Nchi: Kanada
Lugha: Kiingereza
Chanzo: 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 PRESCRIBING INFORMATION OXSORALEN 10 mg Capsules (Methoxsalen, USP) Melanin Repigmentation 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 PRESCRIBING INFORMATION OXSORALEN 10 mg CAPSULES (methoxsalen, USP) Melanin repigmentation Photochemotherapy of Psoriasis and Atopic Dermatitis INDICATIONS Repigmentation of vitiliginous lesions, to protect against solar sensitivity and to promote tanning in persons with very complexion. Oral route is preferred if extensive repigmentation is desired since topical application can only be applied to a small area at a time. For treatment of psoriasis and atopic dermatitis in combination with high intensity UVA light. CONTRAINDICATIONS Hepatic insufficiency. Diseases associated with photosensitivity, such as porphyria, acute lupus erythematosus or infectious leukoderma. Safety in those 12 years and under, in aphasic people, in pregnant women or in women of childbearing age has not been established. In albinism it increases tolerance to sunlight, but has no effect on pigmentation. No preparation with any photosensitizing capacity, internal or external, should be used concomitantly with methoxsalen therapy. WARNINGS 3 Methoxsalen is a potent drug and it is recommended that the entire brochure be read before prescribing or dispensing the information. Safety during pregnancy or lactation has not been demonstrated. Use in these conditions should be undertaken only when in the judgment of the physician, the probable benefits outweigh the possible risks. All patients should wear goggles and should close their eyes during treatment with UV light. PRECAUTIONS Should be used only by healthy adults, and use solely to produce a cosmetic tan is not recommended because of its potential toxicity and uncertain results. When used to increase tolerance to sunlight (albinism) and accelerate suntan (people with very light compl Soma hati kamili