Tramadol hydrochloride

SCOPE — READ FIRST: this covers ORAL IMMEDIATE-RELEASE tramadol only, which is this page's primary route and formulation. The fetched SPC is for a 50 mg immediate-release capsule and contains NO parenteral and NO modified-release posology. An immediate-release regimen and its 400 mg ceiling must never be transferred to a prolonged-release product — the US extended-release label in this same bundle carries a different and lower limit ('Do not exceed a daily dose of 300 mg tramadol. Do not use with other tramadol products.'), which belongs to that ER product and not to this one. || VERBATIM §4.2 (Adults and adolescents aged 12 years and over), Acute Pain: 'An initial dose of 100mg is usually necessary. This can be followed by doses of 50 or 100mg at 4 - 6 hourly intervals, and duration of treatment should be matched to clinical need.' Pain Associated with Chronic Conditions: 'An initial dose of 50mg is advised and then titration according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported.' || TITRATION PRINCIPLE, VERBATIM §4.2: 'The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.' || BEFORE STARTING, VERBATIM §4.2: 'Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with tramadol in order to minimise the risk of addiction and drug withdrawal syndrome.' and 'Before initiating treatment with ZYDOL, 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.' || STOPPING, VERBATIM §4.2: 'When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered.' || GERIATRIC PATIENTS, VERBATIM §4.2: 'A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.' || STRENGTH IS PINNED: every figure above is stated in milligrams in the SPC, not as a capsule count, and the product itself is Zydol 50 mg Capsules. || WHY paedDose IS NULL: this SPC gives no separate paediatric regimen and no per-kilogram figure. Adolescents aged 12 years and over are dosed with the adult regimen above (§4.2 heading: 'Adults and adolescents aged 12 years and over'), and below that age, verbatim: 'ZYDOL capsules are not suitable for children below the age of 12 years.' Verify any under-18 use against a children's formulary and current prescribing references. || PROVENANCE: this draft supersedes an earlier draft of the same bundle that left the dose field empty; that draft already quoted this regimen verbatim in its notes, and the SPC doses this page's primary route and indication, so the dose field is now populated from it.