Consumer medicine information

Oxycodone Wockhardt

Oxycodone hydrochloride

BRAND INFORMATION

Brand name

Oxycodone Wockhardt

Active ingredient

Oxycodone hydrochloride

Schedule

What is in this leaflet

This leaflet answers some common questions about Oxycodone Wockhardt solution for injection or infusion.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of using Oxycodone Wockhardt against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, talk to your doctor or pharmacist.

Keep this leaflet in a safe place. You may need to read it again.

What Oxycodone Wockhardt is given for

Oxycodone Wockhardt solution for injection or infusion contains oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.

Oxycodone Wockhardt injection or infusion is given for short term management of severe pain for which other treatment options have failed or are otherwise inappropriate to provide sufficient management of pain. It can be given as a single injection or as an infusion into a vein or into the tissue under the skin.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

As with all strong painkillers, your body may become used to you having oxycodone. Being given it may result in physical dependence.

Physical dependence means that you may experience withdrawal symptoms if you stop having oxycodone suddenly, so it is important that you are given Oxycodone Wockhardt injection or infusion exactly as directed by your doctor.

This medicine is only available with a doctor's prescription.

Before you are given Oxycodone Wockhardt

Long-term use of Oxycodone Wockhardt injection or infusion may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycle in females. Talk to your doctor if you have any concerns.

When you must not have it

You should not be given Oxycodone Wockhardt injection or infusion if you:

have any breathing problems such as acute asthma, respiratory depression (breathing slows or weakens) or other obstructive airways disease.
are severely drowsy or have a reduced level of consciousness
suffer from irregular or fast heartbeats or changes in the way the heart beats.
have heart disease due to long-term lung disease.
have just consumed a large amount of alcohol, regularly consume large amounts of alcohol or have confusion and shaking due to alcohol withdrawal.
suffer anxiety from taking hypnotics, medicines that are given to help people sleep.
suffer from convulsions, fits or seizures.
Have a head injury, brain tumour or have raised pressure within the head, brain or spinal cord
have sudden, severe abdominal pain or chronic constipation.
have a condition where your stomach empties more slowly than it should, or your small bowel does not work properly.
have severe kidney disease.
have moderate to severe liver disease.
are about to have surgery on your spine for pain relief in the next 6 hours.
take a medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks.

You should not have Oxycodone injection or infusion if you are allergic to oxycodone, opioid painkillers, or any of the ingredients listed at the end of this leaflet.

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

You should not continue to have Oxycodone Wockhardt infusion if you have been given Oxycodone Wockhardt infusion for more than 4 consecutive weeks.

You should not be given this medicine if you are 18 years of age or younger.

Safety and effectiveness in children younger than 18 years of age have not been established.

Do not use this medicine after the expiry date (EXP) printed on the pack. If you are given it after the expiry date has passed, it may not work very well.

Do not use this medicine if the packaging is torn or shows signs of tampering or if the injection shows any visible signs of deterioration.

Before you start to have 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 medical conditions, especially the following:

have sleep apnoea (temporarily stopping breathing while you sleep)
low blood pressure
increased prostate size or difficulty passing urine
chronic lung, liver or kidney disease
disease of your gall bladder or bile duct
inflammation of the pancreas
underactive adrenal glands
underactive thyroid gland
inflammatory bowel disease.
you have had recent abdominal surgery, you are about to have surgery or you have had surgery within the last 24 hours
severe mental condition involving losing contact with reality, hearing voices or an inability to think clearly
an addiction or history of abuse of alcohol, opioids or other drugs.

Pregnancy and breastfeeding

This medicine is not recommended to be used during labour. Oxycodone given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Tell your doctor if you are currently breastfeeding or you plan to breastfeed.

Oxycodone can pass into the breast milk and can affect the baby. Your doctor can discuss the risks involved.

If you have not told your doctor about any of the above, tell them before you have Oxycodone Wockhardt injection or infusion.

You should not be given this medicine if you are pregnant or intend to become pregnant.

Like most medicines of this kind, Oxycodone Wockhardt injection or infusion is not recommended to be given during pregnancy. Your doctor will discuss the risks of having it if you are pregnant.

Addiction
You can become addicted to Oxycodone Wockhardt even if you take it exactly as prescribed. Oxycodone Wockhardt may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence
As with all other opioid containing products, your body may become used to you taking Oxycodone Wockhardt. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Oxycodone Wockhardt suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance
Tolerance to Oxycodone Wockhardt may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:

nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating.

