Instructions for Nifuroxazide-Sperko capsules 200 mg container No. 12
Composition
active ingredient: nifuroxazide;
1 capsule contains nifuroxazide 200 mg;
excipients: sucrose, anhydrous lactose, corn starch, talc, magnesium stearate.
The capsule shell contains: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), sunset yellow FCF (E 110).
Dosage form
Capsules.
Main physicochemical properties: hard gelatin capsules with a yellow body and cap. Capsule contents – yellow powder, granules or plugs. White inclusions are permissible.
Pharmacotherapeutic group
Antimicrobial agents used for intestinal infections. Nifuroxazide. ATC code A07A X03.
Pharmacodynamics
Nifuroxazide is an intestinal antiseptic, a derivative of 5-nitrofuran; active against most pathogens of intestinal infections (including mutant strains resistant to other antimicrobial agents): gram-positive (family Staphylococcus) and gram-negative (family Enterobacteriaceae: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Proteus, Yersinia), as well as Vibrio cholerae. Inactive against bacteria of the genus Pseudomonas and the genus Proteus (species Proteus inconstans), as well as strains of subgroup A of the species Providencia alcalifaciens. It is assumed that the drug inhibits the activity of dehydrogenases and disrupts protein synthesis in pathogenic bacteria. In medium therapeutic doses, it exhibits bacteriostatic activity, and in higher doses, it has a bactericidal effect. The effect is manifested from the first hours of treatment. In therapeutic doses, it practically does not disrupt the balance of intestinal microflora; does not cause the development of resistant strains of pathogenic microorganisms and cross-resistance of bacteria to other antimicrobial agents, which makes it possible, if necessary, to prescribe it in complex therapy with systemic drugs for generalized infections. In intestinal infections of viral origin, it prevents the development of bacterial superinfection.
Pharmacokinetics
After oral administration, it is practically not absorbed from the gastrointestinal tract, creating a high concentration of the active substance in the intestine. Due to such pharmacokinetic features, the drug has an exclusively enteral antiseptic effect, has no systemic antibacterial activity, does not cause general toxic effects; is excreted from the body with feces. The drug does not affect clinical and biochemical blood parameters.
Indication
Acute diarrhea of infectious etiology.
Contraindication
Hypersensitivity to any of the components of the drug, including other 5-nitrofuran derivatives. Children's age up to 7 years (children under 7 years of age use Nifuroxazide-Sperko in the form of a suspension).
Interaction with other medicinal products and other types of interactions
During treatment with nifuroxazide, alcoholic beverages and drugs containing alcohol should not be consumed due to the possibility of developing a disulfiram-like reaction, which is manifested by exacerbation of diarrhea, vomiting, abdominal pain, feeling of heat, skin hyperemia, tinnitus, difficulty breathing, tachycardia, and a feeling of fear. Simultaneous administration of other oral medications should be avoided due to the strong adsorption properties of nifuroxazide.
Application features
Treatment with nifuroxazide does not exclude dietary regimen and rehydration. If diarrhea does not stop after 3 days of treatment, it is necessary to review the dosage and decide on rehydration. If necessary, use concomitant rehydration therapy depending on the age, condition of the patient and 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 the average daily requirement of 2 liters of water).
Dietary recommendations during diarrhea should be considered: avoid fresh vegetables and fruits, spicy foods, frozen foods and drinks. Rice should be preferred. The decision on the use of dairy products is made on a case-by-case basis.
If diarrhea is accompanied by clinical manifestations indicating aggressive phenomena (deterioration of the general condition, fever, symptoms of intoxication), Nifuroxazide-Sperko should be prescribed together with systemic 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 sepsis.
Nifuroxazide-Sperko contains sucrose, which should be taken into account when prescribing the drug to patients with diabetes.
This medicinal product contains sucrose and lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product is not recommended for patients with hereditary problems of sucrose or fructose intolerance.
During treatment, alcohol consumption is strictly prohibited due to the risk of developing a disulfiram-like reaction (see section "Interaction with other medicinal products and other types of interactions").
Ability to influence reaction speed when driving vehicles or other mechanisms
Nifuroxazide-Sperko does not affect the speed of psychomotor reactions.
Use during pregnancy or breastfeeding
There is insufficient data on possible teratogenic and fetotoxic effects of nifuroxazide during pregnancy. Therefore, as a precautionary measure, the use of nifuroxazide during pregnancy is not recommended. The drug can be used in women during breastfeeding, provided that the treatment is short-term.
Method of administration and doses
Adults and children over 7 years of age are prescribed 1 capsule 4 times a day, regardless of meals. The maximum daily dose is 800 mg. The duration of treatment is no more than 7 days.
Children
Nifuroxazide-Sperko in capsule form is prescribed for children aged 7 and over.
For the treatment of children under 7 years of age, Nifuroxazide-Sperko is prescribed in the form of a suspension.
Overdose
Cases of overdose have not been described. In case of overdose, gastric lavage and symptomatic treatment are recommended.
Adverse reactions
The drug is well tolerated, occasionally temporary abdominal pain, nausea, vomiting, increased diarrhea may occur. In the event of mild gastrointestinal symptoms, there is no need for special therapy or discontinuation of nifuroxazide, since such symptoms disappear on their own.
In patients with hypersensitivity to nitrofuran derivatives, granulocytopenia may occur; allergic reactions, usually of the skin type (skin rash, itching, urticaria, pustulosis). In isolated cases, as with the use of other nitrofuran derivatives, shortness of breath, severe hypersensitivity reactions, including angioedema and anaphylactic shock, may occur.
In case of severe adverse reactions, the drug should be discontinued and symptomatic therapy should be carried out. In the future, the patient should avoid taking nifuroxazide and other nitrofuran derivatives.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
12 capsules in a plastic container and a cardboard pack.
Vacation category
According to the recipe.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and its business address
Ukraine, 21027, Vinnytsia, 600-anniversary st., 25.
