Seknidox, 1 g 2 pcs

Pharmacological action – bactericidal.

Pharmacodynamics

Secnidazole is a nitroimidazole derivative. It has bactericidal (against Gram-positive and Gram-negative anaerobic bacteria) and amebicidal (intra- and extraintestinal) effects. Seknidazole is especially active against Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia. Penetrating into the cell of the microorganism, secnidazole is activated by reducing the 5-nitrogroup, due to which it interacts with cellular DNA. Violation of its helical structure and destruction of strands, inhibition of nucleotide synthesis and cell death occur.

Pharmacokinetics

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

Indications

– urethritis and vaginitis caused by Trichomonas vaginalis;

– intestinal amoebiasis caused by Entamoeba histolytica;

– liver amoebiasis caused by Entamoeba histolytica;

– giardiasis caused by Giardia lamblia.

Active ingredient

Composition

A film-coated tablet contains:

the active substance:

secnidazole – 1 g;

excipients:

the core of the tablet: corn starch – 103.73 mg, microcrystalline cellulose – 62.25 mg, sodium carboxymethyl starch – 37.35 mg, calcium hydrophosphate – 32.25 mg, povidone K30 – 17.40 mg, magnesium stearate – 7.40 mg, talc – 4.50 mg;

Pill shell: E-15 hypromellose – 32.30 mg, titanium dioxide (E 171) – 5.20 mg, talc – 5.20 mg, indigo carmine-based aluminum varnish (E 132) – 4.20 mg, propylene glycol – 4.50 mg.

How to take, the dosage

Orally, immediately before meals, with a small amount of water.

Urethritis and vaginitis

Adults – once 2 g of secnidazole (2 tablets), treatment course – 1 day. Both sexual partners should be treated simultaneously.

Amoebiasis of the intestine

Acute amoebiasis with severe symptoms (form histolytica). Adults – once 2 g of secnidazole (2 tablets), treatment course – 1 day; children – once 30 mg/kg, treatment course – 1 day.

Amoebiasis without clinical symptoms. Adults – 2 g of secnidazole (2 tablets) in 1 or more doses over 3 days; children – 30 mg/kg/day in 1 or more doses over 3 days.

Hepatic amebiasis

Adults – 1.5 g of secnidazole (1.5 tablets) in 1 or more doses over 5 days; children – 30 mg/kg/day in 1 or more doses over 5 days.

Giardiasis

Children – once 30 mg/kg, course of treatment – 1 day.

Interaction

Disulfiram: in co-administration of secnidazole with disulfiram psychotic reactions and states of confusion are possible.

Anticoagulants for oral administration (e.g., warfarin): Secnidazole increases the effect of indirect anticoagulants (coumarin or indandion derivatives) and increases the risk of bleeding by reducing hepatic metabolism of anticoagulants.

Interaction with alcohol: combination with alcohol causes symptoms of antabuse reaction (abdominal cramps, nausea, vomiting, headache, hot flashes, tachycardia).

Special Instructions

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

In concomitant administration of indirect anticoagulants, PV should be determined more frequently and INR should be monitored and, if necessary, the anticoagulant dose should be adjusted throughout therapy with secnidazole and for 8 days after therapy ends.

During therapy with secnidazole and for 5 days after its completion, alcoholic beverages and medications containing alcohol should be avoided.

When treating trichomonad vaginitis in women and trichomonad urethritis in men, patients must abstain from sexual activity. The simultaneous treatment of sexual partners is mandatory. Treatment is not stopped during menstruation.

The use of this drug should be avoided in patients with a history of blood disease. Prolonged use should preferably be performed under control of blood counts. In case of leukopenia the possibility of continuing treatment depends on the risk of developing an infectious process. Appearance of ataxia, dizziness and any other deterioration of patients’ neurological status requires discontinuation of treatment.

The effect on the ability to drive vehicles, mechanisms. Side effects such as dizziness and impaired coordination of movements are possible. If these side effects occur, patients are advised to refrain from performing potentially hazardous activities requiring concentration and quick reaction time.

Contraindications

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

– organic diseases of the central nervous system;

– blood disorders (including a history of diabetes.

– pregnancy;

– lactation;

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

Side effects

Allergic reactions: urticaria, rash, angioedema; very rare – anaphylactic reaction.

Blood and lymphatic system disorders: moderate reversible leukopenia.

Nervous system disorders: dizziness, impaired coordination of movements (ataxia), decreased skin sensitivity (paraesthesia), peripheral neuropathy.

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

Others: fever.

If any of the side effects listed in the instructions are aggravated or any other side effects not listed in the instructions are noticed, you should tell your doctor.

Overdose

Symptoms: intensification of dose-dependent side effects.

Treatment: symptomatic. The drug should be stopped, the stomach should be cleared, activated charcoal should be taken and a doctor should be seen immediately.

Pregnancy use

To date, the accumulated experience is insufficient to assess the possible fetotoxic effects of secnidazole. In animals, secnidazole did not cause teratogenic effects. However, since secnidazole is capable of crossing the placental barrier, and the results obtained in animals cannot always be extended to humans, it is not recommended that secnidazole be administered during pregnancy.

Secnidazole is excreted with breast milk. Breastfeeding should be avoided during treatment.

There have been reported cases of oral and anal candidiasis and diarrhea in breastfed infants of mothers who received imidazole derivatives (but not secnidazole).