Tinidazol-Teva (tinidazole) coated tablets 500 mg. №4

Description

Tinidazol-Teva (tinidazole) coated tablets 500 mg. №4

Composition

active substance: tinidazole;

1 tablet contains tinidazole 500 mg;

Excipients: lactose monohydrate, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, crospovidone;

methacrylate copolymer (type A), titanium dioxide (E 171), talc, macrogol 6000, polysorbate 80.

Dosage form

Film-coated tablets.

Main physical and chemical properties: round, biconvex, coated tablets, white or almost white.

Pharmacotherapeutic group

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

Pharmacological properties

The drug Tinidazole acts against bacteria and protozoa that have a negative effect on the body. It has the properties of eliminating these bacteria and microorganisms due to penetration into the structure of DNA and destroying it from the inside.
It also fights against Trichomonas and anaerobes.
The effect of taking the drug is already noticeable after 2 hours of ingestion. It is well absorbed by the digestive system, penetrates into various body systems, including through the placenta and into breast milk.
It is excreted completely from the body within 10-12 hours.

Indications

Tinidazol-Teva is taken when:

• trichomonasis (in this case, both sexual partners must undergo treatment),
• giardiasis,
• hepatic and amoebic dysentery,
• infections of various etymology and localization (peritonitis, endometritis, sepsis, wounds),
• pulmonary diseases (abscesses, pneumonia, empyema),
• infectious lesions of soft tissues and skin,
• prevention of infectious lesions in the postoperative period,
• acute forms of vaginitis, gingivitis, leishmaniasis.

With a long-term course of drug treatment (more than a week), blood monitoring is required.
When undergoing a course of treatment with the drug, it is prohibited to consume alcohol throughout the course and for three days after.

Contraindications

Hypersensitivity to the drug or its constituents, diseases of the central nervous system, age up to 12 years.
Drinking alcohol and engaging in activities that require increased attention and a good response.
During treatment, the urine darkens.

Application during pregnancy and lactation

The first trimester of pregnancy and lactation is a contraindication to the use of tinidazole.
It is conditionally forbidden to take the drug throughout pregnancy – it is prescribed only in extreme cases, when there is a real threat to the mother’s life.
After childbirth, you can take the drug if the woman is not breastfeeding, since the substance passes into breast milk and remains there for 72 hours.
Otherwise, breastfeeding will have to be interrupted.

Method of application and dosage

Tinidazol-Teva is administered orally during or after a meal with water.

The tablet should be swallowed whole. The schedule of Tinidazol-Teva depends on the indications.

• Eradication of H. pylori associated with duodenal and gastric ulcers (as part of combination therapy with antibiotics and drugs that inhibit acid production).
  Adults.The usual dose is 500 mg (1 tablet) twice daily with omeprazole 20 mg twice daily and clarithromycin 250 mg twice daily for 7 days. Clinical trials using this 7-day regimen have shown levels of H. pylori eradication similar to those of omeprazole once daily.
• Anaerobic infections
  Adults and children from 12 years old. The initial dose is 2 g on the first day, followed by 1 g once a day or 500 mg twice 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 – do not use.
• Nonspecific vaginitis
  Adults. In nonspecific vaginitis, it is optimal to take 2 g of the drug once orally. For more persistent infections, you can take 2 g for two consecutive days (total dose 4 g).
• Acute ulcerative gingivitis
  Adults. The recommended dose is 2 g orally, once.
• Urogenital trichomoniasis (if Trichomonas vaginalis infection is confirmed, concomitant treatment with a partner is recommended).
  Adults. The recommended dose is 2 g orally, once.
  Children from 3 years old. The recommended dose is 50-75 mg / kg 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 from 3 years old. The recommended dose is 50-75 mg / kg body weight once. If necessary, the drug can be repeated in the same dose.
• Intestinal amoebiasis
  Adults. The daily dose is 2 g at a time, for 2-3 days.
  Children from 3 years old. The daily dose is 50-60 mg / kg of body weight once for 3 consecutive days.
• Amoebic liver disease
  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 per day for three days. If the three-day course of treatment is not effective, the drug can be continued for up to 6 days.
  Children from 3 years old. 50–60 mg / kg body weight once daily for 5 consecutive days.
• Prevention of postoperative infections
  Adults and children from 12 years old. The dose is 2 g once orally, approximately 12 hours before surgery.
  Children under 12 years of age – not used for prophylactic purposes in children under 12 years of age.

Children

Tinidazol-Teva is recommended for use in children over 3 years of age in accordance with approved indications, as described in this section.

Overdose

Overdose cases are not described.

Side effects

Usually, when taking tinidazole, headache, dizziness, fatigue, weakness, impaired coordination of the musculoskeletal system, less often – convulsions appear.
Allergic rashes and other effects such as itching, urticaria, edema are possible.
The digestive tract reacts with nausea, decreased appetite, dry mouth, vomiting, and upset.
Transient leukopenia is possible.