The description

The coated tablets are white or almost white, round, biconvex.

Pharmacotherapeutic group

Antiprotozoal agents. Nitroimidazole derivatives.

Pharmacological properties

Tinidazole has an antiprotozoal and antibacterial effect.

The antiprotozoal and antibacterial mechanism of action of tinidazole is based on the penetration of the drug into the cells of the microorganism and damage to the structure of DNA or the inhibition of its synthesis.

Directions for use

Treatment for the following infections:

Infections caused by anaerobic bacteria, such as:

intraperitoneal infections: inflammation of the peritoneum, abscess gynecological infections: endometritis, endomyometritis, tubo-ovarian abscess
bacteraemia
postoperative wound infections
skin and soft tissue infections
respiratory infections: pneumonia, empyema, lung abscess.
Non-specific vaginitis.
Acute ulcerative gingivitis.
Genitourinary trichomoniasis in men and women.
Hyardiosis (giardiasis).
Intestinal amebiasis.
Amoebic liver abscess.
Eradication of Helicobacter pylori in cases of duodenal ulcer and stomach ulcer using antibiotic therapy and therapy aimed at lowering acidity.

Prevention:

Prevention of postoperative infections caused by anaerobic bacteria, in particular in the case of operations on the colon, stomach, intestines, as well as gynecological operations.

Cons-indications

Do not take Tinidazole:

in patients with neurological diseases;
in patients allergic (hypersensitivity) to tinidazole, 5-nitroimidazole derivatives or to any of the excipients;
whether, at present or in the past, changes in the blood picture have been noted;
in the first trimester of pregnancy;
during lactation.

Precautions for use

Special precautions should be taken when taking the drug Tinidazole If the patient drinks alcohol.

During treatment with tinidazole, you should not drink alcoholic beverages, as disulfiram-like reactions may develop (symptoms: abdominal pain, vomiting, heart palpitations, flushing). Do not take alcohol for 72 hours after stopping tinidazole.

If neurological disorders such as dizziness, ataxia (impaired coordination), peripheral neuropathy (for example, decreased sensitivity and muscle strength, muscle atrophy) occur during treatment with tinidazole, stop treatment with tinidazole and seek medical advice immediately. Carcinogenicity has been observed in mice and rats that have received metronidazole and other nitroimidazole derivatives for a long time. Although there is no evidence of carcinogenicity for tinidazole, the comparability of the structure of these two drugs indicates a potential risk for similar biological effects.

For tinidazole, mixed results regarding mutagenicity (both positive and negative) have been obtained. Therefore, longer consumption of tinidazole than the recommended dose should be prescribed with great care.

Use during pregnancy and lactation

Before using any medication, you should consult your doctor.

The pregnancy

Tinidazole is contraindicated in the first trimester of pregnancy. From 4 to 9 months of pregnancy, the drug can be taken only in cases where, according to the doctor, it is absolutely necessary.

Lactation

During the use of the drug and at least 3 days after stopping treatment should not be breastfed.

Influence on the ability to drive and maintain mechanisms

There is no information indicating a contraindication to driving vehicles and maintaining machines when using tinidazole. However, some patients have observed side effects, such as dizziness, impaired coordination, cramps, or altered sensation in the limbs, which may affect psychophysical performance. When such side effects appear, it is impossible to drive a vehicle and maintain working mechanisms.

Interaction with other drugs and other types of interaction

It is necessary to inform the doctor of all recently taken medications, even those that are dispensed without a prescription.

Tell your doctor:

alcohol consumption (disulfiram-type reactions are possible);
on the use of anticoagulants (medicines that inhibit the blood clotting process, used for thromboembolic diseases).

Dosage and administration

Tinidazole should always be used as directed by your doctor. If in doubt, consult a doctor.

The medication should be taken orally, during or after a meal.

Usually take the following dose of the drug:

Infections caused by anaerobic bacteria -
Adults: the first day, 2 g (4 tablets of 500 mg) in a single dose, then 1 g (2 tablets of 500 mg) per day in a single dose or in 2 divided doses. The duration of treatment is usually 5 to 6 days, but some patients may require longer treatment. If treatment is indicated for more than 7 days, the doctor prescribes regular examinations, including blood tests.

Children under 12: dosage not established.
Non-specific vaginitis -
Adults: 2 g tinidazole (4 tablets of 500 mg) once. Significant efficacy of the treatment was observed after taking 2 g of tinidazole (4 tablets of 500 mg) per day in a single dose for 2 days (total therapeutic dose: 4 g).
Acute ulcerative gingivitis -
Adults: 2 g tinidazole (4 tablets of 500 mg) once.
trichomoniasis -
When the infection is confirmed, simultaneous treatment of both sexual partners is indicated.

