Instructions for use: Secnidox film-coated tablets 1 g blister No. 2
Composition
active ingredient: secnidazole;
1 film-coated tablet contains 1.0 g of secnidazole;
excipients: corn starch, calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate (type A), povidone (K 30), magnesium stearate, talc;
shell composition: hypromellose (E 15), titanium dioxide (E 171), indigo carmine lake (E 132), talc, propylene glycol.
Dosage form
Film-coated tablets.
Main physicochemical properties: capsule-shaped tablets, film-coated, blue in color with “SECN” embossed on one side and a score on the other.
Pharmacotherapeutic group
Antiprotozoal agents. Nitroimidazole derivatives. ATC code P01A B07.
Pharmacological properties
Pharmacodynamics
Secnidox is an antiprotozoal drug of the nitroimidazole group with antibacterial action. Secnidox is characterized by a bactericidal (against gram-positive and gram-negative anaerobic bacteria) and amoebicidal (intra- and extra-intestinal) effect. Secnidox is especially active against Trichomonas vaginalis, Entamoeba histolytica, 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. Its helical structure is disrupted and the strands are destroyed, nucleotide synthesis is inhibited and the cell dies.
Pharmacokinetics
After oral administration, Secnidox is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability is approximately 80%. Secnidazole crosses the blood-brain barrier and is excreted in breast milk. The half-life of secnidazole is approximately 25 hours, which simplifies the dosing regimen and makes it more convenient for patients.
Indication
Trichomonas urethritis and vaginitis (caused by Trichomonas vaginalis); bacterial vaginosis; intestinal amebiasis (caused by Entamoeba histolytica); hepatic amebiasis (caused by Entamoeba histolytica); giardiasis (caused by Giardia lamblia).
Contraindication
Hypersensitivity to secnidazole and other imidazole derivatives; Organic diseases of the central nervous system (CNS).
Interaction with other medicinal products and other types of interactions
When used simultaneously, Secnidox enhances the effect of indirect anticoagulants (coumarin and indandione derivatives), increasing the risk of bleeding.
Concomitant administration of Secnidox with disulfiram may cause paranoid reactions and psychosis. Combination with alcohol causes symptoms of a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headache, hot flashes), possible delirious attacks and dizziness.
Secnidox, when used simultaneously with lithium preparations, increases its concentration in blood plasma.
The drug is not recommended to be combined with non-depolarizing muscle relaxants (vecuronium bromide).
When combined with amoxicillin, activity against Helicobacter pylori increases (amoxicillin inhibits the development of resistance).
Application features
Secnidox should not be prescribed to patients with a history of blood dyscrasias. Reversible neutropenia may occur during treatment with the drug. The number of leukocytes recovers after discontinuation of treatment. Alcohol should be avoided during use of the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Method of administration and doses
Secnidox should be taken orally immediately before meals, with a small amount of water.
Adult doses
Trichomonas urethritis and vaginitis, bacterial vaginosis: 2 tablets once.
Intestinal amebiasis:
Acute amebiasis: 2 tablets at a time; asymptomatic amebiasis, including focal and cystic forms: 2 tablets daily in 1 dose for 3 days.
Hepatic amebiasis: 1.5 tablets (1.5 g) daily in 1 or 2 doses, for 5 days.
Giardiasis: 2 tablets once a day for 3 days.
Doses for children
Intestinal amebiasis:
Acute amebiasis: 30 mg/kg body weight once; asymptomatic amebiasis, including focal and cystic forms: daily in 1 or 2 doses at a dose of 30 mg/kg body weight for 3 days.
Hepatic amebiasis: daily in 1 or 2 doses at a dose of 30 mg/kg body weight for 5 days.
Giardiasis: at the rate of 30 mg/kg of body weight (1-1.5 g) once.
Children
The drug should be used in children over 12 years of age.
Overdose
Symptoms: possible increase in side effects.
Treatment: There is no specific antidote. If necessary, symptomatic therapy should be carried out.
Adverse reactions
Secnidox is easily tolerated, but side effects are possible:
general disorders: general weakness;
From the digestive tract: indigestion, nausea, stomach pain, metallic taste in the mouth, glossitis, stomatitis.
Less common:
Allergic reactions: hypersensitivity reactions, including flushing, rash, urticaria.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in a dry place out of the reach of children.
Packaging
2 tablets in a blister; 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
LABORATORY BAILLY-CREAT - VERNOUILLET, France.
Location of the manufacturer and its business address
Chemin de Nuisement, Lieu-dit les 150 Arpents, VERNOUILLET, 28500, France, France.
