{"id":6836,"date":"2025-12-10T11:08:08","date_gmt":"2025-12-10T11:08:08","guid":{"rendered":"https:\/\/bristishpharmacy.co.uk\/?post_type=product&p=6836"},"modified":"2026-09-16T10:23:25","modified_gmt":"2026-09-16T10:23:25","slug":"tramadolor-20x-300mg","status":"publish","type":"product","link":"https:\/\/bristishpharmacy.co.uk\/it\/shop\/tramadolor-20x-300mg\/","title":{"rendered":"Tramadolor 20x 300mg"},"content":{"rendered":"

\u00a0<\/h1>\n
\n
\n

Clinical Monograph: Tramadolor 300 mg (Tramadol Hydrochloride)<\/h3>\n

1. Classification and Chemical Overview<\/h2>\n

Tramadol hydrochloride is a synthetic, centrally acting analgesic belonging to the aminocyclohexanol derivative group. Under the Anatomical Therapeutic Chemical (ATC) classification system, tramadol is indexed under N02AJ13 \/ N02AX02.<\/p>\n

Chemically designated as (\u00b1<\/span><\/span><\/span><\/span><\/span>)-trans<\/i>-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride, tramadol is a racemic mixture of two enantiomers. Tramadolor 300 mg represents the maximum single daily dosage strength in extended-release (prolonged-release) formulations.<\/span> In most global regulatory jurisdictions, tramadol is classified as a Controlled Substance (e.g., Schedule IV in the US) and is available strictly as a Prescription Only Medicine (POM).<\/span><\/p>\n

\n
Healthline<\/span>+ 1<\/span><\/div>\n<\/div>\n

2. Mechanism of Action and Pharmacodynamics<\/h2>\n

Tramadol exhibits a dual, synergistic mechanism of action involving both opioid and non-opioid pathways:<\/p>\n

    \n
  • \n

    Opioid Receptor Binding:<\/b> The parent compound and its primary active metabolite, O<\/span><\/span><\/span><\/span><\/span>-desmethyltramadol (M1), bind as agonists to central \u03bc<\/span><\/span><\/span><\/span><\/span>-opioid receptors (\u03bc<\/span><\/span><\/span><\/span><\/span>-OR). M1 exhibits up to 200-fold higher affinity for \u03bc<\/span><\/span><\/span><\/span><\/span>-receptors compared to parent tramadol.<\/p>\n<\/li>\n

  • \n

    Monoamine Reuptake Inhibition:<\/b> Independent of opioid receptors, the (+)-enantiomer inhibits neuronal serotonin (5-HT) reuptake, while the (\u2013)-enantiomer inhibits norepinephrine (NE) reuptake. This enhances descending central inhibitory pain signaling pathways in the spinal cord.<\/p>\n<\/li>\n<\/ul>\n

    Additional pharmacodynamic effects include mild suppression of cough reflexes, central sedation, and potential lowering of the seizure threshold.<\/p>\n

    3. Approved Clinical Indications and Therapeutic Scope<\/h2>\n

    Licensing for Tramadolor 300 mg extended-release includes:<\/p>\n

      \n
    • \n

      Severe Chronic Pain:<\/b> Management of severe, persistent pain that can only be adequately controlled with extended opioid analgesia (e.g., severe osteoarthritis, chronic spinal pain, or severe neuropathic\/cancer pain refractory to lower-tier analgesics).<\/p>\n<\/li>\n<\/ul>\n

      Dosing & Administration Regimen:<\/i><\/p>\n

        \n
      • \n

        Single Daily Maximum Dose:<\/b> 300 mg once daily represents the absolute maximum safe daily dose limit for extended-release tramadol.<\/span><\/p>\n

        \n
        Healthline<\/span><\/div>\n<\/div>\n<\/li>\n
      • \n

        Administration Rules:<\/b> Tablets\/capsules must be swallowed whole with fluid and <\/span>never<\/span><\/b> crushed, split, chewed, or dissolved.<\/span> Disruption of the prolonged-release mechanism leads to immediate release of the total dose (“dose dumping”), risking severe toxicity, seizures, or fatal overdose.<\/span><\/p>\n

