OXSORALEN-ULTRA CAP 10MG CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

METHOXSALEN

Disponibil de la:

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

Codul ATC:

D05BA02

INN (nume internaţional):

METHOXALEN, SYSTEMIC

Dozare:

10MG

Forma farmaceutică:

CAPSULE

Compoziție:

METHOXSALEN 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PIGMENTING AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2015-08-05

Caracteristicilor produsului

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