Nifuroxazide bosnalek

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NIFUROXAZIDE BOSNALEK (NIFUROXAZIDE BOSNALIJEK)

Composition:

Active ingredient: nifuroxazide;

5 ml of suspension contains 200 mg of nifuroxazide;

Excipients: sucrose, carbomer, banana flavor, sodium hydroxide, methylparahydroxybenzoate (E 218), ethanol 96%, anhydrous citric acid, purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical characteristics: yellow, viscous suspension with a banana odor.

Pharmacotherapeutic group. Antidiarrheal agents, drugs used in the treatment of infectious and inflammatory intestinal diseases. Antimicrobial agents for the treatment of intestinal infections. Nifuroxazide.

ATC code A07AX03.

Pharmacological Properties

Pharmacodynamics

Nifuroxazide is an antimicrobial agent belonging to the nitrofuran class. Its mechanism of action is not fully understood. The antimicrobial and antiparasitic properties of nifuroxazide are possibly due to the presence of an amino group. The local activity and lack of penetration into organs and tissues make nifuroxazide unique compared to other nitrofuran derivatives, as this antidiarrheal agent lacks systemic effects. It is effective against Gram-positive and Gram-negative bacteria: Streptococcus pyogenes, Staphylococcus aureus, E. coli, Salmonellae, Shigellae.

Pharmacokinetics

After oral administration, the drug is partially absorbed (10–20%) from the gastrointestinal tract and extensively metabolized, with metabolites being the main circulating components in the blood. Biotransformation of nifuroxazide occurs in the intestine, and approximately 20% of the administered dose is excreted unchanged. Nifuroxazide and its metabolites are eliminated with feces. The rate of elimination depends on the amount of drug administered and on gastrointestinal motility. Overall, elimination of nifuroxazide is slow, and it remains in the gastrointestinal tract for a prolonged period.

At therapeutic doses, nifuroxazide practically does not suppress normal intestinal microflora, does not induce the emergence of resistant microbial forms, and does not promote the development of cross-resistance to other antibacterial agents. Therapeutic effect is achieved within the first hours of treatment.

Preclinical Safety Data. Nifuroxazide demonstrates mutagenic potential.

The carcinogenic potential of nifuroxazide was evaluated in mice (50 animals of each sex per group) and rats (52 animals of each sex per group), which received nifuroxazide in the diet for 2 years at doses of 0, 200, 600, or 1800 mg/kg/day. Despite its mutagenic properties, carcinogenicity of nifuroxazide was not demonstrated in either mice or rats.

The doses administered to mice and rats (5400 mg/m² and 10,800 mg/m², respectively) were 11 and 22 times higher than the maximum human dose of 1800 mg (493 mg/m² for a 60 kg patient), respectively, when adjusted for body surface area.

Clinical characteristics.

Indications.

Acute infectious diarrhea.

Contraindications.

Hypersensitivity to nifuroxazide, other 5-nitrofuran derivatives, or any other components of the drug.

Interaction with other medicinal products and other forms of interactions.

Nifuroxazide is not recommended to be used concomitantly with adsorbents, alcohol-containing preparations, drugs that may cause disulfiram-like reactions, and drugs that suppress the central nervous system (CNS).

Special precautions for use.

Treatment with nifuroxazide does not exclude dietary management and rehydration. If necessary, concomitant rehydration therapy should be administered according to the patient's age, clinical condition, and severity of diarrhea.

Rehydration is a key component in the treatment of acute diarrhea in children. Children should be given frequent small amounts of fluids (every 15 minutes).

Prevention or treatment of dehydration should be performed using oral or intravenous rehydration solutions. If rehydration is indicated, it is recommended to use rehydration solutions specifically designed for this purpose, according to the instructions for dilution and administration. The required volume of oral rehydration solutions depends on the degree of body weight loss. Intravenous rehydration is necessary in cases of severe diarrhea, persistent vomiting, or refusal to eat.

If intravenous rehydration is not required, fluid losses should be compensated by drinking large amounts of fluids containing salt and sugar (based on an average daily requirement of 2 liters of water).

Dietary recommendations during diarrhea should be followed: avoid fresh vegetables and fruits, spicy foods, frozen foods and beverages. Rice-based meals are recommended. The decision on consumption of dairy products should be made on a case-by-case basis.

If diarrhea is accompanied by clinical signs indicating severe disease (worsening general condition, fever, signs of intoxication), NIFUROXAZIDE BOSNALEK should be administered together with antibacterial agents used for the treatment of intestinal infections, as the drug is not absorbed from the gastrointestinal tract and does not enter systemic circulation. The drug should not be used as monotherapy for intestinal infections complicated by septicemia.

NIFUROXAZIDE BOSNALEK contains sucrose, which should be taken into account when prescribing the drug to patients with diabetes mellitus. The drug is not recommended for patients with hereditary fructose or sucrose intolerance.

The medicinal product contains methylparaben (E 218), which may cause allergic reactions.

Alcohol consumption is strictly prohibited during treatment due to the risk of developing a disulfiram-like reaction, manifested by worsening diarrhea, vomiting, abdominal pain, sensation of warmth in the face and upper body, facial flushing, tinnitus, breathing difficulties, and tachycardia.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of nifuroxazide in pregnant women are limited. Reproductive toxicity studies in animals are insufficient. Nifuroxazide has shown mutagenic potential. Therefore, NIFUROXAZIDE BOSNALEK is not recommended during pregnancy and should not be administered to women of childbearing potential who are not using effective contraception.

Lactation

It is unknown whether nifuroxazide or its metabolites are excreted in breast milk. Since nifuroxazide has low bioavailability (gastrointestinal absorption is approximately 10–20% of the dose), its concentration in milk is likely to be low. However, an effect on the gastrointestinal microbiome of breastfed infants cannot be excluded. Due to the lack of clinical experience with the use of NIFUROXAZIDE BOSNALEK during breastfeeding, its use is not recommended.

Fertility

There is insufficient data from animal studies regarding the effect of nifuroxazide on fertility.

Ability to affect reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

Take orally, regardless of food intake. Shake the suspension well before use. The maximum daily dose of nifuroxazide is 800 mg.

Children aged 2 years and older: 5 ml of suspension three times a day.

Adults: 5 ml of suspension four times a day.

Treatment duration should not exceed 7 days.

Children.

Do not administer to children under 2 years of age.

Overdose.

Cases of overdose have not been reported. In case of overdose, gastric lavage and symptomatic treatment are recommended.

Side effects.

Possible temporary abdominal pain, nausea, vomiting, and worsening of diarrhea.

Possible allergic reactions, including itching, skin rash, urticaria, Quincke's edema (angioedema), anaphylactic shock. If an allergic reaction occurs, the drug must be discontinued.

In the future, the patient must avoid taking nifuroxazide and other nitrofuran derivatives.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Shelf life after first opening – 14 days.

Storage conditions.

Store out of reach of children, at a temperature not exceeding 30 °C.

Do not freeze.

Packaging.

90 mL in a bottle, with 1 bottle fitted with a child-resistant cap, a plastic dosing spoon, and a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Bosnalék d.d.

Manufacturer's address.

Yukicheva 53, 71000 Sarajevo, Bosnia and Herzegovina