Secnidazole (Microgranules) Instructions for Use

ATC Code

P01AB07 (Secnidazole)

Active Substance

Secnidazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent

Pharmacological Action

An 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.

It increases tumor sensitivity to radiation, causes sensitization to ethanol (disulfiram-like effect). It 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%.

It is metabolized in the liver. C_max after a single oral dose of 2 g is achieved in 4 hours. T_1/2 of secnidazole from blood plasma is about 25 hours.

It is slowly eliminated from the body, mainly with urine: about 50% of the administered dose is excreted within 120 hours. It is excreted in breast milk, penetrates the blood-brain barrier and the placental barrier.

Indications

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

ICD codes

Dosage Regimen

Administer orally. The dose, regimen, and duration of therapy are determined individually based on the indication, clinical situation, patient age, and the specific dosage form used.

For trichomoniasis, administer a single dose of 2 g (2000 mg). Simultaneously treat sexual partners.

For intestinal amebiasis, administer 2 g (2000 mg) once daily for 3 days.

For hepatic amebiasis, administer 1.5 g (1500 mg) once daily for 5 days. In the suppuration phase, combine with drainage or surgical removal of abscesses.

For giardiasis, administer a single dose of 2 g (2000 mg) for adults. For children, calculate the dose based on 30 mg per kg of body weight as a single dose.

For the microgranule formulation, sprinkle the entire contents of the sachet onto a small amount of soft food (e.g., yogurt, applesauce, pudding). Consume the entire mixture immediately without chewing or crushing the microgranules. Do not store the mixture for later use.

Take the dose during or after a meal to minimize gastrointestinal discomfort.

Complete the full prescribed course of therapy. Do not interrupt treatment during menstruation when treating trichomoniasis.

Adjust the dosage in patients with severe hepatic impairment under strict medical supervision. No specific dosage adjustment is required for renal impairment.

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 (breastfeeding) period; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

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

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

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

Pediatric Use

Use in children is possible according to indications, in doses and dosage forms recommended for the respective age. 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 of pus or removal of abscesses.

When taken concomitantly with indirect anticoagulants, it is necessary to determine prothrombin time more frequently and monitor INR, adjusting the dose of the anticoagulant 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 trichomonas vaginitis in women and trichomonas urethritis in men, patients should refrain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment should not be 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 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 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 concomitantly 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.