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OXYCODONE AND NALOXONE MUNDIPHARMA 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. Second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Analgesia The analgesic efficacy of Oxycodone and Naloxone Mundipharma is equivalent to oxycodone hydrochloride prolonged-release formulations. The dosage should be adjusted to the intensity of pain and the sensitivity of the individual patient.
Unless otherwise prescribed, these tablets should be administered as follows:
Adults The usual starting dose for an opioid naïve patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals. Lower strengths are available to facilitate dose titration when initiating opioid therapy and for individual dose adjustment.
Patients already receiving opioids may be started on higher doses depending on their previous opioid experience. The maximum daily dose of these tablets is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. The maximum daily dose is reserved for patients who have previously been maintained on a stable daily dose and who have become in need of an increased dose.
Special attention should be given to patients with compromised renal function and patients with mild hepatic impairment if an increased dose is considered. For patients requiring higher doses, administration of supplemental prolonged-release oxycodone hydrochloride at the same time intervals should be considered, taking into account the maximum daily dose of 400 mg prolonged-release oxycodone hydrochloride.
In the case of supplemental oxycodone hydrochloride dosing, the beneficial effect of naloxone hydrochloride on bowel function may be impaired. After complete discontinuation of therapy with these tablets with a subsequent switch to another opioid a worsening of the bowel function can be expected.
Some patients taking these prolonged-release tablets according to a regular time schedule require immediate-release analgesics as “rescue” medication for breakthrough pain. Oxycodone and Naloxone Mundipharma is a prolonged-release formulation and therefore not intended for the treatment of breakthrough pain.
For the treatment of breakthrough pain, a single dose of “rescue medication” should approximate one sixth of the equivalent daily dose of oxycodone hydrochloride. The need for more than two “rescues” per day is usually an indication that the dosage requires upward adjustment.
The following frequencies are the basis for assessing undesirable effects:
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) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4) Gastrointestinal disorders Common: Abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, vomiting, nausea, flatulence Uncommon: Abdominal distension Rare: Tooth disorder Not known: Eructation Hepatobiliary disorders Uncommon: Hepatic enzymes increased, biliary colic Skin and subcutaneous tissue disorders Common: Pruritus, skin reactions, hyperhidrosis Musculoskeletal and connective tissue disorders Uncommon: Muscle spasms, muscle twitching, myalgia Renal and urinary disorders Uncommon: Micturition urgency Not known: Urinary retention Reproductive system and breast disorders Not known: Erectile dysfunction General disorders and administration site conditions Common: Asthenia, fatigue Uncommon: Chest pain, chills, malaise, pain, peripheral oedema, thirst Not known: Drug withdrawal syndrome Investigations Uncommon: Weight decreased Rare: Weight increased Injury, poisoning and procedural complications Uncommon: Injuries from accidents For the active substance oxycodone hydrochloride, the following additional undesirable effects are known: Due to its pharmacological properties, oxycodone hydrochloride may cause respiratory depression, miosis, bronchial spasm and spasms of nonstriated muscles as well as suppress the cough reflex.
g. derealisation) Nervous system disorders Uncommon: Concentration impaired, migraine, hypertonia, involuntary muscle contractions, hypoaesthesia, abnormal coordination Not known: Hyperalgesia Ear and labyrinth disorders Uncommon: Hearing impaired Vascular disorders Uncommon: Vasodilatation Respiratory, thoracic and mediastinal disorders Uncommon: Dysphonia Gastrointestinal disorders Common: Hiccups Uncommon: Dysphagia, ileus, mouth ulceration, stomatitis Rare: Melaena, gingival bleeding, Not known: Dental caries Hepatobiliary disorders Not known: Cholestasis, Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Uncommon: Dry skin Rare: Urticaria Renal and urinary disorders Common: Dysuria Reproductive system and breast disorders Uncommon: Hypogonadism Not known: Amenorrhoea General disorders and administration site conditions Uncommon: Oedema Not known: Drug withdrawal syndrome neonatal, drug tolerance Undesirable effects in the treatment of restless legs syndrome The list below reflects the adverse drug reactions seen with Oxycodone and Naloxone Mundipharma in a 12-week, randomised, placebo-controlled clinical trial comprising a total of 150 patients on Oxycodone and Naloxone Mundipharma and 154 patients on placebo with daily dosages between 10 mg/5 mg and 80 mg/40 mg oxycodone hydrochloride/naloxone hydrochloride.
5) • Tolerance, physical dependence and withdrawal (see below) • Psychological dependence [addiction], abuse profile and history of substance and/or alcohol abuse (see below) • Elderly or infirm • Head injury, intracranial lesions or increased intracranial pressure, reduced level of consciousness of uncertain origin • Epileptic disorder or predisposition to convulsions • Hypotension • Hypertension • Pancreatitis • Mild hepatic impairment • Renal impairment • Opioid-induced paralytic ileus • Myxoedema • Hypothyroidism • Addison’s disease (adrenal cortical insufficiency) • Prostate hypertrophy • Toxic psychosis • Alcoholism • Delirium tremens • Cholelithiasis • Pre-existing cardiovascular diseases 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.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of opioids, including oxycodone hydrochloride 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 and Naloxone Mundipharma 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). MAOIs Oxycodone and Naloxone Mundipharma must be administered with caution in patients taking MAOIs or who have received MAOIs within the previous two weeks.
