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SUBUTEX is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Subutex prolonged-release injection is indicated in adults (16 years and older) who have agreed to be treated for opioid addiction.
Verbatim from this product's MHRA label. Tap a section to expand.
Administration of Subutex prolonged-release injection is restricted to healthcare professionals. Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring according to the patient's needs, should be taken when prescribing and dispensing buprenorphine.
Take-home use or self-administration of the medicinal product by patients is not allowed. Subutex prolonged-release injection is not interchangeable with other buprenorphine prolonged-release solutions for injection. Posology Patients should first undergo induction and stabilization by initiating a transmucosal buprenorphine-containing product, delivering the equivalent of 8 mg/day to 24 mg/day of buprenorphine for a minimum of 7 days.
Dosing and induction with this transmucosal buprenorphine-containing product should be based on instructions in its appropriate product label. Dosing should be stopped on the day of the first Subutex prolonged-release injection. Following stabilisation on a transmucosal buprenorphine-containing product, the patient should be given an initial dose of 300 mg Subutex prolonged-release injection.
1 month later, a second dose of 300 mg Subutex prolonged-release injection should be given. 1 month later, the patient should commence the monthly maintenance dose of 100 mg Subutex prolonged-release injection. 1); however, patients who tolerate the 100-mg maintenance dose but do not show a satisfactory clinical response may receive a monthly maintenance dose of 300 mg.
Transition of patients established on long-term treatment with transmucosal buprenorphine Patients established on long-term treatment with transmucosal buprenorphine (8 mg/day to 24 mg/day) and whose disease symptoms are controlled can be transitioned directly to Subutex prolonged-release injection [see Table 1 for treatment initiation].
2]. These levels need to be taken into consideration when transitioning a patient established on long-term treatment with transmucosal buprenorphine to Subutex prolonged-release injection. Table 1 Transition of patients established on long-term treatment with transmucosal buprenorphine whose disease symptoms are controlled Subutex prolonged-release injection Transmucosal Buprenorphine Doses Injection 1 Injection 2 Maintenance Dose 8 mg/day to 18 mg/day 300 mg 100 mg* 100 mg 20 mg/day to 24 mg/day 300 mg 300 mg 100 mg * For patients still experiencing craving or withdrawal symptoms after the initial 300-mg dose, consider giving 300 mg as the second dose.
, insomnia, headache, nausea and hyperhidrosis) and pain. , erythema, induration, pain and pruritus). Tabulated list of adverse reactions • adverse reactions reported from pivotal clinical studies on Subutex sublingual tablets with additional adverse reactions observed during pivotal clinical studies on Subutex prolonged-release injection.
The frequency of possible side effects listed below is defined using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data). • the most commonly reported adverse drug reactions during post- marketing surveillance of Subutex sublingual tablets.
Events occurring in at least 1 % of reports by healthcare professionals and considered expected are included. Frequency of events not reported in pivotal studies cannot be estimated and is given as not known. 4) Hallucination Nervous system disorders Headache Dizziness Hypertonia Lethargy* Migraine Paraesthesia Sedation* Somnolence Syncope Tremor Hepatic encephalopathy Seizures Eye disorders Lacrimal disorder Mydriasis Ear and labyrinth disorders Vertigo Cardiac disorders Palpitations Vascular disorders Vasodilatation Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Cough Dyspnoea Yawning Bronchospasm Gastrointestinal disorders Nausea Abdominal pain Constipation Diarrhoea Dry mouth Dyspepsia Gastrointestinal disorder Flatulence Tooth disorder Vomiting Hepatobiliary disorders Hepatitis Hepatitis acute Hepatic cytolysis Hepatic necrosis Hepatorenal syndrome Jaundice System organ class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders Hyperhidrosis Rash Angioedema Musculoskeletal and connective tissue disorders Arthralgia Back pain Bone pain Muscle spasms Myalgia Neck pain Renal and urinary disorders Urinary retention Reproductive system and breast disorders Dysmenorrhoea General disorders and administration site conditions Drug withdrawal syndrome Pain Asthenia Chest pain Chills Fatigue* Injection site erythema* Injection site induration* Injection site pain* Injection site pruritus* Malaise Oedema peripheral Pyrexia Drug withdrawal syndrome neonatal Investigations Hepatic enzyme increased*† *Additional adverse reactions observed during pivotal clinical studies on Subutex prolonged-release injection †The term hepatic enzyme increased includes elevations of ALT, AST, GGT, alkaline phosphatase, and/or bilirubin.
