- Approval Id
- ff7883e0cf742c19
- Drug Name
- OXYNORM® Oral Solution 1mg/ml
- Product Name
- OXYNORM® Oral Solution 1mg/ml
- Approval Number
- SIN14125P
- Approval Date
- 2012-03-28
- Registrant
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Licence Holder
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- **Posology and method of administration**
_Route of administration:_
Oral
_Post-operative pain:_
In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.
_Elderly and adults over 18 years:_
_**OxyNorm**_ ® oral solutions should be taken at 4–6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.
Increasing severity of pain will require an increased dosage of **_OxyNorm_** ® oral solutions. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this.
_**OxyNorm**_ ® oral solutions will generally be used in a short term trial (4–6 weeks) to determine if the pain is opioid responsive, before transferring to a longer acting oxycodone preparation such as **_OxyContin_** ® tablets, in accordance with the clinical guidelines on the use of opioid analgesics in such patients.
The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4–6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.
Patients receiving oral morphine before oxycodone 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 _**OxyNorm**_ ® oral solutions 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.
_Adults with mild to moderate renal impairment and mild hepatic impairment:_
The plasma concentration in this patient population may be increased. Therefore, dose initiation should follow a conservative approach (refer Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Children under 18 years:_
_**OxyNorm**_ ® oral solutions should not be used in patients under 18 years.
_Use in non-malignant pain:_
Opioids 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
- **Therapeutic Indication**
The management of acute exacerbation of moderate to severe chronic pain unresponsive to non-narcotic analgesia, and post-operative pain.
- Contraindications
- **Contraindications**
Hypersensitivity to oxycodone or to any of the excipients listed in section _‘Pharmaceutical Particulars’_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, cor pulmonale, acute abdomen, severe chronic obstructive lung disease, cor pulmonale, elevated carbon dioxide levels in the blood, cardiac arrhythmias, severe bronchial asthma, chronic bronchial asthma or other chronic obstructive airways disease, elevated carbon dioxide levels in the blood, paralytic ileus, suspected surgical abdomen, moderate to severe hepatic impairment, severe renal impairment (creatinine clearance < 10 mL/min), delayed gastric emptying, acute alcoholism, brain tumor, increased cerebrospinal or intracranial pressure, head injury, severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, chronic constipation, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Not recommended for pre-operative use.
- Atc Code
- N02AA05
- Atc Item Name
- oxycodone
- Pharma Manufacturer Name
- MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
- Company Detail Path
- /organization/mundipharma-pharmaceuticals-pte-ltd
