There are no adequate and well controlled studies of oxycodone in pregnant women. 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, should be observed closely for signs of respiratory depression.
A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate. Nursing Mothers Oxycodone has been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped.
Pediatric Use The safety and efficacy of oxycodone in pediatric patients have not been evaluated. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment Since oxycodone is extensively metabolized, its clearance may decrease in hepatic failure patients.
Dose initiation in patients with hepatic impairment should follow a conservative approach. Dosages should be adjusted according to the clinical situation. Renal Impairment Published data reported that elimination of oxycodone was impaired in end-stage renal failure. Mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Dose initiation should follow a conservative approach. The patient using this drug should be cautioned accordingly.
Supportive measures including oxygen and vasopressors should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. The narcotic antagonists, naloxone or nalmefene, are specific antidotes for opioid overdose. If needed the appropriate dose of naloxone hydrochloride or nalmefene should be administered simultaneously with efforts at respiratory resuscitation see package insert for each drug for the details.
Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Gastric emptying may be useful in removing unabsorbed drug. Opioid antagonists should be administered cautiously to persons who are suspected to be physically dependent on any opioid agonist, including oxycodone. In an individual physically dependent on opioids, administration of a usual dose of antagonist will precipitate an acute withdrawal.
The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed.
If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses.
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. Oxycodone, as the hydrochloride salt, is a pure agonist opioid whose principal therapeutic action is analgesia and has been in clinical use since Like all pure opioid agonists, there is no ceiling effect to analgesia, such as is seen with partial agonists or non-opioid analgesics.
Based upon a single-dose, relative-potency study conducted in humans with cancer pain, 10 to 15 mg of oxycodone given intramuscularly produced an analgesic effect similar to 10 mg of morphine given intramuscularly. Both drugs have a 3 to 4 hour duration of action. Oxycodone retains approximately one half of its analgesic activity when administered orally.
Effects on Central Nervous System The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.
A significant feature of opioid-induced analgesia is that it occurs without loss of consciousness. The relief of pain by morphine-like opioids is relatively selective, in that other sensory modalities, e. Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.
Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e. Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Effects on Gastrointestinal Tract And Other Smooth Muscle Oxycodone, like other opioid analgesics, produces some degree of nausea and vomiting which is caused by direct stimulation of the chemoreceptor trigger zone CTZ located in the medulla.
The frequency and severity of emesis gradually diminishes with time. Oxycodone may cause a decrease in the secretion of hydrochloric acid in the stomach that reduces motility while increasing the tone of the antrum, stomach, and duodenum.
Accidental Ingestion Accidental ingestion of even one dose of Oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of Oxycodone [see Warnings and Precautions 5. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions 5. In addition, discontinuation of a concomitantly used cytochrome P 3A4 inducer may result in an increase in Oxycodone plasma concentration.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions 5. Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation. Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Slideshow Oxycodone Dosage and Administration 2. Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions 5.
Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred.
This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient. Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone hydrochloride tablets, attention should be given to: Conversion from Other Opioids to Oxycodone Hydrochloride Tablets There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Oxycodone hydrochloride tablets.
If a patient has been receiving opioid-containing medications prior to taking Oxycodone hydrochloride tablets, the potency of the prior opioid relative to Oxycodone should be factored into the selection of the total daily dose TDD of Oxycodone. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of Oxycodone hydrochloride tablets may be necessary, especially in patients who have disease states that are changing rapidly.
If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of Oxycodone hydrochloride tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose Oxycodone hydrochloride tablets should be based upon the most recent dose of opioid as a baseline for further titration of Oxycodone.
Incremental increases should be gauged according to side effects to an acceptable level of analgesia. The relative bioavailability of Oxycodone hydrochloride tablets compared to extended-release Oxycodone is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Continually reevaluate patients receiving Oxycodone hydrochloride tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions 5.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Oxycodone hydrochloride tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
Do not abruptly discontinue Oxycodone hydrochloride tablets in a physically-dependent patient [see Warnings and Precautions 5. Significant respiratory depression [see Warnings and Precautions 5. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions 5. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions 5.