Subutex prolonged-release injection is recommended only for the treatment of opioid drug dependence. It is also recommended that treatment is prescribed by a physician who ensures comprehensive management of the opioid-dependent patient(s).
Risk of Serious Harm or Death with Intravenous Administration (Incorrect Administration) Intravenous injection presents significant risk of serious harm or death as Subutex prolonged-release injection forms a solid mass upon contact with body fluids.
Occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, could result if administered intravenously. Do not administer intravenously or intramuscularly. Drug dependence, tolerance and potential for abuse Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Some risks of misuse and abuse include overdose, spread of blood borne viral or localised infections, respiratory depression and hepatic injury. Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use or if the medicine is not safeguarded against theft.
Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as buprenorphine. Abuse or intentional misuse of buprenorphine may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). g. too early requests for refills). This includes the review of concomitant opioids and psychoactive drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Subutex prolonged-release injection is injected as a solution and following administration, the poly (DL-lactide-co-glycolide) polymer creates a depot which contains buprenorphine. After initial formation of the depot, buprenorphine is released via diffusion from, and the biodegradation of, the depot.
1 • Severe respiratory insufficiency • Severe hepatic impairment • Acute alcoholism or delirium tremens
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Frequency of dosing In consideration of its long half-life, Subutex prolonged-release injection should be administered once monthly and separated by a minimum of 26 days between doses. Missed doses A patient who misses a dose should receive the next dose as soon as possible.
Unavoidable occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect. Treatment goals and discontinuation Before initiating treatment with Subutex, a treatment strategy including treatment duration and treatment goals, should be agreed together with the patient.
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. There is no maximum recommended duration of maintenance treatment.
The need for continuing medication-assisted treatment should be re- evaluated periodically. 4). If Subutex is discontinued, its extended. 2) and the patient should be monitored for several months for signs and symptoms of withdrawal and treated appropriately After steady-state has been achieved, patients discontinuing Subutex prolonged-release injection may have detectable plasma levels of buprenorphine for twelve months or longer.
The correlation between plasma concentrations of buprenorphine and those detectable in urine is not known. Special populations Elderly The safety and efficacy of buprenorphine in patients over 65 years of age has not been established.
Due to possible decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients, the decision to prescribe Subutex prolonged-release injection should be made cautiously in individuals 65 years of age or older and these patients should be monitored for signs and symptoms of toxicity or overdose.
2). 4). 4). 3). Renal impairment Modification of the buprenorphine dose is not required for patients with renal impairment. 2). Paediatric population No data are available in individuals less than 16 years of age; […]
There were no cases of severe drug-induced liver injury. 4). • In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a withdrawal effect similar to that associated with naloxone. Drug dependence Repeated use of buprenorphine 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.
Clinical monitoring for evidence at the injection site of tampering or attempting to remove the depot should be ongoing throughout treatment. Pain Management While on Subutex prolonged-release injection, situations may arise where patients need acute pain management, or may require anaesthesia (including regional/local anaesthesia).
Treat patients receiving Subutex prolonged-release injection with a non- opioid analgesic whenever possible. Patients requiring opioid therapy for analgesia may be treated with a high-affinity full opioid analgesic under the supervision of a healthcare professional, with particular attention to respiratory function.
Titration of full opioid analgesics to the desired analgesic effect might require higher doses. Therefore, a higher potential for toxicity exists with opioid administration and the patient should be monitored during treatment. If opioid therapy is required as part of anaesthesia, patients should be continuously monitored by anaesthesia staff not involved in the conduct of the surgical or diagnostic procedure.
The opioid therapy should be provided by individuals specifically trained in the use of anaesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent/open airway and giving of assisted/controlled ventilation.
Advise patients of the importance of instructing their family members and close friends, in the event of emergency, to inform the treating healthcare professional or emergency room staff that the patient is physically dependent on an opioid and that the patient is being treated with Subutex prolonged-release injection.
The above guidance should also be considered for any patient who has discontinued Subutex prolonged-release injection within the last 6 months. 5) or when buprenorphine was not used according to prescribing information. Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) or other opioids.
g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis). Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it.
Protect children and non-opioid-dependent persons against exposure. CNS depression Buprenorphine may cause drowsiness particularly when used with alcohol or other central nervous system depressants (such as benzodiazepines, gabapentinoids.
7). Withdrawal signs and symptoms 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 buprenorphine. The decision to maintain a patient on a long- term opioid prescription should be an active decision agreed between the clinician and patient with review at regular […]