OXYCODONE MOLTENI

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: The following starting doses are recommended for opioid-naïve patients. The initial dose should be adjusted to previous or concurrent medication (especially if the patient has been treated with other opioids before), the total condition of the patient, and the severity of pain.

A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. v. 9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes in opioid-naïve patients.

Doses should not be administered more frequently than every 4 hours. v. 9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended for opioid-naïve patients. v. 9% saline, 5% dextrose or water for injections.

03 mg/kg should be administered with a minimum lock-out time of 5 minutes for opioid-naïve patients. c. 9% saline, 5% dextrose or water for injections. A starting dose of 5 mg is recommended at 4-hourly intervals as required for opioid-naïve patients.

c. 9% saline, 5% dextrose or water for injections if required. 5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patients between oral and parenteral oxycodone:

The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

Elderly:

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.

Patients with renal or hepatic impairment:

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.

Pediatric population:

There are no data on the use of Oxycodone injection in patients under 18 years of age.

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.

Method of administration Subcutaneous injection or infusion. Intravenous injection or infusion. Treatment goals and discontinuation Before initiating treatment with Oxycodone Molteni, 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:

Oxycodone should not be used for longer than necessary. 6

Adverse drug reactions are typical of full opioid agonists. 4). Constipation may be prevented with an appropriate laxative. If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic. Adverse reactions reported either spontaneously or observed in clinical trials are depicted in the following table.

Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse Reaction Immune system disorders Uncommon Frequency not known Hypersensitivity. Anaphylactic responses, anaphylactoid reaction. Metabolism and nutritional disorders Common Uncommon Anorexia (decreased appetite).

Dehydration. Psychiatric disorders Common Uncommon Frequency not known Anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams. 4), disorientation, mood altered, restlessness, dysphoria. Aggression.

Nervous System Disorders Very Common Common Uncommon Frequency not known Headache, dizziness, somnolence. Tremor, lethargy, sedation. Amnesia, convulsions, hypertonia, hypoaesthesia, involuntary muscle contractions, speech disorder, syncope, paraesthesia, dysgeusia, hypotonia.

Hyperalgesia. Eye disorders Uncommon Miosis, visual impairment. Ear and labyrinth disorders Uncommon Vertigo. Cardiac disorders Uncommon Palpitations (in the context of withdrawal syndrome), supraventricular tachycardia. Vascular disorders Uncommon Rare Vasodilatation, facial flushing.

Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon Common Frequency not known Respiratory depression, hiccups. Bronchospasm, dyspnoea, cough decreased. Central sleep apnoea syndrome. Gastrointestinal disorders Very Common Common Uncommon Frequency not known Constipation, nausea, vomiting.

Dry mouth, dyspepsia, abdominal pain, diarrhoea. Dysphagia, eructation, flatulence, ileus, gastritis. Dental caries Hepato-biliary disorders Uncommon Frequency not known Biliary colic, increased hepatic enzymes Cholestasis. Sphincter of Oddi dysfunction Skin and subcutaneous tissue Very common Common Uncommon Rare Pruritus.

Hyperhidrosis, rash. Dry skin, exfoliative dermatitis. Urticaria. Renal and urinary disorders Uncommon Urinary retention, ureteral spasm. Reproductive system and breast disorders Uncommon Frequency not known Erectile dysfunction, hypogonadism Amenorrhoea, General disorders and administration site conditions Common Uncommon Frequency not known Asthenia, fatigue.

Drug tolerance, oedema, peripheral oedema, malaise, thirst, pyrexia, drug withdrawal syndrome, chills. Drug withdrawal syndrome neonatal. Description of selected adverse reactions Drug dependence Repeated use of Oxycodone Molteni can lead to drug dependence, even at therapeutic doses.

4). 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. uk/yellowcard.

The major risk of opioid excess is respiratory depression. Caution must be exercised when administering oxycodone to the debilitated elderly, patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxoedema, hypothyroidism, Addison’s disease, toxic psychosis, prostate hypertrophy adrenocortical insufficiency, alcoholism, delirium tremens, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, hypotension, hypovolaemia, raised intracranial pressure, head injury (due to risk of increased intracranial pressure) or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors.

Oxycodone injection should not be used where there is a possibility of paralytic ileus occurring. 3). Oxycodone injection should be used with caution pre- or intra-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.

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. The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control.

Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

The opioid abstinence or withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased blood pressure, respiratory rate or heart rate.

Hyperalgesia that will not respond to a further dose increase of oxycodone may occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required. 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. 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 Oxycodone Molteni may 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 Oxycodone Molteni 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.

As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth. Concomitant use of Oxycodone Molteni 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. If a decision is made to prescribe Oxycodone Molteni concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Concomitant use of alcohol and Oxycodone injection may increase the undesirable effects of Oxycodone; concomitant use should be avoided.

Opioids may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can […]

1. Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia; paralytic ileus; acute abdomen; severe chronic obstructive lung disease; cor pulmonale; severe bronchial asthma; elevated carbon dioxide levels in the blood; moderate to severe hepatic impairment; chronic constipation.