FDA label d611362d-3d75-2e57-e053-2995a90a40de

BOXED WARNING Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL to avoid dosing errors due to confusion between mg and mL, and other oxycodone ... WARNING: RISK OF MEDICATION ERRORS Take care when prescribing and administering Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. Keep Oxycodone Hydrochloride Oral Solution, USP out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

5. WARNINGS AND PRECAUTIONS 5.1 Risk of Medication Errors Use caution when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Use caution to ensure the dose is communicated clearly and dispensed accurately. Always use the enclosed calibrated measuring cup when administering Oxycodone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately. 5.2 Respiratory Depression Respiratory depression is the primary risk of Oxycodone Hydrochloride Oral Solution. Respiratory depression occurs most frequently in elderly or debilitated patients, and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation, or following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Use Oxycodone Hydrochloride Oral Solution with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Oxycodone Hydrochloride Oral Solution may increase airway resistance and decrease respiratory drive to the point of apnea. Consider alternative non-opioid analgesics, and use Oxycodone Hydrochloride Oral Solution only under careful medical supervision at the lowest effective dose in such patients. 5.3 Misuse and Abuse of Opioids Oxycodone Hydrochloride Oral Solution is a Schedule II controlled substance with an abuse liability similar to other opioids. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Oxycodone Hydrochloride Oral Solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone Hydrochloride Oral Solution in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse. Oxycodone Hydrochloride Oral Solution may be abused by injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death [see DRUG ABUSE AND DEPENDENCE (9.2) and OVERDOSAGE (10)]. Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product. 5.4 Interactions with Alcohol and Drugs of Abuse Oxycodone Hydrochloride Oral Solution may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, profound sedation, coma or death may result [see DRUG INTERACTIONS (7.1)]. 5.5 Use in Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of Oxycodone Hydrochloride Oral Solution and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, Oxycodone Hydrochloride Oral Solution can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. 5.6 Hypotensive Effect Oxycodone Hydrochloride Oral Solution may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or general anesthetics or other agents which compromise vasomotor tone. Oxycodone Hydrochloride Oral Solution may produce orthostatic hypotension in ambulatory patients. Administer Oxycodone Hydrochloride Oral Solution with caution in hypovolemic patients, such as those suffering acute myocardial infarction, because oxycodone may cause or further aggravate their hypotension. Administer Oxycodone Hydrochloride Oral Solution with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure. 5.7 Gastrointestinal Effects Do not administer Oxycodone Hydrochloride Oral Solution to patients with gastrointestinal obstruction, especially paralytic ileus because oxycodone hydrochloride diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction. The administration of Oxycodone Hydrochloride Oral Solution may obscure the diagnosis or clinical course in patients with acute abdominal condition. 5.8 Use in Pancreatic/Biliary Tract Disease Use Oxycodone Hydrochloride Oral Solution with caution in patients with biliary tract disease, including acute pancreatitis, as oxycodone hydrochloride may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions. 5.9 Special Risk Groups Use Oxycodone Hydrochloride Oral Solution with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients [see USE IN SPECIFIC POPULATIONS (8.5)] . Exercise caution in the administration of Oxycodone Hydrochloride Oral Solution to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens. All opioids may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings. Keep Oxycodone Hydrochloride Oral Solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately. 5.10 Driving and Operating Machinery Caution patients that oxycodone hydrochloride could impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients about the potential combined effects of Oxycodone Hydrochloride Oral Solution with other CNS depressants, including other opioids, phenothiazines, sedative/hypnotics and alcohol [see DRUG INTERACTIONS (7)]. 5.11 Cytochrome P450 3A4 Inhibitors and Inducers Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations. The expected clinical results with CYP3A4 inhibitors would be an increase in oxycodone plasma concentrations and possibly increased or prolonged opioid effects. The expected clinical results with CYP3A4 inducers would be a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration is necessary, caution is advised when initiating Oxycodone Hydrochloride Oral Solution treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved [see DRUG INTERACTIONS (7.4) and CLINICAL PHARMACOLOGY (12.3)]. 5.12 Seizures Oxycodone Hydrochloride Oral Solution may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

6. ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Respiratory depression [see Warnings and Precautions (5.2)] Seizures [see Warnings and Precautions (5.12)] Hypotension [see Warnings and Precautions (5.6)] Spasm of the sphincter of Oddi and increases in the serum amylase level [see Warnings and Precautions (5.8)] Serious adverse reactions that may be associated with oxycodone 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 Overdose (10.1) and Warnings and Precautions (5.1, 5.3)]. The less severe adverse events seen on initiation of therapy with oxycodone 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. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving immediate-release oxycodone, the following adverse events were recorded in oxycodone 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