Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride capsule
Lannett Company, Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

A ddiction, Abuse, and Misuse

Oxycodone Hydrochloride Capsules expose patients and other users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk prior to prescribing Oxycodone Hydrochloride Capsules and monitor all patients regularly for the development of these behaviors and conditions. [see Warnings and Precautions ( 5.1 )].

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 REMS for these products [see Warnings and Precautions (5.2)] . 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

  • complete a REMS-compliant education program,

  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,

  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and

  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone Hydrochloride Capsules. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride Capsules or following a dose increase. [see Warnings and Precautions ( 5.3)] .

Acc idental Ingestion

Acc idental ingestion of even one dose of Oxycodone Hydrochloride Capsules, especially by children, can result in a fatal overdose of oxycodone. [see Warnings and Precautions (5.3)].

Ne onatal Opioid Withdrawal Syndrome

P r olonged use of Oxycodone Hydrochloride Capsules during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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 (5.4)].

C ytochrome P450 3A4 Interaction

The concomitant use of Oxycodone Hydrochloride Capsules with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone Hydrochloride Capsules and any CYP3A4 inhibitor or inducer. [see Warnings and Precautions (5.5), Drug Interactions (7), Clinical Pharmacology (12.3)].

R isks 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 (5.6 ) , Drug Interactions ( 7 )] .

  • Re serve concomitant prescribing of Oxycodone Hydrochloride Capsules and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • F ollow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS AND USAGE

Oxycodone Hydrochloride Capsules are an opioid agonist 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, even at recommended doses, [see Warnings and Precautions ( 5.1) ] , reserve Oxycodone Hydrochloride Capsules for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5) ] .

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 ( 5.1) ].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Oxycodone Hydrochloride Capsules and adjust the dosage accordingly [see Warnings and Precautions ( 5.3)] .

2.2 Initial Dosage

Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone Hydrochloride Capsules, attention must be given to:

1. the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously

2. the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed

3. the degree of opioid tolerance

4. the general condition and medical status of the patient, including the patient’s weight and age

5. the balance between pain management and adverse reactions

6. the type and severity of the patient’s pain

7. risk factors for abuse or addiction, including a prior history of abuse or addiction

Use of Oxycodone Hydrochloride Capsules as the First Opioid Analgesic

Initiate treatment with Oxycodone Hydrochloride Capsules in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. Titrate the dose based upon the individual patient’s response to their initial dose of Oxycodone Hydrochloride Capsules. 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.

For control of severe chronic pain, Oxycodone Hydrochloride Capsules should be administered on a regularly scheduled basis, every 4 to 6 hours, at the lowest dosage level that will achieve adequate analgesia.

Conversion from Other Opioids to Oxycodone Hydrochloride Capsules

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 Capsules. It is safer to underestimate a patient’s 24-hour Oxycodone Hydrochloride Capsules dosage than to overestimate the 24-hour Oxycodone Hydrochloride Capsules dosage and manage an adverse reaction due to overdose. If a patient has been receiving opioid-containing medications prior to taking Oxycodone Hydrochloride Capsules, 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 Hydrochloride Capsules, close observation and adjustment of dosage based upon the patient’s response to Oxycodone Hydrochloride Capsules is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of Oxycodone Hydrochloride Capsules may be necessary, especially in patients who have disease states that are changing rapidly.

Conversion from Oxycodone Hydrochloride Capsules to Extended-Release Oxycodone Hydrochloride

The relative bioavailability of Oxycodone Hydrochloride Capsules 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.

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