SECNAPOL [Secnidazole] 1 g Film-coated tablets

SEKNAPOL

instructions for medical use of the medicinal product

Tradename

Seknapol, Секнапол

International non-proprietary name

Secnidazole, Секнидазол

Composition

Each film-coated tablet contains:

active ingredient: secnidazole CP 1 g

Excipients: croscarmellose sodium, microcrystalline cellulose, magnesium stearate.

Dosage form

Tablets.

Pharmacotherapeutic group

Antimicrobial and antiprotozoal agents.

Pharmacological properties

Pharmacodynamics

Secnidazole is a derivative of nitroimidazole. It has a bactericidal (against gram-positive and gram-negative anaerobic bacteria) and amebicidal (intra- and extra-intestinal) action. Secnidazole is especially active against Trichomonas vaginalis, Entamoeba histolytic and Giardia lamblia. Penetrating into the cell of a microorganism, secnidazole is activated as a result of the reduction of the 5-nitro group, due to which it interacts with cellular DNA . There is a violation of its spiral structure and the destruction of threads, inhibition of nucleotide synthesis and cell death.

Pharmacokinetics

After oral administration, secnidazole is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80%. After taking 2 g of secnidazole, _Cmax in plasma is reached after 3-4 hours.

Seknidazol gets through a blood-brain barrier and a placental barrier, is excreted with breast milk.

T1 / 2 of secnidazole from blood plasma is about 25 hours. The drug is slowly excreted from the body, mainly with urine: about 50% of the dose taken is excreted in 120 hours.

Indications for use

·        urethritis and vaginitis caused by Trichomonas vaginalis,

·        intestinal amoebiasis caused by Entamoeba histolytica,

·        amoebiasis of the liver caused by Entamoeba histolytica,

·        giardiasis caused by Giardia lamblia.

Contraindications

·        Hypersensitivity to secnidazole, other imidazole derivatives,

·        organic diseases of the central nervous system,

·        blood diseases (including history),

·        pregnancy,

·        lactation period,

·        children's age up to 3 years.

Dosage and administration

inside. Tablets should be swallowed whole, without chewing, with a small amount of water before meals.

Urethritis and vaginitis

Adults - once 2 g (2 tablets), course of treatment - 1 day. Simultaneous treatment of both sexual partners should be carried out.

Intestinal amebiasis

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

Amoebiasis without clinical symptoms, including focal and cystic forms (minuta and cystic). Adults - 2 g (2 tablets) in 1 or more doses for 3 days; children - 30 mg / kg / day in 1 or several doses for 3 days.

Amoebiasis of the liver

Adults - 1.5 g (1.5 tablets) in 1 or more doses for 5 days; children - 30 mg / kg / day in 1 or several doses for 5 days.

Giardiasis

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

Special instructions and precautions

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

While taking indirect anticoagulants, it is necessary to more often determine the prothrombin time and monitor the INR (international normalized ratio) and, if necessary, adjust the dose of the anticoagulant throughout the course of therapy and within 8 days after the end of therapy.

During therapy with Seknapol and within 5 days after its completion, it is necessary to stop drinking alcoholic beverages.

In the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men, patients should abstain from sexual activity. Mandatory simultaneous treatment of sexual partners. Treatment does not stop during menstruation.

The use of this drug in patients with a history of blood disease should be avoided. Long-term use is desirable to carry out under the control of the blood count. With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process. The appearance of ataxia, dizziness and any other deterioration in the neurological status of patients requires discontinuation of treatment.

Influence on the ability to drive vehicles and mechanisms

Side effects such as dizziness and incoordination are possible. When these side effects occur, patients are advised to refrain from performing potentially hazardous activities that require concentration and reaction time.

Use during pregnancy or lactation

The experience accumulated to date is insufficient to assess the possible fetotoxic effect of secnidazole. Since secnidazole is able to cross the placental barrier, it is not recommended to prescribe the drug during pregnancy.

Secnidazole is excreted in breast milk. At the time of treatment should stop breastfeeding.

Interaction with other drugs

Disulfiram: with the combined use of secnidazole with disulfiram, psychotic reactions, a state of confusion are possible.

Oral anticoagulants (eg, warfarin): secnidazole enhances the effect of indirect anticoagulants (coumarin or indandione derivatives) and increases the risk of bleeding by reducing hepatic metabolism of anticoagulants.

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

Side effect

Allergic reactions: urticaria, rash, angioedema, anaphylactic reaction.

On the part of the blood and lymphatic system: moderate reversible leukopenia.

From the nervous system: dizziness, impaired coordination of movements (ataxia), decreased skin sensitivity (paresthesia), peripheral neuropathy.

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

Other: fever.

Overdose

Symptoms: increased dose-dependent side effects.

Treatment: gastric lavage, activated charcoal, symptomatic therapy.

Storage conditions

Store in a cool and dry place, at a temperature not exceeding 30º C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

2 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.