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OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE 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 hydrochloride/Naloxone hydrochloride 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, Oxycodone hydrochloride/Naloxone hydrochloride should be administered as follows: Adults The usual starting dose for an opioid naive patient is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals.
Patients already receiving opioids may be started on higher doses of Oxycodone hydrochloride/Naloxone hydrochloride depending on their previous opioid experience. 5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment.
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 hydrochloride/Naloxone hydrochloride 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:
Term Frequency 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.
Undesirable effects in the treatment of pain System organ class MedDRA Common Uncommon Rare Very rare Not known Immune system disorders Hypersensitivity Metabolism and nutrition disorders Decreased appetite up to loss of appetite Psychiatric disorders Insomnia Abnormal thinking, Anxiety, Confusional state, Depression, Libido decreased, Nervousness, Restlessness Drug dependence Euphoric mood, Hallucination, Nightmares Aggression Nervous system disorders Dizziness, Headache, Somnolence Convulsions1, Disturbance in attention, Dygeusia, Speech disorder, Syncope, Tremor, Lethargy Paraesthesia, Sedation Eye disorders Visual impairment Ear and labyrinth disorders Vertigo Cardiac disorders Angina pectoris2, Palpitations Tachycardia System organ class MedDRA Common Uncommon Rare Very rare Not known Vascular disorders Hot flush Blood pressure decreased, Blood pressure increased Respiratory, thoracic and mediastinal disorders Dyspnoea, Rhinorrhoea, Cough Yawning Respiratory depression Gastrointesti nal disorders Abdominal pain, Constipation, Diarrhoea, Dry mouth, Dyspepsia, Vomiting, Nausea, Flatulence Abdominal distention Tooth disorder Eructation Hepatobiliar y disorders Hepatic enzymes increased, Biliary colic Skin and subcutaneou s tissue disorders Pruritus, Skin reactions, Hyperhydros is Musculoskel etal and connective tissue disorders Muscle spasm, Muscle twitching, Myalgia Renal and urinary disorders Micturition urgency Urinary retention Reproductiv e system and breast disorders Erectile dysfunction General disorders and administrati on site conditions Asthenia, Fatigue Chest pain, Chills, Drug withdrawal syndrome, Malaise, System organ class MedDRA Common Uncommon Rare Very rare Not known Pain, Peripheral oedema, Thirst Investigatio ns Weight decreased Weight increased Injury, poisoning and procedural complicatio ns Injury from accidents 1 particulary in persons with epileptic disorder or predisposition to convulsions 2 in particular in patients with history of coronary artery disease 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 spam and spasms of nonstriated muscles as well as suppress the cough reflex.
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 manner. 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 hydrochloride/Naloxone hydrochloride 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 hydrochloride/Naloxone hydrochloride 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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5 mg twice daily, or where ¨necessary 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.
Oxycodone hydrochloride/Naloxone hydrochloride 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 hydrochloride/Naloxone hydrochloride 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 hydrochloride/Naloxone hydrochloride 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 hydrochloride/Naloxone hydrochloride 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 hydrochloride/Naloxone hydrochloride 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 […]
g. derealisation), System organ class MedDRA Common Uncommon Rare Very rare Not known Nervous system disorders Concentration impaired, Migraine, Hypertonia, Involuntary muscle contractions, Hypoaesthesia, Abnormal co- ordination Hyperalgesia Ear and labyrinth disorders Hearing impaired Vascular disorders Vasodilatation Respiratory, thoracic and mediastinal disorders Dysphonia Gastrointestina l disorders Hiccups Dysphagia, Ileus, Mouth ulceration, Stomatitis Melaena, Gingival bleeding Dental caries Hepatobiliary disorders Cholestasis Skin and subcutaneous tissue disorder Dry skin Urticaria Renal and urinary disorders Dysuria Reproductive system and breast disorders Hypogonadism Amenorrhoea General disorders and application site conditions Oedema, Drug tolerance Drug withdrawal syndrome neonatal Undesirable effects in the treatment of restless leg syndrome The list below reflects the adverse drug reactions seen with Oxycodone hydrochloride /Naloxone hydrochloride in a 12-week, randomised, placebo-controlled clinical trial comprising a total of 150 patients on Oxycodone hydrochloride/Naloxone hydrochloride and 154 patients on placebo with daily dosages between 10 mg/5 mg and 80 mg/40 mg oxycodone hydrochloride/naloxone hydrochloride.
Adverse drug reactions associated with these tablets in pain and not observed in RLS study population were added with the frequency of not known. System organ class MedDRA Very common Common Uncommon Rare Very rare Not known Immune system disorders Hypersensitivity Metabolism and nutritional disorders Decreased appetite up to loss of appetite Psychiatric disorders Insomnia, depression Libido decreased, sleep attacks Abnormal thinking, anxiety, confusional state, nervousness, restlessness, euphoric mood, hallucination, nightmares, drug dependence, aggression Nervous system disorders Headache, somnolence Dizziness, disturbance in attention, tremor, paraesthesia Dysgeusia Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions), sedation, speech disorder, syncope, lethargy Eye disorders Visual impairment Ear and labyrinth disorders Vertigo Cardiac disorders Angina pectoris (in particular in patients with history of coronary artery disease), palpitations, tachycardia Vascular disorders Hot flush, blood pressure decreased, blood pressure increased Respiratory, thoracic and mediastinal disorders Dyspnoea Cough, rhinorrhoea, respiratory depression, yawning System organ class MedDRA Very common Common Uncommon Rare Very rare Not known Gastrointestinal disorders Constipation, nausea Abdominal pain, dry mouth, vomiting Flatulence Abdominal distension, diarrhoea, dyspepsia, eructation, tooth disorder Hepatobiliary disorders Hepatic enzymes increased (alanine aminotransferase increased, gamma- glutamyltransferase increased) Biliary colic Skin and subcutaneous tissue disorder Hyperhidrosis Pruritus, skin reactions Musculoskeletal and […]
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 dependence, tolerance and potential for abuse Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone. Iatrogenic addiction following therapeutic use of opioids is known to occur.
Repeated use of Oxycodone hydrochloride/Naloxone hydrochloride may lead to Opioid Use Disorder (OUD). Abuse or intentional misuse of Oxycodone hydrochloride/Naloxone hydrochloride may result in overdose and/or death. g. major depression, anxiety and personality disorders).
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.
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. Tolerance 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. Withdrawal symptoms may occur upon the abrupt cessation of therapy. 2). 2). 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.
9). Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating […]