Dezenterol^® (Suspension) Instructions for Use

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Dosage Form

Dezenterol®

Suspension for oral administration 200 mg/5 ml: 50 ml, 90 ml, 100 ml, 120 ml or 150 ml fl.

Dosage Form, Packaging, and Composition

Suspension for oral administration yellow in color, with a banana odor; sediment may appear, and a homogeneous suspension is formed after shaking.

Excipients : sucrose – 1000 mg, carbomer 974R – 10.5 mg, simethicone emulsion 30% – 10.5 mg, sodium hydroxide – 2 mg, citric acid monohydrate – 0.7 mg, methylparahydroxybenzoate – 5 mg, banana flavor – 10 mg, purified water – up to 5 ml.

50 ml – bottles – cardboard packs with a measuring spoon.
90 ml – bottles – cardboard packs with a measuring spoon.
100 ml – bottles – cardboard packs with a measuring spoon.
120 ml – bottles – cardboard packs with a measuring spoon.
150 ml – bottles – cardboard packs with a measuring spoon.

Clinical-Pharmacological Group

Intestinal antiseptic. Antidiarrheal agent

Pharmacotherapeutic Group

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

Pharmacological Action

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 – chemically altered.

Indications

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

ICD codes

Dosage Regimen

Administer orally. Shake the bottle vigorously before each use to form a homogeneous suspension.

Use the provided measuring spoon to ensure accurate dosing. The standard treatment duration is 5 to 7 days; do not exceed 7 days of therapy.

For adults and children over 6 years: take 10 ml (2 measuring spoons) containing 400 mg of nifuroxazide, four times daily.

For children from 2 to 6 years: take 5 ml (1 measuring spoon) containing 200 mg of nifuroxazide, three times daily.

For children from 1 to 2 months: take 2.5 ml (half a measuring spoon) containing 100 mg of nifuroxazide, two or three times daily.

Maintain consistent intervals between doses. Initiate oral rehydration concurrently with nifuroxazide therapy to prevent dehydration.

Discontinue use and consult a physician if symptoms persist after 3 days of treatment or if high fever, severe abdominal pain, or blood in the stool occurs.

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 must be carried out simultaneously with nifuroxazide therapy.

In case of bacterial diarrhea occurring with deterioration of general condition, fever, symptoms of intoxication or infection, a physician 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 is prohibited during nifuroxazide therapy.

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.