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Oxycodone Hydrochloride is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Oxycodone hydrochloride (HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Oxycodone HCl tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. 1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals.
Reserve titration to higher doses of oxycodone HCl tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. , the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.
Clinical guidelines on opioid prescribing for some acute pain conditions are available. 1) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying case and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse.
1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with oxycodone HCl tablets. Consider this risk when selecting an initial dose and when making dose adjustments.
2) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with oxycodone HCl tablets. Consider prescribing naloxone based on the patient’s risk factors for overdose.
3) Initiate treatment with oxycodone HCl tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of oxycodone HCl tablets.
4) Do not abruptly discontinue oxycodone HCl in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. 1 Important Dosage and Administration Instructions Oxycodone HCl tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of oxycodone HCl tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.
14) ] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. gov/medwatch. 1 Clinical Trials Experience 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.
Oxycodone HCl tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone HCl tablets are associated with adverse experiences similar to those seen with other opioids. Serious adverse reactions associated with oxycodone HCl use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
The common adverse reactions seen on initiation of therapy with oxycodone HCl are dose related and are typical opioid-related adverse reactions. The most frequent of these included nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
The frequency of these reactions depended on several factors, including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving oxycodone HCl, the following adverse events were recorded in oxycodone HCl treated patients with an incidence ≥ 3%.
In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of oxycodone.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 4) ] Respiratory, thoracic and mediastinal disorders: pharyngeal edema Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs [see Drug Interactions (7) ] .
5 WARNINGS AND PRECAUTIONS Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation.
7) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate closely, particularly during initiation and titration. 8) Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
9) Severe Hypotension: Regularly evaluate during dosage initiation and titration. Avoid use of oxycodone HCl in patients with circulatory shock. 10) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression.
Avoid use of oxycodone HCl tablets in patients with impaired consciousness or coma. 1 Addiction, Abuse, and Misuse Oxycodone HCl tablets contains oxycodone, a Schedule II controlled substance. As an opioid, oxycodone HCl 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 HCl. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone HCl, and reassess all patients receiving oxycodone HCl for the development of these behaviors and conditions.
, major depression). 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 HCl, but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone HCl along with frequent reevaluation for signs of addiction, abuse, and misuse.
2) ]. 8) ]. 12) ] . 2) ] . Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus.
( 4 ) Hypersensitivity to oxycodone. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available.
There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. 1) ] . Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with oxycodone HCl tablets.
Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5) ] . 3) ] . , by prescription, directly from a pharmacist, or as part of a community-based program). Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose.
3) ] . Consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose . 3 Initial Dosage Although it is not possible to list every condition that is important to the selection of the initial dose of oxycodone HCl tablets, attention must be given to: the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously.
the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed. the degree of opioid tolerance. the general condition and medical status of the patient, including the patient’s weight and age. the balance between pain management and adverse reactions.
the type and severity of the patient’s pain. risk factors for abuse or addiction, including a prior history of abuse or addiction. Use of Oxycodone HCl Tablets as the First Opioid Analgesic Initiate treatment with oxycodone HCl tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia.
Titrate the dose based upon the individual patient’s response to their initial dose of oxycodone HCl tablets. Conversion from Other Opioids to Oxycodone HCl 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 HCl tablets. It is safer to underestimate a patient’s 24-hour oxycodone HCl tablets dosage than to overestimate the 24-hour oxycodone HCl tablets dosage and manage an adverse reaction due to overdose.
If a patient has been receiving opioid-containing medications prior to taking oxycodone HCl tablets, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to oxycodone HCl tablets close observation and adjustment of dosage based upon the patient’s response to oxycodone HCl tablets are imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of oxycodone HCl tablets may be necessary, especially in patients who have disease states that are changing rapidly.
Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic.
If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of oxycodone HCl 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 HCl 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. Conversion from Oxycodone HCl Immediate-Release Tablets to Extended-Release Oxycodone The relative bioavailability of oxycodone HCl immediate-release tablets compared to extended-release oxycodone is unknown, so conversion to extended-release oxycodone may lead to increased risk of excessive sedation and respiratory depression.
4 Titration and Maintenance of Therapy Individually titrate oxycodone HCl tablets to a dose that provides adequate analgesia and minimizes adverse reactions. 14) ] . Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the oxycodone HCl tablets dosage. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [see Warnings and Precautions (5) ] .
Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 5 Safe Reduction or Discontinuation of Oxycodone HCl Tablets Do not abruptly discontinue oxycodone HCl in patients who may be physically dependent on opioids.
Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking oxycodone HCl, there are a variety of factors that should be considered, including the total daily dose of opioid (including oxycodone HCl tablets) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder.
Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients.
Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. , no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.
Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge.
Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time, and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
3) ] .
9) ] .
Anaphylaxis:
Anaphylactic reaction has been reported with ingredients contained in oxycodone HCl tablets [see Contraindications (4) ] . 2) ] . 7) ] .
Hypoglycemia:
Cases of hypoglycemia have been reported in patients taking opioids. , diabetes).
2) ] . Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing oxycodone HCl. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and on the proper disposal of unused drugs.
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. 2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10) ] .
Carbon dioxide (CO 2 ) 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 HCl, the risk is greatest during the initiation of therapy or following a dosage increase.
To reduce the risk of respiratory depression, proper dosing and titration of oxycodone HCl are essential [see Dosage and Administration (2) ] . Overestimating the oxycodone HCl 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 HCl, especially by children, can result in respiratory depression and death due to an overdose of oxycodone. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. 5) ] . Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxycodone HCl.
, by prescription, directly from a pharmacist, or as part of a community-based program). Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information (17) ] .
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient.
Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose. 3) , Overdosage (10) ] . , non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids).
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.
Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). 2) , Overdosage (10) ] . Advise both patients and caregivers about the risks of respiratory depression and sedation when oxycodone HCl is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs).
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) ] .
4 Neonatal Opioid Withdrawal Syndrome Use of oxycodone HCl for an extended period of time during pregnancy can result in withdrawal in the neonate. 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. 1) ] . 5 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to do all of the following:
Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.
Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. gov/OpioidAnalgesicREMSPCG. Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.
Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. com. gov/OpioidAnalgesicREMSBlueprint. 3) ] , particularly when an inhibitor is added after a stable dose of oxycodone HCl is achieved.
Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in oxycodone HCl-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions. When using oxycodone HCl with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in oxycodone HCl-treated patients, evaluate patients at frequent intervals and consider dosage reduction of oxycodone HCl until stable drugs effects are achieved [see Drug Interactions (7) ] .
Concomitant use of oxycodone HCl 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 HCl with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, evaluate patients 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) ] .
7 Opioid-Induced Hyperalgesia and Allodynia Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. 3)] . Symptoms of OIH include (but may not be limited to) increased levels of pain upon opioid dosage increase, decreased levels of pain upon opioid dosage decrease, or pain from ordinarily non-painful stimuli (allodynia).
These symptoms may suggest OIH only if there is no evidence of underlying disease progression, opioid tolerance, opioid withdrawal, or addictive behavior. Cases of OIH have been reported, both with short-term and longer-term use of opioid analgesics.
Though the mechanism of OIH is not fully understood, multiple biochemical pathways have been implicated. Medical literature suggests a strong biologic plausibility between opioid analgesics and OIH and allodynia. 14) ] . 8 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of oxycodone HCl in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
2) ] . 2) ] . 3) , Drug Interactions (7) ] . Alternatively, consider the use of non-opioid analgesics in these patients. 9 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
10 Severe Hypotension Oxycodone HCl may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. , phenothiazines or general anesthetics) [see Drug Interactions (7) ] . Regularly evaluate these patients for signs of hypotension after initiating or titrating the dosage of oxycodone HCl.
In patients with circulatory shock, use of oxycodone HCl may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid use of oxycodone HCl in patients with circulatory shock. , those with evidence of increased intracranial pressure or brain tumors), oxycodone HCl may reduce the respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure.
Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with oxycodone HCl. Opioids may obscure the clinical course in a patient with a head injury. Avoid the use of oxycodone HCl in patients with impaired consciousness or coma.
12 Risks of Use in Patients with Gastrointestinal Conditions Oxycodone HCl is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. The oxycodone in oxycodone HCl tablets may cause spasm of the sphincter of Oddi.
Opioids may cause increases in serum amylase. Regularly evaluate patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. 13 Increased Risk of Seizures in Patients with Seizure Disorders The oxycodone in oxycodone HCl may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Regularly evaluate patients with a history of seizure disorders for worsened seizure control during oxycodone HCl therapy. 14 Withdrawal Do not abruptly discontinue oxycodone HCl in a patient physically dependent on opioids. When discontinuing oxycodone HCl in a physically dependent patient, gradually taper the dosage.
3) ] . , buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including oxycodone HCl. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions (7) ] .
15 Risks of Driving and Operating Machinery Oxycodone HCl may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of oxycodone HCl and know how they will react to the medication [see Patient Counseling Information (17) ] .