Instructions for use Nifuroxazide-Sperco oral suspension 200 mg/5 ml container 100 ml
Composition
active ingredient: nifuroxazide;
5 ml of suspension contain 200 mg of nifuroxazide;
excipients: methylparaben (methyl parahydroxybenzoate) (E 218), sugar, carbomer, citric acid monohydrate, simethicone emulsion, food flavoring "banana" (contains propylene glycol), sodium hydroxide, purified water.
Dosage form
Oral suspension.
Main physicochemical properties: yellow suspension with a banana odor. During storage, it can easily sediment, but when shaken, it returns to a homogeneous state.
Pharmacotherapeutic group
Antidiarrheal drugs, drugs used to treat infectious and inflammatory diseases of the intestines. Antimicrobial drugs for the treatment of intestinal infections. Nifuroxazide. ATC code A07A X03.
Pharmacodynamics
Nifuroxazide is an antimicrobial drug, a derivative of 5-nitrofuran. The mechanism of action of the drug is not fully understood, the antimicrobial and antiparasitic properties of nifuroxazide are probably 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 this antidiarrheal drug has no systemic effect. Nifuroxazide is effective against gram-positive and gram-negative bacteria: Streptococcus spp., Staphylococcus spp., E. coli, Salmonella spp., Shigella spp.
Pharmacokinetics
After oral administration, it is almost not absorbed from the gastrointestinal tract, more than 99% of the dose taken remains in the intestine. Biotransformation of nifuroxazide occurs in the intestine, approximately 20% of the dose taken is excreted unchanged. Nifuroxazide and its metabolites are excreted in the feces. The rate of excretion of the drug 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. In therapeutic doses, nifuroxazide almost does not suppress the normal intestinal microflora, does not cause the appearance of resistant microbial strains, as well as the development of cross-resistance of bacteria to other antibacterial drugs. The therapeutic effect is achieved from the first hours of treatment.
Indication
Acute diarrhea of infectious etiology.
Contraindication
Hypersensitivity to nifuroxazide, to other 5-nitrofuran derivatives or to other components of the drug.
Interaction with other medicinal products and other types of interactions
Nifuroxazide is not recommended for use simultaneously with sorbents, drugs containing alcohol, drugs that may cause antabuse reactions, and drugs that depress the central nervous system.
Application features
Nifuroxazide treatment does not exclude dietary regimen and rehydration. If necessary, concomitant rehydration therapy should be used depending on the age, condition of the patient and the intensity of diarrhea. Rehydration should be the main element of the treatment of acute diarrhea in children. Children should be provided with frequent (every 15 minutes) drinking. Prevention or treatment of dehydration should be carried out with oral or intravenous solutions. If rehydration is prescribed, it is recommended to use solutions intended for this purpose, in accordance with the instructions for dilution and use. The intended volume of oral rehydration solutions depends on body weight loss. In case of severe diarrhea, intense vomiting and refusal to eat, intravenous rehydration is required. If such rehydration is not necessary, it is necessary to compensate for fluid loss by drinking plenty of drinks containing salt and sugar (based on the average daily need of 2 liters of water). Dietary recommendations during diarrhea should be taken into account: avoid fresh vegetables and fruits, spicy foods, frozen foods and drinks. Rice should be preferred. The decision on the use of dairy products should be made depending on the specific case. If diarrhea is accompanied by clinical manifestations indicating aggressive phenomena (deterioration of the general condition, fever, symptoms of intoxication), nifuroxazide 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 contains sugar, which should be taken into account when prescribing the drug to patients with diabetes mellitus. It is not recommended to prescribe the drug to patients with hereditary disorders of tolerance to sucrose or fructose.
The drug contains methyl parahydroxybenzoate (E 218), which may cause an allergic reaction.
During treatment, it is strictly forbidden to drink alcohol due to the risk 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
There are 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 by women during breastfeeding, provided that treatment with nifuroxazide is short-term.
Method of administration and doses
Nifuroxazide should be taken orally, regardless of food intake, at regular intervals. The suspension must be shaken before use. For dosing, a measuring spoon (capacity 5 ml), graduated in 2.5 ml, is used, enclosed in the package.
Children over 2 years of age: 5 ml of suspension 3 times a day.
Adults: 5 ml of suspension 4 times a day.
The maximum daily dose of nifuroxazide is 800 mg. The duration of treatment should not exceed 7 days.
Children
Do not use in children under 2 years of age.
Overdose
Cases of overdose have not been described. In case of overdose, gastric lavage and symptomatic treatment are recommended.
Adverse reactions
Temporary abdominal pain, nausea, vomiting, and increased diarrhea may occur.
Allergic reactions, including itching, skin rashes, urticaria, angioedema, anaphylactic shock, are also possible. The occurrence of allergic reactions requires discontinuation of the drug and prohibition of taking nifuroxazide and other nitrofuran derivatives in the future.
On the part of the hematopoietic and lymphatic system, one case of granulocytopenia was reported.
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
100 ml in a dark brown container and a cardboard pack with a dosing spoon.
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.
