Samitol (secnidazole) tablets coated 500 mg. №4

Description

Samitol (secnidazole) tablets coated 500 mg. №4

Composition

active ingredient: secnidazole (secnidazole);

1 film-coated tablet contains 500 mg of secnidazole;

excipients: microcrystalline cellulose, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A), magnesium stearate, hypromellose, polyethylene glycol.

Medicinal form

Film-coated tablets.

The main physicochemical properties: round, biconvex, smooth on both sides tablets, covered with a white to almost white film coating.

Pharmacotherapeutic group

Antiprotozoal agents. Nitroimidazole derivatives.
ATX code P01A B07.

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.

Indication:

• 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).

Contraindication

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 used internally immediately before eating with a small amount of water.

Doses for adults

Urogenital trichomoniasis, bacterial vaginosis: use 4 tablets of 500 mg in one dose once a day or in two doses a day with an interval of 12 hours (total ‒ 2 g).

Acute intestinal amoebiasis and giardiasis: use 4 tablets of 500 mg in one dose 1 time a day or in two doses a day with an interval of 12 hours (total ‒ 2 g).

Chronic carriage of cysts or amoeba: use 3 tablets of 500 mg in one dose or in several doses within 3 days.

Liver amoebiasis: 3 tablets of 500 mg to be used in one dose or in several doses within 5 days.

Doses for children*

At the discretion of the doctor – from 25 to 30 mg/kg/day. The duration of treatment depends on the indication and is similar to that for adults.

*this medicinal form is intended for use by children with a body weight of more than 20 kg.

Children

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.

Overdose

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.

Side effects:

• 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.