Consumer medicine information

Mayne Pharma Oxycodone IR Tablets

Oxycodone hydrochloride

BRAND INFORMATION

Brand name

Mayne Pharma Oxycodone IR Tablets

Active ingredient

Oxycodone hydrochloride

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Mayne Pharma Oxycodone IR Tablets.

What is in this leaflet

This leaflet answers some common questions about Mayne Pharma Oxycodone IR 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 oxycodone 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 it again.

What Oxycodone is used for

Oxycodone belongs to a group of medicines called narcotic analgesics. Narcotic analgesics are used to relieve pain.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Oxycodone can be addictive. If used for a long time Oxycodone may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Oxycodone is available only with a doctor's prescription.

Before you take Oxycodone Tablets

When you must not take it

Do not take Oxycodone Tablets if you have an allergy to:

  • any medicine containing oxycodone hydrochloride
  • any of the ingredients listed at the end of this leaflet.
  • any other similar medicines known as narcotic analgesics e.g. morphine, codeine, opium.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine during pregnancy or during breastfeeding. It may cause difficulty in breathing in an unborn or newborn child.

Women who are pregnant, planning to become pregnant or who are breastfeeding should discuss this with their doctor.

Do not give this medicine to children. There is not enough information available to recommend the use of Oxycodone in children.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • muscle weakness
  • underactive thyroid
  • kidney disease
  • liver disease
  • low blood pressure
  • if a male, prostate problems or difficulty passing urine
  • bowel disorders

It may not be safe for you to take Oxycodone if you have these conditions. Your doctor will need to consider all these factors when advising you about taking Oxycodone.

If you have not told your doctor about any of the above, tell him/her before you start taking Oxycodone.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Oxycodone may interfere with each other. These include:

  • anaesthetics
  • medicines used to thin the blood
  • medicines used to treat epilepsy
  • medicines used to help with sleeping
  • blood pressure lowering medicines
  • medicines used to treat mental health problems
  • medicines used to treat anxiety or depression
  • medicines used to treat 'flu' symptoms
  • pain relievers
  • medicines used to relieve stomach cramps or spasms
  • (example) warfarin, a medicine used to prevent blood clots

These medicines and alcohol may be affected by Oxycodone or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Oxycodone.

How to take Oxycodone Tablets

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The usual dose is ONE tablet every six hours.

Your doctor may prescribe a different dose for you. Be sure to follow your doctor's directions about when and how to take Oxycodone.

How to take it

Swallow the tablet whole with a full glass of water.

When to take it

Oxycodone should be taken after meals or with milk.

How long to take it

The length of treatment will depend on your condition. Your doctor will advise you when to stop taking Oxycodone Tablets.

If you forget to take it

If it is less than 2-3 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Oxycodone. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include feeling sleepy and/or difficulty in breathing which could lead to unconsciousness and loss of muscle control. Your heart may stop and death may occur.

While you are using Oxycodone Tablets

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Oxycodone.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must not do

Do not take Oxycodone to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you have been taking this medicine for a long period of time and stop taking it suddenly, you may have unwanted side effects such as withdrawal symptoms. If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.

Things to be careful of

Be careful driving or operating machinery until you know how Oxycodone affects you. This medicine may cause dizziness, light-headedness, tiredness, drowsiness in some people. It may affect alertness. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Oxycodone.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dizziness, light headedness, confusion
  • drowsiness
  • low blood pressure
  • constipation
  • vomiting
  • nausea

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • difficulty passing urine
  • decreased frequency of passing urine
  • dry mouth
  • sweating
  • itchy rash
  • muscle stiffness
  • redness of the face
  • loss of appetite
  • faintness or feeling weak
  • slow, abnormal or fast heart rate
  • fall in blood pressure on standing
  • decrease in body temperature
  • restlessness
  • severe headache due to increased pressure within the head
  • changes of mood
  • constriction of pupils.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • unconsciousness
  • inability to breathe properly
  • severe dizziness, drowsiness or disorientation
  • symptoms of allergy (e.g. itchy skin rash, skin blisters or discolouration of skin upon exposure to sunlight).

