OXSORALEN CAP 10MG CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHOXSALEN

Available from:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

ATC code:

D05BA02

INN (International Name):

METHOXALEN, SYSTEMIC

Dosage:

10MG

Pharmaceutical form:

CAPSULE

Composition:

METHOXSALEN 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PIGMENTING AGENTS

Product summary:

Active ingredient group (AIG) number: 0107802002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-08-05

Summary of Product characteristics

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