Warnings and Precautions 5. As an opioid, Oxycodone hydrochloride tablets exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence 9 ].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxycodone hydrochloride tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol abuse or addiction or mental illness e.
The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Oxycodone hydrochloride tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Oxycodone hydrochloride tablets along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Oxycodone hydrochloride tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drugs [see Patient Counseling Information 17 ].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Carbon dioxide CO2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Oxycodone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dosage increase.
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of Oxycodone hydrochloride tablets. To reduce the risk of respiratory depression, proper dosing and titration of Oxycodone hydrochloride tablets are essential [see Dosage and Administration 2 ].
Overestimating the Oxycodone hydrochloride tablets dosage when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental ingestion of even one dose of Oxycodone hydrochloride tablets, especially by children, can result in respiratory depression and death due to an overdose of Oxycodone.
Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly.
Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations 8. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Oxycodone hydrochloride tablets-treated patients may increase Oxycodone plasma concentrations and prolong opioid adverse reactions.
When using Oxycodone hydrochloride tablets with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Oxycodone hydrochloride tablets-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of Oxycodone hydrochloride tablets until stable drugs effects are achieved [see Drug Interactions 7 ].
Concomitant use of Oxycodone hydrochloride tablets with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease Oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to Oxycodone. When using Oxycodone hydrochloride tablets with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see Drug Interactions 7 ].
Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone.
Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions 7 ].
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise patients not to drive or operate dangerous machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions 7 , Patient Counseling Information 17 ].
Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Tolerance to the analgesic effects of opioids is usually paralleled by tolerance to side effects except for constipation. In descending order of frequency they were: Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of max contractions. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations 8. Pediatric Use The safety and efficacy of oxycodone in pediatric patients have not been evaluated, oxycodone t max. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions 5. Respiratory depression occurs most frequently in elderly or debilitated patients, oxycodone following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. These effects could be more pronounced with concomitant use of Oxycodone hydrochloride tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone hydrochloride tablets is achieved [see Warnings and Precautions 5, oxycodone t max. Drug addiction is a treatable max, utilizing a multi-disciplinary approach, but relapse is common. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. If concomitant use is necessary, consider dosage reduction of Oxycodone hydrochloride tablets until stable drug oxycodone are achieved.
Advise patients not to drive or operate dangerous machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as max seen with partial agonists or non-opioid analgesics. When discontinuing Oxycodone hydrochloride tablets in a physically-dependent patient, gradually taper the dosage [see Dosage and Max 2. Neonates, whose mothers received opioid analgesics during labor, should be observed closely for signs of respiratory depression. Other less frequently observed adverse reactions from opioid analgesics, including Oxycodone hydrochloride tablets included: Oxycodone retains approximately one half of its analgesic activity when administered orally. The narcotic antagonists, naloxone or nalmefene, are specific antidotes for opioid oxycodone. Since the duration of action of oxycodone may exceed that of the antagonist, oxycodone t max, the patient should be oxycodone under continued surveillance and repeated doses of the antagonist should be administered oxycodone needed to maintain adequate respiration, oxycodone t max. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: The potential for these risks should not, however, prevent the proper management of pain in any given patient. Oxycodone depresses the cough reflex max direct effect on the cough center oxycodone the medulla. Monitor max patients for signs of hypotension after initiating or titrating the dosage of Oxycodone hydrochloride tablets, oxycodone t max.
© Copyright 2017 Oxycodone t max - ROXICODONE (Oxycodone Hydrochloride Tablets USP) [Xanodyne Pharmaceuticals, Inc.] /01 CII Rx only. DESCRIPTION. ROXICODONE® (oxycodone hydrochloride tablets USP) is an opioid analgesic..