{"id":2660,"date":"2026-10-04T10:35:43","date_gmt":"2026-10-04T08:35:43","guid":{"rendered":"https:\/\/vitalonga.gr\/?page_id=2660"},"modified":"2026-10-05T12:59:41","modified_gmt":"2026-10-05T10:59:41","slug":"oxybatin-for-healthcare-professionals","status":"publish","type":"page","link":"https:\/\/vitalonga.gr\/en\/oxybatin\/oxybatin-for-healthcare-professionals\/","title":{"rendered":"Oxybatin\u00ae For Healthcare Professionals"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column preset=&#8221;mpc_preset_91&#8243; content_preset=&#8221;_mpc_preset_91&#8243;][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;Oxybatin\u00ae&#8221; font_container=&#8221;tag:h2|font_size:24|text_align:left|color:%23398791&#8243; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1769364893198{margin-bottom: 10px !important;}&#8221;][vc_custom_heading text=&#8221;Sodium Oxybate Oral Solution 500mg\/ml&#8221; font_container=&#8221;tag:h2|font_size:14|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1791197316867{margin-bottom: 10px !important;}&#8221;][vc_custom_heading text=&#8221;BT X 1 BOTTLE (PET) X 180ML + 1 GRADUATED DOSING SYRINGE (PP) + 2 DOSING CUPS (PP)&#8221; font_container=&#8221;tag:h2|font_size:14|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1791197343770{margin-bottom: 10px !important;}&#8221;][\/vc_column_inner][vc_column_inner width=&#8221;2\/3&#8243; css=&#8221;.vc_custom_1531988352789{padding-right: 0px !important;}&#8221; offset=&#8221;vc_col-xs-4&#8243;]<div data-id=\"mpc_divider-416ac586bd5b2a1\" class=\"mpc-divider-wrap\"><div class=\"mpc-divider mpc-init mpc-align--left mpc-disable--left \" ><div class=\"mpc-divider__line mpc-side--left\"><span><\/span><\/div><div class=\"mpc-divider__line mpc-side--right\"><span><\/span><\/div><\/div><\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243; css=&#8221;.vc_custom_1531988358229{padding-left: 0px !important;}&#8221; offset=&#8221;vc_col-xs-8&#8243;]<div data-id=\"mpc_divider-526ac586bd5b2d8\" class=\"mpc-divider-wrap\"><div class=\"mpc-divider mpc-init mpc-align--left mpc-disable--left \" ><div class=\"mpc-divider__line mpc-side--left\"><span><\/span><\/div><div class=\"mpc-divider__line mpc-side--right\"><span><\/span><\/div><\/div><\/div>[\/vc_column_inner][\/vc_row_inner][vc_empty_space height=&#8221;45px&#8221;][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;2493&#8243; img_size=&#8221;&#8221; alignment=&#8221;center&#8221; onclick=&#8221;link_image&#8221; css_animation=&#8221;none&#8221; css=&#8221;&#8221;][\/vc_column][vc_column width=&#8221;2\/3&#8243;]<div id=\"mpc_accordion-156ac586bd5b340\" class=\"mpc-accordion mpc-init mpc-transition \" ><ul class=\"mpc-accordion__content\"><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-active mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>General<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\"  data-active=\"true\"><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]<strong>Oxybatin\u00ae <\/strong>contains the active substance sodium oxybate. <strong>Oxybatin\u00ae <\/strong>acts by stabilising nocturnal sleep, although its exact mechanism of action is not known.[\/vc_column_text]<\/div><\/div><\/li><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>Indications<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\" ><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from 7 years of age.[\/vc_column_text]<\/div><\/div><\/li><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>Posology and Method of Administration<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\" ><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]Treatment initiation and continuation should be under the guidance of a physician experienced in the treatment of narcolepsy. Physicians should strictly observe the contraindications, warnings and precautions.<\/p>\n<p><u>Dosage: <\/u><\/p>\n<p>Adults<\/p>\n<p>The recommended starting dose of sodium oxybate is 4.5g daily divided into two equal doses of 2.25g. The dose should be titrated on the basis of efficacy and tolerability (see section 4.4) up to a maximum of 9g per day, divided into two equal doses of 4.5g per dose, adjusting up or down in increments of 1.5g per day (i.e. 0.75g per dose). A minimum interval of one to two weeks is recommended before each stepwise dose change. The dose of 9g daily must not be exceeded, because of the possible occurrence of serious symptoms at doses of 18g per day or greater (see section 4.4).