Fazizhin

General characteristics. Structure:

Active ingredient: tinidazole; 1 tablet contains 500 mg of Tinidazolum;

excipients: magnesium stearate, starch corn, cellulose microcrystallic, sodium lauryl sulfate, acid of an alginiyev, gidroksipropilmetiltsellyuloz, propylene glycol, titanium dioxide (E 171).

Main physical and chemical properties: round biconvex tablets, film coated, white color, with a diameter about 12,7 mm and about 4,7 mm thick, with an engraving of "FAS 500" on the one hand.

Pharmacological properties:

Фазижин® it is active as against protozoa, and obligate anaerobic bacteria. Activity against simple appears concerning Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia.

The way of effect of drug фазижин against anaerobic bacteria and protozoa is shown by penetration of drug into a cell of a microorganism and the subsequent damage of DNA threads or ingibitsiy their synthesis.

Фазижин® Bacteroides fragilis, Bacteroides and Veillonella SPP is active against Helicobacter pylori, Gardnerella vaginalis and the majority of anaerobic bacteria, in particular.

Helicobacter pylori (H. Pylori) is connected with developing of peptic acid diseases of a digestive tract, including an ulcer of a duodenum and stomach ulcer at which about 95% and 80% of patients are respectively infected with this microorganism. H. pylori is also the main factor in development of gastritis and a recurrence of ulcers in such patients. Experience shows that there is a causal relationship between H. pylori and a carcinoma of a stomach.

Clinical data show that at use of a combination of the drug Fazizhin® and an omeprazol and klaritromitsin to eradikuyetsya by 91-96% of H. pylori isolates.

Various modes of an eradikation H. pylori showed that the eradikation of H. pylori leads to healing of duodenal ulcers and reduces risk of a recurrence of ulcers.

Pharmacokinetics. Фазижин® it is quickly and completely absorbed after oral administration. In researches with participation of healthy volunteers who received 2 g of Tinidazolum inside peak levels in blood serum which made 40-51 mkg/ml, were reached within two hours, and for 24 hours level decreased to 11-19 mkg/ml. At the healthy volunteers receiving 800 mg and 1,6 g of Tinidazolum intravenously in 10-15 minutes the maximum concentration in a blood plasma made 14-21 mkg/ml for a dose of 800 mg and 32 mkg/ml for a dose of 1,6 g. In 24 hours after performing infusion Tinidazolum level in a blood plasma decreased to 4-5 mkg/ml and 8,6 mkg/ml, respectively, that proves dosing of 1 times a day. Plasma level decreased slowly, and Tinidazolum can be defined in a blood plasma in concentration to 1 mkg/ml in 72 hours after intake. Tinidazolum elimination half-life makes 12-14 hours of a blood plasma.

Tinidazolum is widely distributed on all body tissues, and also gets through a blood-brain barrier, reaching clinically effective concentration in all fabrics. The obvious volume of distribution makes about 50 liters. About 12% from Tinidazolum of a blood plasma are connected with proteins.

Tinidazolum is removed by a liver and kidneys. The research with participation of healthy volunteers was shown that in 5 days of 60-65% of the accepted dose is removed by kidneys, and 20-25% of a dose are removed in not changed type of Tinidazolum. To 5% of the accepted dose it is allocated with a stake.

Research at patients with a renal failure (the clearance of creatinine <22 ml/min.) is pointed that these patients have no statistically significant changes in Tinidazolum pharmacokinetics indicators.

Indications to use:

Prevention of the postoperative infections caused by anaerobic bacteria, especially after a large intestine, digestive tract operations and after gynecologic operations.

Treatment.

Eradikation Helicobacter pylori associated with duodenum ulcers together with an antibiotic and drug, suppresses products of acid.

Mephitic gangrenes: intraperitoneal infection (peritonitis, abscess); gynecologic infections (endometritis, endomyometritis, tubo-ovarian abscess); bacterial septicaemia; postoperative infections of wounds; infections of skin and soft tissues; infections of upper and lower respiratory tracts (pneumonia, empyema, abscess of lungs). Nonspecific vaginitis. Acute ulocace. Urogenital trichomoniasis at men and women. Lambliasis. Intestinal amebiasis. Amoebic damages of a liver.

Route of administration and doses:

Fazizhin ® accept inside during meal or after food.

Eradikation of H. pylori associated with duodenum ulcers

Adults. A usual dose of Fazizhin® - 500 mg 2 times a day together with omeprazoly in a dose of 20 mg 2 times a day and klaritromitsiny in a dose of 250 mg 2 times a day within 7 days. Clinical trials using such 7-day mode showed similar levels of an eradikation H. pylori when омепразол it was applied once a day.

Mephitic gangrenes

Adults and children are more senior than 12 years. An initial dose - 2 g in the first day with the subsequent use on 1 g of 1 times a day or on 500 mg two times a day. Use of drug within 5-6 days, as a rule, will be enough, but determination of duration of treatment has to depend on a clinical state, especially when the eradikation of a contagium of a certain localization can be heavy. If necessary to continue therapy within more than 7 days it is recommended to conduct standard clinical and laboratory examination.

Children up to 12 years - do not apply.

Nonspecific vaginitis

Adults. At a nonspecific vaginitis one-time reception of 2 g of drug was optimum. Efficiency of treatment increased at use of drug in a dose of 2 g of 1 times a day within two days (the general dose - 4 g).

Acute ulocace

Adults. The recommended dose - 2 g orally once.

Urogenital trichomoniasis (at confirmation of infection of Trichomonas vaginalis simultaneous treatment of the partner is recommended).

Adults. The recommended dose - 2 g orally once.

