APO-QUININE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

QUININE SULFATE

Available from:

APOTEX INC

ATC code:

P01BC01

INN (International Name):

QUININE

Dosage:

300MG

Pharmaceutical form:

CAPSULE

Composition:

QUININE SULFATE 300MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0106604002; AHFS:

Authorization status:

MARKETED

Authorization date:

2013-11-02

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
APO-QUININE
QUININE SULFATE CAPSULES
200 MG AND 300 MG APOTEX STANDARD
ANTIMALARIAL AGENT
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 19, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 215567
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PRESCRIBING INFORMATION
PR
APO-QUININE
Quinine Sulfate Capsules
Apotex Standard
Antimalarial Agent
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Capsule, 200 mg and
300 mg
Carboxymethylcellulose sodium, colloidal
silicon dioxide, gelatin, magnesium stearate,
talc, titanium dioxide.
INDICATIONS AND CLINICAL USE
APO-QUININE (quinine sulfate) is indicated (in combination with a
second antimalarial drug)
for the treatment of uncomplicated _Plasmodium falciparum _malaria.
Quinine sulfate has been
shown to be effective in geographical regions where resistance to
chloroquine has been
documented.
Strains of _P. falciparum _with decreased susceptibility to quinine
can be selected _in vivo_. _P. _
_falciparum _malaria that is clinically resistant to quinine has been
reported in some areas of
South America, Southeast Asia, and Bangladesh.
GERIATRICS (≥ 65_ _YEARS OF AGE):
Reported clinical experience has not identified differences in
responses between the elderly and
younger patients.
PEDIATRICS (< 16 YEARS OF AGE):
Quinine is considered acceptable for use in children at doses
recommended for the treatment of
malaria.
CONTRAINDICATIONS

Patients who are hypersensitive to this drug or to any ingredient in
the formulation or
component of the container. For a complete listing, see the Dosage
Forms, Composition and
Packaging section of the prescribing information.

Hypersensitivity reactions include, but are not limited to the
following:
o
Thrombocytopenia
o
Idiopathic thrombocytopenia purpura (ITP) and Thrombotic
thrombocytopenic
purpura (TTP)
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o
Hemolytic uremic syndrome (HUS)
o
Blackwater fever (acute intravascular hemolysis, hemoglobinuria, and
hemoglobinemia)
(s