<\/p>\n<p>Doses of 4.5g are administered only if the patient has previously been titrated to this dose level.<\/p>\n<p><u>Discontinuation of Oxybatin <\/u><\/p>\n<p>The effects of discontinuing sodium oxybate have not been systematically evaluated in controlled clinical trials.<\/p>\n<p>If the patient stops taking the medicinal product for more than 14 consecutive days, titration must be restarted from the lowest dose.<\/p>\n<p><u>Special Populations: <\/u><\/p>\n<p><em>Elderly <\/em><\/p>\n<p>Elderly patients should be closely monitored for impairment of motor and\/or cognitive function when taking sodium oxybate.<\/p>\n<p><em>Hepatic Impairment <\/em><\/p>\n<p>The starting dose should be halved in all patients with hepatic impairment and the response to each stepwise dose increase should be carefully monitored.<\/p>\n<p><em>Renal Impairment <\/em><\/p>\n<p>All patients with impaired renal function should take into account the recommendation to reduce sodium intake.<\/p>\n<p><em>Paediatric Population <\/em><\/p>\n<p>Adolescents and children from 7 years of age with a minimum body weight of 15 kg:<\/p>\n<p>Oxybatin is administered orally twice at night. Dosing recommendations are provided in the table below:<\/p>\n<table width=\"688\">\n<tbody>\n<tr>\n<td width=\"108\">Patient Weight<\/td>\n<td width=\"256\">Starting total daily dose (taken in 2 divided doses)*<\/td>\n<td width=\"171\">Titration regimen (until clinical effect)<\/td>\n<td width=\"153\">Recommended maximum total daily dose<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">15kg &#8211; &lt;20kg<\/td>\n<td width=\"256\">\u2264 1g\/day<\/td>\n<td width=\"171\">\u2264 0.5g\/day\/week<\/td>\n<td width=\"153\">0.2g\/kg\/day<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">20kg &#8211; &lt;30kg<\/td>\n<td width=\"256\">\u2264 2g\/day<\/td>\n<td width=\"171\">\u2264 1g\/day\/week<\/td>\n<td width=\"153\">0.2g\/kg\/day<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">30kg &#8211; &lt;45kg<\/td>\n<td width=\"256\">\u2264 3g\/day<\/td>\n<td width=\"171\">\u2264 1g\/day\/week<\/td>\n<td width=\"153\">0.2g\/kg\/day<\/td>\n<\/tr>\n<tr>\n<td width=\"108\">\u226545kg<\/td>\n<td width=\"256\">\u2264 4.5g\/day<\/td>\n<td width=\"171\">\u2264 1.5g\/day\/week<\/td>\n<td width=\"153\">9g\/day<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>[\/vc_column_text]<\/div><\/div><\/li><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>Undesirable Effects<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\" ><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]Summary of the safety profile<\/p>\n<p><u>Clinical Studies <\/u><\/p>\n<p>The safety profile was qualitatively the same in adult and paediatric studies.<\/p>\n<p>In adults, the most frequently reported adverse reactions are dizziness, nausea and headache, all of which occur in 10% to 20% of patients. The most serious adverse reactions are suicide attempt, psychosis, respiratory depression and convulsions.<\/p>\n<p>In adults, the safety and efficacy of sodium oxybate for the management of narcolepsy symptoms were established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group studies in patients with narcolepsy with cataplexy, except for one study in which patients were not required to have narcolepsy in order to be enrolled. Two Phase 3 and one Phase 2, double-blind, parallel-group, placebo-controlled studies were conducted to evaluate the indication of sodium oxybate for fibromyalgia in adults. In addition, randomised, double-blind, placebo-controlled, crossover drug interaction studies were conducted with ibuprofen, diclofenac and valproate in healthy subjects.<\/p>\n<p><u>Post-marketing experience <\/u><\/p>\n<p>In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported during post-marketing experience. It is not always possible to reliably estimate their frequency in the population to be treated.<\/p>\n<p><u>Tabulated list of adverse reactions <\/u><\/p>\n<p>Adverse reactions are listed by System Organ Class according to the MedDRA database.