Taking other medicines

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

Some medicines, dietary supplements and Oxycodone Wockhardt injection or infusion may interfere with each other. These include:

medicines to treat depression, psychiatric or mental disorders.
medicines to treat depression belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before Oxycodone injection or infusion is given
antidepressants e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine
medicines to help you sleep
medicines to put you to sleep during an operation or procedure
medicines to relax your muscles
medicines to lower blood pressure
quinidine and other medicines to treat the heart
medicines to treat convulsions e.g. phenytoin, carbamazepine
medicines to thin the blood e.g. coumarin derivatives such as warfarin
cimetidine, a medicine to treat stomach ulcers or heartburn
medicines to relieve stomach cramps or spasms, to prevent travel sickness,
medicines to treat Parkinson's disease
medicines to treat urinary incontinence
medicines to stop nausea or vomiting e.g. metoclopramide
other pain relievers including other opioids
antibiotics, e.g. clarithromycin erythromycin, rifampicin
medicines to treat fungal infections e.g. ketoconazole
alcohol
medicine to treat HIV infection and AIDS e.g. ritonavir
St John's wort (a herbal preparation)
grapefruit and grapefruit juice
medicines to treat epilepsy, pain, and anxiety e.g. gabapentin and pregabalin

These medicines, dietary supplements or alcohol may be affected by Oxycodone Wockhardt injection or infusion, may affect how well Oxycodone Wockhardt injection or infusion works or may increase side effects. You may need to use different amounts of the medicines, or take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using this medicine.

How Oxycodone Wockhardt is given

How much is given

Your doctor will decide the appropriate dose for you.

How it is given

A doctor or nurse will usually prepare and administer Oxycodone Wockhardt injection or infusion.

Oxycodone Wockhardt injection or infusion 10 mg in 1 mL or 20 mg in 2 mL can be given as a single injection or infusion into a vein. It can also be administered through a fine needle into the tissue under the skin.

Your doctor will decide the most appropriate way to administer Oxycodone Wockhardt injection or infusion.

Using this medicine in a manner other than that prescribed by your doctor can be harmful to your health.

When it is given

You should be given Oxycodone Wockhardt injection or infusion as directed by your doctor.

If you begin to experience pain, tell your doctor as your dosage may have to be reviewed.

How long it is given for

You should be given this medicine for as long as directed by your doctor.

You should not be given Oxycodone Wockhardt infusion for more than 4 consecutive weeks.

If you stop having this medicine suddenly, the pain may worsen and you may experience withdrawal symptoms such as:

body aches
loss of appetite, nausea, stomach cramps or diarrhoea
fast heart rate
sneezing or runny nose
chills, tremors, shivering or fever
trouble sleeping
increased sweating and yawning
weakness
nervousness or restlessness.

If you are given too much (overdose)

If you or someone else receive too much (overdose), and experience one or more of the symptoms below, call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the steps even if someone other than you have accidentally used Oxycodone Wockhardt that was prescribed for you. If someone takes an overdose, they may experience one or more of the following symptoms:

slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or vomiting
convulsions or fits

If you think you or someone else may have taken too much Oxycodone WKT, you should immediately telephone your doctor, or the Poisons Information Centre (Australia: telephone 13 11 26) for advice or go to Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

When seeking medical attention, take this leaflet, any remaining medicine or the empty ampoule if you still have it with you to show your doctor.

Also tell them about any other medicines or alcohol which have been taken.

While you are given Oxycodone Wockhardt

Things you must do

Before you start on a new medicine, remind your doctor and pharmacist that you are being given Oxycodone Wockhardt injection or infusion.

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

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

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

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

Tell your doctor if your pain is getting worse. Always discuss any problems or difficulties you have while you are being treated with Oxycodone Wockhardt injection or infusion.

Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may review the dose so that you get adequate pain relief.

Things you must not do

Do not drink alcohol while you are being given this medicine. Drinking alcohol whilst using Oxycodone Wockhardt injection or infusion may make you feel sleepier and increase the risk of serious side effects, such as shallow breathing with the risk of stopping breathing and loss of consciousness.

Do not use Oxycodone Wockhardt injection or infusion to treat any other complaint unless your doctor tells you to.

Do not give the medicine to anyone else, even if they have the same condition as you. Oxycodone injection or infusion is intended for use in one patient only.

Do not stop using the medicine, exceed the dose recommended or change the dosage without checking with your doctor. Over time your body may become used to oxycodone so if it is stopped suddenly, the pain may worsen and you may have unwanted side effects such as withdrawal symptoms. This is called physical dependence.

If you need to stop having this medicine, your doctor will gradually reduce the amount each day, if possible, before stopping the medicine completely.

Things to be careful of

Do not drive or operate machinery until you know how Oxycodone Wockhardt injection or infusion affects you. Oxycodone Wockhardt injection or infusion may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. If you are affected, you should not drive or operate machinery. Discuss these effects with your doctor.

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly 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.

Tell your doctor if you suffer from nausea or vomiting when having Oxycodone Wockhardt injection or infusion. Your doctor may prescribe some medicine to help you stop vomiting.

Tell your doctor if having Oxycodone Wockhardt injection or infusion causes constipation. Your doctor can advise you about your diet, the proper use of laxatives and suitable exercise you can do to help you manage this.

Tell your doctor if you find that you cannot concentrate or that you feel more sleepy than normal when you are being treated with Oxycodone Wockhardt injection or infusion or when the dose is increased. This feeling should wear off after a few days.

