Tinidazolum of 500 mg

General characteristics. Structure:

Active ingredient: Tinidazolum - 500 mg, excipients: cellulose microcrystallic, silicon dioxide colloid, magnesium stearate, gipromelloz, titanium dioxide, macrogoal.

Description. Tablets, film coated, color, white or white with a yellowish shade, round, biconvex. The insignificant roughness of a surface is allowed. Color of tablets on cross section - from white to white with grayish or with a yellowish shade.

Pharmacological properties:

Pharmacodynamics. Tinidazolum is active concerning Trichomonas vaginalis, Entamoeba histolytica, Lamblia spp; activators of mephitic gangrenes (Bacteroides spp., including B.fragilis, B.melaninogenicus, Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp.). Being high-lipophilic drug, gets in cells of activators where it is recovered by nitroreductase, synthesis oppresses and damages structure of DNA.

Absorption - high, bioavailability - about 100%. Communication with proteins of plasma - 12%. The maximum concentration (Cmax) after intake of 2 g - 40-51 mkg/ml, in 24 h - 11-19 mkg/ml, in 72 h - 1 mkg/ml; time of achievement of the maximum concentration (TCmax) - 2 h. Distribution volume - 50 l. Gets through a blood-brain barrier (GEB), a placenta. It is allocated with breast milk during 72 h after reception. It is metabolized in a liver with formation pharmacological of active hydroxylated derivatives which suppress growth of anaerobic microorganisms and can strengthen action of Tinidazolum. An elimination half-life (T1/2) - 12-14 h. It is removed with bile - 50%, kidneys - 25% in not changed look and 12% in the form of metabolites. Is exposed to the return absorption in renal tubules.

Indications to use:

- trichomoniasis, lambliasis, amebiasis (including hepatic form and amoebic dysentery);

acute ulocace, nonspecific vaginitis, skin leushmaniosis;

- the infections of various localization caused by anaerobic bacteria: peritonitis, abscess, endometritis, pyosalpinx; sepsis, wound fevers (including prevention of postoperative mephitic gangrenes), infections of skin and soft tissues, pneumonia, empyema, abscess of lungs;

- the mixed aerobic-anaerobic infections (in a combination with antibiotics);

- Helicobacter pylori eradikation (in a combination with drugs of bismuth and antibiotics).

Route of administration and doses:

Inside, in time or right after food. At a lambliasis the adult appoint 2 g once; to children - 50-75 mg/kg of body weight (no more than 2 g). At inefficiency (presence of lyambliya at contents of a 12-perstny gut or at excrements in 7-10 days after the end of therapy), treatment is repeated in the same dose. Treatment at the same time of all family members is recommended. At urogenital trichomoniasis adult appoint 2 g once. To children - 50-75 mg/kg of body weight; if necessary perhaps repeated appointment in the same dose. Intestines amebiasis: adult - 2 g/days in 1 reception within 2-3 days. Children - 50-60 mg/kg once a day, within 3 days. Liver amebiasis: adult - 1,5-2 g/days in 1 reception within 3 days; if necessary treatment is continued by the same doses up to 5-6 days. To children - on 50-60 mg/kg of 1 times a day within 5 days. An acute ulocace - 2 g once. At a nonspecific vaginitis - 2 g, once, or on 2 g are consecutive within 2 days. At mephitic gangrenes (Bacteroides, Fusobacterium, Clostridium spp.) course of treatment - 5-6 days; in the first day of treatment - 2 g/days, then on 1 g once a day or on 0,5 g 2 times a day. For prevention of postoperative mephitic gangrenes appoint 2 g for 12 h before operation.

Features of use:

At treatment of genital trichomoniasis it is necessary to carry out simultaneous treatment of sexual partners. In the course of treatment it is necessary to abstain from alcohol intake (a possibility of development of disulfiramopodobny reactions). Causes dark coloring of urine. At appointment more than 6 days control of a picture of peripheral blood is necessary. Safety and efficiency of use for treatment and prevention of mephitic gangrenes at children are younger than 12 years are not established. During treatment it is necessary to be careful during the driving of motor transport and occupation other types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: a loss of appetite, dryness of a mucous membrane of an oral cavity, "metal" smack in a mouth, nausea, vomiting, diarrhea. From a nervous system: a headache, dizziness, increased fatigue, lacks of coordination of movements (including a locomotory ataxy), a dysarthtia, a peripheral neuropathy, it is rare - spasms, weakness. Allergic reactions: urticaria, skin itch, skin rash, Quincke's disease. Other: tranzitorny leukopenia.

Interaction with other medicines:

Strengthens effect of indirect anticoagulants (for reduction of risk of development of bleedings the dose is reduced by 50%) and effect of ethanol (disulfiramopodobny reactions). Let's combine with streptocides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins). It is not recommended to appoint with Etioniamidum. Phenobarbital accelerates metabolism.

Contraindications:

Hypersensitivity to drug components, organic diseases of the central nervous system (CNS), oppression of a marrowy blood formation, pregnancy (the I trimester), the period of a lactation (breastfeeding), children's age (up to 12 years).

Overdose:

Treatment: symptomatic. There is no specific antidote. It is removed at dialysis.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 500 mg. On 4 tablets in a blister strip packaging. On 1 blister strip packaging together with the application instruction in a pack cardboard.