Levoximed (Levofloxacin)
COMPOSITION
Each100 ml contain levofloxacin (as hemihydrate)
0.5 g.
THERAPEUTIC INDICATIONS
- ENT-organs infections: acute sinusitis, otitis
media;
- Lower respiratory tract infections: chronic bronchitis exacerbation,
out-of-hospital pneumonia;
- Complicated kidney and urinary tract infections, including pyelonephritis;
- Uncomplicated urinary tract infections;
- Infection of generative organs, including cervicitis, salpingoophoritis,
endometritis;
- Prophylaxis after abortion;
- Abdominal cavity organs infections, including cholecystitis, enterocolitis
etc.;
- Skin and soft tissue infections;
- Bone and joint infections;
- Combinated therapy of drug resistant tuberculosis.
CONTRAINDICATIONS
- Increased sensitivity to Levofloxacin or other
quinolones;
- Epilepsy;
- Children or juveniles under 18 years old (having the possibility of articular
cartilage defects);
- Pregnancy and lactation;
- Tendon defects, connected with quinolones application in anamnesis.
ADVERSE EFFECTS
Allergic reactions: itch and redness; anafilactic
and anaphylactoid reactions;
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; very 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: sometimes – eosinophilia, leukopenia; rare –
hypogranulocytosis,
thrombocytopenia; very rare – acute form agranulocytosis (accompanied by steady
or recurring
temperature rise, tonsillitis and steady health worsening with possible serious
infections development).
DRUG INTERACTIONS
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.
DOSAGE AND ADMINISTRATION
Levoximed is given slowly intravenous by drop
infusion. Duration of Levoximed 500 mg IV infusion (100 ml) should consist 60
minutes. Recommendations for the duration of treatment is 48-78 hours since the
body temperature normalization and trusted elimination of causative agent.
Course of treatment depends on severity level, clinical response and
bacteriological test data.
- Pneumonia: 500 mg 1-2 times daily;
- Urinary tracts infections: 250 mg 1 time daily (in case of severe infections
doze can be extended);
- Skin and soft tissues infections: 500 mg 2 times daily.
After several days IV infusions can be shifted to tablet administration with the
same dosage.
In case of kidney failure dose is changed according to dysfunction level:
• CC 20-50 ml/min – 125-250 mg/day
• CC 10-19 ml/min – 125 mg 1/24-48 hours
• Less than 10 ml/mg – 125 mg every 24 or 48 hours.
Treatment course: 7-14 days.
PREGNANCY AND LACTATION
Administration of the drug is not recommended
during pregnancy and lactation.
DRUG INTERACTIONS
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.
MANUFACTURED FORM
1 vial with solution for infusion 500 mg/100 ml.
1 vial with leaflet in a carton box.
10 vials with solution for infusion 500 mg/100 ml in a carton box.
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