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Levoximed (Levofloxacin)
TRADE NAME
Levoximed
INTERNATIONAL
NON-PATENTED NAME
Levofloxacin
CHEMICAL NAME
(-)-(S)-9-fluoro-2,3-dyhidro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4
benzoxazin-6- carboxylic acid hemihydrate
PHARMACEUTICAL
FORM
Film coated
tablets.
Description: a light yellow coloured, caplet shaped tablets with
“LVXN” embossed on one side and break line on the other side.
COMPOSITION
Film coated tablet contains
Active ingredient: levofloxacin (as
hemihydrate) 500 mg.
Inactive ingredients: lactose, maize
starch, sodium starch glycollate, povidone (К30), magnesium
stearate.
Conposition of coated
tablet:
hypromellose (E15), titanium dioxide, iron oxide yellow, purified talc, propylene
glycol.
АТС CODE J01MA12
PHARMACOTHERAPEUTIC GROUP
Antimicrobial agents of
the fluorochinolone group.
PHARMACOLOGIC
PROPERTIES
PHARMACODYNAMICS
Levoximed is a broad spectrum antimicrobial agent of the fluorochinolone
group. The active preparation ingredient Levofloxacin represents an optical
active levorotatory isomer of ofloxacin L- ofloxacin. Inhibiting DNA-gyrase and
topoisomerasa IV, it violates the process of bacterial DNA forming.
Levofloxacin is
active in relation to the majority of microorganisms’ strains both in vitro,
and in vivo:
- aerobic gram-positive microorganisms: Corynebacterium
diphtheriae, Enterococcus spp. (including
Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp.,
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp. группы С and G (including Streptococcus agalactiae, Streptococcus pneumoniae,
Streptococcus pyogenes, Streptococcus viridans);
- aerobic gram-negative microorganisms: Acinetobacter
baumannii, Acinetobacter spp., Actinobacillus actinimycetemcomitans,
Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter
agglomerans, Enterobacter spp. (including
Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus
ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Helicobacter
pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella
pneumoniae), Moraxella cattaralis, Morganella morganii, Neisseria gonnorrhoeae,
Neisseria meningitidis, Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella
multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri,
Providencia stuartii), Pseudomonas spp. (including Pseudomonas
aeruginosa), Salmonella spp., Serratia spp. (Serratia marcescens);
- anaerobic microorganisms: Bacteroides
fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp.,
Peptostreptococcus spp., Propionibacterum spp., Veilonella spp.;
- other
microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci,
Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium
spp. (including Mycobacterium leprae,
Mycobacterium tuberculosis), Mycoplasma
hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.
pharmacokinetics
After per oral
application it completely and fast absorbs from the GIT. Maximum blood plasma
concentration is reached in 1-2 hours. The bioavailability makes 99%. The bond
with plasma protein makes 30-40%. The elimination half-life makes 6-8 h.
therapeutic
indicationS
Infection-inflammatory
diseases caused by sensitive to the preparation microorganisms:
- ENT – organs
infections: acute sinusitis, otitis media;
- lower
respiratory tract infections: chronic bronchitis exacerbation, out-of-hospital pneumonia;
- complicated
kidneys and urinary tract infections, including pielonephritis;
- uncomplicated
urinary tract infections;
- infection of
generative organs, including cervicitis, salpingoophorite, endometritis;
- prophylaxis
after abortion;
- abdominal
cavity organs infections, including cholecystitis, enterocolitis etc.;
- skin and soft
tissues infections;
- bones and
joints infections;
- complex
therapy of drug resistant tuberculosis.
CONTRAINDICATIONS
- heighten
sensitivity to Levofloxacin or other quinolones;
- epilepsy;
- child or
juvenile under 18 years (having the possibility of articular cartilage
defects);
- pregnancy and
lactation;
- tendon
defects, connected with quinolones application in anamnesis.
SPECIAL
INDICATIONS
At prescription
of Levoximed the following persons should be cautious:
- old age
patients (in connection with high probability of the concomitant kidney
function diminishing);
- patients with
preceding cerebral affection (including with insults and heavy brain injury);
- patients with diabetes mellitus (there is a possibility of hypoglycemia development);- patients with renal dysfunction (the preparation is prescribed with cautious concurrently
with preparations blocking canal secretion).
It is recommended to avoid being in the sun or UV-radiation
for the avoidance of photosensibilisation development.
The alcohol use should be excluded during the treatment.
