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OXYCODONE HYDROCHLORIDE GL PHARMA CONCENTRATED is a brand name for Oxycodone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oxycodone Hydrochloride G.L. Pharma is indicated in adults and adolescents (from 12 years and older) for the treatment of severe pain, which can be adequately managed only with opioid analgesics.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage depends on the pain intensity, the total condition of the patient, previous or concurrent medication, and the patient’s individual susceptibility to the treatment. L. Pharma are available.
The following general dosage recommendations apply:
Adults and adolescents (from 12 years and older) The initial dose for opioid-naïve patients is usually 5 mg oxycodone hydrochloride given at intervals of every 6 hours. The dose may be increased in steps of 25% to 50% of the respective dose.
The aim is a patient-specific dosage which allows for adequate analgesia with tolerable undesirable effects. Therefore, the dosing interval may be shortened to 4 hours if needed. L. Pharma should not be taken more often than 6 times a day.
Some patients receiving modified-release oxycodone medication according to a fixed time schedule may require immediate-release analgesics as rescue medication for the management of breakthrough pain. L. Pharma is appropriate for the management of breakthrough pain.
Single doses of the rescue medication should be adjusted based on the patients’ individual requirements. In general, 1/8 to 1/6 of the daily modified-release oxycodone dose is appropriate. The requirement of rescue medication more than twice daily may indicate that higher doses of modified-release oxycodone are necessary.
The aim is to establish a patient- specific dosage which ensures adequate analgesia with tolerable undesirable effects and as low rescue medication as possible for as long as pain medication is necessary in patients receiving modified-release oxycodone treatment twice daily.
Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies. Conversion from oral morphine Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg oxycodone hydrochloride correspond to approximately 20 mg of oral morphine.
Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with oxycodone hydrochloride after conversion from other opioids, with 50-75% of the calculated oxycodone dose.
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 treatment) and constipation.
Respiratory depression is the chief hazard of an opioid overdose and occurs predominantly in elderly or debilitated patients. The adverse reactions considered at least possibly related to treatment are listed below by system organ class and absolute frequency.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. L. Pharma can lead to drug dependence, even at therapeutic doses. 4). 1). 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.
g. alcohol) - prostatic hypertrophy - alcoholism, - known opioid dependence - delirium tremens - head injury, increased intracranial pressure - impaired consciousness of unknown cause - hypotension, - hypovolaemia, - epileptic disorder or predisposition to convulsions - pancreatitis - diseases of the biliary tract, biliary or ureteric colic - inflammatory bowel disorders - obstructive or inflammatory intestinal diseases, - conditions with increased brain pressure (including head injuries) - disturbances of circulatory regulation (including hypotension, hypovolaemia) - in patients taking MAO inhibitors 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. Oxycodone should not be used where there is a possibility of paralytic ileus occurring.
L. Pharma 10 mg/ml solution for injection/infusion should be discontinued immediately. 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.
Respiratory depression 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, 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, head injury (due to risk of increased intracranial pressure) or patients taking MAO inhibitors.
1. Oxycodone must not be used in any situation where opioids are contraindicated: - severe respiratory depression with hypoxia and/or hypercapnia - elevated carbon dioxide levels in the blood - severe chronic obstructive pulmonary disease - cor pulmonale - severe bronchial asthma - paralytic ileus - acute abdomen, delayed gastric emptying
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In general, patients should be titrated individually until pain relief is achieved, provided that undesirable adverse events can be adequately managed. Use in non-malignant pain Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment.
Special populations Elderly Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control. 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%, and each patient should be titrated to adequate pain control according to his/her clinical situation. Other risk patients In patients with low body weight or slow metabolism of drugs who are also opioid- naive, the recommended starting dose should be reduced to half the normally recommended starting dose for adults.
It is therefore possible that the lowest single dose recommended in this SmPC, is not suitable as a starting dose. Paediatric population Opioids must only be used for appropriate indications and prescribed by a specialist experienced in managing severe pain in children, with careful assessments of the benefits and risks.
Children below the age of 12 years The safety and efficacy of oxycodone in children below 12 years of age has not yet been established. No data are available. Method of administration Oral use. L. Pharma oral solution should be taken every 4-6 hours based on a fixed schedule at the dosage determined.
The oral solution may be taken with or independent of meals with or without an amount of liquid. L. Pharma oral solution should not be used with alcoholic beverages. L. Pharma 10 mg/ml oral solution is provided with a graduate oral syringe for conventional withdrawal or together with an adapter for over-head withdrawal.
5). L. Pharma, 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). L. Pharma should not be taken longer than necessary. Instructions for use are provided in the package leaflet.
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.
L. Pharma 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.
L. Pharma 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). Adrenal insufficiency Opioids, such as oxycodone hydrochloride, may occasionally cause reversible adrenal insufficiency, with some hormonal changes including increases in serum prolactin, and decreases in plasma cortisol and testosterone.
, severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss. Adrenal insufficiency may require monitoring and glucocorticoid replacement therapy. 5). Tolerance, physical dependence and tapering off The patient may develop tolerance to the medicinal product with chronic use and require progressively higher doses to maintain pain control.
Prolonged use of oxycodone 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 withdrawal symptoms.
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 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. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone.
L. Pharma may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. L. Pharma […]