BICAFAR 1G STERILE

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFOPERAZONE SODIUM

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

CEFOPERAZONE SODIUM

Units in package:

1gm mcg/mL; 25Units Units; 100Units Units; 50Units Units; 10 Units

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
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[Revision Date:16.11.2020]
BICAFAR 1G STERILE
DESCRIPTION:
BICAFAR 1G STERILE: White or slightly yellowish powder; constituted
solution is colourless or straw yellow.
COMPOSITION: Each vial contains 1 g of Cefoperazone (as Cefoperazone
Sodium).
PHARMACODYNAMICS:
Cefoperazone sodium has similar antimicrobial activity to ceftazidime
and cefotaxime. Cefoperazone has a bactericidal action similar to
cephamandole, but a broader spectrum of activity. It
is highly stable to hydrolysis by most beta-lactamases and has greater
activity against Gram-negative bacteria than first- or
second-generation cephalosporins. However, it generally has
slightly less activity than first-generation cephalosporins against
Gram-positive organisms. Cefoperazone has similar antimicrobial
activity to ceftazidime although it is slightly less active
against some Enterobacteriaceae. It has good activity against
Pseudomonas aeruginosa, but is less active than ceftazidime.
PHARMACOKINETICS:
Cefoperazone is administered parenterally as the sodium salt. After
intramuscular administration of doses equivalent to cefoperazone 1 to
2 g, peak plasma concentration of 65 and 97
μg per mL have been reported after 1 to 2 hours. The half-life of
cefoperazone is about 2 hours, and 82 to 93% in the circulation is
bound to plasma proteins. Cefoperazone is widely
distributed in body tissues and fluids. It diffuses across the
placenta, and is excreted in breast milk in low concentrations.
Cefoperazone is excreted principally in the bile where it rapidly
achieves high concentrations. Up to 30% of a dose is excreted in the
urine within 12 to 24 hours. Urinary excretion is primarily by
glomerular filtration and this proportion may be
increased in patients with hepatic or biliary disease. Cefoperazone
penetration into CFS is generally poor.
INDICATIONS:
Cefoperazone is indicated for the treatment for the following
infections when caused by susceptible organisms.
Respiratory tract infections (upper and lower); urinary tract
infect