Morphine (Paediatric)

PAEDIATRIC REGIMEN AS STATED IN THE SPC - AGE BANDS, NOT PER-KG. Verbatim section 4.2 'Paediatric population': 'Children 13 to 18 years: Recommended dose: 5-20 mg (2.5-10 ml) every 4 hours. Maximum daily dose: 120 mg per day. Children 6-12 years: Recommended dose: 5-10 mg (2.5-5 ml) every 4 hours. Maximum daily dose: 60 mg per day. Children 1-5 years: Recommended dose 5 mg (2.5 ml) every 4 hours. Maximum daily dose: 30 mg per day. Children under 1 year: Not recommended.' 'Dosage can be increased under medical supervision according to the severity of the pain and the patient's previous history of analgesic requirements.' paedDose is null because the SPC states these as fixed mg doses per AGE BAND and gives NO mg/kg figure anywhere; no per-kg dose has been derived from the bands. FORMULATION AND ROUTE CAVEAT: this source covers ORAL SOLUTION ONLY. It gives no intravenous, subcutaneous, intramuscular or infusion regimen, and no neonatal regimen. If the clinical need is parenteral or infused morphine, or a child under 1 year, the regimen must be sourced separately and verified against a children's formulary. CONVERSION NOTE, verbatim: 'when Morphine Oral Solution is used in place of parenteral morphine, a 50% to 100% increase in dosage is usually required in order to achieve the same level of analgesia'; 'When patients are transferred from other morphine preparations to Morphine Oral Solution dosage titration may be appropriate.' SPECIAL POPULATIONS: 'Reductions in dosage may be appropriate in the elderly, and in patients with chronic hepatic disease (for acute hepatic disease see section 4.3), renal impairment, severe hypothyroidism, adrenocortical insufficiency, prostatic hypertrophy, shock or where sedation is undesirable.' TREATMENT GOALS: before initiating, agree a treatment strategy including duration, goals and a plan for ending treatment; maintain frequent physician-patient contact to evaluate the need for continued treatment; taper the dose gradually on stopping to prevent withdrawal; do not use longer than necessary; in the absence of adequate pain control consider hyperalgesia, tolerance and progression of underlying disease. US LABELLING (openFDA, morphine sulfate tablets, Ascend Laboratories, 2025-10-10) is NOT the basis of the fields above and differs; quoted only for cross-check: adults 15 to 30 mg every 4 hours as needed; paediatric patients weighing at least 50 kg and able to swallow tablets, 15 mg every 4 hours as needed, do not exceed 30 mg as an initial dose; the tablets are 'not recommended for use in pediatric patients who weigh less than 50 kg'; section 8.4 notes an open-label study in patients 2 through 17 years in which 'Initial dosing was approximately 0.15 mg/kg to 0.3 mg/kg' - that is a description of study dosing, not a labelled recommendation, and has NOT been carried into paedDose. SOURCE COMPLETENESS: eMC section 4.5 (interactions) was NOT captured in this bundle, and sections 4.4 and 4.8 were truncated at the source-fetch limit.