The above list includes serious side effects. You may need urgent medical attention or hospitalisation. These side effects are uncommon.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

High doses of Oxycodone can cause unconsciousness, heart failure, low blood pressure and an inability to breathe properly.

In long term use, physical dependence and tolerance may develop and the following withdrawal symptoms may be observed after Oxycodone is discontinued:

  • body aches
  • loose bowel motions or diarrhoea
  • loss of appetite
  • nervousness
  • restlessness
  • runny nose
  • sneezing
  • shivering
  • stomach cramps
  • nausea
  • trouble with sleeping
  • an increase in sweating and yawning
  • weakness
  • fast heart rate
  • unexplained fever

These symptoms are mild if withdrawal from Oxycodone is gradual once it is no longer needed.

After using Oxycodone Tablets

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Oxycodone or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

White to off-white, round tablet. One side is plain, the other side is scored and debossed "112".

The tablets come in packs of 10 and 20.

Ingredients

Mayne Pharma Oxycodone IR tablets contain 5 mg of oxycodone hydrochloride as the active ingredient.

  • Lactose monohydrate
  • microcrystalline cellulose
  • maize starch
  • Sodium starch glycollate type A
  • Stearic acid
  • Silicon dioxide

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer

Mayne Pharma Oxycodone IR tablets are distributed in Australia by:

Mayne Pharma International Pty Ltd
1538 Main North Rd
Salisbury South, SA, 5106

This leaflet was prepared in August 2020

AUST R 225335

CMI Version Number: 2.0


Published by MIMS October 2020

BRAND INFORMATION

Brand name

Mayne Pharma Oxycodone IR Tablets

Active ingredient

Oxycodone hydrochloride

Schedule

S8

 

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

4.1 Therapeutic Indications

Mayne Pharma Oxycodone IR is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

4.2 Dose and Method of Administration

Usual adult dose.

5 mg every six hours, preferably after meals or with milk. Do not divide the tablet.
It may be necessary to increase the usual dose in cases of more severe pain or in those who have become tolerant of narcotics.
In patients with hepatic and renal impairment, dosage should be reduced and adjusted according to the clinical situation (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Hypersensitivity to opiate narcotics, severe respiratory disease, acute respiratory disease, respiratory depression, cor pulmonale, cardiac arrhythmias, bronchial asthma, acute alcoholism, brain tumour, head injuries, increased cerebrospinal or intracranial pressure, severe CNS depression, convulsive disorders, delirium tremens, suspected surgical abdomen and concomitant MAOIs or within 14 days of such therapy.

4.4 Special Warnings and Precautions for Use

Hazardous and harmful use.

Mayne Pharma Oxycodone IR contains the opioid oxycodone hydrochloride and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Mayne Pharma Oxycodone IR at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Mayne Pharma Oxycodone IR.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal). Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal.
Patients should be advised not to share Mayne Pharma Oxycodone IR with anyone else.

Respiratory depression.

Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Mayne Pharma Oxycodone IR but the risk is greatest during initiation of therapy or following an increase in dose. Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients, in patients with hepatic and renal impairment (see Section 4.4 Special Warnings and Precautions for Use, Use in hepatic and renal impairment) and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma). Opioids should be used with caution and with close monitoring in these patients (see Section 4.2 Dose and Method of Administration). The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).
The risk of respiratory depression is greater with the use of high doses of opioids, especially high potency and modified release formulations, and in opioid naïve patients. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate release to modified release formulations, together with consideration of pharmacological differences between opioids. Consider starting the new opioid at a reduced dose to account for individual variation in response.
Oxycodone should be used with extreme caution in patients with head injuries and raised intracranial pressure as respiratory depression and ability to increase CSF pressure may be exaggerated, thereby complicating the clinical course.

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Mayne Pharma Oxycodone IR with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Mayne Pharma Oxycodone IR concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Mayne Pharma Oxycodone IR.

Use of opioids in chronic (long-term) non-cancer pain (CNCP).

