Nifuroxazide bosnalek

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

Composition:

Active substance: nifuroxazide

1 hard capsule contains 100 mg or 200 mg of nifuroxazidе;

Excipients: maize starch, sucrose, powdered cellulose, magnesium stearate.
The gelatin capsule of Nifuroxazide Bosnalijek 100 mg contains: titanium dioxide (E 171), quinoline yellow (E 104), azorubine (E 122), ponceau 4R (E 124), gelatin;
The gelatin capsule of Nifuroxazide Bosnalijek 200 mg contains: titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

Pharmaceutical form. Hard capsules.

Main physicochemical properties: elongated hard gelatin capsules consisting of a body and a cap, yellow (Nifuroxazide Bosnalijek 100 mg) or orange-yellow (Nifuroxazide Bosnalijek 200 mg), filled with yellow granules or slightly compressed yellow granular mass that disintegrates upon light pressure. Capsule size 2 (Nifuroxazide Bosnalijek 100 mg) or size 0 (Nifuroxazide Bosnalijek 200 mg).

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

Nitrofurazone is an antimicrobial agent belonging to the nitrofuran class. Its mechanism of action is not fully understood. The antimicrobial and antiparasitic properties of nitrofurazone are possibly due to the presence of an amino group. Its local activity and lack of penetration into organs and body tissues distinguish nitrofurazone from 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 undergoes extensive metabolism, with the main circulating components in the blood being metabolites. Biotransformation of nitrofurazone occurs in the intestine, and approximately 20% of the administered dose is excreted unchanged. Nitrofurazone and its metabolites are eliminated in the feces. The rate of elimination depends on the amount of drug administered and gastrointestinal motility. Overall, elimination of nitrofurazone is slow, allowing it to remain in the gastrointestinal tract for a prolonged period.

At therapeutic doses, nitrofurazone does not significantly 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. Nitrofurazone demonstrates mutagenic potential.

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

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

Clinical characteristics.

Indications.

Acute infectious diarrhea.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Nifuroxazide should not be used concomitantly with adsorbents, alcohol-containing preparations, drugs that may cause disulfiram-like reactions, and drugs that suppress the central nervous system.

Special precautions for use.

Treatment with rifamycin does not exclude dietary regimen and rehydration. If diarrhea does not stop after 3 days of treatment, dosage should be reviewed and a decision on rehydration therapy should be made. When necessary, concomitant rehydration therapy should be administered according to the patient's age, clinical condition, and severity of diarrhea.

In case of prescription of oral or intravenous rehydration, it is necessary to strictly follow instructions for dilution and administration of the designated solutions. If such rehydration is not required, fluid loss should be compensated by drinking large amounts of fluids containing salt and sugar (based on average daily requirement of 2 liters of water).

Dietary recommendations during diarrhea should be observed: avoid consumption of fresh vegetables and fruits, spicy food, frozen products and beverages. Rice is recommended. Consumption of dairy products should be decided on a case-by-case basis.

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

Nifuroxazide Bosnaliek 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 sucrose intolerance or fructose intolerance.

The gelatin capsule of Nifuroxazide Bosnaliek 100 mg contains colorants azorubine (E 122) and Ponceau 4R (E 124), 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 of diarrhea, vomiting, abdominal pain, sensation of warmth in the face and upper body, hyperemia, tinnitus, breathing difficulties, and tachycardia.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of nifuroxazide in pregnant women are limited. Data from animal studies on reproductive toxicity are insufficient. Nifuroxazide has mutagenic potential. Therefore, Nifuroxazide Bosnaliek is not recommended during pregnancy and should not be used in women of reproductive age who do not use 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 Bosnaliek during breastfeeding, its use is not recommended.

Fertility

Based on animal studies, there is insufficient information on the effect of nifuroxazide on fertility.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Dosage and Administration

Take orally, independently of food intake, swallowing the capsule with a glass of water.

For use in adults and children aged 6 years and older.

Adults and children aged 15 years and older: 200 mg (2 capsules of 100 mg or 1 capsule of 200 mg) four times daily. Maximum daily dose of rifamoxazole – 800 mg.

Children aged 6 years and older: 200 mg (2 capsules of 100 mg) 3–4 times daily. Daily dose of rifamoxazole – 600–800 mg.

Duration of treatment – no more than 7 days for 100 mg capsules and no more than 3 days for 200 mg capsules.

Children.

Nifuroxazide Bosnaliek 100 mg is indicated for children aged 6 years and older.

For treatment of children under 6 years of age, prescribe Nifuroxazide Bosnaliek as a suspension.

Nifuroxazide Bosnaliek 200 mg is indicated for children aged 15 years and older.

Overdose.

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

Side effects

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

Possible allergic reactions, including itching, skin rashes, urticaria, Quincke's edema (angioedema), and anaphylactic shock. If an allergic reaction occurs, the drug must be discontinued. The patient should subsequently avoid taking nitroxoline and other nitrofuran derivatives.

Reporting suspected adverse reactions

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

Shelf life

5 years.

Storage conditions

No special storage conditions required.

Keep out of reach of children.

Packaging

10 hard capsules in a blister, 3 blisters per cardboard box (Nifuroxazide Bosnaliek, 100 mg).

8 hard capsules in a blister, 1 or 2 blisters per cardboard box (Nifuroxazide Bosnaliek, 200 mg).

Prescription status

Prescription only.

Manufacturer

Bosnalijek d.d.

Manufacturer's address and place of business

Yukicheva 53, 71000 Sarajevo, Bosnia and Herzegovina

Applicant's representative: [email protected]