Levofloxacin Werth 500mg N10 coated pills
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Active ingredients
Levofloxacin
Release form
Pills
Composition
1 tablet contains: levofloxacin hemihydrate 512.46 mg, which corresponds to the content of levofloxacin 500 mg. Excipients: microcrystalline cellulose 61.66 mg, hypromellose 17.98 mg, croscarmellose sodium 18.6 mg, polysorbate 80-1.3 mg, calcium stearate 6.2 mg. The composition of the shell: (hypromellose - 15 mg, gidroloza (hydroxypropylcellulose) - 5.82 mg, talc - 5.78 mg, titanium dioxide - 3.26 mg, iron oxide yellow (yellow oxide) - 0.14 mg) or (dry mixture for film coating containing hypromellose 50 %, hyprolosis (hydroxypropylcellulose) 19.4%, talc 19.26%, titanium dioxide 10.87%, iron yellow oxide (yellow oxide 0.47%) - 30 mg.
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: Acute sinusitis. Exacerbation of chronic bronchitis. Community-acquired pneumonia. Complicated urinary tract infections (including pyelonephritis). Uncomplicated urinary tract infections. Prostatitis. Infections of the urinary tract. Indications for use. Intra-abdominal infection.
Contraindications
Hypersensitivity to levofloxacin or to other quinolones. Renal failure (with creatinine clearance less than 20 ml / min. Due to the impossibility of dosing this dosage form). Epilepsy. Tendon lesions during previous treatment with quinolones. Children and adolescents (under 18 years). Pregnancy and lactation period. With caution should be used in the elderly due to the high likelihood of a concomitant decrease in kidney function, as well as glucose deficiency. 6-phosphate dehydrogenase.
Dosage and administration
The drug is taken orally 1 or 2 times a day. Tablets do not chew and drink enough liquid (0.5 to 1 cup), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. For patients with normal or moderately reduced renal function (creatinine clearance> 50 ml / min.), The following dosing regimen is recommended: sinusitis: 500 mg 1 time per day - 10-14 days; exacerbation of chronic bronchitis: 250 mg or 500 mg 1 time per day - 7-10 days; community-acquired pneumonia: 500 mg 1-2 times a day - 7-14 days.uncomplicated urinary tract infections: 250 mg 1 time per day - 3 days; prostatitis: 500 mg - 1 time per day - 28 days; complicated urinary tract infections, including pyelonephritis: 250 mg 1 time per day - 7-10 days; infections of the skin and soft tissues: 250 mg once a day or 500 mg 1-2 times a day - 7-14 days; septicemia / bacteremia: 250 mg or 500 mg 1-2 times a day - 10-14 days; intra-abdominal infection: 250 mg or 500 mg 1 time per day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora). Patients after hemodialysis or permanent ambulatory peritoneal dialysis do not require additional doses. Patients with impaired liver function do not require a special selection of doses, since levofloxacin is metabolized in the liver only to an insignificant extent. As with the use of other antibiotics, treatment with Levofloxacin is recommended to continue for at least 48-78 hours after normalization of body temperature or after a laboratory-confirmed recovery.
Side effects
Allergic reactions sometimes - itching and redness of the skin. rarely, general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, bronchoconstriction, and possibly severe suffocation. very rarely - swelling of the skin and mucous membranes (for example, in the face and throat), a sudden drop in blood pressure and shock, increased sensitivity to solar and ultraviolet radiation (see Special Instructions), allergic pneumonitis, vasculitis. in some cases - severe skin rash with blistering, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme. General hypersensitivity reactions can sometimes be preceded by lighter skin reactions. The above-mentioned reactions may develop already after the first dose in a few minutes or hours after the administration of the drug. On the part of the digestive system, there is often nausea, diarrhea, increased activity of liver enzymes (for example, alanine aminotransferase and aspartate aminotransferase). sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders. rarely, diarrhea mixed with blood, which in very rare cases may be a sign of intestinal inflammation and even pseudomembranous colitis (seeSpecial instructions). From the side of metabolism it is very rare - a decrease in the concentration of glucose in the blood, which is of particular importance for patients with diabetes mellitus (possible signs of hypoglycemia, increased appetite, nervousness, sweat, trembling). Experience with other quinolones suggests that they can cause exacerbation of porphyria in patients already suffering from this disease. A similar effect is not excluded when using the drug levofloxacin. From the nervous system sometimes - headache, dizziness and / or numbness, drowsiness, sleep disturbances. Rarely - anxiety, paresthesia in the hands, trembling, psychotic reactions such as hallucinations and depressions, an excited state , convulsions and confusion. very rarely - impaired vision and hearing, impaired taste sensitivity and smell, a decrease in tactile sensitivity. On the part of the cardiovascular system, rarely - increased heartbeat, lowering blood pressure. very rarely - vascular (shock-like) collapse. in some cases - lengthening of the Q-T interval. From the side of the musculoskeletal system it is rare - tendon lesions (including tendonitis), joint and muscle pain. very rare - tendon rupture (for example, Achilles tendon). this side effect may occur within 48 hours after the start of treatment and may be bilateral in nature (see Specific Instructions), muscular weakness, which is of particular importance for patients with bulbar syndrome. in some cases - muscle lesions (rhabdomyolysis). From the urinary system it is rare - an increase in serum bilirubin and creatinine levels. very rarely - deterioration of renal function up to acute renal failure, interstitial nephritis. On the part of the blood-forming organs, sometimes - an increase in the number of eosinophils, a decrease in the number of leukocytes. rarely - neutropenia, thrombocytopenia, which may be accompanied by increased bleeding. very rarely - agranulocytosis and the development of severe infections (persistent or recurrent fever, deterioration of well-being). in some cases - hemolytic anemia. pancytopenia. Others sometimes - general weakness. very rarely - fever.