GLN-ATOVAQUONE SUSPENSION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ATOVAQUONE

可用日期:

GLENMARK PHARMACEUTICALS CANADA INC.

ATC代码:

P01AX06

INN（国际名称）:

ATOVAQUONE

剂量:

750MG

药物剂型:

SUSPENSION

组成:

ATOVAQUONE 750MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0124073001; AHFS:

授权状态:

APPROVED

授权日期:

2022-06-29

产品特点

_GLN-Atovaquone (Atovaquone Oral Suspension USP) _
_ _
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
GLN-ATOVAQUONE
Atovaquone Oral Suspension USP
750 mg / 5 mL
ANTIPROTOZOAL AGENT
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, ON
L4K 4M2
Date of Preparation:
June 28, 2022
SUBMISSION CONTROL NO: 221273
_GLN-Atovaquone (Atovaquone Oral Suspension USP) _
_ _
_Page 2 of 34_
PRODUCT MONOGRAPH
PR
GLN-ATOVAQUONE
Atovaquone Oral Suspension USP 750 mg / 5 mL
ANTIPROTOZOAL AGENT
CLINICAL PHARMACOLOGY
Atovaquone is a hydroxy-1,4-naphthoquinone, an analog of ubiquinone,
with anti- pneumocystis
activity. The mechanism of action against _Pneumocystis carinii _has
not been fully elucidated.
The pharmacokinetics of atovaquone have been studied in healthy
volunteers, HIV- infected
adults with varying stages and manifestations of HIV infection and in
immunocompromised
children. The half-life of atovaquone is long (2 to 3 days) due to
presumed enterohepatic cycling
and eventual fecal elimination. There is no evidence that the drug is
metabolized in man.
Atovaquone is a highly lipophilic compound with a low aqueous
solubility. It is extensively bound
to plasma proteins (>99.9%).
The bioavailability of atovaquone is highly dependent on formulation
and diet. Atovaquone oral
suspension, which has now replaced atovaquone tablets, has atovaquone
particles significantly
smaller than those in the tablet formulation, and provides an
approximately two-fold increase in
atovaquone bioavailability in the fasting or fed state compared to the
tablet formulation studied
under the same conditions. The bioavailability of atovaquone oral
suspension can be increased
greatly when administered with meals. In healthy volunteers, a
standard meal (23 g fat; 610
kCal) increased the bioavailability two to three-fold following 750 mg
single doses of
atovaquone suspension.
The mean area under the atovaquone plasma concentration-time curve
(AUC) was increased
2.5 fold and the mean C
max
was increased 3.4. Fat has been shown to enhance ab