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Mirofuril (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

Antimicrobial agent – nitrofuran

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 deterioration of general condition, fever, or intoxication.

ICD codes

ICD-10 code Indication
A09 Other and unspecified gastroenteritis and colitis of infectious origin
ICD-11 code Indication
1A40.Z Infectious gastroenteritis or colitis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Adhere strictly to the age-specific dosing schedule. The maximum duration of therapy is seven days.

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

For the oral suspension, shake the bottle vigorously before each use. Use the measuring spoon provided. For children aged 3 to 6 years: Administer one 5 ml spoonful (220 mg) three times daily. For children aged 7 to 14 years: Administer one 5 ml spoonful (220 mg) four times daily.

Do not exceed the recommended daily dose. If no clinical improvement is observed within three days, discontinue use and consult a physician. Concurrently with therapy, implement oral rehydration to 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, traumatic brain injury, 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 should be carried out simultaneously with nifuroxazide therapy.

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.

Alcohol consumption during nifuroxazide therapy is prohibited.

Drug Interactions

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

Storage Conditions

Store at 15°C (59°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

OHFK, JSC (Russia)

Manufactured By

Abc Farmaceutici, S.p.A. (Italy)

Labeled By

OHFK, JSC (Russia)

Dosage Form

Bottle OTC Icon Mirofuril Capsules 100 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 2, yellow body and cap; capsule contents – yellow powder or yellow powder with inclusions in the form of small pieces of compressed mass, or compressed yellow powder that crumbles with light pressure.

1 caps.
Nifuroxazide 100 mg

Excipients : sucrose – 35.5 mg, corn starch – 34 mg, microcrystalline cellulose – 4.5 mg, magnesium stearate – 1 mg.

Capsule shell composition gelatin – 60.085 mg, titanium dioxide (E171) – 0.61 mg, yellow iron oxide – 0.305 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

OHFK, JSC (Russia)

Manufactured By

Abc Farmaceutici, S.p.A. (Italy)

Labeled By

OHFK, JSC (Russia)

Dosage Form

Bottle OTC Icon Mirofuril Capsules 200 mg: 7, 8, 10, 14, 16, 20, 21, 24, 28, 30, 32, 35, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, white body and cap; capsule contents – yellow powder or yellow powder with inclusions in the form of small pieces of compressed mass, or compressed yellow powder that crumbles with light pressure.

1 caps.
Nifuroxazide 200 mg

Excipients : sucrose – 71 mg, corn starch – 68 mg, microcrystalline cellulose – 9 mg, magnesium stearate – 2 mg.

Capsule shell composition gelatin – 94.08 mg, titanium dioxide (E171) – 1.92 mg.

7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
8 pcs. – contour cell packs (1) – cardboard packs.
8 pcs. – contour cell packs (2) – cardboard packs.
8 pcs. – contour cell packs (3) – cardboard packs.
8 pcs. – contour cell packs (4) – cardboard packs.
8 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.

Marketing Authorization Holder

OHFK, JSC (Russia)

Manufactured By

Abc Farmaceutici, S.p.A. (Italy)

Dosage Form

Bottle OTC Icon Mirofuril Oral suspension 200 mg/5 ml: bottle 90 ml with measuring cup

Dosage Form, Packaging, and Composition

Oral suspension yellow in color, with a banana smell.

5 ml
Nifuroxazide 200 mg

Excipients : sucrose – 1000 mg, methylparahydroxybenzoate – 5 mg, ethanol 96% – 0.05 ml, carbomer – 10.5 mg, citric acid – 0.75 mg, banana flavor – 10 mg, sodium hydroxide solution 32% – to pH 5.2-5.8, purified water – up to 5 ml.

90 ml – dark glass bottles (1) complete with a measuring cup – cardboard packs.

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