TEVA-QUININE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

QUININE SULFATE

Available from:

TEVA CANADA LIMITED

ATC code:

P01BC01

INN (International Name):

QUININE

Dosage:

200MG

Pharmaceutical form:

CAPSULE

Composition:

QUININE SULFATE 200MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0106604001; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-11-25

Summary of Product characteristics

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_TEVA-QUININE 1 of 18 _
PRESCRIBING INFORMATION
PR
TEVA-QUININE
Quinine Sulfate Capsules
200 mg and 300 mg
Teva Standard
ANTIMALARIAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control#: 198967
Date of Revision:
December 29, 2016
________________________________________________________________________
_TEVA-QUININE 2 of 18 _
PRESCRIBING INFORMATION
PR
TEVA-QUININE
Quinine Sulfate Capsules
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
Ammonium hydroxide, black iron oxide,
butyl alcohol, colloidal silicon dioxide,
dehydrated alcohol, gelatin, isopropyl
alcohol, lactose monohydrate,
magnesium stearate, potassium
hydroxide, pregelatinized starch,
propylene glycol, purified water, shellac,
sodium lauryl sulfate and talc.
INDICATIONS AND CLINICAL USE
TEVA-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.
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_TEVA-QUININE 3 of 18 _
CONTRAINDICATIONS

Patients who are hypersensitive to this drug or to any ingredient in
the