There is potential for abuse of oxycodone and the development of addiction to oxycodone. It is important that you discuss this issue with your doctor.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for many other medicines of this type, that is opioid analgesics, many side effects tend to reduce over time, with the exception of constipation. This means that the longer you have this medicine, the less it may cause problems for you.

Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects. Not everybody experiences them.

Tell your doctor as soon as possible if you do not feel well while you are having Oxycodone Wockhardt injection or infusion.

This medicine helps most people with moderate to severe pain, but it may have unwanted side effects in a few people. Other side effects not listed here may also occur in some people.

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

Tell your doctor if you notice any of the following and they worry you.

mild abdominal symptoms such as diarrhoea, feeling sick (nausea), decreased appetite, constipation or excessive wind
dry mouth, hiccups or trouble swallowing
excessive sweating
feeling anxious or nervous or have trouble sleeping
trouble with your balance (vertigo)
looking pale or feeling excessively tired
new problems with your eyesight
skin rash, itching, chills or fever
unusually reduced or slow body movements
muscle problems such as spasms
pain and sensitivity at the injection site
absence of menstrual periods
erectile dysfunction
decreased sexual drive.

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

stomach discomfort, vomiting, indigestion or abdominal pain
abnormal thinking, changes in mood or feeling deep sadness
drowsiness, fainting or dizziness especially when standing up
slow or noticeable heartbeats
headache, confusion, hallucinations, disorientation, sleepiness or impaired consciousness
unusual weakness or loss of strength
fatigue, feeling of tiredness, drowsiness or lack of energy
changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently or difficulty passing urine

The above list includes serious side effects that may require medical treatment.

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

your breathing slows or weakens
you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
seizures, fits or convulsions
fast or irregular heartbeats
chest pain or chest tightness.

The above list includes very serious side effects. You may need urgent medical attention or hospitalization.

When seeking medical attention take this leaflet and any remaining medicine with you to show the doctor.

After having it

Storage

Oxycodone Wockhardt injection or infusion should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. If you are being given Oxycodone Wockhardt injection or infusion in hospital, unopened ampoules will be stored in the pharmacy or on the ward.

If you have some of this medicine at home, keep the unopened ampoules in a cool, dry place where the temperature stays below 25°C and protected from light.

Do not store it or any other medicine in the bathroom, near a sink or on a window sill.

Do not leave it in the car. Heat and damp 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 having this medicine or the medicine has passed the expiry date, ask your pharmacist how to dispose of medicines no longer required.

Product description

What it looks like

Oxycodone Wockhardt solution for injection or infusion is available in glass ampoules containing a clear, colourless solution. It is available in two presentations:

10 mg in 1 mL
20 mg in 2 mL.

Oxycodone Wockhardt solution for injection or infusion are supplied in packs of 5 ampoules.

Ingredients

Active ingredient:

Oxycodone Wockhardt solution for injection or infusion Contain oxycodone hydrochloride 10 mg in 1 mL and 20 mg in 2 mL.

Inactive ingredients:

citric acid monohydrate
sodium citrate
sodium chloride
hydrochloric acid
sodium hydroxide
water for injections.

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

Sponsor

Wockhardt Bio Pty Ltd
Suite 103,
39 East Esplanade
Manly NSW 2095, Australia

Australian Registration Numbers

AUST R 277847

AUST R 277849

Date of Revision

This leaflet was revised in October 2020

Published by MIMS January 2021

BRAND INFORMATION

Brand name

Oxycodone Wockhardt

Active ingredient

Oxycodone hydrochloride

Schedule

1 Name of Medicine

Oxycodone hydrochloride.

2 Qualitative and Quantitative Composition

Oxycodone Wockhardt 10 mg in 1 mL; 20 mg in 2 mL Solution for injection or infusion contains 10 mg/mL of oxycodone hydrochloride.
The inactive ingredients in Oxycodone Wockhardt solution for injection or infusion are: citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

3 Pharmaceutical Form

Oxycodone Wockhardt Injection, solution: is a clear colourless sterile solution of oxycodone hydrochloride in water for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Oxycodone Wockhardt 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

Adults, elderly and children over 18 years.

Prior to initiation and titration of doses, (see Section 4.4 Special Warnings and Precautions for Use) for information on special risk groups such as females and the elderly. The lowest dose should be administered with careful titration to pain control. Oxycodone solution for injection or infusion should not be used in patients under 18 years as there are no data on use in children under 18 years of age.

Routes of administration.

Oxycodone solution for injection or infusion 10 mg in 1 mL and 20 mg in 2 mL.

Intravenous injection or infusion, and subcutaneous injection or infusion.

Posology.

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults over 18 years.

Oxycodone solution for injection or infusion 10 mg in 1 mL and 20 mg in 2 mL.

The following starting doses are recommended for the 10 mg in 1 mL and 20 mg in 2 mL solution for injections, although the starting dose will vary with age, medical status, surgery, pre-existing opioid tolerance, concomitant medications, individual tolerability, severity of pain and the indication, and may require subsequent dosage adjustment. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases.