Opioid analgesics have an established role in the treatment of acute pain, cancer pain and palliative and end of life care. Current evidence does not generally support opioid analgesics in improving pain and function for most patients with chronic non-cancer pain. The development of tolerance and physical dependence and risks of adverse effects, including hazardous and harmful use, increase with the length of time a patient takes an opioid. The use of opioids for long-term treatment of CNCP is not recommended.
The use of an opioid to treat CNCP should only be considered after maximised nonpharmacological and non-opioid treatments have been tried and found ineffective, not tolerated or otherwise inadequate to provide sufficient management of pain. Opioids should only be prescribed as a component of comprehensive multidisciplinary and multimodal pain management.
Opioid therapy for CNCP should be initiated as a trial in accordance with clinical guidelines and after a comprehensive biopsychosocial assessment has established a cause for the pain and the appropriateness of opioid therapy for the patient (see Hazardous and harmful use, above). The expected outcome of therapy (pain reduction rather than complete abolition of pain, improved function and quality of life) should be discussed with the patient before commencing opioid treatment, with agreement to discontinue treatment if these objectives are not met.
Owing to the varied response to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose and titrated to achieve an adequate level of analgesia and functional improvement with minimum adverse reactions. Immediate-release products should not be used to treat chronic pain, but may be used for a short period in opioid-naïve patients to develop a level of tolerance before switching to a modified-release formulation. Careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment. Discontinue opioid therapy if there is no improvement of pain and/or function during the trial period or if there is any evidence of misuse or abuse. Treatment should only continue if the trial has demonstrated that the pain is opioid responsive and there has been functional improvement. The patient's condition should be reviewed regularly, and the dose tapered off slowly if opioid treatment is no longer appropriate (see Ceasing opioids).

Tolerance, dependence and withdrawal.

Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence. Tolerance is the need for increasing doses to maintain analgesia. Tolerance may occur to both the desired and undesired effects of the opioid.
Physical dependence, which can occur after several days to weeks of continued opioid usage, results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced. Withdrawal symptoms can also occur following the administration of an opioid antagonist (e.g. naloxone) or partial agonist (e.g. buprenorphine). Withdrawal can result in some or all of the following symptoms: dysphoria, restlessness/agitation, lacrimation, rhinorrhoea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, increasing pain, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, increased blood pressure, increased respiratory rate and increased heart rate.
When discontinuing Mayne Pharma Oxycodone IR in a person who may be physically-dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually (see Ceasing opioids; see Section 4.2 Dose and Method of Administration).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Mayne Pharma Oxycodone IR, especially by children, can result in a fatal overdose of oxycodone hydrochloride. Patients and their caregivers should be given information on safe storage and disposal of unused Mayne Pharma Oxycodone IR (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Hyperalgesia.

Hyperalgesia may occur with the use of opioids, particularly at high doses. Hyperalgesia may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain. Hyperalgesia should not be confused with tolerance (see Tolerance, dependence and withdrawal). If opioid induced hyperalgesia is suspected, the dose should be reduced and tapered off if possible. A change to a different opioid may be required.

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms and uncontrolled pain (see Tolerance, dependence and withdrawal). Such symptoms may lead the patient to seek other sources of licit or illicit opioids. Opioids should not be ceased abruptly in a patient who is physically dependent but withdrawn by tapering the dose slowly. Factors to take into account when deciding how to discontinue or decrease therapy include the dose and duration of the opioid the patient has been taking, the type of pain being treated and the physical and psychological attributes of the patient. A multimodal approach to pain management should be in place before initiating an opioid analgesic taper. During tapering, patients require regular review and support to manage any increase in pain, psychological distress and withdrawal symptoms.
There are no standard tapering schedules suitable for all patients and an individualised plan is necessary. In general, tapering should involve a dose reduction of no more than 10 percent to 25% every 2 to 4 weeks. If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to go back to the previous dose until stable before proceeding with a more gradual taper.
When ceasing opioids in a patient who has a suspected opioid use disorder, the need for medication assisted treatment and/or referral to a specialist should be considered.

