Seknidox tablets 1g, No. 2

• urethritis and vaginitis caused by Trichomonas vaginalis; intestinal amebiasis caused by Entamoeba histolytica;

• liver amebiasis caused by Entamoeba histolytica;

• giardiasis caused by Giardia lamblia.

The drug is taken orally, immediately before meals, with a small amount of water.

Urethritis and vaginitis

Adults - a single dose of 2 g of secnidazole (2 tablets), the course of treatment is 1 day. Simultaneous treatment of both sexual partners should be carried out.

Intestinal amoebiasis

Acute amebiasis with severe symptoms (histolytica form): for adults - a single dose of 2 g secnidazole (2 tablets), course of treatment 1 day; children - a single dose of 30 mg / kg, the course of treatment is 1 day. Amoebiasis without clinical symptoms, including focal and cystic forms (minuta and cystic): for adults - 2 g of secnidazole (2 tablets) in one or more doses for 3 days; children - 30 mg / kg / day in one or more doses for 3 days.

Liver amebiasis

Adults - 1.5 g of secnidazole (1.5 tab.) In one or more doses for 5 days; children - 30 mg / kg / day in one or more doses for 5 days. Giardiasis

Blue film-coated tablets, capsule-shaped, engraved with 'SECN' on one side and cross-scored on the other.

1 tab. secnidazole 1 g

Excipients: corn starch - 103.73 mg, microcrystalline cellulose - 62.25 mg, sodium carboxymethyl starch - 37.35 mg, calcium hydrogen phosphate - 32.25 mg, povidone K30 - 17.4 mg, magnesium stearate - 7.4 mg, talc - 4.5 mg.

• hypersensitivity to secnidazole, other imidazole derivatives or any other component of the drug;

• organic diseases of the central nervous system;

• blood diseases (including history);

• pregnancy;

• lactation period;

• children under 3 years of age or body weight less than 16 kg (for this dosage form).

pharmachologic effect

Secnidazole is a nitroimidazole derivative. It has bactericidal (against gram-positive and gram-negative anaerobic bacteria) and amoebicidal (intra- and extraintestinal) action. Secnidazole is especially active against Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. Penetrating into the cell of the microorganism, secnidazole is activated as a result of the reduction of the 5-nitro group, due to which it interacts with cellular DNA. There is a violation of its spiral structure and destruction of filaments, inhibition of nucleotide synthesis and cell death.

Pharmacokinetics

Absorption and distribution

After oral administration, secnidazole is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80%. After taking 2 g of secnidazole, Cmax in plasma is reached after 3-4 hours. Secnidazole penetrates the BBB and the placental barrier, and is excreted in breast milk. The elimination of T1 / 2 secnidazole from blood plasma is about 25 hours. The drug is slowly excreted from the body, mainly in the urine: about 50% of the dose taken is excreted in 120 hours.

Side effect

Allergic reactions: urticaria, rash, angioedema; very rarely - anaphylactic reaction. On the part of the blood and lymphatic system: moderate reversible leukopenia. From the nervous system: dizziness, impaired coordination of movements (ataxia), decreased skin sensitivity (paresthesia), peripheral neuropathy. From the digestive system: nausea, vomiting, pain in the stomach, a 'metallic' taste in the mouth, glossitis, stomatitis. Others: fever.

Application during pregnancy and lactation

Pregnancy

The experience accumulated to date is insufficient to assess the possible fetotoxic effect of secnidazole. In animals, secnidazole did not cause teratogenic effects. However, since secnidazole is able to cross the placental barrier, and the results obtained in animals may not always be generalized to humans, it is not recommended to prescribe secnidazole during pregnancy.

Breast-feeding

Secnidazole is excreted in breast milk. At the time of treatment, you should stop breastfeeding. Cases of candidiasis of the oral mucosa and anal region have been reported, as well as cases of diarrhea in infants who were breastfed by mothers who received imidazole derivatives (but not secnidazole).

Application for violations of liver function

There is no data.

Application for impaired renal function

There is no data.

Application in children

The use of the drug in children under 3 years of age or with a body weight of less than 16 kg (for this dosage form) is contraindicated.

Use in elderly patients

There is no data.

special instructions

With hepatic amebiasis in the suppuration phase, the drug should be combined with drainage removal of pus or with removal of abscesses. With the simultaneous administration of indirect anticoagulants, it is necessary to more often determine the prothrombin time and monitor the INR and, if necessary, adjust the dose of the anticoagulant throughout the entire course of therapy with secnidazole and within 8 days after the end of therapy. During therapy with secnidazole and within 5 days after its completion, it is necessary to stop drinking alcoholic beverages and medications containing ethanol. When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, patients should abstain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment is not stopped during menstruation.Avoid using the drug in patients with a history of blood disease. Long-term use is desirable under the control of the blood count. With 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 treatment. Influence on the ability to drive vehicles and mechanisms Possible side effects such as dizziness and impaired coordination of movements. When these side effects appear, patients are advised to refrain from performing potentially hazardous activities that require concentration of attention and quick response.With 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 treatment. Influence on the ability to drive vehicles and mechanisms Possible side effects such as dizziness and impaired coordination of movements. When these side effects appear, patients are advised to refrain from performing potentially hazardous activities that require concentration of attention and quick response.With 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 treatment. Influence on the ability to drive vehicles and mechanisms Possible side effects such as dizziness and impaired coordination of movements. When these side effects appear, patients are advised to refrain from performing potentially hazardous activities that require concentration of attention and quick response.like dizziness and lack of coordination of movements. When these side effects appear, patients are advised to refrain from performing potentially hazardous activities that require concentration of attention and quick response.like dizziness and lack of coordination of movements. When these side effects appear, patients are advised to refrain from performing potentially hazardous activities that require concentration of attention and quick response.

Overdose

Symptoms: increased dose-related side effects. Treatment: symptomatic. The drug should be discontinued, it is necessary to cleanse the stomach, take activated charcoal; the patient should consult a doctor immediately.

Drug interactions

Disulfiram: with the combined use of secnidazole with disulfiram, psychotic reactions, a state of confusion are possible. Oral anticoagulants (eg warfarin): secnidazole enhances the effect of indirect anticoagulants (coumarin or indandione derivatives) and increases the risk of bleeding by reducing hepatic anticoagulant metabolism. Ethanol: Combination with ethanol causes symptoms of an 'antabuse reaction' (abdominal cramps, nausea, vomiting, headache, hot flashes, tachycardia).