IV (injection).

Dilute to 1 mg/mL in 0.9% saline, 5% glucose solution or water for injections.
To establish analgesia, administer an intravenous bolus dose of 1 to 5 mg slowly over 1-2 minutes. Incremental bolus doses may be required at 5-10 min intervals, with monitoring of the patient. Previous studies have indicated that higher single bolus doses (5-15 mg) oxycodone have been associated with significant sedation and respiratory depression.
For maintenance analgesia, doses should not be administered more frequently than every 4 hours.

IV (infusion).

Dilute to 1 mg/mL in 0.9% saline, 5% glucose solution or water for injections. A starting dose of 2 mg/hour is recommended.

IV (PCA).

Dilute to 1 mg/mL in 0.9% saline, 5% glucose solution or water for injections. A starting PCA bolus dose of up to 0.03 mg/kg (e.g. 1-2 mg per 70 kg) should be administered with a minimum lock-out time of 5 minutes.

SC (injection).

Use as 10 mg/mL concentration. A starting dose of 5 to 10 mg is recommended, depending on age and medical status, repeated at 4-hourly intervals as required.

SC (infusion).

Dilute in 0.9% saline, 5% glucose solution or water for injections if required. For non-surgical pain in palliative care in opioid-tolerant patients, titrate gradually according to pain control.

Transferring patients from oral to parenteral oxycodone.

The dose should be based on the following ratio: 2 mg of oral oxycodone is approximately equivalent to 1 mg of parenteral oxycodone. The approximate conversion ratio between oral and parenteral oxycodone is 2:1 (oral:parenteral), based on an oral liquid bioavailability of 46% (90% CI 41% to 51%). It is emphasised that this is a guide to the required dose only. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. For cancer patients transferring from oral oxycodone, or rotating from other opioid infusions, dosage requirements may be higher.

Transferring patients from IV morphine to IV oxycodone.

The dose should be based on the following ratio: 1 mg of IV oxycodone is approximately equivalent to 1 mg of IV morphine. The approximate conversion ratio between IV oxycodone and IV morphine is 1:1, based on the PCA study described, see Section 5.1 Pharmacodynamic Properties, Clinical trials. It is emphasised that this is a guide to the required dose only. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. For cancer patients transferring from oral oxycodone, or rotating from other opioid injections or infusions, the dosage requirements may be higher.

Elderly.

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.
As with other opioid initiation and titration, doses in elderly patients who are debilitated should be reduced to 1/3 to 1/2 of the usual doses.

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 with careful titration to pain control (see Section 4.4 Special Warnings and Precautions for Use).
As with other opioid initiation and titration, doses in patients with renal impairment (CLcr < 60 mL/min) or hepatic impairment should be reduced to 1/3 to 1/2 of the usual doses.

Cessation of therapy.

When a patient no longer requires therapy with oxycodone, it is advisable to reduce the daily dose gradually to minimise or prevent symptoms of withdrawal (see Section 4.4 Special Warnings and Precautions for Use, Ceasing opioids).

4.3 Contraindications

Hypersensitivity to opioids or any of the constituents of oxycodone solution for injection or infusion.
Severe respiratory disease, acute respiratory disease, respiratory depression, acute asthma or other obstructive airways disease.
Cor pulmonale, cardiac arrhythmias.
Paralytic ileus, suspected surgical abdomen.
Severe renal impairment (creatinine clearance < 10 mL/min).
Moderate to severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use, Special risk patients).
Acute abdominal pain, chronic constipation, delayed gastric emptying. Acute alcoholism, coma, brain tumour, increased cerebrospinal or intracranial pressure, head injury (due to risk of raised intracranial pressure), severe CNS depression, convulsive disorders, delirium tremens, hypercarbia.
Concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use.
Anxiety states under the influence of alcohol or hypnotics and pregnancy.

4.4 Special Warnings and Precautions for Use

As with all opioids, a reduction in dosage may be advisable in hypothyroidism. Use with caution in opioid-dependent patients and in patients with hypotension, hypovolaemia, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency (Addison's disease), toxic psychosis, chronic pulmonary, renal and hepatic disease, myxoedema and debilitated elderly or infirm patients. As with all opioid preparations, patients who are to undergo cordotomy or other pain-relieving neural blockade procedures should not receive oxycodone solution for injection or infusion for 6 hours before surgery. As with all opioid preparations, oxycodone solution for injection or infusion should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function. Should paralytic ileus be suspected or occur during use, oxycodone solution for injection or infusion should be discontinued immediately. Oxycodone solution for injection or infusion should be used with caution pre- or intra-operatively and within the first 12-24 hours post-operatively.