<\/p>\n<p>Frequency estimation: very common (\u2265 1\/10), common (\u2265 1\/100 to &lt; 1\/10), uncommon (\u2265 1\/1,000 to &lt; 1\/100), rare (\u2265 1\/10,000 to &lt; 1\/1,000), very rare (&lt; 1\/10,000), not known (frequency cannot be estimated from the available data).<\/p>\n<p>Within each frequency category, adverse reactions are presented in order of decreasing seriousness.<\/p>\n<p><u>Infections and infestations <\/u><\/p>\n<p><em>Common<\/em>: nasopharyngitis, vaginitis<\/p>\n<p>Immune system disorders<\/p>\n<p><em>Uncommon: <\/em>hypersensitivity<\/p>\n<p>Metabolism and nutrition disorders<\/p>\n<p><em>Common: <\/em>anorexia, decreased appetite<\/p>\n<p><em>Frequency not known<\/em>: dehydration, increased appetite<\/p>\n<p><u>Psychiatric disorders <\/u><\/p>\n<p><em>Common: <\/em>depression, cataplexy, anxiety, abnormal dreams, abnormal thinking, confusional state, disorientation, nightmares, sleepwalking, sleep disorder, insomnia, middle insomnia, nervousness.<\/p>\n<p><em>Uncommon<\/em>: suicide attempt, psychosis, paranoia, hallucinations, abnormal thinking, agitation, initial insomnia<\/p>\n<p><em>Frequency not known<\/em>: suicidal ideation, homicidal ideation, aggression, euphoric mood, sleep-related eating disorder, panic attack, mania \/ bipolar disorder, delusion, bruxism, irritability and increased libido<\/p>\n<p><u>Nervous system disorders <\/u><\/p>\n<p><em>Very common<\/em>: dizziness, headache<\/p>\n<p><em>Common<\/em>: sleep paralysis, somnolence, tremor, balance disorder, disturbance in attention, hypoaesthesia, paraesthesia, sedation, dysgeusia.<\/p>\n<p><em>Uncommon<\/em>: myoclonus, amnesia, restless legs syndrome<\/p>\n<p><em>Frequency not known<\/em>: convulsions, loss of consciousness, dyskinesia<\/p>\n<p>Eye disorders<\/p>\n<p><em>Common<\/em>: blurred vision<\/p>\n<p><u>Ear and labyrinth disorders <\/u><\/p>\n<p><em>Common: <\/em>vertigo<\/p>\n<p><em>Frequency not known<\/em>: tinnitus<\/p>\n<p><u>Cardiac disorders <\/u><\/p>\n<p><em>Common: <\/em>palpitations<\/p>\n<p>Vascular disorders<\/p>\n<p><em>Common: <\/em>hypertension<\/p>\n<p><u>Respiratory, thoracic and mediastinal disorders <\/u><\/p>\n<p><em>Common<\/em>: dyspnoea, snoring, nasal congestion<\/p>\n<p><em>Frequency not known<\/em>: respiratory depression, sleep apnoea<\/p>\n<p><u>Gastrointestinal disorders <\/u><\/p>\n<p><em>Very common: <\/em>nausea (the frequency of nausea is higher in women than in men)<\/p>\n<p>Common: vomiting, diarrhoea, upper abdominal pain<\/p>\n<p><em>Uncommon<\/em>: faecal incontinence<\/p>\n<p><em>Frequency not known<\/em>: dry mouth<\/p>\n<p><u>Skin and subcutaneous tissue disorders <\/u><\/p>\n<p><em>Common<\/em>: hyperhidrosis, rash<\/p>\n<p><em>Frequency not known<\/em>: urticaria, angioedema, seborrhoea.<\/p>\n<p><u>Musculoskeletal and connective tissue disorders <\/u><\/p>\n<p><em>Common<\/em>: arthralgia, muscle spasms, back pain<\/p>\n<p><u>Renal and urinary disorders <\/u><\/p>\n<p><em>Common<\/em>: nocturnal enuresis, urinary incontinence<\/p>\n<p><em>Frequency not known<\/em>: pollakiuria \/ urgency, nocturia<\/p>\n<p><u>General disorders and administration site conditions <\/u><\/p>\n<p><em>Common<\/em>: asthenia, fatigue, feeling drunk, peripheral oedema<\/p>\n<p><u>Investigations <\/u><\/p>\n<p><em>Common: <\/em>blood pressure increased, weight decreased<\/p>\n<p><u>Injury, poisoning and procedural complications <\/u><\/p>\n<p><em>Common: <\/em>fall<\/p>\n<p><u>Description of selected adverse reactions <\/u><\/p>\n<p>In some patients, a relapse of cataplexy is observed with greater frequency upon discontinuation of sodium oxybate treatment; however, the greater frequency may be due to the usual fluctuations of the disease. Although the experience from clinical trials of sodium oxybate in patients with narcolepsy\/cataplexy at therapeutic doses does not clearly demonstrate the induction of a withdrawal syndrome, in rare cases adverse reactions such as insomnia, headache, anxiety, dizziness, sleep disorders, somnolence, hallucinations and psychotic disorders have been observed following discontinuation of GHB.<\/p>\n<p><u>Special Populations <\/u><\/p>\n<p>Paediatric Population<\/p>\n<p>In the paediatric population, the efficacy and safety of sodium oxybate for the treatment of narcolepsy with symptoms of cataplexy were established in a phase 2\/3 double-blind, placebo-controlled, multicentre, randomised-withdrawal study.