Oxycod Forte Syrup

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Post-operative pain: In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.
Elderly and adults over 18 years: Oxycod Forte syrup 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 Oxycod Forte syrup. 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 naive 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. 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 Oxycod Forte syrup required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
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 untoward2 adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.
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. The starting dose for opioid naïve patients is 2.5 mg 6- hourly.
Children under 18 years: Oxycod Forte syrup 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 non-malignant pain should be assessed at regular intervals.
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.
See prescribing information for full details.

For the relief of moderate to severe pain.

Hypersensitivity to oxycodone or to any of the excipients.
Oxycodone 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.

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
– Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
– Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
– Limit dosages and durations to the minimum required.
– Follow patients for signs and symptoms of respiratory depression and sedation.
The major risk of opioid excess is respiratory depression.
Caution must be exercised when administering oxycodone to the debilitated elderly; opioiddependent patients; patients with severely impaired pulmonary function, patients with impaired hepatic or renal function; patients with myxedema, 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.
Concomitant use of benzodiazepines and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe benzodiazepines concomitantly with opioids, 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. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms.
Oxycod Forte Syrup should not be used where there is a possibility of paralytic ileus occurring.
Should paralytic ileus be suspected or occur during use, Oxycod Forte Syrup should be discontinued immediately.
Oxycod Forte Syrup 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.
Patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive Oxycod Forte Syrup 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. There must be frequent contact between physician and patient so that dosage adjustments can be made. It is strongly recommended that the physician defines treatment
outcomes in accordance with pain management guidelines. The physician and patient can then agree to discontinue treatment if these objectives are not met.
Oxycodone should not be used for longer than necessary. In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.
The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. Prolonged use of Oxycod Forte Syrup 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.
Sunset yellow, a constituent of Oxycod Forte Syrup, can cause allergic-type reactions such as asthma. This is more common in people who are allergic to aspirin.
Oxycodone has an abuse profile similar to other strong opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders.
There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone. Oxycod Forte Syrup, should be used with particular care in patients with a history of alcohol and drug abuse.
As with other opioids, infants who are born to dependent mothers may exhibit withdrawal symptoms and may have respiratory depression at birth.
Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.
Concomitant use of alcohol and Oxycod Forte Syrup may increase the undesirable effects of Oxycod Forte Syrup; concomitant use should be avoided.
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.

Very common: Somnolence, dizziness, headache, constipation, nausea, vomiting, pruritus.
Common: Decreased appetite, anxiety, confusional state, depression, insomnia, nervousness, abnormal thinking, abnormal dreams, tremor, lethargy, sedation,
dyspnoea, bronchospasm, cough decreased, abdominal pain, diarrhoea, dry mouth, dyspepsia, rash, hyperhidrosis, asthenia, fatigue.
See prescribing information for full details.

The concomitant use of sedative medicines such as benzodiazepines or related drugs with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited.
Drugs which affect the CNS include, but are not limited to tranquillisers, anaesthetics, hypnotics, antidepressants, non-benzodiazepine sedatives,  henothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives.
Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, antiParkinson drugs) may result in increased anticholinergic adverse effects. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.
MAO inhibitors are known to interact with narcotic analgesics. MAO-inhibitors cause CNS excitation or depression associated with hypertensive or hypotensive crisis.
Alcohol may enhance the pharmacodynamic effects of Oxycod Forte Syrup, concomitant use should be avoided.
Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements.
CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azole-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted accordingly.
See prescribing information for full details.

Pregnancy: Oxycod Forte Syrup is not recommended for use in pregnancy nor during labour. There are limited data from the use of oxycodone in pregnant women. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression.
Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.
Lactation: Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn. Oxycod syrup should, therefore, not be used in breast-feeding mothers.

Acute overdose with oxycodone can be manifested by miosis, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, hypotonia, bradycardia, pulmonary oedema and death may occur in more severe cases.
Treatment of oxycodone overdosage: primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation. The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose. Other supportive measures should be employed as needed.
In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children), if the patient is in a coma or respiratory depression is present.
Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient’s clinical state.
Intramuscular naloxone is an alternative in the event IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients.
For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.
Additional/other considerations:
– Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected.
– Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.