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 Oxycodone Wockhardt 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 renal and hepatic 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, (see Section 4.2 Dose and Method of Administration), together with consideration of pharmacological differences between opioids. Consider starting the new opioid at a reduced dose to account for individual variation in response.
Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner in some patients. Opioids may also cause worsening of pre-existing sleep apnoea (see Section 4.8 Adverse Effects (Undesirable Effects)). In patients who present with CSA, consider decreasing the total opioid dosage.

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 Oxycodone Wockhardt 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 Oxycodone Wockhardt 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 Oxycodone Wockhardt.

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 non-pharmacological 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). 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 Section 4.4 Special Warnings and Precautions for Use, Ceasing opioids).

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.

Special risk patients.

As with all opioids, a reduction in dosage may be advisable in hypothyroidism. Use with caution in patients with hypotension, hypovolaemia, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency (Addison's disease), toxic psychosis, sleep apnoea, constipation and myxoedema. As with all opioid preparations, patients who are to undergo cordotomy or other pain-relieving neural blockade procedures should not receive Oxycodone Wockhardt solution for injection or infusion for 6 hours before surgery. As with all opioid preparations, Oxycodone Wockhardt solution for injection or infusion should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function. Should paralytic ileus be suspected or occur during use, Oxycodone Wockhardt solution for injection or infusion should be discontinued immediately. Oxycodone Wockhardt solution for injection or infusion should be used with caution pre- or intra-operatively and within the first 12-24 hours post-operatively. Oxycodone Wockhardt solution for infusion 50 mg/mL should not be used for more than 4 weeks consecutively.

Endocrine effects.

Opioids, such as oxycodone hydrochloride, may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

Hazardous and harmful use.

Oxycodone Wockhardt contains the opioid oxycodone hydrochloride and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Oxycodone Wockhardt 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 Oxycodone Wockhardt.
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 Oxycodone Wockhardt with anyone else.

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 Oxycodone Wockhardt 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).

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 percent every 2 to 4 weeks (see Section 4.2 Dose and Method of Administration). 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.

Accidental ingestion/exposure.

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

Gender.

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a body weight adjusted basis. The reason for this difference is unknown. There were no significant male/female differences detected for efficacy or adverse events in clinical trials.

Use in hepatic impairment.

In hepatic impairment, the administration of oxycodone solution for injection or infusion does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal or hepatic function. Therefore, initiation of dosing in patients with renal impairment or hepatic impairment should be reduced to 1/3 to 1/2 of the usual dose with cautious titration.

Use in renal impairment.

In renal impairment, the administration of oxycodone solution for injection or infusion does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal or hepatic function. Therefore, initiation of dosing in patients with renal impairment (CLcr < 60 mL/min) or hepatic impairment should be reduced to 1/3 to 1/2 of the usual dose with cautious titration.

Use in the elderly.

The plasma concentrations of oxycodone are only nominally affected by age, being approximately 15% greater in elderly as compared with young subjects. There were no differences in adverse event reporting between young and elderly subjects.

Use in elderly, debilitated patients.

As with other opioid initiation and titration, doses in elderly patients who are debilitated should be reduced to 1/3 to 1/2 of the usual doses.

Paediatric use.

See Section 4.2 Dose and Method of Administration, Adults, elderly and children over 18 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticholinergic agents.

Concurrent use with oxycodone with anticholinergics or medications with anticholinergic activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson medications) may result in increased anticholinergic adverse effects, including an increased risk of severe constipation and/or urinary retention.

Antihypertensive agents.

Hypotensive effects of these medications may be potentiated when used concurrently with oxycodone, leading to an increased risk of orthostatic hypotension.

CNS depressants.

Concurrent use of oxycodone with medicines such as benzodiazepines or other CNS depressants, general anaesthetics, including alcohol increases the risk of profound sedation, respiratory depression, hypotension, death or coma because of additive CNS depressant effect. 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, 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 solution for injection or infusion 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.

Coumarin derivatives.

Although there is little substantiating evidence, opiate agonists have been reported to potentiate the anticoagulant activity of coumarin derivatives.

CYP3A4 and CYP2D6 inducers and inhibitors.

Oxycodone is metabolised in part via the CYP2D6 and CYP3A4 pathways. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements, which may alter plasma concentrations. Oxycodone doses may need to be adjusted accordingly. Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. Concurrent administration of quinidine does not alter the pharmacodynamic effects of oxycodone. CYP3A4 inhibitors such as macrolide antibiotics (e.g. clarithromycin), azole antifungal agents (e.g. ketoconazole), protease inhibitors (e.g. ritonavir) and grapefruit juice may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. Oxycodone metabolism may be blocked by a variety of drugs (e.g. cimetidine, certain cardiovascular drugs, fluoxetine and other antidepressants and erythromycin), although such blockade has not yet been shown to be of clinical significance with oxycodone solution for injection or infusion.
CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin and St. John's wort, may induce the metabolism of oxycodone and cause increased clearance of the drug, resulting in a decrease in oxycodone plasma concentrations.
Oxycodone did not inhibit the activity of P450 isozymes 2D6, 3A4, 1A2, 2A6, 2C19 or 2E1 in human liver microsomes in vitro. Non-clinical data in vitro and in vivo indicate that oxycodone can act as a P-glycoprotein substrate and can induce over-expression of P-glycoprotein in rats.

