Instructions for Nifuroxazide Richter film-coated tablets 100 mg No. 24
Composition
active ingredient: 1 tablet contains nifuroxazide 100 mg;
excipients: colloidal anhydrous silicon dioxide, potato starch, gelatin, talc, magnesium stearate; shell: hypromellose (E 464), polyethylene glycol, quinoline yellow (E 104), titanium dioxide (E 171), talc.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, round, biconvex, yellow in color. Diameter about 9 mm.
Pharmacotherapeutic group
Antimicrobial agents used to treat intestinal infections.
ATX code A07A X03.
Pharmacological properties
Pharmacodynamics.
Nifuroxazide is an antimicrobial drug, a derivative of nitrofuran. The mechanism of action is not fully understood. It is assumed that nifuroxazide inhibits the activity of dehydrogenases and disrupts protein synthesis in pathogenic bacteria. The antimicrobial and antiparasitic properties of nifuroxazide are possibly due to the presence of an amino group. Local activity and lack of penetration into organs and tissues of the body make nifuroxazide unique compared to other nitrofuran derivatives, since there is no systemic effect of this antidiarrheal drug.
Nifuroxazide is effective against most pathogens of intestinal infections (including mutant strains resistant to other antimicrobial agents). It has a local antibacterial effect in the intestinal lumen against some species of gram-positive bacteria from the Staphylococcus family and some species of gram-negative bacteria from the Enterobacteriaceae family of species: Yersinia sp., Escherichia sp., Citobacter sp., Enterobacter sp., Klebsiella sp., Salmonella sp.
In medium therapeutic doses, it exhibits bacteriostatic activity, and in higher doses, it has a bactericidal effect. In therapeutic doses, it practically does not disturb the balance of saprophytic bacterial flora of the large intestine, does not cause the development of resistant strains of pathogenic microorganisms and cross-resistance of bacteria to other antimicrobial agents, which allows, if necessary, to prescribe it in complex therapy with systemic antibacterial drugs for generalized infections. In intestinal infections of viral genesis, it prevents the development of bacterial superinfection. The effectiveness of the drug does not depend on the pH in the intestinal lumen. The therapeutic effect is achieved from the first hours of treatment.
Pharmacokinetics.
After oral administration, it is practically not adsorbed from the gastrointestinal tract and does not enter the organs and tissues, creating a high concentration of the active substance in the intestine (more than 99% of the drug taken remains in the intestine). Biotransformation of nifuroxazide occurs in the intestine, more than 20% is excreted unchanged. Nifuroxazide and its metabolites are excreted in the feces. The rate of excretion depends on the amount of the drug taken and on the motility of the gastrointestinal tract. In general, the excretion of nifuroxazide is slow, it remains in the gastrointestinal tract for a long time.
Indication
Acute diarrhea of infectious etiology.
Contraindication
Hypersensitivity to nifuroxazide and other nitrofuran derivatives or to any of the excipients.
Interaction with other drugs and other types of interactions.
Simultaneous (at the same time) administration of other oral medications should be avoided due to the strong adsorption properties of nifuroxazide.
Nifuroxazide is not recommended for use simultaneously with sorbents, drugs containing alcohol, drugs that may cause antabuse reactions, and drugs that depress the CNS.
During treatment with nifuroxazide, alcohol consumption is strictly prohibited due to the possibility of developing a disulfiram-like reaction, which is manifested by exacerbation of diarrhea, vomiting, abdominal pain, a feeling of heat in the face and upper body, hyperemia, tinnitus, difficulty breathing, tachycardia.
Application features
During treatment with nifuroxazide, it is strictly forbidden to drink alcohol (see section "Interaction with other medicinal products and other types of interactions").
Treatment with nifuroxazide does not exclude dietary regimen and rehydration. If diarrhea does not stop after 3 days from the start of treatment, in-depth diagnostics are necessary to determine the cause of the symptoms. Antibiotic therapy may be necessary. If necessary, concomitant rehydration therapy is used depending on the age and condition of the patient and the intensity of diarrhea.
If oral or intravenous rehydration is prescribed, the instructions for dilution and use of the solutions intended for this purpose must be followed. If such rehydration is not necessary, fluid loss must be compensated by drinking plenty of drinks containing salt and sugar (based on an average daily requirement of 2 liters of water).
If diarrhea is accompanied by clinical manifestations indicating aggressive phenomena (deterioration of the general condition, fever, symptoms of intoxication), Nifuroxazide Richter should be prescribed together with antibacterial drugs used to treat intestinal infections, since the drug is not absorbed in the intestine and does not enter the systemic circulation. The drug should not be prescribed as monotherapy for the treatment of intestinal infections complicated by septicemia.
In the event of a hypersensitivity reaction (shortness of breath, swelling of the face, lips, tongue, skin rashes, itching), nifuroxazide should be discontinued immediately.
Use during pregnancy or breastfeeding
There is insufficient data on the possible teratogenic and fetotoxic effects of nifuroxazide during pregnancy. Therefore, as a precautionary measure, the use of the drug during this period is not recommended.
Nifuroxazide Richter can be used by women during breastfeeding, provided that the treatment is short-term.
Ability to influence reaction speed when driving vehicles or other mechanisms
Nifuroxazide does not affect the reaction rate when driving vehicles or other mechanisms.
Method of administration and doses
The tablets should be taken orally, whole, with sufficient water, regardless of meals. The maximum daily dose is 800 mg.
Adults and children over 15 years of age: 200 mg (2 tablets of 100 mg) 4 times a day.
Children over 6 years of age: 200 mg (2 tablets of 100 mg) 3-4 times a day.
Duration of treatment is no more than 7 days. If symptoms persist, consult a doctor.
Children
Nifuroxazide Richter in the form of 100 mg tablets can be used in children over 6 years of age. Children under 6 years of age are recommended to use Nifuroxazide Richter in the form of a suspension.
Overdose
One case of overdose has been described, accompanied by short-term symptoms of diarrhea and drowsiness. In case of overdose, gastric lavage and symptomatic treatment are recommended.
Adverse reactions
Blood and lymphatic system disorders: One case of granulocytopenia has been described.
On the part of the immune system: allergic reactions are possible, including angioedema, urticaria, and skin itching.
On the part of the gastrointestinal tract: individual cases of hypersensitivity to nifuroxazide are manifested by abdominal pain, nausea, vomiting and exacerbation of diarrhea. In the event of the appearance of such symptoms of minor intensity, there is no need to use special therapy or discontinue the use of nifuroxazide, since the symptoms quickly subside. If the exacerbation is severe, nifuroxazide should be discontinued. In the future, the patient should avoid taking nifuroxazide and other nitrofuran derivatives.
Skin and subcutaneous tissue disorders: Rarely, skin reactions in the form of skin rash may occur.
One case of pustulosis in an elderly person and one case of pruritus nodosa in the presence of contact allergy to nifuroxazide have been reported.
Expiration date
4 years.
Storage conditions
The medicinal product does not require any special storage conditions.
Keep out of reach and sight of children!
Packaging
24 (24×1) tablets in a blister, 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "Gedeon Richter Poland".
Location of the manufacturer and its business address
05- 825, Grodzisk Mazowiecki, ul. kn. J. Ponyatowskiego, 5, Poland
Applicant
Gedeon Richter OJSC, Hungary.
Location of the applicant and/or applicant's representative
H-1103, Budapest, Demrei Street 19-21, Hungary.
