- Approval Id
- e095104aeb491c9a
- Drug Name
- OXYCONTIN 20mg prolonged release tablets
- Product Name
- OXYCONTIN 20mg prolonged release tablets
- Approval Number
- SIN13078P
- Approval Date
- 2005-04-07
- Registrant
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Licence Holder
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Dosage
- **Administration and dosage**
**OxyContin® tablets 80 mg should only be used in opioid-tolerant patients.**
**OxyContin® tablets are to be swallowed whole, and are not to be broken, chewed or crushed. Taking broken, chewed or crushed OxyContin® tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone.**
_Adults, elderly and children over 18 years_: Prior to initiation and titration of doses, refer to the **Warnings and precautions** section for information on special risk groups such as females and the elderly – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
OxyContin® tablets should be taken at 12-hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements.
OxyContin® tablets are not intended for use as prn analgesic.
Increasing severity of pain will require an increased dosage of OxyContin® tablets using individual tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated, for a full 12 hours. There is no ceiling dose and so patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary, increases should be made, where possible, in 25% –50% increments. The need for escape medication more than twice a day indicates that the dosage of OxyContin® tablets should be increased.
The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg 12 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. For the majority of patients, the maximum dose is 200 mg 12 hourly.
However, a few patients may require higher doses. Doses in excess of 1000 mg daily have been recorded.
Patients receiving oral morphine before OxyContin® tablets therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of OxyContin® tablets required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that compared with younger adults the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.
_Children under 18 years_: Not recommended.
_Adults with mild to moderate renal impairment and mild hepatic impairment_: The plasma concentration in this population may be increased. Therefore, dose initiation should follow a conservative approach. Patients should be started on OxyContin® tablets 5 mg 12 hourly or OxyNorm® liquid 2.5 mg 6 hourly and titrated to pain relief as described above.
Patients receiving other oral oxycodone formulation may be transferred to OxyContin® tablets at the same total daily dosage, equally divided into two 12-hourly OxyContin® tablet doses.
For patients who are receiving an alternative opioid, the “oral oxycodone equivalent” of the analgesic presently being used should be determined. Having determined the total daily dosage of the present analgesic, the following equivalence table can be used to calculate the approximate daily oral oxycodone dosage that should provide equivalent analgesia. The total daily oral oxycodone dosage should then be equally divided into two 12 hourly OxyContin® tablet doses.
_Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Daily Dose of Oral Oxycodone\*_
(Mg/Day Prior Opioid x Factor = Mg/Day Oral Oxycodone)
**Oral Prior Opioid****Parenteral Opioid**Oxycodone1--Codeine0.15--Fentanyl TTSSEE BELOW\*\*SEE BELOW\*\*Hydromorphone420Pethidine0.10.4Methadone1.53Morphine0.53
\\* To be used for conversion to oral oxycodone. For patients receiving high-dose parenteral opioids, a more conservative conversion is warranted. For example, for high-dose parenteral morphine, use 1.5 instead of 3 as a multiplication factor.
\\*\\* Conversion from transdermal fentanyl to OxyContin® tablets: 18 hours following the removal of the transdermal fentanyl patch, OxyContin® tablets treatment can be initiated. Although there has been no systematic assessment of such conversion, a conservative oxycodone dose, approximately 10 mg q12h of OxyContin® tablets, should be initially substituted for each 25mcg/hr fentanyl transdermal patch. The patient should be followed closely.
_Use in non-malignant pain:_ Opiods are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals.
_Cessation of Therapy:_ When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
- Route Of Administration
- ORAL
- Indication Info
- **Indication**
The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.
- Contraindications
- **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, , elevated carbon dioxide levels in the blood, paralytic ileus, suspected surgical abdomen, acute abdomen, severe constipation, 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. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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.
- Atc Code
- N02AA05
- Atc Item Name
- oxycodone
- Pharma Manufacturer Name
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Company Detail Path
- /organization/mundipharma-pharmaceuticals-pte-ltd
