Stopdiar (Tablets, Capsules, Suspension) Instructions for Use

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibacterial drug, a derivative of nitrofuran. Antidiarrheal drug

Pharmacotherapeutic Group

Antidiarrheals, intestinal anti-inflammatory/antimicrobial agents; intestinal antimicrobial agents; other intestinal antimicrobial agents

Pharmacological Action

Nifuroxazide is an antimicrobial agent, a derivative of nitrofuran. It blocks the activity of dehydrogenases and inhibits the respiratory chains, the tricarboxylic acid cycle, and a number of other biochemical processes in the microbial cell. It destroys the microbial cell membrane and reduces toxin production by microorganisms.

Highly active against Campylobacter jejuni, Escherichia coli, Salmonella spp., Shigella spp.; Clostridium perfringens, Vibrio cholerae, pathogenic Vibrions and Vibrio parahaemolytique, Staphylococcus spp.

Weakly sensitive to nifuroxazide: Citrobacter spp., Enterobacter cloacae and Proteus indologenes.

Resistant to nifuroxazide: Klebsiella spp., Proteus mirabilis, Providencia spp., Pseudomonas spp.

Nifuroxazide exerts its antibacterial action exclusively in the intestinal lumen. Nifuroxazide does not disturb the balance of the intestinal microflora. In acute bacterial diarrhea, it restores intestinal eubiosis. When infected with enterotropic viruses, it prevents the development of bacterial superinfection.

Preclinical safety data

Nifuroxazide exhibits a possible mutagenic potential.

The carcinogenic potential of nifuroxazide was evaluated in mice (50/sex/group) and rats (52/sex/group) receiving Nifuroxazide with food for 2 years at doses of 0, 200, 600, or 1800 mg/kg/day. Despite mutagenic properties, the carcinogenicity of nifuroxazide was not proven in either mice or rats.

Based on a comparison of doses converted to body surface area, in two-year studies in mice and rats (at doses of 5400 mg/m² and 10800 mg/m², respectively), the drug had an effect 11 and 22 times, respectively, greater than the effect of the maximum human dose (1800 mg, or 493 mg/m² for a patient weighing 60 kg).

Pharmacokinetics

Absorption and metabolism

After oral administration, Nifuroxazide is partially absorbed (10-20%) from the gastrointestinal tract and is largely metabolized. The main part of the active substance circulates in the blood in the form of metabolites.

Excretion

Nifuroxazide is excreted through the intestine: 20% unchanged, and the remaining amount of nifuroxazide is chemically altered.

Indications

Adults and children from 1 month of age

• Acute bacterial diarrhea occurring without deterioration of general condition, fever, intoxication.

ICD codes

Dosage Regimen

Capsules

Take orally.

Children from 3 to 6 years: 200 mg of nifuroxazide (1 capsule) 3 times/day (8-hour interval between doses).

Children from 6 to 18 years: 200 mg of nifuroxazide (1 capsule) 3-4 times/day (6-8 hour interval between doses).

Adults: 200 mg of nifuroxazide (1 capsule) 4 times/day (6-hour interval between doses).

The duration of the treatment course is 5-7 days, but not more than 7 days. If improvement does not occur within the first 3 days of administration, a doctor should be consulted.

The drug should be used only according to the method of application and in the doses indicated in the instructions. It is not recommended to take a double dose to compensate for a missed dose.

If necessary, the patient should consult a doctor before using the medicinal product.

Tablets

Take orally.

Adults: 200 mg (2 tablets of 100 mg) 4 times/day (6-hour interval between doses).

Children aged 3 to 6 years: 200 mg (2 tablets of 100 mg) 3 times/day (8-hour interval between doses).

Children aged 6 to 18 years: 200 mg (2 tablets of 100 mg) 3-4 times/day (6-8 hour interval between doses).

The duration of the treatment course is 5-7 days, but not more than 7 days.

This drug should not be used in children under 3 years of age.

If improvement does not occur within the first 3 days of administration, the patient should consult a doctor.

Suspension

The drug is taken orally.

The supplied measuring spoon should be used to take the suspension.

Before taking the drug, the bottle should be shaken several times to make the suspension homogeneous. The drug can be taken with water.

Adults: 220 mg (1 large measuring spoon of suspension) 4 times/day (6-hour interval between doses).

