Tagera (Tablets) Instructions for Use

Marketing Authorization Holder

Unichem Laboratories, Ltd. (India)

ATC Code

P01AB07 (Secnidazole)

Active Substance

Secnidazole (Rec.INN registered by WHO)

Dosage Form

Tagera

Film-coated tablets, 1 g: 20 pcs.

Dosage Form, Packaging, and Composition

2 pcs. – blister packs (10) – cardboard packs.
2 pcs. – blister packs (1) – cardboard packs (10) – cardboard boxes.

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent

Pharmacological Action

Antimicrobial and antiprotozoal agent, a synthetic derivative of nitroimidazole.

Active against obligate anaerobic bacteria (spore-forming and non-spore-forming), causative agents of some protozoal infections: Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica.

Not active against aerobic bacteria.

Increases tumor sensitivity to radiation, causes sensitization to ethanol (disulfiram-like effect). Interacts with DNA, causes disruption of the helical structure, strand breakage, suppression of nucleic acid synthesis, and cell death.

Pharmacokinetics

After oral administration, Secnidazole is rapidly absorbed from the gastrointestinal tract, bioavailability is 80%. Metabolized in the liver. C_max after a single oral dose of 2 g is achieved after 4 hours. T_1/2 of secnidazole from blood plasma is about 25 hours. Slowly eliminated from the body, mainly with urine: about 50% of the administered dose is excreted within 120 hours. Excreted in breast milk, penetrates the blood-brain barrier and placental barrier.

Indications

Trichomonal urethritis and vaginitis, intestinal amebiasis, hepatic amebiasis, giardiasis.

ICD codes

Dosage Regimen

Administer orally. The dose and duration are determined by the specific indication and patient factors.

For trichomoniasis, take a single 2 g dose (two 1 g tablets). Treat sexual partners simultaneously.

For intestinal amebiasis, take 2 g once daily for 3 days.

For giardiasis, take a single 2 g dose (two 1 g tablets).

For hepatic amebiasis, take 1.5 g once daily for 5 days. Combine with drainage procedures for abscesses.

Adjust dose in patients with severe hepatic impairment. Do not use in children under 12 years of age with this formulation.

Take tablets with food to minimize gastrointestinal upset. Complete the full prescribed course.

Avoid alcohol consumption during treatment and for at least 5 days after the last dose due to a disulfiram-like reaction.

Adverse Reactions

Allergic reactions: urticaria, rash, angioedema, very rarely – anaphylactic reactions.

From the hematopoietic system: moderate reversible leukopenia.

From the nervous system: dizziness, ataxia, paresthesia, peripheral neuropathy.

From the digestive system: nausea, vomiting, stomach pain, metallic taste in the mouth, glossitis, stomatitis.

Other: fever.

Contraindications

Hypersensitivity to imidazole derivatives; organic diseases of the central nervous system, pathological changes in the peripheral blood picture (including in the anamnesis), pregnancy, lactation period (breastfeeding); childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Secnidazole is contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Penetrates the placental barrier. Clinical data on safety during pregnancy are not available. Experimental studies have not revealed a teratogenic effect of secnidazole.

Secnidazole is excreted in breast milk, therefore, if it is necessary to use it during lactation, breastfeeding should be discontinued.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the secnidazole drug leaflets regarding contraindications for the use of specific secnidazole dosage forms in children of different ages.

Special Precautions

In hepatic amebiasis in the suppuration phase, secnidazole administration should be combined with drainage removal of pus or removal of abscesses.

When used concomitantly with indirect anticoagulants, it is necessary to determine prothrombin time more frequently and monitor INR, adjusting the anticoagulant dose if necessary throughout the course of secnidazole therapy and for 8 days after its completion.

During secnidazole therapy and for 5 days after its completion, it is necessary to refrain from consuming alcoholic beverages and medications containing alcohol.

When treating trichomonal vaginitis in women and trichomonal urethritis in men, patients should refrain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment is not interrupted during menstruation.

Long-term treatment with secnidazole is recommended to be carried out under the control of the blood count. In case of leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process. The appearance of ataxia, dizziness, and any other deterioration in the neurological status of patients requires discontinuation of secnidazole treatment.

Effect on the ability to drive vehicles and mechanisms

During the use of secnidazole, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use of secnidazole with anticoagulants (coumarin or indandione derivatives), the effect of the latter may be enhanced, so prothrombin time should be periodically monitored and the doses of anticoagulants should be adjusted if necessary.

With simultaneous use of secnidazole with disulfiram, the development of paranoid reactions and psychosis is possible; with ethanol – the development of effects similar to the action of disulfiram (abdominal cramps, nausea, vomiting, headache, sudden flushing of the face) is possible.

Combination with non-depolarizing muscle relaxants (vecuronium bromide) is not recommended.

When taken simultaneously with lithium preparations, Secnidazole increases its plasma concentration.

In combination with amoxicillin, activity against Helicobacter pylori increases (amoxicillin suppresses the development of resistance).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.