        \n
        Healthline<\/span>+ 1<\/span><\/div>\n<\/div>\n<\/li>\n<\/ul>\n

        4. Pharmacokinetic Profile and Metabolic Fate<\/h2>\n
          \n
        • \n

          Absorption:<\/b> Following oral administration of extended-release tramadol 300 mg, drug absorption occurs continuously over 24 hours.<\/span> Absolute bioavailability is approximately 70% to 75% for single doses and increases to ~90% at steady-state. Peak plasma concentrations (C<\/span>ma<\/span>x<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>) occur at approximately 6 to 12 hours (T<\/span>ma<\/span>x<\/span><\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>).<\/p>\n

          \n
          Healthline<\/span><\/div>\n<\/div>\n<\/li>\n
        • \n

          Distribution:<\/b> Rapidly distributed across blood-brain and placental barriers. Volume of distribution (V<\/span>d<\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>) is approximately 2.6 to 2.9 L\/kg. Plasma protein binding is relatively low (~20%).<\/p>\n<\/li>\n

        • \n

          Biotransformation:<\/b> Extensively metabolised in the liver via two primary Cytochrome P450 pathways:<\/p>\n

            \n
          • \n

            CYP2D6 Pathway:<\/b> Converts tramadol into its pharmacologically active metabolite, O<\/span><\/span><\/span><\/span><\/span>-desmethyltramadol (M1).<\/p>\n<\/li>\n

          • \n

            CYP3A4 Pathway:<\/b> Converts tramadol into inactive N<\/span><\/span><\/span><\/span><\/span>-desmethyltramadol (M2).<\/p>\n<\/li>\n

          • \n

            Subsequent Phase II conjugation yields inactive glucuronides and sulfates.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n

          • \n

            Elimination:<\/b> Excreted predominantly via the kidneys in urine (~90%, including unchanged drug and metabolites). Elimination half-life (<\/span>t<\/span>1\/2<\/span><\/span><\/span><\/span>\u200b<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>) of parent tramadol is 6 to 7 hours, whereas the extended-release formulation maintains therapeutic plasma levels over a 24-hour interval.<\/span><\/p>\n

            \n
            Healthline<\/span><\/div>\n<\/div>\n<\/li>\n<\/ul>\n

            5. Physiological Effects and Adverse Event Spectrum<\/h2>\n

            Tramadol affects central nervous system pain perception, gut motility, and monoaminergic signaling.<\/p>\n

            Adverse Drug Reaction Spectrum<\/h3>\n
              \n
            • \n

              Very Common (\u2265<\/span><\/span>1\/10<\/span><\/span><\/span><\/span><\/span>):<\/b> Nausea, dizziness.<\/span><\/p>\n

              \n
              RxList<\/span><\/div>\n<\/div>\n<\/li>\n
            • \n

              Common (\u2265<\/span><\/span>1\/100<\/span><\/span><\/span><\/span><\/span> to <<\/span><\/span>1\/10<\/span><\/span><\/span><\/span><\/span>):<\/b> Constipation, headache, somnolence, vomiting, dry mouth, hyperhidrosis (sweating), fatigue.<\/span><\/p>\n

              \n
              RxList<\/span><\/div>\n<\/div>\n<\/li>\n
            • \n

              Uncommon (\u2265<\/span><\/span>1\/1<\/span>,<\/span>000<\/span><\/span><\/span><\/span><\/span> to <<\/span><\/span>1\/100<\/span><\/span><\/span><\/span><\/span>):<\/b> Cardiovascular regulation effects (palpitations, tachycardia, orthostatic hypotension), gastrointestinal irritation, pruritus, rash.<\/p>\n<\/li>\n

            • \n

              Rare (<1\/1,000):<\/b> Seizures (convulsions), hallucinations, confusion, anxiety, sleep disturbances, muscle weakness, respiratory depression, urinary retention, hypersensitivity reactions.<\/p>\n<\/li>\n<\/ul>\n