1, • Severe respiratory depression with hypoxia and/or hypercapnia, • Severe chronic obstructive pulmonary disease, • Cor pulmonale, • Severe bronchial asthma, • Non-opioid induced paralytic ileus, • Moderate to severe hepatic impairment.
Additionally for restless legs syndrome: • History of opioid abuse
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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25 mg or 10 mg/5 mg, oxycodone hydrochloride/naloxone hydrochloride until a stable dose is reached. The aim is to establish a patient-specific twice daily dose that will maintain adequate analgesia and make use of as little rescue medication as possible for as long as pain therapy is necessary.
25 mg tablet is used. Oxycodone and Naloxone Mundipharma is taken at the determined dosage twice daily according to a fixed time schedule. While symmetric administration (the same dose mornings and evenings) subject to a fixed time schedule (every 12 hours) is appropriate for the majority of patients, some patients, depending on the individual pain situation, may benefit from asymmetric dosing tailored to their pain pattern.
In general, the lowest effective analgesic dose should be selected. In non-malignant pain therapy, daily doses of up to 40 mg/20 mg oxycodone hydrochloride/naloxone hydrochloride are usually sufficient, but higher doses may be needed.
For doses not realisable/practicable with this strength other strengths of this medicinal product are available. Restless legs syndrome Oxycodone and Naloxone Mundipharma is indicated for patients suffering from RLS for at least 6 months.
RLS symptoms should be present daily and during daytime (≥ 4 days/week). Oxycodone and Naloxone Mundipharma should be used after failure of previous dopaminergic treatment. Dopaminergic treatment failure is defined as inadequate initial response, a response that has become inadequate with time, occurrence of augmentation or unacceptable tolerability despite adequate doses.
Previous treatment with at least one dopaminergic medicinal product should have lasted in general 4 weeks. A shorter period might be acceptable in case of unacceptable tolerability with dopaminergic therapy. The dosage should be adjusted to the sensitivity of the individual patient.
Treatment of patients with restless legs syndrome with Oxycodone and Naloxone Mundipharma should be under the supervision of a clinician with experience in the management of restless legs syndrome. 5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals.
Titration on a weekly basis is recommended in case higher doses are required. The mean daily dose in the pivotal study was 20mg/10mg oxycodone hydrochloride/naloxone hydrochloride. Some patients may benefit from higher daily doses up to a maximum of 60 mg/30 mg oxycodone hydrochloride/naloxone hydrochloride.
Oxycodone and Naloxone Mundipharma is taken at the determined dosage twice daily according to a fixed time schedule. While symmetric administration (the same dose mornings and evenings) subject to a fixed time schedule (every 12 hours) is appropriate for the majority of patients, some patients, depending on the individual situation, may benefit from asymmetric dosing tailored to the individual patient.
In general, the lowest effective dose should be selected. For doses not realisable/practicable with this strength other strengths of this medicinal product are available. Analgesia / Restless legs syndrome Elderly patients As for younger adults the dosage should be adjusted to the intensity of the pain or RLS symptoms and the sensitivity of the individual patient.
Patients with impaired hepatic function A clinical trial has shown that plasma concentrations of both oxycodone and naloxone are elevated […]
Adverse drug reactions associated with these tablets in pain and not observed in RLS study population were added with the frequency of not known.
Immune system disorders Not known:
Hypersensitivity Metabolism and nutrition disorders Common: Decreased appetite up to loss of appetite Psychiatric disorders Common: Insomnia, depression Uncommon: Libido decreased, sleep attacks Not known: Abnormal thinking, anxiety, confusional state, nervousness, restlessness, euphoric mood, hallucination, nightmares, drug dependence, aggression Nervous system disorders Very common: Headache, somnolence Common: Dizziness, disturbance in attention, tremor, paraesthesia Uncommon: Dysgeusia Not known: Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions), sedation, speech disorder, syncope, lethargy Eye disorders Common: Visual impairment Ear and labyrinth disorders Common: Vertigo Cardiac disorders Not known: Angina pectoris (in particular in patients with history of coronary artery disease), palpitations, tachycardia Vascular disorders Common: Hot flush, blood pressure decreased, blood pressure increased Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea Not known: Cough, rhinorrhoea, respiratory depression, yawning Gastrointestinal disorders Very common: Constipation, nausea Common: Abdominal pain, dry mouth, vomiting Uncommon: Flatulence Not known: Abdominal distension, diarrhoea, […]
Caution is advised in treating restless legs syndrome patients with additional sleep apnoea syndrome with these tablets due to the additive risk of respiratory depression. No data about the risk exist because in the clinical trial patients with sleep apnoea syndrome were excluded.
Caution must also be exercised when administering these tablets to patients with mild hepatic or renal impairment. Careful medical monitoring is particularly necessary for patients with severe renal impairment. Diarrhoea may be considered as a possible effect of naloxone.
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 Oxycodone and Naloxone Mundipharma. 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 newborn infants will experience neonatal withdrawal syndrome. Oxycodone and Naloxone Mundipharma is not suitable for the treatment of withdrawal symptoms. 2). 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 and Naloxone Mundipharma 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 and Naloxone Mundipharma 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.
In order not to impair the prolonged-release characteristic of the prolonged-release tablets, the prolonged-release tablets must be taken whole and must not be broken, chewed or crushed. Breaking, chewing or crushing the prolonged-release tablets for ingestion leads to a faster release of the active […]