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OXYPRO 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 adequately managed only with opioid analgesics. Oxypro is indicated in adults and adolescents aged 12 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The dosage should be adjusted to the intensity of pain and the patient’s individual susceptibility. Unless otherwise prescribed, the following general dosage recommendations apply for Oxypro: Adults and adolescents (12 years of age and older) Dose titration The usual starting dose for an opioid naïve patient or patients with severe pain that cannot be controlled by weaker opioids is 10 mg oxycodone hydrochloride given at intervals of 12 hours.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. Switching from morphine to oxycodone The inter-patient variability requires that each patient be carefully adjusted to the dose that is appropriate for them.
At the beginning of the change, a dose that is lower than the dose equivalent may be recommended. Patients who have received oral morphine prior to oxycodone therapy should receive their daily dose based on the following ratio: 10 mg oral oxycodone is equivalent to 20 mg oral morphine.
Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with oxycodone hydrochloride prolonged-release tablets after conversion from other opioids, with 50-75% of the calculated oxycodone dose.
Dose adjustment Some patients who receive Oxypro following a fixed schedule additionally need rapid release analgesics as rescue medication in order to control breakthrough pain. Oxypro prolonged-release tablets are not indicated for the treatment of breakthrough pain.
The single dose of the rescue medication should amount to 1/4 of the equianalgesic daily dose of Oxypro and can be administered every 6 hours. Use of the rescue medication more than twice daily indicates that the dose of Oxypro prolonged-release tablets needs to be increased.
The dose should not be adjusted more often than once every 1-2 days until a stable 12-hour dose is reached. 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 until the desired effect is obtained.
The aim is a patient-specific 12 hourly dose maintaining adequate analgesia with tolerable undesirable effects and as little rescue medication as possible for as long as pain control is needed. Even distribution (the same dose mornings and evenings) following a fixed schedule (every 12 hours) is appropriate for the majority of patients.
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 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. Increased appetite.
Psychiatric disorders:
Anxiety, confusional state, depression, decreased activity, restlessness, psychomotor hyperactivity, nervousness, insomnia, abnormal thinking. g. hallucinations, derealisation), decreased libido Aggression. 4) Nervous system disorders: Somnolence; sedation, dizziness; headache.
Tremor, lethargy. Amnesia, convulsion (especially in patients with epilepsy or predisposition to convulsions), concentration impaired, migraine, hypertonia; involuntary muscle contractions, hypoaesthesia; abnormal coordination, speech disorder, syncope, paraesthesia, dysgeusia.
5) • Tolerance, physical dependence, and withdrawal (see below) • Psychological dependence [addiction], abuse profile and history of substance and/or alcohol abuse (see below) • Debilitated elderly • Head injury, intracranial lesions or increased intracranial pressure, reduced level of consciousness of uncertain origin • Hypotension • Hypovolemia • Epileptic disorder or predisposition to convulsions • Pancreatitis • Obstructive and inflammatory intestinal diseases • Impaired hepatic or renal function • Myxoedema • Hypothyroidism • Addison’s disease • Prostate hypertrophy • Alcoholism • Toxic psychosis • Delirium tremens • Constipation • Disease of the biliary tract.
With the occurrence or suspicion of paralytic ileus, Oxypro should be immediately discontinued. Respiratory depression The primary risk of opioid excess is respiratory depression. 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. Risks of 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 Oxypro concomitantly with sedative 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. 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.
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.
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For some patients it may be advantageous to distribute the doses unevenly. In general, the lowest effective analgesic dose should be chosen. 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 require in general 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.
Duration of treatment Oxypro should not be taken longer than necessary. Elderly patients Elderly patients without clinical manifestation of impaired liver or kidney function usually do not require dose adjustments. Patients with hepatic or renal impairment The treatment 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.
, 10 mg, may not be suitable as a starting dose. In this case Oxypro 5 mg prolonged release tablets should be used. Other risk patients In patients with low body weight or in slow metabolisers who are also opioid-naive, the recommended starting dose should be reduced to half of the recommended starting dose for adults.
e. 10 mg, may not be suitable as a starting dose. In this case Oxypro 5 mg prolonged release tablets should be used. Children (under 12 years of age) Oxycodone is not recommended for use in children below 12 years of age due to insufficient data on safety and efficacy.
Method of administration For oral use. Oxypro 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.
Oxypro must not be broken, divided, chewed or crushed. Treatment goals and discontinuation Before initiating treatment with Oxypro, 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).
Hyperalgesia. 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 Constipation; nausea; abdominal pain; Oral ulcers; stomatitis; Malaena, dental disease, Dental caries. al disorders: vomiting. diarrhoea; dry mouth, hiccups, dyspepsia.
flatulence; eructation; dysphagia; ileus. tooth disorders, gingival bleeding Hepatobiliary disorders: Increased hepatic enzymes. Cholestasis; biliary colic; Sphincter of Oddi dysfunction.
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, Hypogonadis m. Amenorrhoea.
General disorders and administration site conditions:
Asthenic conditions, fatigue. , chest pain); malaise; oedema; peripheral oedema; drug tolerance; thirst. Drug withdrawal syndrome 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 above. 6. Drug dependence Repeated use of Oxypro 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.
9). MAOIs Oxycodone must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks. Tolerance 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.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with Oxypro.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their new-born infants will experience neonatal withdrawal syndrome. Opioids are not the first line of treatment for chronic non-cancer 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.
If appropriate, the dose is to be adjusted. In case the treatment objectives are not met, discontinuation of therapy should be considered. Psychological dependence [addiction], abuse profile and history of substance and/or alcohol abuse There is potential for development of psychological dependence [addiction] to opioid analgesics, including oxycodone.
Oxycodone has an abuse profile similar to other strong opioid receptor agonists. Oxycodone may be abused by people with latent or manifest dependence disorders. There is potential for development of psychological dependence (addiction) after administration of opioid containing analgesics like Oxypro.
Oxycodone should be used with particular care in patients with a history of alcohol and drug abuse. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or […]