Influence on ability for driving and for operating with
other mechanisms
Levoximed may cause the decrease of ability for fixing of attention and
psychomotor reactions rate. It should be taken into consideration if the
administration of the preparation is required for patients, whose activity is
connected with driving a car, operating of mechanisms and machines, with fulfilling
of job in unstable state.
SIDE EFFECTS
Allergic
reactions: rare – itch and
redness; rare – anafilactic and anaphylactoid reactions (hives, bronchospasm
and possible heavy asthma, in rare cases – facial edema, laryngeal edema).
Dermatological
reactions: rare – photosensibilisation.
From
digestive system: nausea, diarrhea; rare – appetite
loss, vomit, abdominal pains, digestion disturbance; rare –diarrhea with blood.
From
metabolism: very rare – hypoglycemia; rare
–exacerbation of porphyry.
From CNS and
peripheral nervous system: rare – ache pain,
dizziness, stiffness, drowse; rare – paresthesia in hands, trembling, anxiety,
state of fear, cramps attacks and mental confusion; rare – visual and ear
impairment, disturbances of taste and smell, decrease in hepatic acuity,
hallucinatory and depressive type psychotic reactions, motor disturbances
(including walking).
From
cardiovascular system: rare - tachycardia, AP
lowering; rare – vascular collapse.
From
musculoskeletal system: rare – tendon defects,
joints and muscular paints.
From urinary
excretion system: rare – creatinine level increase
in serum blood; very rare – kidney function worsening to the extent of sharp
renal insufficiency.
From
hematopoietic system: somtimes - eosinophilia,
leukopenia; rare - hypogranulocytosis, thrombocytopenia; very rare – acute form
agranulocytosis (accompanied by steady or recur temperature rise, tonsillitis
and steady health worsening with possible serious infections development).
DOSAGE
AND ADMINISTRATION
Levoximed is taken 1-2 times per day in dose of 250-500 mg irrespective of
food intake, not chewing and washing down with sufficient quantity of water.
The doses are
determined by the infection character and severity as well as the sensitivity
of supposed pathogen.
The following
dosage regimen can be recommended for the patients’ treatment with normal and
reasonably decreased kidney function (creatinine clearance >50 ml/min):
- acute
sinusitis: intake 500 mg 1 time/day. Treatment course: 10-14 days.
- heavy exacerbation
of chronic bronchitis: intake 250-500 mg 1
time/day. Treatment course: 7-10 days.
- pneumonia: intake 500 mg 1-2 times/day. Treatment course: 7-14 days.
- urinary
tracts infections: intake 250-500 mg 1 time/day.
Treatment course: 7-10 days.
- prostatitis: intake 500 mg 1 time/day. Treatment course: 28 days.
- skin and
soft tissues infections: intake 250-500 mg 1-2
times/day. Treatment course: 7-14 days.
Consisting of
complex therapy of drug resistant tuberculosis Levoximed is prescribed at 500-1000 mg
dose 1-2 times /day. Treatment course: to 3 months.
It is necessary
the dosage correction to the patients with kidney function impairment depending
on the creatinine clearance value. It is not required a special dose selection
at the compromised liver function, as Levoximed is
not metabolized in liver in significant extent.
It is not
allowable an interruption or pre-term treatment cessation.
OVERDOSE
Sympthoms: mental confusion, dizziness, impairment of consciousness and cramp attacks, vomiting, blennosis.
Treatment: symptomatic therapy. Levofloxacin is not removed
by hemodialysis. There is no any specific antidote.
interaction WITN OTHER MEDICAMENTS
The effect of Levoximed is significantly reduced at
co-administration with sucralfate, magnesium-aluminium-containing-antacids, as
well as iron salts.
Levofloxacin, as all quinolones, can strengthen the ability
of preparations (nonsteroid anti-inflammatory preparations, teophillin) to
reduce the threshold readiness for convulsions.
The elimination (renal clearance) Levoximed is
slightly slowed down under the action of cimetidine and probenecid that
virtually doesn’t have any clinical significance.
Levoximed
can provoke a slight increase of cyclosporin elimination half-life from blood
or plasma.
PACKAGING
Film coated tablets. 6 tablets in blister.
1 blister in carton box with enclosed leaflet.
STORAGE CONDITIONS
Store in a dry place at temperature not exceeding
25°С.
Keep out of reach of children.
SHELF LIFE
3 years from the manufacture date.
Do not use if the labeled working life is expired.
SALES TERMS
Sold under prescription.
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