{"id":10835,"date":"2026-09-19T11:53:53","date_gmt":"2026-09-19T11:53:53","guid":{"rendered":"https:\/\/europepharmacy.eu\/?post_type=product&#038;p=10835"},"modified":"2026-09-19T11:53:54","modified_gmt":"2026-09-19T11:53:54","slug":"abstral-sublingual-tablets","status":"publish","type":"product","link":"https:\/\/europepharmacy.eu\/de\/shop\/abstral-sublingual-tablets\/","title":{"rendered":"Abstral-Sublingual Tablets"},"content":{"rendered":"<p data-path-to-node=\"11\">Abstral sublingual tablets deliver fentanyl citrate\u2014a potent, highly lipophilic synthetic phenylpiperidine opioid agonist\u2014via a specialized rapidly disintegrating sublingual matrix. Breakthrough cancer pain is characterized by severe, transient flare-ups of pain that peak rapidly (often within minutes) against a background of controlled chronic pain. Standard oral opioids exhibit delayed systemic onset due to gastrointestinal absorption and hepatic clearance; Abstral is engineered to circumvent extensive first-pass metabolism through direct vascular uptake across the oral sublingual mucosa.<\/p>\n<p data-path-to-node=\"12\"><b data-path-to-node=\"12\" data-index-in-node=\"0\">Clinical Formulations &amp; Physical Presentation<\/b><\/p>\n<ul data-path-to-node=\"13\">\n<li>\n<p data-path-to-node=\"13,0,0\"><b data-path-to-node=\"13,0,0\" data-index-in-node=\"0\">Active Ingredient:<\/b> Fentanyl citrate (formulated in precise microgram increments: 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg base equivalents).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"13,1,0\"><b data-path-to-node=\"13,1,0\" data-index-in-node=\"0\">Physical Identification:<\/b> Small, round or custom-shaped white tablets designed to disintegrate on contact with saliva, debossed with unique numerical or geometric identifiers corresponding to the specific microgram strength (e.g., debossed with &#8220;1&#8221; for 100 mcg, &#8220;2&#8221; for 200 mcg, etc.).<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"13,2,0\"><b data-path-to-node=\"13,2,0\" data-index-in-node=\"0\">Sublingual Matrix Formulation:<\/b> Utilizes a fast-dissolving carrier matrix that disperses rapidly upon placement on the floor of the mouth beneath the tongue, releasing active fentanyl microcrystals for local mucosal uptake without requiring water.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"14\"><b data-path-to-node=\"14\" data-index-in-node=\"0\">Pharmacodynamics &amp; Mechanism of Action<\/b><\/p>\n<ul data-path-to-node=\"15\">\n<li>\n<p data-path-to-node=\"15,0,0\"><b data-path-to-node=\"15,0,0\" data-index-in-node=\"0\">Selective Receptor Agonism:<\/b> Operates as a selective, high-potency full agonist at <span class=\"math-inline\" data-math=\"\\mu\" data-index-in-node=\"82\">$\\mu$<\/span>-opioid receptors (<span class=\"math-inline\" data-math=\"\\text{MOR}\" data-index-in-node=\"104\">$\\text{MOR}$<\/span>) distributed throughout the spinal cord, periaqueductal gray, thalamus, and cortex.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,1,0\"><b data-path-to-node=\"15,1,0\" data-index-in-node=\"0\">Intracellular Signaling:<\/b> Binds to G-protein-coupled <span class=\"math-inline\" data-math=\"\\mu\" data-index-in-node=\"52\">$\\mu$<\/span>-receptors, triggering the dissociation of heterotrimeric <span class=\"math-inline\" data-math=\"G_i\/G_o\" data-index-in-node=\"113\">$G_i\/G_o$<\/span> subunits. This cascade inhibits adenylyl cyclase, reduces intracellular cyclic adenosine monophosphate (cAMP), closes voltage-gated N-type calcium channels, and stimulates inwardly rectifying potassium channels.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"15,2,0\"><b data-path-to-node=\"15,2,0\" data-index-in-node=\"0\">Rapid Central Uptake:<\/b> Because fentanyl possesses high octanol:water partition lipophilicity (approximately 800 times more lipophilic than morphine), it rapidly crosses the blood-brain barrier following systemic absorption, yielding swift onset of central analgesia and sedation.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"16\"><b data-path-to-node=\"16\" data-index-in-node=\"0\">Pharmacokinetics &amp; Bioavailability<\/b><\/p>\n<ul data-path-to-node=\"17\">\n<li>\n<p data-path-to-node=\"17,0,0\"><b data-path-to-node=\"17,0,0\" data-index-in-node=\"0\">Transmucosal Absorption:<\/b> Approximately 50% to 54% of the total administered dose is absorbed directly across the sublingual mucosa into the systemic circulation, escaping hepatic first-pass elimination. The remaining fraction is swallowed with saliva and absorbed slowly through the gastrointestinal tract, where it undergoes extensive first-pass degradation.