Fludroxycortide Tape Prescribing Information.pdf

- Product: Fludroxycortide 4 micrograms per square centimetre Tape
- Indications: Adjunctive therapy for chronic, localised, recalcitrant dermatoses, particularly dry, scaling lesions.
- Posology:
- Adults/Elderly: Apply to clean, dry skin; tape should remain in place 12 out of 24 hours. Cut tape to cover lesion and a quarter inch margin of normal skin.
- Paediatric Population: Limit courses to five days; avoid tight coverings and consult a physician if irritation or infection develops.
- Contraindications: Chicken pox, vaccinia, tuberculosis of the skin, hypersensitivity, facial rosacea, acne vulgaris, perioral dermatitis, pruritus, certain dermatoses in infancy, and active skin infections.
- Warnings:
- Not for acute, weeping dermatoses.
- Local and systemic toxicity common with long-term use or large areas of application.
- Systemic absorption may suppress the hypothalamic-pituitary-adrenal (HPA) axis.
- Avoid long-term continuous therapy; restrict occlusion to small areas.
- Be cautious when treating face, as topical steroid withdrawal syndrome can occur.
- Pregnancy/Lactation: Use only if no safer alternative; exercise caution in nursing mothers.
- Undesirable Effects: Local reactions like burning, itching, irritation, dryness, folliculitis, hypertrichosis, allergic contact dermatitis, and secondary infections. Systemic effects may include Cushing’s syndrome, hyperglycaemia, glycosuria, and adrenal suppression in children.
- Storage: Keep in a dry place below 25°C.
- Pack Sizes/Pricing: 20cm or 50cm rolls; £16.49 and £23.75 respectively.
- Legal Category: POM (Prescription Only Medicine)
- Marketing Authorisation: PL 00551/0014, Typharm Ltd.
- Adverse Event Reporting: Report forms available at www.mhra.gov.uk/yellowcard; contact Typharm Limited on 02037 694160.