Metoclopramide.

Concurrent use with oxycodone may antagonise the effects of metoclopramide on gastrointestinal motility.

Monoamine oxidase inhibitors (MAOIs).

Non-selective MAOIs intensify the effects of opioid drugs which can cause anxiety, confusion and significant respiratory depression. Severe and sometimes fatal reactions have occurred in patients concurrently administered MAOIs and pethidine. Oxycodone should not be given to patients taking non-selective 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.

Neuromuscular blocking agents.

Oxycodone may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.

Opioid agonist analgesics (including morphine, pethidine).

Additive CNS depressant, respiratory depressant and hypotensive effects may occur if two or more opioid agonist analgesics are used concurrently.

Opioid agonist-antagonist analgesics (including pentazocine, butorphanol, buprenorphine).

Mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms.

Selective serotonin re‐uptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI).

Concurrent administration of oxycodone with serotonin agents, such as a selective serotonin re-uptake inhibitor (SSRI) or a serotonin norepinephrine re‐uptake inhibitor (SNRI) may cause serotonin toxicity. The symptoms of serotonin toxicity may include mental‐status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g. hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea). Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In reproductive toxicology studies, no evidence of impaired fertility was seen in male or female rats at oxycodone doses of 8 mg/kg/day, with estimated exposure (plasma AUC) equivalent to 8 mg/day in men and 17 mg/day in women.
Despite these fertility studies in animals, prolonged use of opioids may result in impairment of reproductive function, including fertility and sexual dysfunction in both sexes, and irregular menses in women.
(Category C)
Australian Pregnancy Category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Oxycodone used during pregnancy or labour may cause withdrawal symptoms and/or respiratory depression in the newborn infant. Oral administration of oxycodone during the period of organogenesis did not elicit teratogenicity or embryofoetal toxicity in rats or rabbits at doses up to 8 mg/kg/day in rats (equivalent to 17 mg/day in women, based on estimated plasma AUC values) or 125 mg/kg/day in rabbits.
Oral administration of oxycodone to rats from early gestation to weaning did not affect postnatal development parameters at doses up to 6 mg/kg/day (equivalent to 9 mg/day in women, based on estimated AUC values). In a study designed specifically to investigate the effect of pre-natal oxycodone on the hypothalamic-pituitary-adrenal axis in adolescent rats, intravenous administration of oxycodone 0.8 mg/kg/day (equivalent to 11 mg/day in pregnant women, based on estimated AUC values) had no effect on the corticosterone response, but delayed and enhanced the peak ACTH response to corticotrophin releasing hormone in males, but not females. The clinical significance of this observation is unknown.
There are no adequate and well-controlled studies with oxycodone in pregnant women. Because animal reproduction studies are not always predictive of human responses, oxycodone should not be used during pregnancy unless clearly needed. Prolonged use of oxycodone during pregnancy can result in neonatal opioid withdrawal syndrome. Oxycodone is not recommended for use in women during or immediately prior to labour. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression.
Oxycodone accumulates in human milk, with a median maternal milk:plasma ratio of 3:1 recorded in one study. Oxycodone (7.5 nanogram/mL) was detected in the plasma of one of forty-one infants 72 hours after Caesarean section. Opioids may cause respiratory depression in the newborn and withdrawal symptoms can occur in breastfeeding infants when maternal administration of an opioid analgesic is stopped. Oxycodone solution for injection or infusion should not be used in breastfeeding mothers unless the benefits outweigh the risks. Breastfed infants should be monitored for respiratory depression, sedation, poor attachment and gastrointestinal signs.

4.7 Effects on Ability to Drive and Use Machines

This medicine may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

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.
Adverse drug reactions are typical of full opioid agonists, and tend to reduce with time, with the exception of constipation. Anticipation of adverse drug reactions and appropriate patient management can improve acceptability.

Injectable formulation.

In a clinical trial where intravenous oxycodone was delivered via patient-controlled analgesia, 50 of 64 (78%) patients on oxycodone had at least one adverse drug reaction rated treatment-related or not determined. The very common adverse drug reactions included nausea (50%), vomiting (17%) and pruritus (14%), and the more common reactions included headache (6%), constipation (5%) and insomnia (5%). All of the adverse drug reactions were mild or moderate in intensity, except for one report of vomiting and one of nausea which were rated severe. One treatment-related serious adverse event (abdominal pain caused by postoperative constipation) was noted 17 days after intravenous oxycodone was ceased. In two smaller trials, the very common adverse reactions included headache, dizziness and somnolence.
Drowsiness often abates after a few days, and nausea and vomiting after use for a sustained period. Spasms in the bile duct and urinary tract may arise in predisposed individuals. The respiratory depressive effect is dose dependent.

Cardiac disorders.