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,1,0\"><b data-path-to-node=\"17,1,0\" data-index-in-node=\"0\">Onset &amp; Peak Concentration (<span class=\"math-inline\" data-math=\"T_{\\max}\" data-index-in-node=\"28\">$T_{\\max}$<\/span>):<\/b> Detectable systemic plasma levels are observed within 10 to 15 minutes post-administration, with peak plasma concentrations (<span class=\"math-inline\" data-math=\"C_{\\max}\" data-index-in-node=\"164\">$C_{\\max}$<\/span>) achieved between 30 and 60 minutes.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,2,0\"><b data-path-to-node=\"17,2,0\" data-index-in-node=\"0\">Hepatic Biotransformation:<\/b> Systemic fentanyl is cleared primarily by hepatic cytochrome P450 3A4 (CYP3A4) via <span class=\"math-inline\" data-math=\"N\" data-index-in-node=\"110\">$N$<\/span>-dealkylation to the inactive metabolite norfentanyl.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"17,3,0\"><b data-path-to-node=\"17,3,0\" data-index-in-node=\"0\">Elimination Half-Life:<\/b> Features a multi-phasic elimination profile: a rapid distribution half-life (<span class=\"math-inline\" data-math=\"\\alpha\" data-index-in-node=\"100\">$\\alpha$<\/span>-phase) of several minutes, followed by a terminal elimination half-life (<span class=\"math-inline\" data-math=\"\\beta\" data-index-in-node=\"180\">$\\beta$<\/span>-phase) of approximately 5 to 15 hours due to slow redistribution from deep lipid stores.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"18\"><b data-path-to-node=\"18\" data-index-in-node=\"0\">Strict Opioid-Tolerance Criteria<\/b><\/p>\n<ul data-path-to-node=\"19\">\n<li>\n<p data-path-to-node=\"19,0,0\"><b data-path-to-node=\"19,0,0\" data-index-in-node=\"0\">Absolute Contraindication in Opioid-Naive Individuals:<\/b> Abstral is strictly contraindicated in the management of acute or postoperative pain (e.g., headache, dental pain, surgical recovery) and must <b data-path-to-node=\"19,0,0\" data-index-in-node=\"198\">never<\/b> be prescribed to opioid-naive patients due to the certainty of life-threatening respiratory arrest.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,0\"><b data-path-to-node=\"19,1,0\" data-index-in-node=\"0\">Definition of Opioid Tolerance:<\/b> Patients must be established as clinically opioid-tolerant prior to initiating Abstral. Opioid tolerance is defined as receiving continuously for one week or longer at least:<\/p>\n<ul data-path-to-node=\"19,1,1\">\n<li>\n<p data-path-to-node=\"19,1,1,0,0\">60 mg oral morphine daily, or<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,1,1,0\">25 mcg\/hour transdermal fentanyl, or<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,1,2,0\">30 mg oral oxycodone daily, or<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,1,3,0\">8 mg oral hydromorphone daily, or<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,1,4,0\">25 mg oral oxymorphone daily, or<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"19,1,1,5,0\">An equianalgesic daily dose of another opioid.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"20\"><b data-path-to-node=\"20\" data-index-in-node=\"0\">Administration Protocols &amp; Precautions<\/b><\/p>\n<ul data-path-to-node=\"21\">\n<li>\n<p data-path-to-node=\"21,0,0\"><b data-path-to-node=\"21,0,0\" data-index-in-node=\"0\">Administration Instructions:<\/b> The tablet must be placed under the tongue at the deepest part of the sublingual cavity and allowed to dissolve completely. It <b data-path-to-node=\"21,0,0\" data-index-in-node=\"156\">must not<\/b> be chewed, sucked, swallowed, or crushed. Patients should refrain from eating or drinking until the tablet has completely dissolved.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"21,1,0\"><b data-path-to-node=\"21,1,0\" data-index-in-node=\"0\">Titration &amp; Conversion:<\/b> Dosing must begin at the lowest titration unit (100 mcg) and be adjusted upward by a physician until an effective dose is identified. Strengths of Abstral cannot be converted on a microgram-for-microgram basis from other transmucosal or transdermal fentanyl products, as bioavailabilities differ substantially.