<\/p>\n<p>In a study in children and adolescents the most frequently reported related adverse reactions were enuresis (18.3%), nausea (12.5%), vomiting (8.7%) and weight decreased (8.7%), decreased appetite (6.7%), headache (5.8%), dizziness (5.8%). Adverse reactions of suicidal ideation (1%) and acute psychosis (1%) were also reported. (see section 4.4 and section 6).<\/p>\n<p>In some children between 7 and &lt; 18 years of age, post-marketing surveillance showed that sodium oxybate was discontinued because of abnormal behaviour, aggression and mood change.[\/vc_column_text]<\/div><\/div><\/li><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>SmPC<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\" ><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]Find the full SmPC of <strong>Oxybatin\u00ae <a href=\"https:\/\/vitalonga.gr\/wp-content\/uploads\/2026\/01\/SPC-OXYBATE-500mg_ml-clean.pdf\" target=\"_blank\" rel=\"noopener\"><u>here<\/u><\/a><\/strong>[\/vc_column_text]<\/div><\/div><\/li><li class=\"mpc-accordion__item \"><div class=\"mpc-accordion-item__heading mpc-transition mpc-typography--default\"><div data-id=\"mpc_icon-586ac586bd5b328\" class=\"mpc-icon mpc-init mpc-transition mpc-effect-fade mpc-icon-hover \"><div class=\"mpc-icon-wrap\"><i class=\"mpc-icon-part mpc-regular mpc-transition  eti eti_arrow_down\"><\/i><i class=\"mpc-icon-part mpc-hover mpc-transition  eti eti_arrow_down\"><\/i><\/div><\/div><h3>Additional Links<\/h3><\/div><div class=\"mpc-accordion-item__content mpc-container\" ><div class=\"mpc-accordion-item__wrapper mpc-typography--default\">[vc_column_text css=&#8221;&#8221;]<a href=\"https:\/\/www.narcolepsy-com.gr\/\" target=\"_blank\" rel=\"noopener\"><strong>Hellenic Association of Patients with Narcolepsy and Idiopathic Hypersomnia<\/strong><\/a>[\/vc_column_text]<\/div><\/div><\/li><\/ul><\/div>[\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space][vc_column_text css=&#8221;&#8221;]<strong>Warning<\/strong>:<br \/>\nThe above information is provided for informational or educational purposes. The initiation, continuation and discontinuation of treatment with <strong>Oxybatin<\/strong><strong>\u00ae <\/strong>should be done strictly and only under the direction of a physician.<\/p>\n<p>The links provided on this website that lead to external websites of international organisations, regulatory authorities and other bodies are for informational purposes only.<\/p>\n<p>Vita Longa does not maintain any commercial, financial or other cooperation with the specific organisations, unless expressly stated. Reference or referral to them does not imply endorsement, sponsorship or recommendation of the views, information or services provided on the respective websites.<\/p>\n<p>Vita Longa is not responsible for the content, accuracy or updating of the information hosted on external websites.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column preset=&#8221;mpc_preset_91&#8243; content_preset=&#8221;_mpc_preset_91&#8243;][vc_row_inner][vc_column_inner][vc_custom_heading text=&#8221;Oxybatin\u00ae&#8221; font_container=&#8221;tag:h2|font_size:24|text_align:left|color:%23398791&#8243; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1769364893198{margin-bottom: 10px !important;}&#8221;][vc_custom_heading text=&#8221;Sodium Oxybate Oral Solution 500mg\/ml&#8221; font_container=&#8221;tag:h2|font_size:14|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221; css=&#8221;.vc_custom_1791197316867{margin-bottom: 10px !important;}&#8221;][vc_custom_heading text=&#8221;BT<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2602,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-left-sidebar.php","meta":{"_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-2660","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Oxybatin\u00ae For Healthcare Professionals - Vita Longa<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/vitalonga.gr\/en\/oxybatin\/oxybatin-for-healthcare-professionals\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Oxybatin\u00ae For Healthcare Professionals - Vita Longa\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column preset=&#8221;mpc_preset_91&#8243; 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