MYLAN-HYDROXYCHLOROQUINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HYDROXYCHLOROQUINE SULFATE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

P01BA02

INN (International Name):

HYDROXYCHLOROQUINE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

HYDROXYCHLOROQUINE SULFATE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0107403001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-07-12

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
MYLAN-HYDROXYCHLOROQUINE
HYDROXYCHLOROQUINE SULFATE TABLETS
200 MG
USP
ANTI-INFLAMMATORY - ANTIMALARIAL
Mylan Pharmaceuticals ULC
Date of Revision: April 13, 2018
85 Advance Road
Etobicoke, Ontario
Canada, M8Z 2S6
Control Number: 214821
2
PR
MYLAN-HYDROXYCHLOROQUINE HYDROXYCHLOROQUINE SULFATE TABLET 200 MG
USP
THERAPEUTIC CLASSIFICATION
ANTI-INFLAMMATORY - ANTIMALARIAL
ACTIONS AND CLINICAL PHARMACOLOGY
Mylan-Hydroxychloroquine (Hydroxychloroquine sulfate) belongs to the
4-aminoquinoline
class. Mylan-Hydroxychloroquine has been beneficial for patients with
rheumatoid arthritis and
lupus erythematosus, especially chronic discoid lupus. The exact mode
of action in controlling
these diseases is unknown. The action of this compound against
malarial parasites is similar to
that of chloroquine phosphate.
INDICATIONS AND CLINICAL USE
MYLAN-HYDROXYCHLOROQUINE (hydroxychloroquine sulfate) is indicated for
the
treatment of rheumatoid arthritis, and discoid and systemic lupus
erythematosus, in patients who
have not responded satisfactorily to drugs with less potential for
serious side effects.
It is also indicated for the suppressive treatment and treatment of
acute attacks of malaria due to
_P. vivax, P. malariae, P. ovale_
, and susceptible strains of
_P. falciparum_
. It is not active against
the exo-erythrocytic forms of
_P. vivax, P. malariae and P. ovale_
and therefore will neither
prevent infection due to these organisms when given prophylactically,
nor prevent relapse of
infection due to these organisms. It is highly effective as a
suppressive agent in patients with
_vivax_
or
_malariae malaria_
in terminating acute attacks and significantly lengthening the
interval
between treatment and relapse. In patients with
_falciparum malaria_
, it abolishes the acute attack
and effects complete cure of the infection, unless due to a resistant
strain of
_P. falciparum_
.
CONTRAINDICATIONS
-
pre-existing retinopathy of the eye
-
patients with known hypersensitivity to 4-aminoquinoline compounds
-
use in c