Hypotension.

Administration of oxycodone may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of such drugs as phenothiazines or certain anaesthetics. Oxycodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Use in other disorders.

Opioid analgesics should be used with caution in patients with myasthenia gravis.
The euphoric activity of opioid compounds has led to their abuse. It should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with obstructive bowel disorders.

Use in hepatic and renal impairment.

The plasma concentration of oxycodone may be increased in patients with hepatic or renal impairment. Therefore, dosage in such patients should be reduced and adjusted according to the clinical situation.

Use in the elderly.

Oxycodone should be administered with caution, and in reduced dosages, to elderly or debilitated patients.

Paediatric use.

Oxycodone should not be administered to children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Generally, the effects of oxycodone may be antagonised by acidifying agents, and potentiated by alkalising agents.
Concurrent administration of oxycodone with anticholinergic agents may result in an increased risk of severe constipation and/or urinary retention.
Oxycodone may potentiate hypotensive effects when used concurrently with antihypertensive agents, especially ganglionic blockers, leading to increased risk of orthostatic hypotension.
Concurrent use of oxycodone with CNS depressants (including but not limited to other opioid agonist analgesics, sedative hypnotics, general anaesthetics, phenothiazines, tricyclics antidepressants and alcohol) may result in increased respiratory depression, hypotension, profound sedation or coma due to increased CNS depressant, respiratory depressant and hypotensive effects. Because of these risks, concomitant prescribing of oxycodone with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids such as pregabalin, cannabis, sedatives, hypnotics, anxiolytics, tricyclic antidepressants, antipsychotics, neuroleptics, phenothiazines, other tranquillisers, antihistamines (including hydroxyzine), centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).
Intake of alcoholic beverages while being treated with oxycodone should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression. Oxycodone hydrochloride containing products should be avoided in patients with a history of or present alcohol, drug or medicines abuse.
Mixed agonist/ antagonist analgesics (including pentazocine, butorphanol, buprenorphine) may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms. Naloxone, naltrexone antagonize the analgesic, CNS, and respiratory depressant effects of oxycodone and precipitate withdrawal symptoms. Dosage of the antagonist agents should be carefully titrated when used to treat opioid overdosage in dependent patients.
Oxycodone hydrochloride is metabolised in the intestine and liver to form noroxycodone and oxymorphone via cytochrome P450 isoenzymes of the CYP3A4 and CYP2D6, respectively. Metabolic interactions with drugs that involve the cytochrome P450 enzyme system (CYP3A4, CYP2D6) can cause the plasma concentration of oxycodone to increase. Quinidine, which is a potent CYP2D6 inhibitor, has blocked the formation of oxymorphone, while the oxycodone concentration increased marginally. Concurrent administration of quinidine does not alter the pharmacodynamic effects of oxycodone. The metabolic pathway may be blocked by various drugs (e.g. cimetidine, certain cardiovascular drugs and antidepressants), although such blockade has not yet been shown to be of clinical significance with oxycodone. The potential effects of oxycodone on CYP enzymes have not been studies either in vitro or in vivo.
Oxycodone may antagonize the effects of metoclopramide on gastrointestinal motility.
Oxycodone may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.
Nonselective MAOIs (including furazolidone, pargyline and procarbazine) intensify the effects of oxycodone which can cause anxiety, confusion and significant respiratory depression. Oxycodone should not be given to patients taking nonselective MAOIs or within 14 days of stopping such treatment. As it is unknown whether there is an interaction between selective MAOIs (e.g. selegiline) and oxycodone, caution is advised with this drug combination.
Oxycodone may increase the anticoagulant activity of coumarin derivatives.

4.6 Fertility, Pregnancy and Lactation

Effect on fertility.

