Refurox (Capsules) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Dosage Form

Refurox

Capsules 200 mg: 16, 20, 24, or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 0, with a yellow body and cap; the capsule contents are a mixture of granules and powder, yellow or almost yellow in color; compaction of the capsule contents into lumps is allowed, which crumble when pressed with a glass rod.

Excipients: sucrose, microcrystalline cellulose 101, corn starch, magnesium stearate.

Hard gelatin capsule:
capsule body composition: titanium dioxide, quinoline yellow dye, sunset yellow FCF dye, gelatin,
capsule cap composition: titanium dioxide, quinoline yellow dye, sunset yellow FCF dye, gelatin.

8 pcs. – blister packs (2) – cardboard packs.
8 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

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 Vibrios and Vibrio parahaemolyticus, Staphylococcus spp. The following are weakly sensitive to nifuroxazide: Citrobacter spp, Enterobacter cloacae and Proteus indologenes. The following are 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. During infection 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 deterioration of general condition, fever, or intoxication.

ICD codes

Dosage Regimen

Take orally. Swallow the capsule whole with a sufficient amount of water.

Adhere strictly to the dosing schedule based on patient age. For adults and children over 6 years of age, administer 200 mg (1 capsule) four times daily.

Maintain an interval of approximately 6 hours between doses. The maximum daily dosage for this age group is 800 mg (4 capsules).

The standard treatment duration for acute bacterial diarrhea is 5 to 7 days. Do not exceed a 7-day course of treatment.

If symptoms persist beyond 3 days of therapy, re-evaluate the patient’s condition.

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

This dosage information is specific to the 200 mg capsule formulation. Do not use this formulation in children under 6 years of age.

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 with nifuroxazide therapy, rehydration therapy must be carried out simultaneously.

In the case of bacterial diarrhea occurring with a deterioration in 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, 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 30°C (86°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.