OXYORA

Adults over 18 years:

Oxyora (Oxycodone Hydrochloride) oral solution should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. Increasing severity of pain will require an increased dosage of Oxyora (Oxycodone Hydrochloride) oral solution.

The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly.

The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses.

Conversion from oral morphine:

Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of Oxyora (Oxycodone Hydrochloride) oral solution required.

Inter- patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly patients:

A dose adjustment is not usually necessary in elderly patients. Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that, compared with younger adults, the clearance of oxycodone is only slightly reduced.

No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Patients with renal or hepatic impairment:

The plasma concentration in this patient population may be increased. The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Paediatric population:

Oxyora (Oxycodone Hydrochloride) oral solution should not be used in patients under 18 years.

Use in non-malignant pain:

Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease.

The need for continued treatment in nonmalignant pain should be assessed at regular intervals. Mode of administration Oxyora (Oxycodone Hydrochloride) oral solution is for oral use. Treatment goals and discontinuation Before initiating treatment with Oxyora (Oxycodone Hydrochloride), a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). Duration of treatment Oxyora (Oxycodone Hydrochloride) oral solution should not be used for longer than necessary.

Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea and vomiting are troublesome, oxycodone may be combined with an anti-emetic. The following frequency categories form the basis for classification of the undesirable effects: Term Frequency Very common Common Uncommon Rare Very rare Frequency not known ≥1/10 ≥1/100 to <1/10 ≥1/1,000 to <1/100 ≥1/10,000 to <1/1,000 <1/10,000 Cannot be estimated from the available data Immune system disorders: Uncommon: hypersensitivity.

Frequency not known: anaphylactic reaction, anaphylactoid reaction.

Metabolism and nutrition disorders:

Common: decreased appetite. Uncommon: dehydration. 4) Nervous system disorders: Very common: somnolence, dizziness, headache. Common: tremor, lethargy, sedation. Uncommon: amnesia, convulsion, hypertonia, hypoaesthesia, involuntary musclecontractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.

Frequency not known: hyperalgesia.

Eye disorders:

Uncommon: visual impairment, miosis.

Ear and labyrinth disorders:

Uncommon: vertigo.

Cardiac disorders:

Uncommon: palpitations (in the context of withdrawal syndrome), supraventricular tachycardia.

Vascular disorders:

Uncommon: vasodilatation, facial flushing. Rare: hypotension, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders:

Common: dyspnoea, bronchospasm, cough decreased. Uncommon: respiratory depression, hiccups.

Not known: central sleep apnoea syndrome Gastrointestinal disorders:

Very common: constipation, nausea, vomiting. Common: abdominal pain, diarrhoea, dry mouth, dyspepsia. Frequency not known: dental caries.

Hepato-biliary disorders:

Uncommon: increased hepatic enzymes, biliary colic. Frequency not known: cholestasis, sphincter of Oddi dysfunction.

Skin and subcutaneous tissue disorders:

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

Renal and urinary disorders:

Uncommon: urinary retention, ureteral spasm.

Reproductive system and breast disorders:

Uncommon: erectile dysfunction, hypogonadism. Frequency not known: amenorrhoea.

General disorders and administration site conditions:

Common: asthenia, fatigue. Uncommon: malaise, oedema, peripheral oedema, thirst, pyrexia, chills. Frequency not known: drug withdrawal syndrome neonatal, opioid tolerance, opioid withdrawal syndrome. g. 8). ‘Not known’ should not be interpreted as an indication of the rarity of the occurrence of opioid tolerance and opioid withdrawal syndrome, but a reflection of the limitations in the available evidence that do not support a precise estimate of frequency.

Drug dependence The frequency above regarding drug dependence reflects the current evidence, including cumulative data from clinical trials and additional post marketing sources, and indicates that the risk of drug dependence with opioids is highly variable depending upon: definition of drug dependence; duration of treatment; dose; individual patient risk factors; and clinical settings.

‘Not known’ should not be interpreted as an indication of the rarity of occurrence of drug dependence, but a reflection of the limitations in available evidence that do not support a precise estimate of frequency. Repeated use of Oxyora (Oxycodone Hydrochloride) can lead to drug dependence, even at therapeutic doses.

4 for monitoring and risk reduction interventions). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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5). The primary risk of opioid excess is respiratory depression. Hepatobiliary disorders Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, oxycodone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.

Sleep related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep related hypoxaemia. Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.

8) Concomitant use of oxycodone and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.

2). The patient should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Oxyora (Oxycodone Hydrochloride) oral solution must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks.

Oxyora (Oxycodone Hydrochloride) oral solution should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, Oxyora (Oxycodone Hydrochloride) oral solution should be discontinued immediately.

Oxyora (Oxycodone Hydrochloride) oral solution should be used with caution pre-operatively and within the first 12-24 hours post-operatively. As with all opioid preparations, oxycodone products 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.

g. surgery, plexus blockade) should not receive Oxyora (Oxycodone Hydrochloride) oral solution for 6 hours prior to the intervention. If further treatment with oxycodone is indicated then the dosage should be adjusted to the new post-operative requirement.

For appropriate patients who suffer with chronic non-malignant pain, opioids should be used as part of a comprehensive treatment programme involving other medications and treatment modalities. A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and substance abuse history.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is not to minimise the dose of opioid but rather to achieve a dose which provides adequate pain relief with a minimum of side effects. 2 for additional information on treatment goals and discontinuation.

Drug dependence, tolerance and potential for abuse Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone. Repeated use of Oxyora (Oxycodone Hydrochloride) oral solution can lead to Opioid Use Disorder (OUD).

A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Oxyora (Oxycodone Hydrochloride) oral solution may result in overdose and/or death. g. major depression, anxiety and personality disorders).

2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines).

For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Tolerance Patients may find that treatment is less effective with chronic use and express a need to increasethe dose to obtain the same level of pain control as initially experienced. Patients may […]

1. Oxyora (Oxycodone Hydrochloride) oral solution must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma, elevated carbon dioxide levels in the blood, moderate to severe hepatic impairment, chronic constipation.