Instructions for use Samitol film-coated tablets 500 mg blister No. 4
Composition
active ingredient: 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.
Dosage form
Film-coated tablets.
Main physicochemical properties: round, biconvex, smooth on both sides, film-coated tablets from white to almost white in color.
Pharmacotherapeutic group
Antiprotozoal agents. Nitroimidazole derivatives.
ATX code P01A B07.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Secnidazole is an antiprotozoal agent of the nitroimidazole group with antibacterial action. Secnidazole is characterized by a bactericidal (against gram-positive and gram-negative anaerobic bacteria) and amoebicidal (intra- and extra-intestinal) effect. Secnidazole 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
Absorption
After oral administration, secnidazole is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability is almost 100%. After oral administration of a single dose of 2 g, peak serum levels of secnidazole are reached after 3 hours.
Distribution
Secnidazole is approximately 15% bound to plasma proteins. Secnidazole crosses the blood-brain barrier and is excreted in breast milk.
Metabolism
Secnidazole is metabolized primarily in the liver.
Breeding
The half-life of secnidazole is approximately 25 hours. Secnidazole is excreted mainly in the urine. Elimination is slow: 16% of the administered dose of secnidazole is excreted within 72 hours and 50% within 120 hours.
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 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 a history.
Interaction with other medicinal products and other types of interactions
Disulfiram: concomitant use with secnidazole may cause paranoid reactions and psychosis.
Alcohol: combination with alcohol causes symptoms of a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headache, flushing), possible delirious attacks and dizziness.
Anticoagulants: secnidazole, when used simultaneously, enhances the effect of indirect anticoagulants (coumarin and indandione derivatives), increasing the risk of bleeding. Monitoring of prothrombin time and dose adjustment if necessary are necessary.
Lithium preparations: simultaneous use with secnidazole increases the concentration of lithium in the blood plasma.
Cyclosporine: risk of increased serum cyclosporine levels. Monitoring of cyclosporine and creatinine levels is necessary when secnidazole is used concomitantly with cyclosporine.
Non-depolarizing muscle relaxants (vecuronium bromide): not recommended for combination with secnidazole.
Amoxicillin: when used simultaneously with secnidazole, activity against Helicobacter pylori increases (amoxicillin inhibits the development of resistance).
5-fluorouracil: when used simultaneously with secnidazole, the clearance of 5-fluorouracil is reduced, which causes an increase in its toxicity.
Application features
Alcohol
During use of the drug and for 72 hours after its completion, alcohol consumption is contraindicated in order to prevent adverse reactions similar to those observed with the use of disulfiram (skin flushing, colic-like abdominal pain, vomiting and tachycardia).
Long-term reception
If it is necessary to use secnidazole for a longer period than recommended, patients should be monitored for blood counts (in particular, leukocyte count). Medical supervision is also recommended due to the risk of adverse reactions from the central nervous system and peripheral nervous system (paresthesia, ataxia, dizziness, seizures).
Hepatic encephalopathy
Secnidazole should be administered with caution to patients with hepatic encephalopathy. Therapy should be discontinued if incoordination, dizziness, or confusion occurs.
Sexual relations
You should abstain from sexual intercourse during treatment with secnidazole.
Ability to influence reaction speed when driving vehicles or other mechanisms
Secnidazole does not affect the reaction rate when driving or using other mechanisms.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy or breastfeeding.
Method of administration and doses
Samitol® should be taken orally immediately before meals, with a small amount of water.
Adult doses
Urogenital trichomoniasis, bacterial vaginosis: 4 tablets of 500 mg should be taken as a single dose once a 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 should be taken as a single dose once a day or in two doses a day with an interval of 12 hours (total - 2 g).
Chronic carriage of cysts or amoebas: 3 tablets of 500 mg should be taken in one dose or in several doses for 3 days.
Hepatic amebiasis: 3 tablets of 500 mg should be taken in one dose or in several doses for 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 dosage form is intended for use in children weighing more than 20 kg.
Dosage for patients with renal or hepatic impairment
For patients with renal or hepatic insufficiency, dose adjustment recommendations depend on those recommended for nitro-5-imidazole derivatives in general.
Moderate to severe renal impairment: Dose adjustment is usually not required, especially for short-term treatment.
Severe hepatic impairment: a reduction in the daily dose is necessary depending on the patient's condition.
Children
The drug is approved for use in children in accordance with the dosage recommendations specified in the "Method of administration and doses" section, taking into account the possibility of using this dosage form in children weighing more than 20 kg.
Overdose
Symptoms: possible increase in adverse reactions, particularly from the nervous system.
Treatment: There is no specific antidote. If necessary, symptomatic therapy or hemodialysis should be performed.
Adverse reactions
Immune system disorders: hypersensitivity reactions including hyperemia (erythema), rash, urticaria, angioedema, bronchospasm, fever and anaphylactic reactions.
Blood and lymphatic system disorders: moderate reversible leukopenia, reversible neutropenia, agranulocytosis, thrombocytopenia.
Cardiovascular system: palpitations.
Gastrointestinal: epigastric and/or abdominal pain, nausea, vomiting, diarrhea, constipation, glossitis, stomatitis, taste disturbance (metallic taste in the mouth), anorexia.
Hepatobiliary disorders: hepatitis.
Nervous system: headache, convulsions, dizziness, loss of consciousness, paresthesia, neuropathy (sensory peripheral and sensorimotor polyneuritis), encephalopathy* (state of clouded consciousness), cerebellar syndrome* (ataxia, dysarthria, impaired coordination of movements, nystagmus, tremor).
On the part of the psyche: psychosis, confusion, hallucinations.
General disorders: general weakness.
Note:*symptoms disappear after treatment is discontinued.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
4 tablets in a blister. 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Kusum Healthcare Pvt Ltd.
Location of the manufacturer and its business address
SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.
