Land: Canada
Taal: Engels
Bron: Health Canada
METHOXSALEN
VALEANT CANADA LP / VALEANT CANADA S.E.C.
D05BA02
METHOXALEN, SYSTEMIC
10MG
CAPSULE
METHOXSALEN 10MG
ORAL
100
Prescription
PIGMENTING AGENTS
Active ingredient group (AIG) number: 0107802002; AHFS:
CANCELLED POST MARKET
2015-08-05
1 PRODUCT MONOGRAPH OXSORALEN-ULTRA CAPSULES 10 mg, Methoxsalen Capsules 10 mg, USP TO FACILITATE REPIGMENTATION IN VITILIGO TO INCREASE TOLERANCE TO SOLAR EXPOSURE FOR USE IN PHOTOCHEMOTHERAPY OF PSORIASIS AND ATOPIC DERMATITIS Valeant Canada LP 2150 St-Elzear Blvd., West Laval, Quebec H7L 4A8 Canada Date of Preparation: September 27, 2004 Address Updated: September 04, 2014 Control#: 094181 2 PRODUCT MONOGRAPH OXSORALEN-ULTRA CAPSULES 10 mg, Methoxsalen Capsules 10 mg, USP TO FACILITATE REPIGMENTATION IN VITILIGO TO INCREASE TOLERANCE TO SOLAR EXPOSURE FOR USE IN PHOTOCHEMOTHERAPY OF PSORIASIS AND ATOPIC DERMATITIS CAUTION THIS NEW DOSAGE FORM OF METHOXSALEN EXHIBITS SIGNIFICANTLY GREATER BIOAVAILABILITY AND EARLIER PHOTOSENSITIZATION ONSET TIME THAN PREVIOUS METHOXSALEN DOSAGE FORMS. EACH PATIENT SHOULD BE EVALUATED BY DETERMINING THE MINIMUM PHOTOTOXIC DOSE (MPD) AND PHOTOTOXIC PEAK TIME AFTER DRUG ADMINISTRATION PRIOR TO ONSET OF PHOTOCHEMOTHERAPY WITH THIS DOSAGE FORM. OXSORALEN-ULTRA IS A POTENT DRUG AND SHOULD BE USED ONLY UNDER SUPERVISION OF A PHYSICIAN WITH SPECIAL TRAINING AND EXPERIENCE IN PHOTOCHEMOTHERAPY (PUVA). ACTION Psoralens are a group of structurally related photoactive compounds. They are called "photoactive" because they are activated selectively in the presence of longwave ultraviolet light (UVA). They may be ingested orally or applied topically but without UVA are totally inactive. 3 OXSORALEN-ULTRA (METHOXSALEN) , when activated by long wavelength ultraviolet radiation (UVA) in the range of 320-400 nm, is strongly erythemogenic, melanogenic, and cytotoxic in the epidermis; the maximal erythemogenic activity occurs in the range of 330-360 nm. Following photoactivation, methoxsalen forms covalent bonds withDNA to produce monofunctional (addition to a single strand of DNA) and bifunctional adducts (crosslinking to both strands of DNA). The photochemical reaction between activated psoralens and DNA has been shown to inhibit epidermal DNA synthesis and this is the rationale for the use of ps Lees het volledige document