OXYCONTIN® NEO CONTROLLED-RELEASE TABLETS 20 MG [SIN14885P]

Product Info

OXYCONTIN® NEO CONTROLLED-RELEASE TABLETS 20 MG

[SIN14885P]

Indications and usage

OxyContin® Neo is 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 OxyContin® Neo 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.

• OxyContin® Neo is not indicated as an as-needed (prn) analgesic

Dosage and administration

1. Initial Dosing

   OxyContin® Neo should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

   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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with OxyContin® Neo [see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

   OxyContin® Neo tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Crushing, chewing, or dissolving OxyContin® Neo tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

   Use of OxyContin® Neo as the First Opioid Analgesic

   Initiate treatment with OxyContin® Neo with one 10 mg tablet orally every 12 hours.

   Use of OxyContin® Neo in Patients who are not Opioid Tolerant

   The starting dose for patients who are not opioid tolerant is OxyContin® Neo 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 OxyContin® Neo

   Patients receiving other oral oxycodone formulations may be converted to OxyContin® Neo by administering one-half of the patient’s total daily oral oxycodone dose as OxyContin® Neo every 12 hours.

   Conversion from other Opioids to OxyContin® Neo

   Discontinue all other around-the-clock opioid drugs when OxyContin® Neo therapy is initiated.

   There are no established conversion ratios for conversion from other opioids to OxyContin® Neo defined by clinical trials. Discontinue all other around-the-clock opioid drugs when OxyContin® Neo therapy is initiated and initiate dosing using OxyContin® Neo 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 OxyContin® Neo

   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 OxyContin® Neo

   Eighteen hours following the removal of the transdermal fentanyl patch, OxyContin® Neo 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 OxyContin® Neo, should be initially substituted for each 25 mcg/hr fentanyl transdermal patch. Follow the patient closely during conversion from transdermal fentanyl to OxyContin® Neo, as there is limited documented experience with this conversion.

2. Titration and Maintenance of Therapy

   Individually titrate OxyContin® Neo to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OxyContin® Neo to assess the maintenance of pain control and the relative incidence of adverse reactions as well as monitoring for the development of addiction, abuse and misuse. 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. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.

   Patients who experience breakthrough pain may require a dose increase of OxyContin® Neo or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the OxyContin® Neo dose. Because steady-state plasma concentrations are approximated in 1 day, OxyContin® Neo dosage may be adjusted every 1 to 2 days. If unacceptable opioid-related adverse reactions are observed, the subsequent dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

   There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours. As a guideline, the total daily oxycodone dose usually can be increased by 25% to 50% of the current dose, each time an increase is clinically indicated.

3. Patients with Hepatic Impairment

   For patients with hepatic impairment, start dosing patients at 1/3 to 1/2 the usual starting dose followed by careful dose titration [see Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

4. Treatment goals and discontinuation of OxyContin® Neo

   Before initiating treatment with OxyContin® Neo, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

   Do not abruptly discontinue OxyContin® Neo.

5. Administration of OxyContin® Neo tablets

   Instruct patients to swallow OxyContin® Neo tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

   Instruct patients to take OxyContin® Neo one tablet at a time and with enough water to ensure complete swallowing immediately after placing in the mouth [see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Contraindications

Hypersensitivity to opioids and to any of the constituents or in any situation where opioids are contraindicated, acute respiratory depression, cor pulmonale, cardiac arrhythmias, severe bronchial asthma, chronic obstructive airways disease, paralytic ileus, suspected surgical abdomen, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance < 10ml/min), delayed gastric emptying, acute alcoholism, brain tumor, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for pre-operative use or for the first 24 hours post-operatively. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.