Instructions Nifuroxazide suspension 220mg/5ml 90ml
Composition
active ingredient: nifuroxazide;
5 ml of suspension contain 220 mg of nifuroxazide;
excipients: confectioner's sugar, carbomer 934, simethicone, methyl parahydroxybenzoate (E 218), sodium hydroxide, citric acid monohydrate, "Peach" flavoring (contains propylene glycol), purified water.
Dosage form
Oral suspension.
Main physical and chemical properties: light yellow suspension, with a characteristic aromatic odor, sweet to the taste. During storage, stratification is possible, which is eliminated by shaking.
Pharmacotherapeutic group
Antimicrobial agents used to treat intestinal infections. ATC code A07A X03.
Pharmacological properties
Pharmacodynamics.
Nifuroxazide is an antimicrobial drug, a derivative of nitrofuran. The mechanism of action 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 there is no systemic effect of this antidiarrheal drug. Effective against gram-positive and gram-negative bacteria: Streptococcus pyogenes, Staphylococcus aureus, E. coli, Salmonellae, Shigellae.
Pharmacokinetics.
Nifuroxazide is partially absorbed (10-20%) from the gastrointestinal tract after oral administration and is extensively metabolized, with the main components circulating in the blood being metabolites.
Nifuroxazide and its metabolites are excreted in the feces. The rate of excretion of metabolites 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 practically does not suppress the normal intestinal microflora, does not cause the appearance of resistant microbial forms, 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.
Preclinical safety data
Nifuroxazide demonstrates possible mutagenic potential.
The carcinogenic potential of nifuroxazide was evaluated in mice (50/sex/group) and rats (52/sex/group) that received nifuroxazide in the diet for 2 years at doses of 0, 200, 600 or 1800 mg/kg/day. Despite its mutagenic properties, the carcinogenicity of nifuroxazide was not proven in either mice or rats.
Nifuroxazide was studied for two years in mice and rats at doses of 5400 mg/m2 and 10800 mg/m2, respectively, based on body surface area, which were 11 and 22 times, respectively, the maximum human dose of 1800 mg (493 mg/m2 for a patient weighing 60 kg).
Indication
Acute diarrhea of infectious etiology.
Contraindication
Hypersensitivity to nifuroxazide, other 5-nitrofuran derivatives or to other components of the drug.
Drug interactions 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 should not be used for more than 7 days. There are no indications for long-term therapy. If diarrhea does not stop within 3 days of starting treatment, in-depth diagnostics are necessary to determine the cause of the symptoms. Antibiotic therapy may be necessary.
In case of severe invasive diarrhea with clinical manifestations of general weakness, fever, and symptoms of intoxication, it is advisable to prescribe a systemic antibiotic used to treat intestinal infections, since nifuroxazide is not absorbed from the gastrointestinal tract and does not enter the systemic circulation.
The drug is not 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.
Food intake should be maintained, but dietary recommendations should be followed during diarrhea: avoid fresh vegetables and fruits, spicy foods, frozen foods, and cold drinks. The decision about dairy products should be made on a case-by-case basis. Baked meat and rice are recommended.
During the treatment of diarrhea, constant additional oral rehydration is required to compensate for fluid loss caused by diarrhea: it is necessary to consume large amounts of drinks containing salt and sugar (based on the average daily need of 2 liters of water for an adult).
In case of severe and prolonged diarrhea, severe vomiting or anorexia, intravenous rehydration is necessary depending on the age and condition of the patient. When oral or intravenous rehydration is used, the instructions for dilution and use of the solutions intended for this purpose must be followed.
Patients should not consume alcoholic beverages during treatment with nifuroxazide 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.
Nifuroxazide contains confectioner's 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 medicine contains methyl parahydroxybenzoate (E 218), which may cause an allergic reaction (delayed type).
Use during pregnancy or breastfeeding
Pregnancy
There are limited data on the use of nifuroxazide in pregnant women. Animal data on reproductive toxicity are insufficient. Nifuroxazide exhibits possible mutagenic potential. Therefore, nifuroxazide is not recommended for use during pregnancy and should not be administered to women of childbearing potential not using effective contraception.
Lactation
It is not known whether nifuroxazide or its metabolites are excreted in human milk. Since nifuroxazide has low bioavailability (approximately 10-20% of the dose is absorbed from the gastrointestinal tract), its amount in milk is likely to be low. However, an effect on the gastrointestinal microbiome of breast-fed infants cannot be excluded. Due to the lack of clinical experience, the use of medicinal products containing nifuroxazide during breastfeeding is not recommended.
Fertility
Based on animal studies, there is insufficient information on the effects of nifuroxazide on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Take orally, regardless of meals. The suspension should be shaken before use. The maximum daily dose of nifuroxazide is 800 mg.
Children over 2 years of age: 5 ml of suspension 3 times a day.
Adults: 5 ml of suspension 4 times a day.
Duration of treatment is no more than 7 days.
Children: Do not administer to 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
Blood and lymphatic system disorders: One case of granulocytopenia has been described.
On the part of the immune system: allergic reactions, including angioedema (Quincke's edema), anaphylactic shock, shortness of breath, urticaria and skin itching. The occurrence of an allergic reaction requires discontinuation of the drug. In the future, the patient should avoid taking nifuroxazide and other nitrofuran derivatives.
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 such as skin rash and itching have been reported. One case of pustulosis in an elderly person and one case of pruritus nodosum in the presence of contact allergy to nifuroxazide have been reported.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of the reach of children.
Packaging
90 ml in a bottle or jar; 1 bottle or jar with a dosing cup in a pack.
Vacation category
According to the recipe.
Producer
LLC "SKP "Pharmaceutical Factory".
Location of the manufacturer and address of its place of business.
Ukraine, 12430, Zhytomyr region, Zhytomyr district, Stanyshivka village, Koroleva st., bldg. 4.
