Trichomonas urethritis and vaginitis (caused by Trichomonas vaginalis); bacterial vaginosis; intestinal amoebiasis (caused by Entamoeba histolytica); liver amoebiasis (caused by Entamoeba histolytica); Giardia lamblia (caused by Giardia lamblia).
active substance: secnidazole;
1 film-coated tablet contains 500 mg of secnidazole;
Excipients: microcrystalline cellulose, colloidal anhydrous silica, sodium starch glycolate (type A), magnesium stearate, hypromellose, polyethylene glycol.
Samitol Pharmacological properties
Secnidazole is an antiprotozoal agent of the nitroimidazole group with antibacterial action. Secnidazole is characterized by bactericidal (against gram-positive and gram-negative anaerobic bacteria) and amebicidal (intra- and external-intestinal) effect. Secnidazole is particularly active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia. Penetrating into the cell of the microorganism, secnidazole is activated by the reduction of the 5-nitro group, thereby interacting with cellular DNA. There is a violation of its helical structure and the destruction of strands, inhibition of nucleotide synthesis and cell death.
- Trichomonas urethritis and vaginitis (caused by Trichomonas vaginalis);
- bacterial vaginosis;
- intestinal amoebiasis (caused by Entamoeba histolytica);
- liver amoebiasis (caused by Entamoeba histolytica);
- giardiasis (caused by Giardia lamblia).
Hypersensitivity to secnidazole or to other components of the drug or to other nitroimidazole derivatives;
organic diseases of the central nervous system (CNS);
1st trimester of pregnancy;
blood dyscrasia, including in the anamnesis.
Method of application and dosage
Samitol® should be administered orally immediately before eating, with a small amount of water.
Doses for adults
Urogenital trichomoniasis, bacterial vaginosis: 4 tablets of 500 mg used in one dose 1 time per day or in two doses per day with an interval of 12 hours (total – 2 g).
Acute intestinal amebiasis and giardiasis: 4 tablets of 500 mg to be used in one dose 1 time per day or in two doses per day with an interval of 12 hours (total – 2 g).
Chronic carriers of cysts or amoebae: 3 tablets of 500 mg used in one dose or in several doses for 3 days.
Amoebiasis of the liver: 3 tablets of 500 mg used in one dose or in several doses for 5 days.
Doses for children *
At the doctor’s discretion – from 25 to 30 mg / kg / day. The duration of treatment depends on the indication and is similar to that for adults.
* this dosage form is intended for use in children weighing more than 20 kg.
Doses for patients with renal or hepatic insufficiency
For patients with renal or hepatic insufficiency, dose adjustment recommendations depend on those generally recommended for nitro-5-imidazole derivatives.
Moderate to severe renal insufficiency: no dose adjustment is usually required, especially with short-term treatment.
Severe hepatic insufficiency: it is necessary to reduce the daily dose depending on the patient’s condition.
The drug is approved for use in children in accordance with the dosing recommendations specified in the section “Method of administration and dosage”, taking into account the possibility of using this dosage form to children weighing more than 20 kg.
Symptoms: possible increase in adverse reactions, in particular from the nervous system.
Treatment: there is no specific antidote. If necessary, carry out symptomatic therapy or hemodialysis.
- Immune system disorders: Hypersensitivity reactions including hyperaemia (erythema), rash, urticaria, angioneurotic edema, bronchospasm, fever and anaphylactic reactions.
- From the blood and lymphatic system: moderate reversible leukopenia, reversible neutropenia, agranulocytosis, thrombocytopenia.
- From the cardiovascular system: the feeling of heartbeat.
- From the gastrointestinal tract: pain in the epigastrium and / or abdomen, nausea, vomiting, diarrhea, constipation, glossitis, stomatitis, taste disturbance (metallic taste in the mouth), anorexia.
- From the liver and biliary tract: hepatitis.
- From the nervous system: headache, convulsions, dizziness, loss of consciousness, paresthesia, neuropathy (peripheral sensory and sensory-motor polyneuritis), encephalopathy * (state of darkened consciousness), cerebellar syndrome * (ataxia, dysarthria, lack of coordination) tremor).
- From the psyche: psychosis, confusion, hallucinations.
- General disorders: general weakness.
Note: * after stopping treatment, the symptoms disappear.
Storage conditions Samitol
Store in the original package at a temperature not exceeding 25 ° C.
Keep out of reach of children.