<\/p>\n<\/li>\n<\/ul>\n<p data-path-to-node=\"22\"><b data-path-to-node=\"22\" data-index-in-node=\"0\">Important Safety Information &amp; Boxed Warnings<\/b><\/p>\n<ul data-path-to-node=\"23\">\n<li>\n<p data-path-to-node=\"23,0,0\"><b data-path-to-node=\"23,0,0\" data-index-in-node=\"0\">Fatal Respiratory Depression:<\/b> Life-threatening hypoventilation, respiratory depression, and apnea can occur even at therapeutic doses.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,1,0\"><b data-path-to-node=\"23,1,0\" data-index-in-node=\"0\">TIRF REMS Requirement:<\/b> In the United States, Abstral is available only through the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program. Outpatient dispensing requires documented certification of the prescriber, pharmacy, and patient.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,2,0\"><b data-path-to-node=\"23,2,0\" data-index-in-node=\"0\">Accidental Exposure:<\/b> Ingestion of even partial tablets by children can lead to immediate, fatal overdose. Storage in child-resistant packaging inside a locked location is mandated.<\/p>\n<\/li>\n<li>\n<p data-path-to-node=\"23,3,0\"><b data-path-to-node=\"23,3,0\" data-index-in-node=\"0\">CYP3A4 Interactions:<\/b> Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) can dramatically increase fentanyl plasma levels, elevating the risk of lethal respiratory arrest.<\/p>\n<\/li>\n<\/ul>\n\n    <div class=\"xs_social_share_widget xs_share_url after_content \t\tmain_content  wslu-style-1 wslu-share-box-shaped wslu-fill-colored wslu-none wslu-share-horizontal wslu-theme-font-no wslu-main_content\">\n\n\t\t\n        <ul>\n\t\t\t        <\/ul>\n    <\/div>","protected":false},"excerpt":{"rendered":"<p>Abstral (fentanyl sublingual tablets) is a rapid-onset, transmucosal formulation of fentanyl citrate indicated strictly for the management of breakthrough cancer pain (BTCP) in adult patients who are already receiving and tolerant to around-the-clock opioid therapy. Formulated to dissolve rapidly under the tongue, it facilitates direct transmucosal absorption into the systemic circulation to provide rapid <span class=\"math-inline\" data-math=\"\\mu\" data-index-in-node=\"410\">$\\mu$<\/span>-opioid receptor-mediated analgesia, aligning with the sudden onset and short duration of breakthrough pain episodes. Available in microgram-range strengths (100 mcg to 800 mcg) and dispensed exclusively under a restricted distribution program (TIRF REMS). Valid prescription required.<\/p>","protected":false},"featured_media":10847,"comment_status":"open","ping_status":"closed","template":"","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""}},"product_brand":[],"product_cat":[107],"product_tag":[1056,1057,1060,1059,1058,893,1063,866,1061,1062],"class_list":["post-10835","product","type-product","status-publish","has-post-thumbnail","product_cat-painkillers","product_tag-abstral","product_tag-abstral-sublingual","product_tag-breakthrough-cancer-pain","product_tag-fentanyl-citrate","product_tag-fentanyl-sublingual-tablets","product_tag-prescription-painkillers","product_tag-rapid-onset-opioid","product_tag-schedule-ii-opioid","product_tag-tirf-rems","product_tag-transmucosal-fentanyl","instock","shipping-taxable","purchasable","product-type-variable"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Abstral-Sublingual Tablets<\/title>\n<meta name=\"description\" content=\"fentanyl sublingual tablets, transmucosal fentanyl citrate, breakthrough cancer pain medication, rapid-onset opioid analgesic, TIRF REMS opioid, Schedule II narcotic\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/europepharmacy.eu\/de\/shop\/abstral-sublingual-tablets\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Abstral-Sublingual Tablets\" \/>\n<meta property=\"og:description\" content=\"Abstral (fentanyl sublingual tablets) is a rapid-onset, transmucosal formulation of fentanyl citrate indicated strictly for the management of breakthrough cancer pain (BTCP) in adult patients who are already receiving and tolerant to around-the-clock opioid therapy. Formulated to dissolve rapidly under the tongue, it facilitates direct transmucosal absorption into the systemic circulation to provide rapid $mu$-opioid receptor-mediated analgesia, aligning with the sudden onset and short duration of breakthrough pain episodes. Available in microgram-range strengths (100 mcg to 800 mcg) and dispensed exclusively under a restricted distribution program (TIRF REMS). 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