TRADE NAME: Neo-medanine F.R. Tablets GENERIC NAME: Methoxsalen (Ammoidin) COMPOSITION: Each tablet contains: Active ingredient: Methoxsalen (Ammoidin) 10mg : Excipients Lactose monohydrate, Maize starch, Talc, Colloidal silicon dioxide(Aerosil 200), Magnesium stearate, Ethyl alcohol, P.V.P. K17 PHARMACEUTICAL FORM: Fast release tablet. PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES: Pharmacotherapeutic class: PHOTOSENSITIZER (D: Dermatology) Methoxsalen [or 8- methoxypsoralen] has a photodynamizing power that sensitizes the skin to the action of solar or artificial ultraviolet rays. Its spectrum of action is between 320 and 380 nm. The maximum efficiency being obtained with 365 nm. PHARMACOKINETIC PROPERTIES: Administration of oral methoxsalen leads to cutaneous photosensitization which is maximal between 2 and 4 hours and disappears after 6 to 8 hours. 90% of the product is eliminated in 12 hours in the urine in the form of hydroxylated or glycuro-conjugated derivatives. There are large individual variations. INDICATIONS: In the field of photo-chemotherapy: Psoriasis, vitiligo, fungoid mycosis, cutaneous T-cells lymphomas, lichen planus, descaling alopecia areata, photodermatoses, cutaneous mastocytosis, atopic dermatitis. DOSAGE AND ADMINISTRATION: For a patient up to 30 kg 1 tablet from 31 to 50 kg 2 tablets from 51 to 65 kg 3 tablets from 66 to 80 kg 4 tablets from 81 to 90 kg 5 tablets > 90 kg 6 tablets The administration of Neo-medanine F.R. should be followed 2 to 3 hours later, from exposure to the sun or irradiation U.V.A. •Sun exposure (although it is recommended in the treatment of Vitiligo) must be progressive: 10 to 15 minutes of exposure at the beginning of treatment. The exposure time may be extended for 30 minutes, or even 1 hour, if the treatment-related erythema is not excessive. CAUTION erythematous reactions are observed 48 hours after exposure. The increase in the duration of exposure can therefore only occur with the least risk every two days. • U.V.A irradiation (photochemotherapy, P.U.V.A.) It requires special equipment with lamps emitting U.V.A. between 320 and 380 nm, with a peak at 365 nm, and practically not emitting from U.V.B. The treatment modalities (duration, rhythm of the sessions) depend on the intensity of the lamps and the phototype. Phototype Doses of UVA- joules /cm2 Initial treatment progression 0.5 0.5 I: Always burn, never bronze 0.5 II: Always burn, slightly bronze 1
