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Composition:


active ingredient: tinidazole;


1 tablet contains tinidazole 500 mg;


excipients: lactose monohydrate, corn starch, microcrystalline cellulose, colloidal anhydrous Silicon Dioxide, Magnesium Stearate, crospovidone;


methacrylate copolymer (type a), titanium dioxide (e 171), talc, macrogol 6000, polysorbate 80.


Dosage form. Film-coated tablets.


Basic physical and chemical properties: round, biconvex coated tablets, white or almost white in color.


Pharmacotherapeutic group. Antimicrobial agents for systemic use. Imidazole derivatives. ATX code J01X D02.


Pharmacological properties.


Pharmacodynamics.


Synthetic drug of the imidazole group, active against protozoal microorganisms and obligate anaerobic bacteria. Causes intracellular reduction of specific metabolism of anaerobic microorganisms. It affects the structure of microbial cell DNA, causing its destruction or inhibition of synthesis.


The spectrum of action of the drug extends to Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. It is also active against Helicobacter pylori, Gardnerella vaginalis and most obligate anaerobic bacteria, including Bacteriodes fragilis, Bacteriodes melaninogenicus, Bacteriodes spp., Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp. and Veillonella spp.


Helicobacter pylori (H. pylori) is associated with the occurrence of peptic acid diseases of the digestive tract, including duodenal ulcer and gastric ulcer, in which about 95% and 80% of patients are infected with this microorganism, respectively. H. pylori is also a major factor in the development of gastritis and recurrent ulcers in such patients. Experience shows that there is a causal relationship between H. pylori and gastric carcinoma.


Clinical data indicate that 91-96% of H isolates are eradicated when using a combination of tinidazole, omeprazole and clarithromycin. pylori.


Different modes of H eradication. pylori has been shown to eradicate H. pylori leads to healing of duodenal ulcers and reduces the risk of ulcer recurrence.


Pharmacokinetics.


After oral administration, the product is rapidly absorbed from the digestive tract. Maximum serum concentrations are detected after approximately 2 hours and maintained for 12 hours. Almost 12% of the drug binds to plasma proteins. It is distributed in tissues in therapeutic concentrations. Penetrates into breast milk and through the blood-brain barrier. It is excreted mainly in the urine and in a smaller amount — in the feces (almost 25% in an unchanged state, and 12 % — in the form of metabolites).


Clinical characteristics.


Indications.


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


Treatment. Eradication of Helicobacter pylori associated with duodenal ulcers — together with an antibiotic and a drug that inhibits acid production.


Anaerobic infections: intraperitoneal infections (peritonitis, abscess); gynecological infections (endometritis, endomyometritis, Tubo-ovarian abscess); bacterial septicemia; postoperative wound infections; skin and soft tissue infections; upper and lower respiratory tract infections (pneumonia, empyema, lung abscess). Non-specific vaginitis. Acute ulcerative gingivitis. Urogenital trichomoniasis in men and women. Giardiasis. Intestinal amoebiasis. Amoebic liver damage.


Contraindications.


* Hypersensitivity to tinidazole, other derivatives of 5‑nitroimidazole or any auxiliary component of the drug.


* Organic lesions of the nervous system.


* Severe hepatic impairment.


* Blood diseases, including in the Anamnesis (although persistent hematological disorders have not been observed during clinical or animal studies).


* First trimester of pregnancy and lactation (see "use during pregnancy or lactation").


Interactions with other drugs and other types of interactions.


Anticoagulants.


Drugs with a similar chemical structure potentiate the effects of oral anticoagulants. Prothrombin time should be checked frequently and, if necessary, the anticoagulant dose should be adjusted.


Alcohol.


Concomitant use of tinidazole with alcohol or with drugs containing alcohol may lead to a disulfiram-like reaction, so this combination should be avoided.


Application features.


Drugs with a chemical structure similar to that of tinidazole can lead to neurological reactions such as confusion, dizziness, lack of coordination, and ataxia. If such reactions develop, treatment with the drug should be discontinued and a doctor should be consulted. Use in organic neurological and hematological diseases is possible only after a thorough assessment by the doctor of the benefits and risks of treatment.


As with other similar medications, you should not take alcoholic beverages during the use of Tinidazole-Teva due to the possible development of a disulfiram-like reaction (redness of the face, abdominal cramps, colic, vomiting, tachycardia). Do not take alcohol within 72 hours of stopping taking Tinidazole-Teva.


Treatment of trichomoniasis should be carried out simultaneously in both partners.


The drug contains lactose. Patients with rare hereditary galactose intolerance, Lappa lactase deficiency, or glucose-galactose malabsorption should not take this medication.


Use during pregnancy or lactation.

Pregnancy.


Tinidazole penetrates the placental barrier. Since the effect of drugs in this class on fetal development is unknown, the use of tinidazole during the first trimester of pregnancy is contraindicated. There is no evidence that tinidazole has harmful effects during the last periods of pregnancy, but its use in the second and third trimester of pregnancy requires an assessment of the potential benefits and possible risks to the mother and fetus.


