Loading…
IXYLDONE is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Severe pain, which can be sufficiently managed only with opioid analgesics. Ixyldone is indicated in adults and adolescents aged 12 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
4). The dosage depends on the intensity of pain and the patient’s individual susceptibility. to the treatment.
The following general dosage recommendations apply:
Adults and adolescents 12 years of age and older Dose titration and adjustment In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg oxycodone hydrochloride to minimize the incidence of adverse reactions.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. For doses not realisable/practicable with this strength other strengths of this medicinal product are available.
According to well-controlled clinical studies 10-13 mg oxycodone ¬hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Ixyldone after conversion from other opioids, with 50-75% of the calculated oxycodone dose.
Some patients who take Ixyldone following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Ixyldone is not indicated for the treatment of acute pain and/or breakthrough pain.
The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Ixyldone. Use of the rescue medication more than twice daily indicates that the dose of Ixyldone needs to be increased. The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved.
Following a dose increase from 10 mg to 20 mg taken every 12 hours dose adjustments should be made in steps of approximately one third of the daily dose. The aim is a patient-specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed.
Even distribution (the same dose mornings and evenings) following a fixed schedule (every 12 hours) is appropriate for the majority of the patients. For some patients it may be advantageous to distribute the doses unevenly. In general, the lowest effective analgesic dose should be chosen.
Due to its pharmacological properties, oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of the smooth muscles and can suppress the cough reflex. The most frequently reported undesirable effects are nausea (especially at the beginning of the treatment) and obstipation.
The most serious adverse reaction, as with other opioids, is respiratory depression. This is most likely to occur in elderly, debilitated or opioid-intolerant patients. In susceptible patients opioids may cause a severe drop in blood pressure.
The frequency of adverse reactions is based on the following categories:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), Not known (cannot be estimated from the available data) Very common Common Uncommon Rare Not known (cannot be estimated from available data) Infections and infestations Herpes simplex.
Immune system disorders:
Hypersen- sitivity reactions. Anaphylactic reactions. Anaphylactoid reaction. Metabolism and nutrition disorders: decreased appetite up to loss of appetite. Dehydration.
Increase appetite Psychiatric disorders:
Anxiety, confusional state, depression,de creased activity, restlessness, psychomotor hyperactivity, nervousness, insomnia, abnormal thinking. g. 4) Aggression Nervous system disorders: Somnolence; sedation, dizziness; headache. Tremor, lethargy.
Amnesia, convulsion (especially in patients with epilepsy or predisposition to convulsions), concentratio n impaired, migraine, hypertonia; involuntary muscle contractions, hypoaesthesia; Hyperalgesia. abnormal coordination, speech disorder, syncope, paraesthesia, dysgeusia.
Respiratory depression is the most significant risk induced by opioids. Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).
Caution must be exercised when administering oxycodone to elderly debilitated patients, in patients with severe impairment of pulmonary function, impaired hepatic or renal function, patients with myxoedema, hypothyroidism, Addison’s disease, prostatic hypertrophy, toxic psychosis, alcoholism, delirium tremens, known opioid dependence, disease of the biliary tract, pancreatitis, obstructive and inflammatory bowel disorders, head injuries (due to risk of increased intracranial pressure), hypotension, hypovolemia, epileptic disorder or predisposition to convulsions or patients taking benzodiazepines, or other CNS depressant (including alcohol) or MAO inhibitors.
With the occurrence or suspicion of paralytic ileus, oxycodone should be discontinued immediately. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of opioids including 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. If a decision is made to prescribe Ixyldone 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). To avoid damage to the controlled release properties of the tablets the prolonged release tablets must be swallowed as a whole, not be chewed, divided or crushed. 9). Long-term use of Ixyldone may cause the development of tolerance which leads to the use of higher doses in order to achieve the desired analgesic effect.
1. • Severe respiratory depression with hypoxia and/or hypercapnia. • Severe chronic obstructive pulmonary disease. • Cor pulmonale. • Severe bronchial asthma. • Paralytic ileus.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Oxycodone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
For the treatment of non-malignant pain a daily dose of 40 mg is generally sufficient; but higher dosages may be necessary. Patients with cancer-related pain may require dosages of 80 to 120 mg, which in individual cases can be increased to up to 400 mg.
If even higher doses are required, the dose should be decided individually balancing efficacy with the tolerance and risk of undesirable effects. Elderly patients Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.
Risk patients Risk patients, for example patients with low body weight or slow metabolism of medicinal products, should initially half the recommended adult dose if they are opioid naïve. e. 10 mg, may not be suitable as a starting dose.
