INSTRUCTIONS FOR MEDICAL USE
Trade name of the drug: Nifustal
Active substance (INN): Nifuroxazide
Dosage form: oral suspension
5 ml of the suspension contains:
active substance: nifuroxazide 220 mg;
Excipients: carbomer, sucrose, citric acid, sodium hydroxide, methylparaben (E219), simethicone emulsion 30%, banana essence, purified water.
Description: light yellow coloured suspension with banana odour; during storage it slightly settles, but after shaking returns to the homogeneous suspension without leaving a thick sediment at the bottom of the bottle.
Pharmacotherapeutic group: Antibacterial synthetic drug (gr. nitrofuran).
ATX code: A07AX03
Nifuroxazide is a derivative of 5-nitrofuran. It has antibacterial action in intestine lumen against some species of Gram-positive bacteria of Staphylococcus genus and some species of Gram-negative bacteria of Yersinia spp, Escherichia spp, Citrobacter spp, Enterobacter spp, Klebsiella spp, Salmonella spp. Nifuroxazide does not exhibit antibacterial activity against bacteria of Proteus vulgaris, Proteus mirabilis and Pseudomonas aeruginosa species.
Nifuroxazid does not destroy saprophytic intestinal flora. It does not cause emergence of strains resistant to nifuroxazide. The exact mechanism of action is not known. Nifuroxazide can inhibit dehydrogenase activity and disrupt protein synthesis in bacterial cells. Efficacy is independent of the pH in the intestinal lumen.
Nifuroxazide is practically not absorbed from the gastrointestinal tract after oral administration. It is excreted unchanged in the feces.
Indications for use
Treatment of acute bacterial diarrhea caused by susceptible strains of Staphylococcus spp., Salmonella spp., Escherichia coli in the absence of signs of invasion (e.g., deterioration of general condition, fever, toxicoin infection, etc.).
The dose and rehydration method (oral or intravenous) are determined according to the severity of the diarrhea, patient’s age, state of health, presence of concomitant diseases.
Dosage and administration method
The drug is administered orally. Shake the bottle thoroughly before use until a homogeneous suspension is obtained. If necessary, the suspension can be taken with water. The drug is taken regardless of meals.
Doses for children:
- 2 to 6 months – 1 to 2 measuring spoons for 2.5 ml 2 times a day, every 12 hours;
- From 7 months to 6 years of age – 1 measuring spoon for 5 ml 3 times a day, every 8 hours;
- Adults and children over 7 years of age – 1 scoop of 5 ml 4 times a day, every 6 hours.
Nifuroxazide should not be taken for more than 3 days without a physician’s consultation. If after that the symptoms do not disappear, a more thorough diagnosis to determine the cause of the symptoms is necessary, and antibiotic therapy should be considered.
During the treatment of acute diarrhea, constant oral replenishment of fluid deficiency in the body is mandatory, depending on the overall condition of the patient.
A measuring spoon for 2.5 ml contains 110 mg of nifuroxazide.
A measuring spoon for 5 ml contains 220 mg of nifuroxazide.
Hepatopoietic and lymphatic system disorders: One case of granulocytopenia has been described.
In cases of individual hypersensitivity to nifuroxazide, abdominal pain, nausea and exacerbation of diarrhea may appear. In the case of such symptoms of minor intensity, there is no need for special therapy or discontinuation of nifuroxazide. If the above symptoms of significant intensity develop, the drug should be discontinued. In the future, the patient should not take nitrofuran derivatives.
Skin and subcutaneous tissue:
Skin reactions in the form of skin rash are rare (1/10,000 to <1/1,000). One case of pustulosis in an elderly person and one case of nodular scabies due to contact allergy to nifuroxazide has been described.
Nifuroxazide is usually well tolerated and has virtually no side effects.
Nifuroxazid is contraindicated for use in hypersensitivity to any of its components, as well as in allergy to 5-nitrofuran derivatives. The drug should not be used in premature infants and children under 2 months of age.
Alcohol consumption during treatment with nifuroxazide may cause disulfiram-like reactions. During administration of Nifuroxazide, concomitant administration of other oral medications should be avoided due to the strong adsorptive properties of the drug.
If diarrhea persists after 3 days of treatment, a physician should be consulted. The physician should determine the cause of the symptoms and consider prescribing antibiotic therapy.
The drug is used with the obligatory observance of a diet, excluding juices, raw vegetables and fruits, as well as spicy and hard-to-digest foods.
During treatment with nifuroxazide, the use of alcoholic beverages is contraindicated, because the drug increases the body’s sensitivity to alcohol and may provoke a reaction expressed as an exacerbation of diarrhea, vomiting, abdominal pain, hyperemia of the skin, a feeling of heat in the face and upper torso, noise in the head, difficulty in breathing, tachycardia, a feeling of fear.
Due to the presence of sucrose in the drug, patients with rare hereditary diseases associated with fructose intolerance, impaired glucose-galactose absorption or sucrose-isomaltose deficiency should not take this drug.
Administration of the drug during pregnancy and lactation
The use of nifuroxazide during pregnancy:
There are no clinical data regarding the use of nifuroxazide during pregnancy.
Animal studies show no direct or indirect effects on the course of pregnancy, the development of the embryo or fetus, the course of labor, or the development of the child after delivery. Nifuroxazide is preferably not used in pregnant women. Before prescribing the drug, the treating physician should carefully weigh the expected benefit/risk of its use.
Nifuroxazide use during lactation:
Nifuroxazide is not absorbed in the gastrointestinal tract. Nevertheless, due to the lack of sufficient clinical data, caution should be exercised when prescribing nifuroxazide to breastfeeding women.
It is necessary to consult a physician for breast-feeding women before taking nifuroxazide.
Effect of the drug on the ability to drive vehicles and operate machinery
Nifuroxazide has no effect on the ability to drive vehicles and operate machinery.
One case of overdose of Nifuroxazid in form of oral suspension has been described in a child aged 2 years old who took unspecified quantity of the drug. The overdose manifested as drowsiness and diarrhea, which passed on their own. In case of overdose, gastric lavage and symptomatic treatment are recommended.
Form of production
Oral suspension 220 mg/5 ml 90 ml (bottles with measuring spoon or cup).
Store in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children!
After opening the bottle shelf life of the suspension – 14 days. Do not use after the expiration date.
Conditions for dispensing from pharmacies
Released by doctor’s prescription.