              6. Contraindications, Drug Interactions, and Clinical Precautions<\/h2>\n

              Contraindications<\/h3>\n
                \n
              • \n

                Known hypersensitivity to tramadol or formulation excipients.<\/p>\n<\/li>\n

              • \n

                Acute intoxication with alcohol, hypnotics, central analgesics, opioids, or psychotropic drugs.<\/p>\n<\/li>\n

              • \n

                Concurrent use of Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI cessation (risk of fatal serotonin syndrome).<\/p>\n<\/li>\n

              • \n

                Uncontrolled epilepsy or patients severely prone to seizures.<\/p>\n<\/li>\n

              • \n

                Severe respiratory depression or severe hepatic\/renal impairment.<\/p>\n<\/li>\n<\/ul>\n

                Key Drug Interactions<\/h3>\n
                  \n
                • \n

                  Serotonergic Agents (SSRIs, SNRIs, Triptans, TCAs):<\/b> Combined use substantially increases the risk of <\/span>Serotonin Syndrome<\/span><\/b> (hyperthermia, neuromuscular excitation, autonomic instability).<\/span><\/p>\n

                  \n
                  Healthline<\/span><\/div>\n<\/div>\n<\/li>\n
                • \n

                  Seizure Threshold-Lowering Drugs (Antipsychotics, Bupropion):<\/b> Co-administration elevated risk of triggering tonic-clonic seizures.<\/p>\n<\/li>\n

                • \n

                  CYP2D6 & CYP3A4 Inhibitors (e.g., Fluoxetine, Paroxetine, Ketoconazole):<\/b> Alter tramadol clearance and reduce M1 metabolite formation, modifying analgesic efficacy and potential toxicity.<\/p>\n<\/li>\n

                • \n

                  CNS Depressants, Benzodiazepines, & Alcohol:<\/b> Synergistic central depression elevating risks of severe sedation, respiratory arrest, coma, and death.<\/span><\/p>\n

                  \n
                  Healthline<\/span><\/div>\n<\/div>\n<\/li>\n<\/ul>\n

                  Clinical Precautions and Monitoring<\/h3>\n
                    \n
                  • \n

                    Seizure Risk:<\/b> Tramadol can induce seizures even at recommended doses. Risk is heightened in patients with seizure history or those exceeding 300 mg daily.<\/span><\/p>\n

                    \n
                    Healthline<\/span><\/div>\n<\/div>\n<\/li>\n
                  • \n

                    Dependence & Withdrawal:<\/b> Prolonged administration creates physical and psychological dependence.<\/span> Abrupt discontinuation causes atypical opioid withdrawal combined with monoaminergic withdrawal symptoms (hallucinations, paranoia, extreme anxiety, paresthesia). Tapering is mandatory upon discontinuation.<\/p>\n

                    \n
                    Mayo Clinic<\/span><\/div>\n<\/div>\n<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n
                    \n\n\t\t\n
                      \n\t\t\t <\/ul>\n <\/div> \n","protected":false},"excerpt":{"rendered":"
                        \n
                      • Tramadolor 300 mg (typically presented as Tramadolor Long \/ extended-release in 20-tablet\/capsule packs) is a central acting synthetic opioid analgesic and monoamine reuptake inhibitor indicated for the management of severe chronic pain requiring continuous, around-the-clock treatment.<\/span><\/li>\n<\/ul>","protected":false},"featured_media":6837,"comment_status":"closed","ping_status":"closed","template":"","meta":{"postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""}},"product_brand":[],"product_cat":[108],"product_tag":[137],"class_list":["post-6836","product","type-product","status-publish","has-post-thumbnail","product_cat-pain-relief","product_tag-tramadolor-20x-300mg","instock","sale","shipping-taxable","purchasable","product-type-simple"],"yoast_head":"\nTramadolor 20x 300mg - British Pharmacy<\/title>\n<meta name=\"description\" content=\"Tramadolor 20x 300mg is a highly effective opioid analgesic designed to manage moderate to severe pain. 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