Oxycodone Hydrochloride

OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated, extended release
Par Pharmaceutical, Inc.

WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse
OXYCODONE HCL EXTENDED-RELEASE TABLETS expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OXYCODONE HCL EXTENDED-RELEASE TABLETS and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions ( 5.1 )].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCODONE HCL EXTENDED-RELEASE TABLETS. Monitor for respiratory depression, especially during initiation of OXYCODONE HCL EXTENDED-RELEASE TABLETS or following a dose increase. Instruct patients to swallow OXYCODONE HCL EXTENDED-RELEASE TABLETS tablets whole; crushing, chewing, or dissolving OXYCODONE HCL EXTENDED-RELEASE TABLETS tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions ( 5.2 )] .
Accidental Ingestion
Accidental ingestion of even one dose of OXYCODONE HCL EXTENDED-RELEASE TABLETS, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions ( 5.2 )] .
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OXYCODONE HCL EXTENDED-RELEASE TABLETS 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 ( 5.3 )] .
Cytochrome P450 3A4 Interaction
The concomitant use of OXYCODONE HCL EXTENDED-RELEASE TABLETS with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects 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 HCL EXTENDED-RELEASE TABLETS and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.14 ) and Clinical Pharmacology ( 12.3 )] .

1 INDICATIONS AND USAGE

OXYCODONE HCL EXTENDED-RELEASE TABLETS are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve OXYCODONE HCL EXTENDED-RELEASE TABLETS for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • OXYCODONE HCL EXTENDED-RELEASE TABLETS are not indicated as an as-needed (prn) analgesic

2 DOSAGE AND ADMINISTRATION

2.1 Initial Dosing

OXYCODONE HCL EXTENDED-RELEASE TABLETS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

OXYCODONE HCL EXTENDED-RELEASE TABLETS 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

Initiate the dosing regimen for each patient individually, taking into account the patient’s 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 with OXYCODONE HCL EXTENDED-RELEASE TABLETS [see Warnings and Precautions ( 5.2 )].

OXYCODONE HCL EXTENDED-RELEASE TABLETS must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see Patient Counseling Information ( 17 )] . Crushing, chewing, or dissolving OXYCODONE HCL EXTENDED-RELEASE TABLETS will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions ( 5.1 )] .

Use of OXYCODONE HCL EXTENDED-RELEASE TABLETS as the First Opioid Analgesic
Initiate treatment with OXYCODONE HCL EXTENDED-RELEASE TABLETS with one 10 mg tablet orally every 12 hours.
Use of OXYCODONE HCL EXTENDED-RELEASE TABLETS in Patients who are not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is OXYCODONE HCL EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

Conversion from other Oral Oxycodone Formulations to OXYCODONE HCL EXTENDED-RELEASE TABLETS

Patients receiving other oral oxycodone formulations may be converted to OXYCODONE HCL EXTENDED-RELEASE TABLETS by administering one-half of the patient’s total daily oral oxycodone dose as OXYCODONE HCL EXTENDED-RELEASE TABLETS every 12 hours.

Conversion from other Opioids to OXYCODONE HCL EXTENDED-RELEASE TABLETS
Discontinue all other around-the-clock opioid drugs when OXYCODONE HCL EXTENDED-RELEASE TABLETS therapy is initiated.
There are no established conversion ratios for conversion from other opioids to OXYCODONE HCL EXTENDED-RELEASE TABLETS defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OXYCODONE HCL EXTENDED-RELEASE TABLETS therapy is initiated and initiate dosing using OXYCODONE HCL EXTENDED-RELEASE TABLETS 10 mg orally every 12 hours.
It is safer to underestimate a patient’s 24-hour oral oxycodone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral oxycodone requirements which could result in adverse reactions. While useful tables of opioid equivalents are readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products.
Conversion from Methadone to OXYCODONE HCL EXTENDED-RELEASE TABLETS
Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

Conversion from Transdermal Fentanyl to OXYCODONE HCL EXTENDED-RELEASE TABLETS

Eighteen hours following the removal of the transdermal fentanyl patch, OXYCODONE HCL EXTENDED-RELEASE TABLETS treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg every 12 hours of OXYCODONE HCL EXTENDED-RELEASE TABLETS, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OXYCODONE HCL EXTENDED-RELEASE TABLETS, as there is limited documented experience with this conversion.

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