LARIAM TAB 250MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEFLOQUINE (MEFLOQUINE HYDROCHLORIDE)

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

P01BC02

INN (International Name):

MEFLOQUINE

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

MEFLOQUINE (MEFLOQUINE HYDROCHLORIDE) 250MG

Administration route:

ORAL

Units in package:

8

Prescription type:

Prescription

Therapeutic area:

ANTIMALARIALS

Product summary:

Active ingredient group (AIG) number: 0124227001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-05-02

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
LARIAM
®
(mefloquine hydrochloride tablets)
mefloquine 250 mg
ANTIMALARIAL AGENT
Hoffmann-La Roche Limited
Date of Revision:
2455 Meadowpine Boulevard
March 3, 2011
Mississauga, Ontario
L5N 6L7
www.rochecanada.com
Submission Control No. 143381
®
Registered Trade Mark of Hoffmann-La Roche Limited
©
Copyright 1993-2011 Hoffmann-La Roche Limited
LARIAM
®
„
Page 2
NAME OF DRUG
PR
LARIAM
®
(mefloquine hydrochloride tablets)
mefloquine 250 mg
THERAPEUTIC CLASSIFICATION
Antimalarial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
LARIAM (mefloquine) acts on the asexual intraerythrocytic forms of the
human malaria
parasites: Plasmodium falciparum, P. vivax, P. malariae and P.
ovale_._
LARIAM is effective against malaria parasites resistant to other
antimalarials such as
chloroquine, proguanil, pyrimethamine and pyrimethamine-sulfonamide
combinations.
Resistance of P. falciparum to mefloquine has been reported,
predominantly in areas of multi-
drug resistance in South-East Asia. Cross-resistance between
mefloquine and halofantrine and
cross-resistance between mefloquine and quinine have been observed in
some regions (see
WARNINGS).
CLINICAL PHARMACOKINETICS
_Absorption _
The absolute oral bioavailability of mefloquine has not been
determined since an intravenous
formulation is not available. The bioavailability of the tablet
formulation compared with an oral
solution was over 85%. The presence of food significantly enhances the
rate and extent of
absorption, leading to about a 40% increase in bioavailability. Plasma
concentrations peak
6-24 hours (median, about 17 hours) after a single dose of LARIAM.
Maximum plasma
concentrations in µg/L are roughly equivalent to the dose in
milligrams (for example, a single
1000 mg dose produces a maximum concentration of about 1000 µg/L). At
a dose of 250 mg
once weekly, maximum steady state plasma concentrations of 1000-2000
µg/L are reached
after 7-10 weeks.
_Distribution _
In healthy adults, the apparent volume of distribution is
approximately 20 L/kg, indicati