AVATAC FILM COATED TABLET 500 MG

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Werkstoffen:

Levofloxacin hemihydrate 512.46mg eqv levofloxacin

Beschikbaar vanaf:

ZIWELL MEDICAL (S) PTE LTD

ATC-code:

J01MA12

farmaceutische vorm:

TABLET, FILM COATED

Samenstelling:

Levofloxacin hemihydrate 512.46mg eqv levofloxacin 500mg

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

Meditop Pharmaceutical Ltd

Autorisatie-status:

ACTIVE

Autorisatie datum:

2017-10-13

Productkenmerken

AVATAC 250 MG FILM-COATED TABLET
AVATAC 500 MG FILM-COATED TABLET
COMPOSITION
AVATAC 250 MG FILM-COATED TABLET
250 mg levofloxacin (in the form of 256.23 mg levofloxacin
hemihydrate) in each film-coated
tablet.
AVATAC 500 MG FILM-COATED TABLET
500 mg levofloxacin (in the form of 512.46 mg levofloxacin
hemihydrate) in each film-coated
tablet.
DESCRIPTION
Yellowish, oblong, biconvex film-coated tablet with a score line in
both side.
The film-coated tablet can be divided into equal halves.
The breaking surface is yellow.
LIST OF EXCIPIENTS
Tablet core:
AquaPolish D clear 099.08 (glycerol, talc, microcrystalline cellulose,
hypromellose),
crospovidone, talc, magnesium stearate, stearic acid, anhydrous
colloid silica.
Film-coating:
Opadry 12F38203 (hypromellose, Talc, yellow iron oxide (E 172),
titanium dioxide (E 171),
Macrogol 6000, polysorbate 80).
ACTIONS
PHARMACOLOGY: The main mechanism of action of levofloxacin is
inhibition of DNA gyrase
and topoisomerase IV. The activity of levofloxacin is bactericidal.
MICROBIOLOGY: Levofloxacin is a broad-spectrum quinolone oral
antibacterial agent
containing levofloxacin, optically active (-)-S-form of racemate
ofloxacin. Levofloxacin has
invitro activity against a wide range of gram-negative and
gram-positive microorganisms.
Levofloxacin is often bactericidal at concentrations equal to or
slightly greater than inhibitory
concentrations.
PHARMACOKINETICS: ABSORPTION :Levofloxacin is rapidly and essentially
completely
absorbed after oral administration. Peak plasma concentrations are
usually attained 1-2 hrs
after oral dosing. The absolute bioavailability of a 500 mg tablet of
levofloxacin is approximately
99%, demonstrating complete oral absorption of levofloxacin. Following
a single IV dose of
levofloxacin to healthy volunteers, the mean ±SD peak plasma
concentration attained was
6.2±1 mcg/mL after a 500 mg dose infused over 60 min and 11.5±4
mcg/mL after a 750 mg
dose infused over 90 min. Levofloxacin pharmacokinetics are linear and
predictable after
single and multiple