Children aged 1 to 6 months: 110 mg (1 small measuring spoon of suspension) 2-3 times/day (8-12 hour interval between doses).

Children aged 6 months to 3 years: 110 mg (1 small measuring spoon of suspension) 3 times/day (8-hour interval between doses).

Children aged 3 to 6 years: 220 mg (1 large measuring spoon of suspension) 3 times/day (8-hour interval between doses).

Children aged 6 to 18 years: 220 mg (1 large measuring spoon of suspension) 3-4 times/day (6-8 hour interval between doses).

Stopdiar should be used for 5-7 days, but not more than 7 days. If improvement does not occur within the first 3 days of administration, a doctor should be consulted.

The drug should be used only according to the method of application and in the doses indicated in the instructions. If necessary, a doctor should be consulted before using the drug.

Adverse Reactions

From the immune system: allergic reactions (skin rash, urticaria, angioedema, anaphylactic shock).

If any of the indicated adverse reactions worsen, or the patient notices any other adverse reactions, they should inform the doctor.

Contraindications

• Hypersensitivity to nifuroxazide, nitrofuran derivatives, or any of the excipients of the drug;
• Fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase and isomaltase deficiency;
• Pregnancy;
• Neonatal period up to 1 month;
• Prematurity.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of nifuroxazide in pregnant women are limited. Animal studies on reproductive toxicity are insufficient. Nifuroxazide exhibits a possible mutagenic potential. Therefore, Nifuroxazide is not recommended during pregnancy and should not be prescribed to women of childbearing potential not using effective methods of contraception.

Breastfeeding period

It is unknown whether Nifuroxazide or its metabolites are excreted in breast milk. Since Nifuroxazide has low bioavailability (absorption from the gastrointestinal tract is 10-20% of the administered dose), its amount in breast milk is likely to be low. However, the impact on the gastrointestinal microflora of breastfed infants cannot be ruled out. Due to the lack of clinical experience, treatment with nifuroxazide during breastfeeding is not recommended.

Fertility

Animal studies have not provided sufficient information on the effect of nifuroxazide on fertility.

Pediatric Use

Contraindicated in newborn infants under 1 month and premature infants.

Special Precautions

When treating diarrhea, rehydration therapy should be carried out simultaneously with nifuroxazide therapy.

When treating diarrhea, it is important to consume plenty of fluids to compensate for fluid loss (the average daily water intake for an adult is 2 liters). In case of severe and prolonged diarrhea, severe vomiting, or anorexia, a doctor’s consultation is necessary. Intravenous fluid replacement may be required.

Treatment of diarrhea in children under 3 years of age is recommended under medical supervision.

In case of bacterial diarrhea with signs of systemic involvement (deterioration of general condition, fever, symptoms of intoxication or infection), a doctor should be consulted to decide on the use of systemic antibacterial drugs.

If symptoms of hypersensitivity (shortness of breath, rash, itching) appear, the drug should be discontinued.

Alcohol consumption is prohibited during therapy.

Special information on excipients

Due to the content of methylparahydroxybenzoate, Stopdiar may cause allergic reactions (possibly delayed).

Stopdiar contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase and isomaltase deficiency should not take this drug.

1 small measuring spoon of suspension contains 0.09 XE, 1 large measuring spoon of suspension contains 0.18 XE.

The daily dose of suspension for children aged 1 month to 3 years contains 0.27 XE. The daily dose of suspension for children aged 3 to 6 years contains 0.54 XE. The maximum daily dose of suspension for children aged 6 to 18 years contains 0.72 XE.

The daily dose of suspension for adults contains 0.72 XE.

Effect on ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles and machinery.

Overdose

Symptoms of overdose are not known.

Treatment in case of overdose should be symptomatic.

Drug Interactions

If the patient has recently taken, is currently taking, or is planning to take other medicinal products (including over-the-counter ones), a doctor should be consulted before using Stopdiar.

Stopdiar should not be taken together with drugs that cause disulfiram-like reactions, such as metronidazole, cephalosporins, chloramphenicol, nitrofurantoin, griseofulvin.

Stopdiar should not be taken together with drugs that depress the function of the central nervous system, for example, benzodiazepines such as bromazepam, alprazolam, lorazepam, midazolam.

Alcohol consumption can cause acute and severe disulfiram-like reactions.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

An opened bottle should be stored for no more than 3 months.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.