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Elufor (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. 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

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 dosage regimen specified for the patient’s age and the selected pharmaceutical form. 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, approximately every six hours.

For children from 3 to 6 years: use the oral suspension. Administer 5 ml of suspension (220 mg nifuroxazide) three to four times daily. Use the measuring spoon provided for accurate dosing.

For children from 2 months to 3 years: use the oral suspension. Administer 2.5 ml of suspension (110 mg nifuroxazide) three times daily. Do not exceed the recommended dose for this age group.

Shake the suspension bottle vigorously before each use to ensure homogeneity. Initiate treatment at the first signs of acute bacterial diarrhea. If no clinical improvement is observed within three days, discontinue use and consult a physician.

Concurrently with nifuroxazide administration, implement oral rehydration therapy to prevent or correct fluid and electrolyte losses. Complete the full prescribed course unless otherwise directed by a physician.

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 case of bacterial diarrhea occurring with deterioration of 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.

Alcohol consumption 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.

Medical Disclaimer

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

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Elufor Oral suspension 200 mg/5 ml: 90 ml bottle in a set with a measuring spoon

Dosage Form, Packaging, and Composition

Oral suspension yellow in color, with a characteristic odor; sediment may appear, and shaking produces a homogeneous suspension.

5 ml
Nifuroxazide 200 mg

Excipients : sucrose – 1000 mg, sodium hydroxide – 2 mg, methylparahydroxybenzoate – 5 mg, carbomer – 10.5 mg, simethicone (30% emulsion) – 10.5 mg, citric acid monohydrate – 0.7 mg, banana flavor – 10 mg, water – up to 5 ml.

90 ml – dark glass bottles (1) in a set with a measuring spoon – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Elufor Capsules 200 mg: 5, 6, 10, 12, 15, 18, 20, 24, 25, 30, 36, 40, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, body and cap yellow, opaque; capsule contents – a mixture of powder and granules, yellow in color; compaction of the capsule contents into lumps is allowed, which crumble when pressed.

1 caps.
Nifuroxazide 200 mg

Excipients : sucrose – 70 mg, microcrystalline cellulose (MCC-101) – 41.5 mg, corn starch – 35 mg, magnesium stearate – 3.5 mg.

Capsule body composition quinoline yellow dye – 0.75%, sunset yellow FCF dye – 0.059%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition quinoline yellow dye – 0.75%, sunset yellow FCF dye – 0.059%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – contour cell packaging (1) – cardboard packs.
5 pcs. – contour cell packaging (2) – cardboard packs.
5 pcs. – contour cell packaging (3) – cardboard packs.
5 pcs. – contour cell packaging (4) – cardboard packs.
5 pcs. – contour cell packaging (5) – cardboard packs.
5 pcs. – contour cell packaging (6) – cardboard packs.
5 pcs. – contour cell packaging (10) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (5) – cardboard packs.
6 pcs. – contour cell packaging (6) – cardboard packs.
6 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.

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