OXYCONTIN® NEO CONTROLLED-RELEASE TABLETS 40 MG

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED, EXTENDED RELEASE

**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. _**OxyContin® Neo**_ 60 mg and 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 \[see Warnings and Precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. 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. Discontinuation of _**OxyContin® Neo**_ When the patient no longer requires therapy with _**OxyContin® Neo**_ tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically-dependent patient. 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 **\[** see **Warnings and Precautions** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ **\].**