Breast-feeding.


Tinidazole passes into breast milk. It can be detected in breast milk more than 72 hours after application. Breast-feeding should be stopped for the duration of treatment and not resumed earlier than 3 days later.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


In rare cases, neurological symptoms such as dizziness, impaired coordination, ataxia, peripheral neuropathy, or seizures may occur, which may affect the ability to drive vehicles and work with machinery.


Dosage and administration.


Tinidazole-Teva is administered orally during or after a meal, washed down with water.


The tablet should be swallowed whole. The scheme of use of Tinidazole-Teva depends on the indications.


Eradication Of H. pylori associated with duodenal and gastric ulcers (as part of complex therapy with an antibiotic and a drug that suppresses acid production).


Adults.


The usual dose is 500 mg (1 tablet) 2 times a day together with omeprazole at a dose of 20 mg 2 times a day and clarithromycin at a dose of 250 mg 2 times a day for 7 days. Clinical studies using this 7-day regimen have demonstrated levels of H eradication. pylori are similar to those when using omeprazole 1 time a day.


Anaerobic infections


Adults and children over 12 years of age. The initial dose is 2 g on the first day, followed by the use of 1 g 1 time a day or 500 mg 2 times a day for 5-6 days. If it is necessary to continue therapy for more than 7 days, it is recommended to conduct a standard clinical and laboratory examination.


Children under 12 years of age – do not use.


Non-specific vaginitis


Adults. With non-specific vaginitis, it is optimal to take 2 g of the drug once inside. For more persistent infections, you can take 2 g for two consecutive days (a total dose of 4 g).


Acute ulcerative gingivitis


Adults. The recommended dose is 2 g orally, once.


Urogenital trichomoniasis (if Trichomonas vaginalis infection is confirmed, simultaneous treatment of the partner is recommended).


Adults. The recommended dose is 2 g orally, once.


Children over 3 years old. The recommended dose is 50-75 mg/kg of body weight once. If necessary, the drug can be repeated in the same dose.


Giardiasis


Adults. The recommended dose is 2 g orally, once.


Children over 3 years old. The recommended dose is 50-75 mg/kg of body weight once. If necessary, the drug can be repeated in the same dose.


Intestinal amoebiasis


Adults. The Daily Dose is 2 g once, for 2-3 days.


Children over 3 years old. The Daily Dose is 50-60 mg/kg of body weight once, for 3 consecutive days.


Amoebic liver damage


Adults. The total dose varies from 4.5 to 12 g, depending on the virulence of the pathogen Entamoeba histolytica. Treatment begins with a dose of 1.5–2 g 1 time a day for three days. In the absence of the effectiveness of a three-day course of treatment, the drug can be continued for up to 6 days.


Children over 3 years old. 50-60 mg/kg of body weight 1 time a day for 5 consecutive days.


Use in patients with impaired renal function.


There is usually no need to adjust the dose in patients with impaired renal function. However, since tinidazole is easily eliminated during hemodialysis, it may be necessary to take an additional dose of the drug.


Prevention of postoperative infections


Adults and children over 12 years of age. The dose is 2 g once inside, approximately 12 hours before surgery.


Children under 12 years of age – do not use for preventive purposes for children under 12 years of age.


Elderly patients.


There are no specific recommendations for patients in this group.


Children.


Tinidazole-Teva is recommended for use in children over 3 years of age in accordance with approved indications, as indicated in the section "dosage and administration".


Overdose.


Symptoms.


After taking a high dose of Tinidazole-Teva, agitation, headache, and tachycardia are observed. In severe cases, shock, hypotension, and dyspnoea are possible.


Treatment.


In case of overdose, you should flush the stomach and conduct symptomatic therapy (antihistamines, glucocorticoids), take general resuscitation measures if necessary.


There is no specific antidote. Tinidazole is easily eliminated from the body during hemodialysis.


Adverse reactions.


Adverse reactions that were reported, as a rule, occurred infrequently, had mild manifestations and passed on their own. Such reactions may occur.


Violation of the general condition.


Infrequent: fever, fatigue, hyperemia of the skin.


Liquid: allergic reactions.


Disorders of the circulatory and lymphatic systems.


Rare: transient leukopenia.


Disorders of the gastrointestinal tract.


Frequent: nausea, vomiting, anorexia, abdominal pain, metallic taste in the mouth.


Infrequent: vomiting, diarrhea, plaque on the tongue.


Liquid: glossitis, stomatitis.


Disorders of the kidneys and urinary tract.


Liquid: dark color of urine.


Disorders of the nervous system.


Infrequent: vertigo (systemic vertigo), headache.


Rare: ataxia, convulsions, non-systemic dizziness, hypesthesia, paresthesia, peripheral neuropathy, sensitivity disorders.


Disorders of the skin and subcutaneous tissue.


Rare: hypersensitivity reactions, sometimes severe, including skin rash, pruritus, urticaria, dermatitis, angioedema.

Tags: Tinidazole