"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Respiratory depression is the primary risk of OXECTA. Respiratory depression occurs more frequently in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration (e.g., benzodiazepines, tricyclic antidepressants, and sedative-hypnotics).
OXECTA must be used with extreme caution in patients with 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 OXECTA may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids must be employed only under careful medical supervision at the lowest effective dose.
Misuse and Abuse of Opioids
OXECTA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone HC1 in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse.
OXECTA may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death [see Drug Abuse and Dependence].
Concerns about abuse and addiction 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 misuse of this product.
Central Nervous System Depressants
Patients receiving narcotic analgesics, general anesthetics, phenothiazines, benzodiazepines, other tranquilizers, sedative-hypnotics, or other central nervous system depressants concomitantly with OXECTA may exhibit an additive central nervous system 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 OXECTA. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Patients should not consume alcoholic beverages, or any medications containing alcohol while taking OXECTA.
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 OXECTA and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, OXECTA can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.
OXECTA may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted intravascular volume, or after concurrent administration with drugs such as phenothiazines, general anesthetics or other agents which compromise vasomotor tone. OXECTA may produce orthostatic hypotension in ambulatory patients. OXECTA must be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
Do not administer OXECTA to patients with gastrointestinal obstruction, especially paralytic ileus because oxycodone HC1 diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction.
The administration of OXECTA may obscure the diagnosis or clinical course in patients with acute abdominal condition.
Use in Pancreatic/Biliary Tract Disease
Special Risk Groups
Use OXECTA 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].
Exercise caution in the administration of OXECTA 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 OXECTA out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.
Driving and Operating Machinery
OXECTA may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating heavy machinery. The patient using OXECTA must be cautioned accordingly [see DRUG INTERACTIONS].
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 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 and CLINICAL PHARMACOLOGY].
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies of oxycodone HC1 to evaluate its carcinogenic potential have not been conducted.
Oxycodone HC1 was genotoxic in an in vitro mouse lymphoma assay in the presence of metabolic activation. There was no evidence of genotoxic potential in an in vitro bacterial reverse mutation assay (Salmonella typhimurium and Escherichia coli) and in an assay for chromosomal aberrations (in vivo mouse bone marrow micronucleus assay).
Impairment of Fertility
The potential effects of oxycodone on male and female fertility have not been evaluated.
Use In Specific Populations
Pregnancy Category B: There are no adequate and well-controlled studies of oxycodone use during pregnancy. Based on limited human data in the literature, oxycodone does not appear to increase the risk of congenital malformations. Animal reproduction studies have not revealed evidence of teratogenicity or fetal harm. Because animal reproduction studies are not always predictive of human response, OXECTA should be used during pregnancy only if clearly needed.
Reproduction studies in Sprague-Dawley rats and New Zealand rabbits revealed that when oxycodone was administered orally at doses up to 16 mg/kg and 25 mg/kg (approximately 2 and 5 times the daily oral dose of 90 mg on a mg/m2 basis) respectively, it was not teratogenic or embryo-fetal toxic.
Neonates whose mothers have taken oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.
Labor and Delivery
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. OXECTA is not recommended for use in women during or immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. Neonates, whose mothers received opioid analgesics during labor, must be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, must be available for reversal of narcotic-induced respiratory depression in the neonate.
Low levels of oxycodone have been detected in maternal milk. The amount of oxycodone delivered to the infant depends on the plasma concentration of the mother, the amount of milk ingested by the infant, and the extent of first-pass metabolism. There is potential for serious adverse reactions in nursing infants from oxycodone that includes respiratory depression, sedation and potentially withdrawal symptoms when the mother stops taking oxycodone HC1. As such, one should consider either discontinuing nursing or discontinuing the drug, while taking into account the importance of the drug to the mother.
The safety, effectiveness, and pharmacokinetics of OXECTA in pediatric patients below the age of 18 have not been established.
Elderly patients (aged 65 years or older) may have increased sensitivity to OXECTA. Use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease, and use of other drug therapy.
Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Follow a conservative approach to initiate dosing in patients with hepatic impairment. Monitor patients closely and adjust the dose based on clinical response [see DOSAGE AND ADMINISTRATION].
Information from oxycodone HC1 indicates that patients with renal impairment (defined as a creatinine clearance < 60 mL/min) had higher plasma concentrations of oxycodone than subjects with normal renal function. Use a conservative approach to initiate dosing in patients with renal impairment. Monitor patients closely and adjust the dose based on clinical response [see DOSAGE AND ADMINISTRATION].
Last reviewed on RxList: 8/1/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Oxecta Information
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