Adults: 2 g tinidazole (4 tablets of 500 mg) once.

Children: 50 to 75 mg / kg bodyweight once. If necessary, the dose can be repeated.
Hyardiose -
Adults: 2 g tinidazole (4 tablets of 500 mg) once.

Children: 50 to 75 mg / kg bodyweight once. If necessary, the dose can be repeated.
Intestinal amebiasis -
Adults: 2 g tinidazole (4 tablets of 500 mg) per day in a single dose for 2 or 3 consecutive days. If necessary, the doctor can extend the treatment to 6 days.

Children: 50 to 60 mg / kg body weight per day in a single dose for 3 consecutive days.
Amoebic liver abscess -
Adults: depending on the severity of the infection, 4.5 to 12 g of tinidazole for the duration of treatment. In some patients, an abscess may be indicated, regardless of treatment with tinidazole.

The treatment begins with 1.5 to 2 g per day, in a single dose, for 3 days. If necessary, the doctor can extend the treatment to 6 days.

Children: 50 to 60 mg / kg body weight per day in a single dose for 5 consecutive days.
Helicobacter pylori eradication for peptic ulcer and duodenal ulcer -
Adults: tinidazole is taken at a dose of 500 mg twice a day for 7 days in combination with another antibacterial drug and omeprazole (which reduces the acidity of gastric juice). The following dosing regimen is recommended: tinidazole 500 mg twice daily, clarithromycin 250 mg twice daily and omeprazole 20 mg twice daily for 7 days.

In clinical studies, a comparable rate of eradication of H. pylori has been demonstrated with 20 mg of omeprazole once daily for 7 days.

More detailed information on the dosing schedule for omeprazole can be found in the instructions for use of omeprazole.
Prevention of postoperative infections -
Adults: 2 g tinidazole (4 tablets of 500 mg) once approximately 12 hours before surgery.

Children under 12: dosage not established.

Elderly patients: there are no specific dosage instructions.
Patients with renal dysfunction -
In most cases, the method of administration and the dose remain unchanged. Tinidazole is removed from the blood during dialysis, so patients after dialysis, the doctor may prescribe an additional dose of tinidazole.
Use in elderly patients -
There are no specific recommendations for this group of patients. If during treatment the patient seems that the effect of the drug is too strong or weak, he should consult a doctor.
Skip the dose of the drug -
If you miss a dose of the drug, you should take it as soon as possible. Do not take a double dose of medicine to make up for the missed dose.

Overdose

If the drug is taken at a dose higher than the recommended dose, you should immediately consult a doctor.

Side effects

Like all medicines, tinidazole can have side effects, although not everybody gets them.

When using tinidazole, side effects rarely occur, are characterized by low or moderate intensity, and most often spread by themselves.

The following definition of the frequency of occurrence of side effects is accepted: often (≥1 / 100 to <1/10); the frequency is unknown (cannot be determined from the available data).

Blood and lymphatic system disorders
Unknown frequency: transient leukopenia.
Immune system disorders
Unknown frequency: hypersensitivity to the drug.
Metabolic and nutritional disorders
Often: lack of appetite.
Nervous system disorders
Often: headache.
Unknown frequency: ataxia (impaired coordination), decreased tactile sensitivity, peripheral neuropathy, paraesthesia, hypesthesia, convulsions, sensory disturbances, impaired taste.
Hearing and labyrinthine disorders
Often: dizziness.
Vascular disorders
Unknown frequency: hot flashes.
Gastrointestinal disorders
Often: nausea, vomiting, diarrhea, abdominal pain.
Unknown frequency: coated tongue, glossitis, stomatitis, metallic taste in the mouth.
Skin and subcutaneous tissue disorders
Often: itching, rash.
Unknown frequency: hives, angioedema.
Violations of the kidneys and urinary tract
Unknown frequency: dark coloration of urine, urogenital candidiasis.
General and injection site disorders
Unknown frequency: fever, feeling tired.

In case of any of the above phenomena or other undesirable phenomena not listed in this instruction, you should inform your doctor or pharmacist.

Storage conditions

Do not store above 77 ° F. Store in the original package to protect from moisture and light.

Medicines should not be disposed of down the drain or thrown into the trash. You should ask the pharmacist what to do with unused medication. It is necessary to protect the environment.

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