NU-HYDROXYQUINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

HYDROXYCHLOROQUINE SULFATE

MAH:

NU-PHARM INC

ATC_code:

P01BA02

INN:

HYDROXYCHLOROQUINE

dosage:

200MG

pharmaceutical_form:

TABLET

composition:

HYDROXYCHLOROQUINE SULFATE 200MG

administration_route:

ORAL

units_in_package:

30/100/500

prescription_type:

Prescription

therapeutic_area:

ANTIMALARIALS

leaflet_short:

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

authorization_status:

CANCELLED (UNRETURNED ANNUAL)

authorization_date:

2018-03-28

SPC

0
PRODUCT MONOGRAPH
NU-HYDROXYQUINE
HYDROXYCHLOROQUINE SULFATE TABLETS USP
200 MG (EXPRESSED AS THE SALT)
EQUIVALENT TO 155 MG HYDROXYCHLOROQUINE
ANTI-RHEUMATIC, ANTIMALARIAL
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
OCTOBER 9, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133285
_ _
1
PRODUCT MONOGRAPH
NU-HYDROXYQUINE
Hydroxychloroquine Sulfate Tablets USP
200 mg (Expressed as the salt)
Equivalent to 155 mg Hydroxychloroquine
THERAPEUTIC CLASSIFICATION
Anti-rheumatic, Antimalarial
ACTIONS AND CLINICAL PHARMACOLOGY
Hydroxychloroquine is highly active against the erythrocytic forms of
_P. vivax _and _malariae_ and
most strains of _P. falciparum_ (but not the gametocytes of _P.
falciparum_). It also exerts a
beneficial effect in patients with lupus erythematosus (chronic
discoid or systemic) and acute or
chronic rheumatoid arthritis. The precise mechanism of action in these
diseases is unknown.
Hydroxychloroquine does not prevent relapses in patients with _vivax_
or _malariae_ malaria because
it is not effective against exo-erythrocytic forms of the parasite,
nor will it prevent _vivax_ or
_malariae_ infection when administered as a prophylactic. It is
however, highly effective as a
suppressive agent in patients with _vivax_ or _malariae_ malaria, in
terminating acute attacks, and in
significantly lengthening the interval between treatment and relapse.
In patients with _falciparum_
malaria, it abolishes an acute attack and effects a complete cure of
the infection, unless due to a
resistant strain of _P. falciparum_.
Comparative Bioavailability
Two comparative bioavailability studies were performed in healthy
human volunteers - one under
fasting conditions and one with food. The rate and extent of
absorption of hydroxychloroquine
was measured and compared following oral administration of a 200 mg
dose of Nu-hydroxyquine
or Plaquenil 200 mg tablets. The results from measured data are
summarized as follows:
2
FASTING STUDY: Summary Table of the Comparative Bioavailability Data
Hydroxychloroquine Sul