Diafuril (Capsules, Suspension) Instructions for Use

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Intestinal antiseptic. Antidiarrheal agent

Pharmacotherapeutic Group

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

Pharmacological Action

An antimicrobial agent, a nitrofuran derivative. 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.

It is 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.

It 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.

Pharmacokinetics

After oral administration, Nifuroxazide is practically not absorbed from the gastrointestinal tract and acts in the intestinal lumen. It is excreted through the intestine: 20% unchanged, the rest is chemically altered.

Indications

Acute bacterial diarrhea occurring without worsening of the general condition, fever, or intoxication.

ICD codes

Dosage Regimen

Administer orally. Select the dosage form and regimen based on the patient’s age.

For adults and children over 6 years: administer two 200 mg capsules four times daily. Maintain regular 6-hour intervals between doses.

For children from 2 to 6 years: use the oral suspension. Administer 5 ml (220 mg) four times daily. Use the measuring spoon provided.

For children from 1 to 2 months: use the oral suspension. Administer 2.5 ml (110 mg) two or three times daily. Adhere to the prescribed frequency.

The standard treatment duration is 5 to 7 days. Do not exceed a 7-day course of therapy.

If symptoms persist after 3 days of treatment, re-evaluate the patient and diagnosis.

Initiate oral rehydration concurrently to prevent and correct fluid and electrolyte losses.

Adverse Reactions

Allergic reactions skin rash, urticaria, angioedema, anaphylactic shock.

Contraindications

Hypersensitivity to nitrofuran derivatives; pregnancy; childhood – depending on the dosage form.

With caution liver disease, alcoholism, craniocerebral trauma, brain diseases; breastfeeding period; childhood.

Use in Pregnancy and Lactation

The use of nifuroxazide during pregnancy is not recommended. During lactation (breastfeeding), it should be used with caution, in a short course.

Pediatric Use

In children, use with caution, according to indications, in doses and dosage forms recommended for the respective age. It is necessary to strictly follow the instructions in the nifuroxazide drug leaflets regarding contraindications for the use of specific nifuroxazide dosage forms in children of different ages.

Special Precautions

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

In case of bacterial diarrhea occurring with a worsening of the general condition, fever, symptoms of intoxication or infection, you should consult a doctor to decide on the use of systemic antibacterial drugs. If symptoms of hypersensitivity (shortness of breath, rash, itching) appear, nifuroxazide should be discontinued.

Consumption of alcohol during nifuroxazide therapy is prohibited.

Drug Interactions

Concomitant use with drugs that cause disulfiram-like reactions, and with drugs that depress the function of the central nervous system, is not recommended.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.