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SOFONAC is a brand name for Naloxone. 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. Sofonac is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For doses not realisable/not practicable with this strength, other strengths of this medicinal product are available. Analgesia The analgesic efficacy of Sofonac 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. 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 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 of oxycodone hydrochloride/naloxone hydrochloride and who have become in need of an increased dose.
For patients requiring higher doses of oxycodone hydrochloride/naloxone hydrochloride, 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. Some patients taking Sofonac according to a regular time schedule require immediate- release analgesics as “rescue” medication for breakthrough pain.
Sofonac 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 dose of Sofonac requires upward adjustment. 5 mg oxycodone hydrochloride/naloxone hydrochloride 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. Sofonac is taken at the determined dose twice daily according to a fixed time schedule.
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) Eye disorders Visual impairment Ear and labyrinth disorders Vertigo System organ class (MedDRA) Common Uncommon Rare Not known 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 Central sleep apnoea syndrome Gastrointestinal disorders Abdominal pain Constipation Diarrhoea Dry mouth Dyspepsia Vomiting Nausea Flatulence Abdominal distension Tooth disorder Eructation Hepatobiliary disorders Hepatic enzymes increased Biliary colic Skin and subcutaneous tissue disorders Pruritus Skin reactions Hyperhidrosis Musculoskeletal 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 conditions Fatigue Chest pain Chills Drug withdrawal syndrome Malaise Pain Oedema peripheral Thirst System organ class (MedDRA) Common Uncommon Rare Not known Investigations Weight decreased Weight increased Injury, poisoning, and procedural complications Injuries from accidents 1 particularly in patients with epileptic disorder or predisposition to convulsions 2 particularly 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.
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 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 manner. In patients who present with CSA, consider decreasing the total opioid dosage.
Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of Sofonac and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Sofonac concomitantly with sedative medicinal products, 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). Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone.
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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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.
Treatment goals and discontinuation Before initiating treatment with Sofonac, 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). Duration of use Sofonac should not be administered for longer than absolutely necessary. Special populations Elderly As for younger adults the dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.
2). Naloxone concentrations were affected to a higher degree than oxycodone. The clinical relevance of a relative high naloxone exposure in renally impaired patients is yet not known. 4) and particularly if a dose increase is considered.
Hepatic impairment 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 relatively high naloxone exposure in patients with hepatic impairment is not yet known.
4). Similarly, special attention is required in patients with mild hepatic impairment if an increased dose is considered. 3). Paediatric population The safety and efficacy of Sofonac in children and adolescents aged below 18 years has not been established.
No data are available. Method of administration Oral use. Sofonac is 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. Sofonac must be swallowed whole with sufficient liquid, and must not be divided, broken, chewed or crushed.
g. derealisation) Nervous system disorders Concentration impaired Migraine Hypertonia Involuntary muscle contractions Hypoaesthesia Abnormal coordination Hyperalgesia Ear and labyrinth disorders Hearing impaired Vascular Vasodilation System organ class MedDRA Common Uncommon Rare Not known disorders Respiratory, thoracic and mediastinal disorders Dysphonia Gastrointestinal disorders Hiccups Dysphagia Ileus Mouth ulceration Stomatitis Melaena Gingival bleeding Dental caries Hepatobiliary disorders Cholestasis, Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Dry skin 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 Drug dependence Repeated use of Sofonac 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.
Repeated use of Sofonac 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 Sofonac 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.
Hepatic or renal impairment Caution must also be exercised when administering Sofonac to patients with mild hepatic or renal impairment. A careful medical monitoring is particularly necessary for patients with severe renal impairment.
Hepatobiliary disorders Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, oxycodone / naloxone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Diarrhoea Diarrhoea may be considered as a possible effect of naloxone. Tolerance, physical dependence and withdrawal. During long-term administration, the patient may develop tolerance to the medicinal product and require higher doses to maintain the desired effect.
Chronic administration of Sofonac may lead to physical dependence. Withdrawal symptoms may occur upon the abrupt cessation of therapy. 2). Sofonac is not suitable for the treatment of withdrawal symptoms. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Furthermore a reduction of the dose or termination of therapy may be considered. 7). Alcohol Concomitant use of alcohol and Sofonac may increase the undesirable effects of Sofonac; concomitant use should be avoided. Cancer There is no clinical data available for cancer patients with peritoneal carcinomatosis or beginning intestinal obstruction in advanced stages of digestive and pelvic cancers.
Therefore, the use of Sofonac in this population is not recommended. Surgery Sofonac is not recommended for pre-operative use or within the first 12 to 24 hours post-operatively. Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).
Depending on the type and extent of surgery, the anaesthetic procedure selected, other co-medication and the individual condition of the patient, the exact […]