Levoximed
(Levofloxacin)




COMPOSITION

Each film coated tablet contains levofloxacin 500 mg.

THERAPEUTIC INDICATIONS

- ENT-organs infections: acute sinusitis, otitis media;
- Lower respiratory tract infections: chronic bronchitis exacerbation, community-aguired;
- 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 (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; very 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: 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).

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 once daily. Treatment course: 10-14 days.
- heavy exacerbation of chronic bronchitis: intake 250-500 mg once daily. 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 once daily. Treatment course: 7-10 days.
- prostatitis: intake 500 mg once daily. 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 up 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.

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.

6 film coated tablets in blister. 1 blister in carton box with enclosed leaflet.

Alimentary Tract and Metabolism

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