OXYCODONE HCl (Page 3 of 12)

2.6 Dosage Modifications with Concomitant Use of Central Nervous System Depressants

If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin OXYCODONE HCl EXTENDED-RELEASE TABLETS, start with one-third to one-half the recommended starting dosage of OXYCODONE HCl EXTENDED-RELEASE TABLETS, consider using a lower dosage of the concomitant CNS depressant, and monitor patients for signs of respiratory depression, sedation, and hypotension [ see Warnings and Precautions ( 5.6), Drug Interactions ( 7) ].

2.7 Dosage Modifications in Geriatric Patients who are Debilitated and not Opioid-Tolerant

For geriatric patients who are debilitated and not opioid tolerant, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage cautiously [ see Use in Specific Populations ( 8.5) ].

2.8 Dosage Modifications in Patients with Hepatic Impairment

For patients with hepatic impairment, start dosing patients at one-third to one-half the recommended starting dosage and titrate the dosage carefully. Monitor for signs of respiratory depression, sedation, and hypotension [ see Use in Specific Populations, ( 8.6), Clinical Pharmacology ( 12.3) ].

2.9 Safe Reduction or Discontinuation of OXYCODONE HCl EXTENDED-RELEASE TABLETS

Do not abruptly discontinue OXYCODONE HCl EXTENDED-RELEASE TABLETS 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 EXTENDED-RELEASE TABLETS, there are a variety of factors that should be considered, including the dose of OXYCODONE HCl EXTENDEDRELEASE 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. For patients on OXYCODONE HCl EXTENDED-RELEASE TABLETS who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., 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, monitor 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 a long duration 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. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions ( 5.14), Drug Abuse and Dependence ( 9.3)].

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets: 10 mg, 20 mg, and 40 mg.

  • 10 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other)
  • 20 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other)
  • 40 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other)

4 CONTRAINDICATIONS

OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with:

  • Significant respiratory depression [ see Warnings and Precautions ( 5.3) ]
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions ( 5.7) ]
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions ( 5.12) ]
  • Hypersensitivity (e.g., anaphylaxis) to oxycodone [ see Adverse Reactions ( 6.2) ]

5 WARNINGS AND PRECAUTIONS

5.1 Addiction, Abuse, and Misuse

OXYCODONE HCl EXTENDED-RELEASE TABLETS contains oxycodone, a Schedule II controlled substance. As an opioid, OXYCODONE HCl EXTENDED-RELEASE TABLETS expose users to the risks of addiction, abuse, and misuse. Because extended-release products such as OXYCODONE HCl EXTENDED-RELEASE TABLETS deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present [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 EXTENDED-RELEASE TABLETS. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing OXYCODONE HCl EXTENDED-RELEASE TABLETS, and monitor all patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS for the development of these behaviors and conditions. 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.g., 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 EXTENDED-RELEASE TABLETS, but use in such patients necessitates intensive counseling about the risks and proper use of OXYCODONE HCl EXTENDED-RELEASE TABLETS along with intensive monitoring for signs of addiction, abuse, and misuse.
Abuse or misuse of OXYCODONE HCl EXTENDED-RELEASE TABLETS by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in overdose and death [ see Overdosage ( 10) ].
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 HCl EXTENDED-RELEASE 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 drug [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.

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