Econazole nitrate

§4.2 verbatim and in full: 'For cutaneous administration. Dosage The dosage regimen is the same for all patients. Apply twice daily to the affected part and rub into the skin gently with the finger. The usual treatment duration is 2 to 4 weeks. If no improvement in symptoms is experienced after 4 weeks, the treatment should be reassessed.' §4.1 verbatim and in full: 'For the treatment of cutaneous candidiasis, dermatophytosis and pityriasis versicolor.' STRENGTH IS QUOTE-PINNED: the product is Pevaryl 1% Topical Cream, and §4.8 independently names the strength — 'The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 470 subjects who participated in 12 clinical trials'. NO MAXIMUM DOSE IS STATED — §4.2 sets no ceiling on the quantity applied; its only limit is one of DURATION (reassess at 4 weeks), which is not a dose ceiling and has therefore been left out of the maxDose field and recorded here instead. A later matcher fix swapped the product to the UK cutaneous cream SPC that the hold asked for, and it confirms the twice-daily frequency the page always carried — the US foam's once-daily frequency is a different formulation and has NOT been used. CAUTION IN ECZEMA — §4.4: 'Care should be taken in the presence of eczematous dermatitis.' DISCONTINUE ON REACTION — §4.4: 'If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.' EXCIPIENTS — §4.4: 'This medicine contains 30 mg benzoic acid in each tube of 15 g which is equivalent to 2 mg/g cream. This medicine contains 60 mg benzoic acid in each tube of 30 g which is equivalent to 2 mg/g cream. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). Butylhydroxyanisole (E320): May cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.' ANTICOAGULANT INTERACTION — §4.5 (whose text sits inside the bundle's 'warnings' value, as eMC does not expose it as a separate section heading): 'Econazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, and acenocoumarol caution should be exercised and anticoagulant effect should be monitored more frequently. Adjustment of the oral anticoagulant dosage may be necessary during the treatment with econazole and after its termination.' RENAL/HEPATIC: no renal- or hepatic-impairment dosing statement appears anywhere in the fetched sections.

This is the label's own statement, not a scaled or extrapolated figure: §4.2 sets one regimen for all patients and states no paediatric age restriction and no weight-based dose, so no per-kg figure exists and the weight calculator is intentionally not populated. NEWBORNS — §4.4 excipient warning: 'Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).' Verify against a current children's formulary before use in a neonate.