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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