Common: tachycardia.
Uncommon: palpitations (as part of withdrawal syndrome).

Ear and labyrinth disorders.

Common: vertigo.

Endocrine disorders.

Common: increased ADH release.

Eye disorders.

Common: miosis, visual impairment.

Gastrointestinal disorders.

Very common: nausea, vomiting, constipation.
Common: abdominal pain, diarrhoea, dry mouth, dyspepsia, flatulence, hiccup.
Uncommon: dental caries, dysphagia, eructation, gastrointestinal disorder, ileus, flatulence.

General disorders and administration site conditions.

Common: asthenia, fatigue, chills, fatigue, hot/warm, injection site hypersensitivity/pain, oedema, pain, pallor.
Uncommon: drug tolerance, drug withdrawal syndrome, malaise, peripheral oedema, thirst.
Not known: drug withdrawal syndrome neonatal.

Hepatobiliary disorders.

Uncommon: biliary spasm, cholestasis, hepatic enzyme increased.

Immune system disorders.

Uncommon: anaphylactic reaction, anaphylactoid reaction, hypersensitivity.

Metabolism and nutrition disorders.

Common: decreased appetite.
Uncommon: dehydration.

Nervous system disorders.

Very common: dizziness, drowsiness, headache, somnolence.
Common: hypokinesia, stupor, tremor, lethargy.
Uncommon: amnesia, convulsion, grogginess, hypertonia, hypoaesthesia, muscle contractions involuntary, paraesthesia, speech disorder, syncope, dysgeusia (taste perversion).
Not known: hyperalgesia. Sleep apnoea syndrome.

Psychiatric disorders.

Very common: euphoric mood.
Common: anxiety, confusional state, disorientation, insomnia, nervousness, thinking abnormal, depression.
Uncommon: affect lability, agitation, drug dependence, dysphoria, hallucination, libido decreased.
Not known: aggression.

Renal and urinary disorders.

Common: urinary retention.
Uncommon: urinary spasm.

Reproductive system and breast disorders.

Uncommon: amenorrhoea, erectile dysfunction, hypogonadism.

Respiratory, thoracic and mediastinal disorders.

Common: dyspnoea, hyperventilation.
Uncommon: bronchoconstriction, respiratory depression.

Skin and subcutaneous tissue disorders.

Very common: pruritus.
Common: hyperhidrosis, rash.
Uncommon: dry skin, urticaria.

Vascular disorders.

Common: hypotension, vasodilatation.
Uncommon: orthostatic hypotension.

Key.

Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Acute overdosage with oxycodone can be manifested by respiratory depression (reduced respiratory rate and/or tidal volume, cyanosis), extreme somnolence progressing to stupor or coma, hypotonia, miosis (dilated if hypoxia is severe), cold and/or clammy skin, and sometimes bradycardia, hypotension, pulmonary oedema, and death. Severe overdose may result in apnoea, pulmonary oedema, circulatory collapse and death.

Treatment of oxycodone overdosage.

Primary attention should be given to immediate supportive therapy with the establishment of adequate respiratory exchange through the provision of a patent airway and institution of assisted or controlled ventilation. Adequate body temperature and fluid balance should be maintained. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated, to manage the circulatory shock accompanying an overdose. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
If there are signs of clinically significant respiratory or cardiovascular depression, the use of an opioid antagonist should be considered. The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression due to overdosage. Concomitant efforts at respiratory resuscitation should be carried out. The patient should be under continued surveillance and doses of the antagonist should be repeated as needed to maintain adequate respiration.
For massive overdosage, associated with clinically significant respiratory or cardiovascular depression, 0.8 mg naloxone may be administered intravenously, repeating at 2-3 minute intervals as necessary, or by a titrated infusion of 2 mg in 500 mL of normal saline or 5% glucose solution (0.004 mg/mL). The infusion should be run at a rate related to previous bolus doses administered and should be in accordance with the patient's response. However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Monitoring for a further 24-48 hours is then recommended in case of possible relapse. Please see naloxone hydrochloride injection Product Information for further information.
In an individual physically dependent on, or tolerant to, opioids, the administration of the usual dose of opioid 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 opioid antagonists in such individuals should be avoided if possible. If an opioid antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care by using dosage titration, commencing with 10 to 20% of the usual recommended initial dose.

Toxicity.

Oxycodone toxicity may result from overdosage but because of the great inter-individual variation in sensitivity to opioids it is difficult to determine an exact dose of any opioid that is toxic or lethal. The toxic effects and signs of overdosage may be less pronounced than expected when pain and/or tolerance are manifest.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Oxycodone is a full opioid agonist with no antagonist properties whose principal therapeutic action is analgesia. It has affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. Other pharmacological actions of oxycodone are in the CNS (respiratory depression, antitussive, anxiolytic, sedative and miosis), smooth muscle (constipation, reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi and transient elevations in serum amylase) and cardiovascular system (release of histamine and/or peripheral vasodilation, possibly causing pruritus, flushing, red eyes, sweating and/or orthostatic hypotension).

