients for whom elective treatment choices [e.g., non-narcotic analgesics or narcotic mix products]:Have not been endured, or are not expected to be endured,
DOSAGE AND ADMINISTRATION
Utilize the most reduced powerful dose for the briefest term reliable with singular patient treatment objectivesIndividualize dosing dependent on the seriousness of torment, understanding reaction, earlier pain relieving experience, and hazard factors for habit, misuse, and abuse.Start treatment with 10 to 20 mg orally every four to six hours.OPANA ought to be taken on a vacant stomach, in any event one hour before or two hours in the wake of eating.Transformation to OPANA: Follow suggestions for change from different narcotics or parenteral oxymorphone.Don’t unexpectedly cease OPANA in a physically reliant patient since quick stopping of narcotic analgesics has brought about genuine withdrawal manifestations, uncontrolled torment, and suicide.Mellow Hepatic Impairment: Initiate treatment with 5 mg and titrate gradually. Screen for indications of respiratory and focal sensory system discouragement.Renal Impairment: Initiate treatment with 5 mg and titrate gradually. Screen for indications of respiratory and focal sensory system despondency.Geriatric Patients: Initiate dosing with 5 mg, titrate gradually, and screen for indications of respiratory and focal sensory system despondency.CNS Depressants: Initiate treatment with 1/3 to 1/2 the prescribed beginning portion, consider utilizing a lower measurement of the accompanying CNS depressant, and screen intently.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg
Noteworthy respiratory despondencyIntense or extreme bronchial asthma in an unmonitored setting or without resuscitative hardwareKnown or suspected gastrointestinal hindrance, including crippled ileusKnown extreme touchiness to oxymorphone, some other fixings in OPANAModerate or serious hepatic weakness
WARNINGS AND PRECAUTIONS
Dangerous Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor intently, especially during inception and titration.Hypersensitivity, Angioedema, and Other Hypersensitivity Reactions: If side effects happen, stop organization promptly, cease forever, and don’t rechallenge with any oxymorphone plan.Adrenal Insufficiency: If analyzed, treat with physiologic substitution of corticosteroids, and wean persistent off of the narcotic.Extreme Hypotension: Monitor during dose inception and titration. Dodge utilization of OPANA in patients with circulatory stun.Dangers of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory despondency. Maintain a strategic distance from utilization of OPANA in patients with disabled awareness or extreme lethargie