TEVA-CHLOROQUINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLOROQUINE PHOSPHATE

Available from:

TEVA CANADA LIMITED

ATC code:

P01BA01

INN (International Name):

CHLOROQUINE

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

CHLOROQUINE PHOSPHATE 250MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0107378001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-07-29

Summary of Product characteristics

1
PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CHLOROQUINE
(Chloroquine
Phosphate)
Tablets
250 mg
USP
Antimalarial
– Antiparasitic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
October 2, 1996
Toronto, Canada
Date of Revision:
M1B 2K9
February 19, 2021
www.tevacanada.com
Control#: 243836
2
PRESCRIBING INFORMATION
Pr
TEVA-CHLOROQUINE
(Chloroquine
Phosphate Tablets)
250 mg
THERAPEUTIC CLASSIFICATION
Antimalarial
– Antiparasitic
ACTION AND CLINICAL PHARMACOLOGY
Chloroquine
has been found to be highly active against the asexual erythrocytic
forms of
Plasmodium vivax, ovale and malariae and many strains of Plasmodium
falciparum (but
not the gametocytes of Plasmodium falciparum). The precise mechanism
of
plasmodicidal
action of the drug is not known. Chloroquine
may exert its effect against
Plasmodium species by concentrating in the acid vesicles of the
parasite and by inhibiting
polymerization
of heme. While the drug can inhibit
certain enzymes, its effect is
believed to result, at least in part, from its interaction with DNA.
Chloroquine
does not prevent infection but acts on the erythrocytic form of the
parasite,
inhibiting
parasite development in the red cell thus preventing or suppressing
clinical
symptoms. Chloroquine does not prevent relapses in patients with vivax
or ovale malaria
because it is not effective against exo-erythrocytic forms of the
disease. It is highly
effective as a suppressive agent in patients with vivax or ovale
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.
_In vitro_ studies with trophozoites of Entamoeba histolytica have
demonstrated that
chloroquine also possesses amebicidal activity comparable to that of
emetine.
Resistance of Plasmodium parasites to chloroquine is widespread (see
INDICATIONS
AND CLINICAL USE, Limitati