Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
oxycodone hydrochloride, Quantity: 60 mg
Mundipharma Pty Ltd
oxycodone hydrochloride
Tablet, modified release
Excipient Ingredients: polyethylene oxide; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; iron oxide black; macrogol 400
Oral
20, 28
(S8) Controlled Drug
OxyContin modified release tablet is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. OxyContin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. OxyContin modified release tablet is not indicated as an as-needed (PRN) analgesia.
Visual Identification: Round, unscored, red-coloured, bi-convex tablets debossed with ON (underscored) on one side and 60 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-10-22
OxyContin ® tablets (10mg, 15mg, 20mg, 30mg, 40mg, 80mg) 1 OxyContin ® tablets Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide) Consumer Medicine Information WARNING: Limitations of use OxyContin should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. Hazardous and harmful use OxyContin poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. Life threatening respiratory depression OxyContin can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting OxyContin and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. Use of other medicines while using OxyContin Using OxyContin with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using OxyContin. What is in this leaflet This leaflet answers some common questions about OxyContin tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read Read the complete document
OxyContin® Modified Release Tablets 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION – OXYCONTIN ® (OXYCODONE HYDROCHLORIDE) MODIFIED RELEASE TABLETS WARNINGS _LIMITATIONS OF USE _ Because of the risks associated with the use of opioids, OxyContin modified release tablets should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use). _HAZARDOUS AND HARMFUL USE _ OxyContin modified release tablets poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient’s risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4. Special Warnings and Precautions for Use). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life-threatening or fatal respiratory depression may occur with the use of OxyContin modified release tablets. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use). _CONCOMITANT _ _USE _ _OF _ _BENZODIAZEPINES _ _AND _ _OTHER _ _CENTRAL _ _NERVOUS _ _SYSTEM _ _(CNS) _ _DEPRESSANTS, INCLUDING ALCOHOL _ Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking OxyContin modified release tablet. 1 NAME OF THE MEDICINE Oxycodone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OxyCo Read the complete document