Dose titration should be performed in accordance with the individual clinical situation. 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.
Children under 12 years of age Oxycodone has not been studied in children younger than 12 years of age. The safety and efficacy of Ixyldone have not been demonstrated and the use in children younger than 12 years of age is therefore not recommended.
Method of administration For oral use. Ixyldone should be taken twice daily based on a fixed schedule at the dosage determined. The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of liquid.
Ixyldone must be swallowed whole, not chewed, divided or crushed. Taking chewed, divided or crushed Ixyldone tablets may lead to a rapid release and absorption of a potentially fatal dose of oxycodone. Ixyldone should not be taken with alcoholic beverages.
Treatment goals and discontinuation Before initiating treatment with Ixyldone, 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 Ixyldone should not be taken longer than necessary. If opioid therapy is no longer indicated, it may be advisable to reduce the daily dose gradually in order to prevent symptoms of a withdrawal syndrome.
Eye disorders: visual impairment; miosis Ear and labyrinth disorders:
Hearing disorders, Vertigo. Cardiac disorders: tachycardia, palpitations (in context of withdrawal syndrome).
Vascular disorders:
Vasodilatation Hypotension; orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders:
Dyspnoea, Respiratory depression; Dysphonia, coughing Central sleep apnoea syndrome Gastrointestin al disorders: Constipation; nausea; vomiting. abdominal pain; diarrhoea; dry mouth, hiccups, dyspepsia. Oral ulcers; stomatitis; flatulence; eructation; dysphagia; ileus.
Malaena, dental disease, tooth disorders, gingival bleeding Dental caries.
Hepatobiliary disorders:
Increased hepatic enzymes. Cholestasis; biliary colic.
Sphincter of Oddi dysfuntion Skin and subcutaneous tissue disorders:
Pruritus Skin reaction/rash hyperhidrosis; Dry skin. urticaria.
Renal and urinary disorders:
Dysuria, Micturition urgency Urinary retention.
Reproductive system and breast disorders:
Erectile dysfunction, Hypogonadi sm. Amenorrhoea.
General disorders and administration site conditions:
Asthenic conditions, Fatigue. g. chest pain); malaise; oedema; peripheral oedema; drug tolerance; thirst. Weight increase or decrease Drug withdrawal syndrome in new-borns. Injury, poisoning and complications Injuries from accidents. Children and adolescents The frequency, nature and severity of adverse reactions in patients under 12 years of age are not expected to be different from those in adults and adolescents 12 years and over.
6. Drug dependence Repeated use of Ixyldone 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Prolonged use of Ixyldone may lead to physical dependence. Withdrawal symptoms may occur following abrupt discontinuation of therapy. If therapy with oxycodone is no longer required, it may be advisable to reduce the daily dose gradually in order to avoid the occurrence of withdrawal syndrome.
Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions, insomnia or myalgia. Opioids, similar to other strong analgesics, are not the first-line treatment for chronic noncancer pain, nor are they recommended as the only treatment.
Opioids should be used as part of a comprehensive treatment program that includes other drugs and treatment modalities. Patients with chronic non- cancer related pain should be monitored for addiction development and abuse. In accordance with the pain guidelines, regular reviews should be made to ensure that treatment goals are being achieved, adjust dosage as necessary and decide on continuation or discontinuation of therapy.
The dosage has to be adjusted if necessary and a decision has to be taken on the continuation or termination of therapy. Concomitant use of alcohol and Ixyldone may increase the undesirable effects of Ixyldone; concomitant use should be avoided.
Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required. Ixyldone should not be used in children younger than 12 years of age because of safety and efficacy concerns.
Ixyldone is not recommended for pre-operative use or within the first 12 – 24 hours post operatively. Depending on the type and extent of the surgical procedure, the selected anaesthetic procedure, the other concomitant medication and the patient's individual condition, the timing of the postoperative use of Ixyldone must be determined after careful consideration of the benefit and risk in each individual case.
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 a decrease in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.
Like all opioid containing preparations, Ixyldone should be used with caution in patients undergoing bowel-surgery due to the known impairments of intestinal motility. Opioids should only be used after the doctor has verified the normalisation of the bowel function.
Ixyldone consists of a polymer matrix and is intended for oral use only. In case of abusive parenteral venous injection, the tablet excipients (especially talc) may lead to serious, potentially fatal events. The empty tablet matrix may be excreted visibly with the faeces.
The use of Ixyldone may lead to positive results for doping controls. Use of Ixyldone as a doping agent may become a health hazard. This medicinal product contains lactose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose- isomaltase insufficiency should not take this medicine.
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 Ixyldone 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 Ixyldone may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family […]