Fluticasone

VERBATIM §4.2 dose selection: 'Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate to the severity of their disease. The dose may be increased until control is achieved or reduced to the minimum effective dose, according to the individual response.' 'Typical Adult Starting Doses: For patients with mild asthma, a typical starting dose is 100 micrograms twice daily. In moderate and more severe asthma, starting doses may need to be 250 to 500 micrograms twice daily.' 'The dose should be titrated down to the lowest dose at which effective control of asthma is maintained.' HIGH-DOSE RESTRICTION (verbatim): 'Due to the risk of systemic effects, doses above 500 micrograms twice daily should be prescribed only for adult patients with severe asthma where additional clinical benefit is expected, demonstrated by either an improvement in pulmonary function and/or symptom control, or by a reduction in oral corticosteroid therapy.' SPACER (verbatim): 'Administration of doses above 1000 micrograms (500 micrograms twice daily) should be via a spacer device to help reduce side-effects in the mouth and throat.' ONSET (verbatim): 'The onset of therapeutic effect is within 4 to 7 days.' POTENCY (verbatim): 'Prescribers should be aware that fluticasone propionate is as effective as other inhaled steroids approximately at half the microgram daily dose. For example, a 100 mcg of fluticasone propionate is approximately equivalent to 200 mcg dose of beclometasone dipropionate (CFC containing) or budesonide.' ESCALATION TRIGGER (verbatim): 'If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.' NOT A RELIEVER (§4.4 verbatim): 'Flixotide Evohaler is not designed to relieve acute symptoms for which an inhaled short-acting bronchodilator is required.' NOT PUBLISHED FROM THIS BUNDLE: the page's nasal dose, topical (Cutivate) dose and fluticasone furoate figures — no source in this bundle quantifies them. The US OTC nasal label in the bundle gives only unpinned spray counts, so it cannot support a nasal dose. PAGE DISCREPANCY for review: the page lists 'Untreated chest infection' as a contraindication; the only contraindication in this SPC is hypersensitivity.

dosePerKg is null because this SPC doses children by FIXED microgram amounts for an age band, not per kilogram — there is no mg/kg or microgram/kg figure anywhere in the fetched text, so no weight calculator is offered. VERBATIM §4.2: 'Typical starting doses for children over 4 years of age: 50 to 100 micrograms twice daily. Many children's asthma will be well controlled using the 50 to 100 microgram twice daily dosing regime. For those patients whose asthma is not sufficiently controlled, additional benefit may be obtained by increasing the dose up to 200 micrograms twice daily. The maximum licensed dose in children is 200 micrograms twice daily. The starting dose should be appropriate to the severity of the disease. The dose should be titrated down to the lowest dose at which effective control of asthma is maintained.' PRESENTATION (verbatim): 'Should Flixotide 50 microgram Evohaler presentation not offer the exact paediatric dose prescribed by the physician, please see data sheets of alternative Flixotide presentation (Accuhaler, Nebules).' No dosing is given for children aged 4 years or under in the fetched text. Growth and adrenal safety (§4.4): systemic effects of inhaled corticosteroids include 'growth retardation in children and adolescents' and 'Prolonged treatment with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis'; the sentence about children aged under 16 taking higher doses is cut off at the fetch truncation marker. Verify any paediatric regimen and any adrenal-suppression threshold against a children's formulary and the full SPC before prescribing.