Children. The recommended dose makes 50-75 mg/kg of body weight once. Repetition of this dose can be required.

Lambliasis

Adults. The recommended dose - 2 g orally once.

Children. The recommended dose makes 50-75 mg/kg of body weight once. Repetition of this dose can be required.

Intestinal amebiasis

Adults. The daily dose makes 2 g once within 2-3 days.

Children. The daily dose makes 50-60 mg/kg of body weight once within 3 consecutive days.

Amoebic damages of a liver

Adults. The general dose - 4,5-12 g, depending on virulence of Entamoeba histolytica. At amoebic impression of a liver carrying out aspiration of pus in addition to drug Fazizhin® use can be required. Treatment begin in a dose 1,5-2 g of 1 times a day within three days. Sometimes, when the three-day course of treatment is inefficient, treatment can be continued up to 6 days.

Children. 50-60 mg/kg of body weight of 1 times a day within 5 days in a row.

Use at a renal failure. Patients have no need for dose adjustment with a renal failure. However, as Tinidazolum is easily removed when carrying out a hemodialysis, there can be a need for reception of an additional dose of drug.

Prevention of postoperative infections

Adults and children are more senior than 12 years. The dose makes 2 g once, approximately for 12:00 before performing surgery.

Children up to 12 years - it is not applied with the preventive purpose to children aged up to 12 years.

Use for patients of advanced age. also there are no special recommendations for this group of patients.

Features of use:

As with at use of other similar drugs, it is not necessary to take alcoholic beverages during use of drug for possible development of Disulfiramum-like reaction (rushes of blood to the person, spasms in a stomach, vomiting, tachycardia). It is not necessary to accept alcohol within 72 hours after the termination of administration of drug фазижин.

Drugs with similar to a chemical structure also cause various neurologic disturbances, such as dizziness, a lack of coordination, an ataxy. If during the period of use of drug there are signs of disturbances from a nervous system, treatment should be stopped.

Ability to influence speed of response at control of motor transport or work with other mechanisms

There is no need for special reservations. However drugs with similar chemical structure, including фазижин®, connected with emergence of such neurologic disturbances as dizziness, an ataxy, a peripheral neuropathy (paresthesias, sensitivity disturbances, a hypesthesia) and it is rare - spasms. If at use of the drug Fazizhin® there are any disturbances from a nervous system, drug should be cancelled.

Use during pregnancy or feeding by a breast

Use during pregnancy. In a fertility research at rats to whom entered Tinidazolum in a dose of 100 mg and 300 mg on kilogram of body weight influence on fertility, body weight of mature animals and posterity, gestation, viability or a lactation was not observed. Increase in frequency of spontaneous abortions at introduction of a dose of 300 mg/kg was observed insignificant.

Tinidazolum gets through a placental barrier. As influence of drugs of this class on fetalis development the unknown, use of Tinidazolum during the I trimester of pregnancy is contraindicated. There are no proofs that Fazizhin® makes harmful effects throughout the last periods of pregnancy, but it is necessary to consider potential advantage and possible harmful effects for mother and a fruit at use of drug during II and III trimesters of pregnancy.

Use during feeding by a breast. Tinidazolum is allocated in breast milk. Tinidazolum gets into breast milk within 72 hours after use. Women should not nurse within at least three days after the termination of administration of drug фазижин ®.

Children

Depending on indications, appoint to children 3 years are more senior or 12 years are more senior (see the Section "Route of Administration and Doses").

Side effects:

Side reactions about which it was reported, as a rule, arose infrequently, were lungs and took place independently.
From system of blood and lymphatic system: tranzitorny leukopenia.

From a nervous system: an ataxy, spasms (seldom), dizziness, a headache, a hypesthesia, paresthesias, a peripheral neuropathy, sensitivity disturbances, вертиго, metal smack in a mouth, rushes of blood.

From digestive tract: abdominal pain, anorexia, diarrhea, fur, glossitis, nausea, stomatitis, vomiting.

From skin and a hypodermic fatty tissue: hypersensitivity reactions, sometimes heavy, are observed seldom and shown in the form of rash on skin, an itch, urticaria and a Quincke's disease.

From kidneys and urinary tract: coloring of urine in dark color.

Disturbance of the general state and to bandages connected with a drug route of administration: fervescence, increased fatigue.

Interaction with other medicines:

Alcohol. Simultaneous use of Tinidazolum and alcohol can lead to Disulfiramum-like reaction therefore such combination should be avoided.

Anticoagulants. Drugs with similar chemical structure exponentiate effects of anticoagulants for oral administration. It is necessary to check often indicators of PV and, if necessary, to adjust an anticoagulant dose.

Contraindications:

Фазижин® patients should not appoint with the known hypersensitivity to Tinidazolum, other derivatives 5 nitroimidazoles or any auxiliary component of drug. Use of Tinidazolum is contraindicated during the I trimester of pregnancy and during feeding by a breast. Drug is contraindicated to patients with organic lesion of a nervous system.
As well as at use of other drugs having similar structure, Tinidazolum is contraindicated to patients with blood diseases (or with those in the anamnesis) though steady hematologic disturbances were not observed in clinical trials or researches on animals.

Not to apply this dosage form to children up to 3 years.

Overdose:

Overdose symptoms.
People have no messages on cases of overdose of the drug Fazizhin®.

Overdose treatment.

Is a specific antidote for treatment of overdose of Tinidazolum. Treatment - symptomatic and supporting. There can be effective a gastric lavage. Tinidazolum is easily removed during a hemodialysis.

Storage conditions:

Period of validity 2 years. To store at a temperature not above 25 °C in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

4 tablets, film coated, in the blister; on 1 blister in a cardboard box.