INDICATIONS AND USAGE ROXICODONE® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
CONTRAINDICATIONS ROXICODONE® is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. ROXICODONE® is contraindicated in any patient who has or is suspected of having paralytic ileus.
ADVERSE REACTIONS ROXICODONE® tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. ROXICODONE® tablets are associated with adverse experiences similar to those seen with other opioids. Serious adverse reactions that may be associated with ROXICODONE® therapy in clinical use are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSAGE , WARNINGS ). The less severe adverse events seen on initiation of therapy with ROXICODONE® are also typical opioid side effects. These events are dose dependent, and their frequency depends on the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent of these include nausea, constipation, vomiting, headache, and pruritus. In many cases the frequency of adverse events during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse events will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy. In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving ROXICODONE®, the following adverse events were recorded in ROXICODONE® treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. The following adverse experiences occurred in less than 3% of patients involved in clinical trials with oxycodone: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis. Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia. Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting. Hemic and Lymphatic: anemia and leukopenia. Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema. Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture. Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation. Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis. Skin and Appendages: herpes simplex, rash, sweating, and urticaria. Special Senses: amblyopia. Urogenital: urinary tract infection. Postmarketing Experience: Review of postmarketing reports showed the occurrence of the following adverse events: Cardiac disorders: myocardial ischemia and ventricular fibrillation with overdose General disorders and administrative site disorders: drug withdrawal syndrome neonatal Immune system disorders: anaphylactic reactions Respiratory, thoracic and mediastinal disorders: pharyngeal edema
Drug Interactions: Oxycodone is metabolized in part to oxymorphone via the cytochrome p450 isoenzyme CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. However, clinicians should be aware of this possible interaction. Neuromuscular Blocking Agents: Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Review of postmarketing reports has also shown that muscle relaxants, such as cyclobenzaprine, when used with oxycodone may potentially enhance serotonergic activity and result in the development of serotonin syndrome. CNS Depressants: Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ROXICODONE® may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of ROXICODONE®. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as ROXICODONE®. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of ROXICODONE® and/or may precipitate withdrawal symptoms in these patients. Monoamine Oxidase Inhibitors (MAOIs): MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of ROXICODONE® is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Review of postmarketing reports has also shown that MAOIs, such as phenelzine, when used with oxycodone may potentially enhance serotonergic activity and result in the development of serotonin syndrome. Other Antidepressants (Tricyclic Antidepressant or TCA, Serotonin-Norepinephrine Reuptake Inhibitor or SNRI and Selective Serotonin Reuptake Inhibitor or SSRI: Review of postmarketing reports has shown that other antidepressants, such as TCAs (e.g. doxepine), SSRIs (e.g. fluvoxamine) and SNRIs (e.g. duloxetine and venlafaxine), when used with oxycodone may potentially enhance serotonergic activity and result in the development of serotonin syndrome.