Fazijin (tinidazolum) coated tablets 500 mg. №4

Description

Fazijin composition:

1 tablet contains 500 mg of tinidazole;

Excipients: microcrystalline cellulose, corn starch, sodium lauryl sulfate, magnesium stearate, alginic acid, hydroxypropyl ethylcellulose, propylene glycol, titanium dioxide.

Fazijin Release form.

Coated tablets.

Fazijin Pharmacotherapeutic group. Other antibacterial agents. PBX code J01X D02.

Pharmacological properties.

Pharmacodynamics.

Tinidazole is a 5-nitroimidazole derivative with a substituted imidazole component that is able to act against anaerobic bacteria and protozoa. The mechanism of action of tinidazole on anaerobic bacteria and protozoa is associated with the penetration of the drug into the cells of microorganisms and with DNA damage or inhibition of its synthesis.

Tinidazole is active against both protozoa and obligate anaerobic bacteria. The simplest microorganisms sensitive to tinidazole include Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia.

Tinidazole is active against Gardnerella vaginalis and against most anaerobic bacteria, including Bacteroides fragilis, Bacteroidesmelaninogenicus, Bacteroides spp., Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostrepto. and Veillonellaspp.

Pharmacokinetics.

Tinidazole is rapidly and completely absorbed when administered orally.

In studies of healthy volunteers receiving tinidazole 2 g orally, serum concentrations peaked at 40-51 μg / ml within 2 hours and decreased to 11-19 μg / ml after 24 hours.

Plasma levels decreased slowly; tinidazole was detected in plasma (at concentrations up to 1 μg / ml) 72 h after oral administration. The elimination half-life of tinidazole from plasma is 12-14 hours.

Tinidazole is actively distributed to all tissues of the body and crosses the blood-brain barrier. It is found in all tissues in therapeutically effective concentrations. The apparent volume of distribution is approximately 50 liters. Almost 12% of plasma tinidazole is protein bound.

Tinidazole is excreted by the liver and kidneys. Studies of healthy volunteers have shown that within 5 days, 60-65% of the dose administered is excreted by the kidneys, with 20-25% excreted unchanged. Approximately 5% of the dose is excreted in the feces.

Studies in patients with renal insufficiency (creatinine clearance below 22 ml / min) show that the pharmacokinetics of tinidazole in such patients do not change significantly.

Indications for use.

Prevention after surgical infections caused by anaerobic bacteria, especially after operations on the large intestine, gastrointestinal tract and after gynecological operations.

Treatment of anaerobic infections: intraperitoneal infections (peritonitis, abscess); gynecological infections (endometritis, endomyometritis, tube and ovarian abscess); bacterial septicemia; after surgical wound infections; skin and soft tissue infections; respiratory tract infections (pneumonia, empyema, lung abscess). Nonspecific vaginitis. Acute ulcerative gingivitis. Urogenital trichomoniasis in men and women. Mixed Trichomonas and candidiasis infections. Giardiasis. Intestinal amebiasis. Amoebic liver disease.