Consumer medicine information

1. Why am I using Mayne Pharma Oxycodone IR Tablets?

Mayne Pharma Oxycodone IR Tablets contain the active ingredient oxycodone hydrochloride. Oxycodone tablets are used to relieve pain where other treatment options are not able to effectively manage your pain or you cannot tolerate them. For more information, see Section 1. Why am I using Mayne Pharma Oxycodone IR Tablets? in the full CMI.

2. What should I know before I use Mayne Pharma Oxycodone IR Tablets?

Do not use if you have ever had an allergic reaction to oxycodone or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Mayne Pharma Oxycodone IR Tablets? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with oxycodone and affect how the tablets work. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Mayne Pharma Oxycodone IR Tablets?

The usual dose is ONE tablet every six hours. Swallow the tablet whole with a full glass of water. More instructions can be found in Section 4. How do I use Mayne Pharma Oxycodone IR Tablets? in the full CMI.

5. What should I know while using Mayne Pharma Oxycodone IR Tablets?

6. Are there any side effects?

Common side effects: dizziness, confusion, drowsiness, low blood pressure, constipation, vomiting and nausea. Serious side effects: difficulty or decreased frequency of passing urine, dry mouth, sweating, itchy rash, muscle stiffness, face redness, loss of appetite, faintness or feeling weak, abnormal or changes in heart rate, fall in blood pressure on standing, decrease in body temperature, restlessness, severe headache, changes of mood, constriction of pupils, unconsciousness, difficulty breathing, severe dizziness, drowsiness or disorientation and symptoms of allergy. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Mayne Pharma Oxycodone IR tablets should only be used in patients for whom other treatment options, including nonopioid 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. Mayne Pharma Oxycodone IR tablets pose 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 Mayne Pharma Oxycodone IR 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 Mayne Pharma Oxycodone IR tablets.

1 Name of Medicine

Oxycodone hydrochloride.

2 Qualitative and Quantitative Composition

Mayne Pharma Oxycodone IR tablets contain 5 mg oxycodone hydrochloride.
Excipients with known effect. Mayne Pharma Oxycodone IR tablets contain sugars as lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mayne Pharma Oxycodone IR tablets are white to off-white, round tablets. One side is plain, the other side is scored and the number "112" is debossed above the score bar.

4 Clinical Particulars

4.9 Overdose

Symptoms. Toxic doses of opioids vary considerably with the individual and regular users may tolerate large doses. Serious overdosage with oxycodone is characterised by respiratory depression and somnolence progressing to coma and skeletal muscle flaccidity. Toxic leukoencephalopathy has been observed with oxycodone overdose. Cardiac arrest and death may occur. Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage. Pulmonary oedema after overdosage is a common cause of fatalities among opiate addicts.
Treatment. Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. Therefore, an appropriate dose of naloxone (usual adult dose: 0.4 mg) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, only 10 to 20% of the usual initial dose of the antagonist should be administered.
In severe toxicity, the cardiovascular system is usually depressed and requires supportive treatment. If hypotension is due to vasodilatation, plasma expansion, or even vasopressors may be required. Additional measures include support of electrolyte balance, maintenance of normal temperature, catheterisation of the bladder to avoid distension and symptomatic treatment of itching, nausea, vomiting, headache and confusion during the recovery period.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Oxycodone was not mutagenic in the Ames Salmonella and Escherichia coli assays, but was positive in the mouse lymphoma assay. In assays of chromosomal damage, genotoxic effects occurred in the human lymphocyte chromosomal aberration assay in vitro, but not in the in vivo bone marrow micronucleus assay in mice.
Carcinogenicity. Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical name of oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular formula is C₁₈H₂₁NO₄.HCl and molecular weight is 351.9.
It has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOXYHCL.gif Oxycodone hydrochloride occurs as white to off white, odourless, crystals or powder. Oxycodone 1 g dissolves in 10 mL water. It is sparingly soluble in alcohol and nearly insoluble in ether.
CAS number. 124-90-3.

7 Medicine Schedule (Poisons Standard)

S8 (Controlled Drug).

Summary Table of Changes

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