Studies have not been performed to assess the effects of oxycodone on fertility.
(Category C)
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human foetus or neonate without causing malformations. These effects may be reversible.
Reproductive toxicity studies with oxycodone in animals have not been conducted. Opioid analgesics cross the placenta. The use of oxycodone during labour may cause respiratory depression in the newborn infant. Babies born to opioid dependent mothers may be physically dependent and suffer withdrawal symptoms (convulsions, irritability, excessive crying, tremors, hyperactive reflexes, fever, vomiting, diarrhoea, sneezing and yawning).
Reproductive toxicity studies with oxycodone in animals have not been conducted. Oxycodone is excreted into human milk in low concentrations. Because of the possibility of adverse effects in breastfed infants (sedation, respiratory depression, withdrawal symptoms upon cessation of maternal administration), oxycodone is not recommended for breastfeeding mothers unless the expected benefits outweigh the potential risk.

4.7 Effects on Ability to Drive and Use Machines

Oxycodone may impair the mental and/or physical abilities needed for certain potentially hazardous activities, such as driving a car or operating machinery. Patients should be cautioned accordingly.
This medication may cause drowsiness. Avoid alcohol.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions are typical of full opioid agonists; tolerance (except constipation) generally develops with long-term use. In normal doses, the most common side effects of oxycodone are nausea, vomiting, constipation, drowsiness, unusual tiredness or weakness, vertigo, faintness, lightheadedness, orthostatic hypotension and confusion. Less frequent side effects include dry mouth, sweating, facial flushing, nervousness or restlessness. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Raised intracranial pressure occurs in some patients. Other uncommon side effects such as bradycardia, supraventricular tachycardia, palpitations, anorexia, changes of mood, respiratory depression, hallucinations have been reported; CNS stimulation, paradoxical and convulsions may occur especially in children. Due to the histamine releasing effect, allergic reactions such as urticaria and pruritus occur in some individuals. Muscle rigidity has been reported following high doses. Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur in infants and children. Death may occur from respiratory failure.
In long-term use, physical and psychological dependence and tolerance may develop.
The following withdrawal symptoms may be observed after narcotics are discontinued: body aches, diarrhoea, gooseflesh, loss of appetite, nervousness, restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, nausea, trouble with sleeping, unusual increase in sweating and yawning, weakness, tachycardia and unexplained fever. With appropriate medical use of narcotics and gradual withdrawal from the drug, these symptoms are usually mild.

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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. 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

5.1 Pharmacodynamic Properties

Mechanism of action.

Oxycodone, the principal ingredient, is 14-hydroxydihydrocodeinone, which is derived from the opium alkaloid, thebaine. It is a semisynthetic narcotic analgesic with multiple actions qualitatively similar to those of morphine. Oxycodone is an opioid agonist and binds to μ (mu) and more weakly to κ (kappa) and δ (delta) opioid receptor subtypes. Opioid receptor binding by oxycodone in the central nervous system produces analgesia with some associated sedation. Additional pharmacologically mediated effects of oxycodone involve the CNS, smooth muscle and cardiovascular system.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The pharmacokinetics of oxycodone are well understood, demonstrating a clear dose-concentration relationship for both the intended therapeutic analgesic effect and characteristic adverse effects such as sedation and respiratory depression. Clinically this translates into a predictable dose response relationship allowing titration of dose according to the analgesic requirements of the patient.

Absorption.

Oxycodone is absorbed from the gastrointestinal tract.

Distribution.

Following oral administration of oxycodone tablets, the analgesic effect occurs within 10-15 minutes, reaches its maximum in 30-60 minutes, and persists for 3-6 hours (nontolerant patients only; duration decreases as tolerance develops during chronic therapy).

Metabolism.

It is extensively metabolised to noroxycodone via cytochrome P450 isoenzymes of the CYP3A family and, to a lesser extent, to oxymorphone via CYP2D6.

Excretion.

Both metabolites undergo glucuronidation and are excreted with unchanged drug in urine. The elimination half-life is reported to be 2 to 4 hours.

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

6.1 List of Excipients

Mayne Pharma Oxycodone IR tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, sodium starch glycollate type A, stearic acid and silicon dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

10 and 20 tablet counts packed in PVC/PVDC/Aluminium blister trays.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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:
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