Clinical trials.

Oxycodone solution for injection or infusion 10 mg in 1 mL.

A randomised, double-blind, parallel group study was performed to compare the tolerability, safety and efficacy of IV oxycodone with IV morphine in patients using patient-controlled analgesia (PCA) for acute postoperative pain. The intention to treat and safety populations included 133 patients (64 oxycodone, 69 morphine); 117 patients completed, 56 on oxycodone and 61 on morphine.
Oxycodone 10 mg/mL or morphine solution for injection was diluted to 1 mg/mL with 0.9% saline, and 2 mg IV bolus doses were used during stabilisation. The PCA machine delivered bolus doses of 1 mg on demand, with a 5 minute lockout. The treatment duration was intended to be 24-72 hours.
The primary efficacy endpoint of the intensity of pain on movement or deep breathing at 24 hours post-operatively, using the BS-11 pain scores was 4.6 ± 2.6 for oxycodone and 4.1 ± 2.0 for morphine with a pain intensity difference of 0.55 (95% CI: -0.37 to 1.48). The 95% CI for the treatment difference was within the established equivalence limits (-1.5 to 1.5). See Table 1.

There was no significant difference in the median drug use, which was 69.0 mg (12-336 mg) for oxycodone and 54.0 mg (7-212 mg) for morphine in the PP population, and similar in the ITT population. The common adverse drug reactions were all known opioid side-effects, but respiratory depression was uncommon. Further details are provided, see Section 4.8 Adverse Effects (Undesirable Effects).

5.2 Pharmacokinetic Properties

Absorption.

The T_max for subcutaneous administration was 0.25-0.5 hours. Considerable inter-individual variability was seen in pharmacokinetic studies.
Pharmacokinetic studies with oxycodone solution for injection or infusion in healthy subjects demonstrated an equivalent availability of oxycodone by intravenous (IV) and subcutaneous (SC) routes, when administered as a single bolus dose or continuous infusion over 8 hours. Following absorption, oxycodone is distributed throughout the entire body. As expected, the C_max for subcutaneous bolus was lower than for intravenous administration.

Distribution.

Approximately 45% is bound to plasma proteins. The plasma concentrations are only minimally affected by age, being 15% greater in the elderly compared with young subjects.

Metabolism.

Oxymorphone has some analgesic activity but is present in plasma in low concentrations and is not considered to contribute to oxycodone's pharmacological effect.
Oxycodone hydrochloride is metabolised in the liver to form noroxycodone, oxymorphone, noroxymorphone, 6 α and β oxycodol and conjugated glucuronides. CYP3A4 and CYP2D6 are involved in the formation of noroxycodone and oxymorphone, respectively (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). The contribution of these metabolites to the analgesic effect is insignificant.
CYP2D6 is expressed as two phenotypes, extensive and poor metabolisers. Poor metabolisers, constituting about 5-10% of the White population, may have increased plasma concentrations of oxycodone because of the decreased oxidation by CYP2D6 and therefore a lower dosage may be needed. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)

Excretion.

Oxycodone has an elimination half‐life of approximately 3 hours.
Patients with mild to severe hepatic or renal dysfunction may have an increase in elimination half-life compared with normal subjects, and therefore, may have higher plasma concentrations of oxycodone and noroxycodone, and lower concentrations of oxymorphone compared with normal subjects. This may be accompanied by an increase in drug effects. Considerable inter-individual variability may be seen in these patients.

5.3 Preclinical Safety Data

Genotoxicity.

Oxycodone was not genotoxic in bacterial gene mutation assays, but was positive in the mouse lymphoma assay. In assays of chromosomal damage, genotoxic effects occurred in the human lymphocyte chromosomal 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

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Oxycodone solution for injection or infusion is formulated at acidic pH and is likely to be incompatible with alkaline pH formulations such as Fluorouracil (5-FU) which may lead to precipitation. In addition, oxycodone solution for injection or infusion has been shown to be chemically incompatible with prochlorperazine.
It is recommended that oxycodone solution for injection or infusion should not be administered in combination with other parenteral formulations unless there is compatibility data to support the combination.

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

Oxycodone solution for injection or infusion should be stored below 25°C and protected from light.

Instructions for storage and handling.

The solution for injection or infusion should be given immediately after opening the ampoule. The diluted solution should be used immediately after dilution. Once opened, any unused portion should be discarded. Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product. Oxycodone solution for injection or infusion is for single use in one patient only.

6.5 Nature and Contents of Container

Clear glass ampoules containing the following strengths of oxycodone hydrochloride:
10 mg in 1 mL and 20 mg in 2 mL in packs of 5 ampoules.
Not all presentations 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

Oxycodone hydrochloride is a white, crystalline, odourless powder freely soluble in water, sparingly soluble in ethanol and nearly insoluble in ether.
Chemical name: 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride.
Molecular formula: C₁₈H₂₁NO₄.HCl.
Molecular weight: 351.83.

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