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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. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets are…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology Analgesia The analgesic efficacy of Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets is equivalent to oxycodone hydrochloride prolonged-release formulations. The dose should be adjusted to the intensity of pain and the sensitivity of the individual patient.
Unless otherwise prescribed, Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets should be administered as follows: Adults The usual starting dose for opioid-naive patients is 10 mg/5 mg of oxycodone hydrochloride/naloxone hydrochloride at 12 hourly intervals.
Patients already receiving opioids may be started on higher doses depending on their previous opioid experience. 5 mg prolonged- release tablets are intended for dose titration when initiating opioid therapy and for individual dose adjustment.
The maximum daily dose is 160 mg/80 mg oxycodone hydrochloride/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 oxycodone hydrochloride/naloxone hydrochloride with a subsequent switch to another opioid a worsening of the bowel function can be expected.
Some patients taking this medicine according to a regular time schedule require immediate-release analgesics as “rescue” medication for breakthrough pain. Oxycodone hydrochloride and Naloxone hydrochloride tablets are 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 dose of Oxycodone hydrochloride and Naloxone hydrochloride requires upward adjustment.
Undesirable effects are presented below in two sections: the treatment of pain, the active substance oxycodone hydrochloride.
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) Nervous system disorders Dizziness, Headache, Somnolence Convulsions1, Disturbance in attention, Dysgeusia, Speech disorder Syncope, Tremor, Lethargy Paraesthesia, Sedation Eye disorders Visual impairment Ear and labyrinth disorders Vertigo Cardiac disorders Angina pectoris2, Palpitations Tachycardia Vascular disorders Hot flush Blood pressure decreased, blood pressure increased Respiratory, thoracic and mediastinal disorders Dyspnoea, Rhinorrhoea, Cough Yawning Respiratory depression Gastrointestin al disorders Abdominal pain, Constipation, Diarrhoea, Dry mouth, Dyspepsia, Vomiting, Nausea, Flatulence Abdominal distention Tooth disorder Eructation Hepatobiliary disorders Hepatic enzymes increased, Biliary colic Skin and subcutaneous tissue disorders Pruritus, Skin reactions, Hyperhidrosis System organ class MedDRA Common Uncommon Rare Very rare Not known Musculo- skeletal and connective tissue disorders Muscle spasms, Muscle twitching, Myalgia Renal and urinary disorders Micturition urgency Urinary retention Reproductive system and breast disorders Erectile dysfunction General disorders and administration site conditions Asthenic, Fatigue Drug withdrawal syndrome, Chest pain, Chills, Malaise, Pain, Peripheral oedema, Thirst Investigations Weight decreased Weight increased Injury, poisoning and procedural complications Injury from accidents 1 particularly in persons with epileptic disorder or predisposition to convulsions 2 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 spasm and spasms of nonstriated muscles as well as suppress the cough reflex.
Caution must be exercised when administering Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets to elderly or infirm patients, patients with opioid-induced paralytic ileus, patients presenting severely impaired pulmonary function, patients with sleep apnoea, myxoedema, hypothyroidism, Addison’s disease (adrenal cortical insufficiency), toxic psychosis, cholelithiasis, prostate hypertrophy, alcoholism, delirium tremens, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
Respiratory depression The major 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 Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets 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 and Naloxone hydrochloride prolonged- release tablets 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). Hepatic or renal impairment Caution must also be exercised when administering Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets to patients with mild hepatic or renal impairment.
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
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.
> Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets are taken at the determined dose 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. Paediatric population The safety and efficacy of Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets in children and adolescents aged below 18 years has not been established.
No data are available. Elderly patients As for younger adults the dose should be adjusted to the intensity of the pain 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 in patients with hepatic impairment.
2). The clinical relevance of a relative high naloxone exposure in hepatic impaired patients is yet not known. 4). 3). 2). Naloxone concentrations were affected to a higher degree than oxycodone. The clinical relevance of a relative high naloxone exposure in renal impaired patients is yet not known.
4). Method of administration For oral use. These prolonged-release tablets are taken in the determined dose twice daily in a fixed time schedule. The prolonged-release tablets may be taken with or without food with sufficient liquid. The tablets must be swallowed whole with […]
g. derealisation), Drug dependence Aggression Nervous system disorders Concentration impaired, Migraine, Hypertonia, Involuntary muscle contraction, Hypoaesthesia, Abnormal coordination Hyperalgesia Ear and labyrinth disorders Hearing impaired Vascular disorders Vasodilation Respiratory, thoracic and mediastinal disorders Dysphonia Central sleep apnoea syndrome Gastrointestinal disorders Hiccups Dysphagia, Ileus, Mouth ulceration, Stomatitis Melaena, Gingival bleeding Dental caries Hepatobiliary disorders Cholestasis Skin and subcutaneous tissue disorders Dry skin Flush Urticaria Renal and urinary disorders Dysuria Reproductive system and breast disorders Hypogonadism Amenorrhoea General disorders and administration site conditions Oedema, Drug tolerance Drug withdrawal syndrome neonatal 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.
A careful medical monitoring is particularly necessary for patients with severe renal impairment. Diarrhoea Diarrhoea may be considered as a possible effect of naloxone. Switching from other opioids In patients under long-term opioid treatment with higher doses of opioids, the switch to Oxycodone hydrochloride and Naloxone hydrochloride can initially provoke withdrawal symptoms.
Such patients may require specific attention. Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets are not suitable for the treatment of withdrawal symptoms. 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 may lead to Opioid Use Disorder (OUD). Abuse or intentional misuse of Oxycodone hydrochloride and Naloxone hydrochloride prolonged-release tablets 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. 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 hydrochloride and Naloxone hydrochloride prolonged-release tablets.
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 […]