Endifuril^® (Capsules, Suspension) Instructions for Use

Instructions
Dosage forms

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 a 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

Open the list of 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 and duration. The maximum treatment course is seven days.

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

For children from 3 to 6 years: use the oral suspension. Administer one 220 mg (5 ml) scoop three times daily.

For children from 1 month to 3 years: use the oral suspension. Administer one 220 mg (5 ml) scoop two times daily.

Shake the suspension bottle vigorously before each use. Use the provided measuring spoon for accurate dosing.

If diarrhea persists beyond three days of treatment, discontinue use and consult a physician. Initiate oral rehydration therapy concurrently to prevent dehydration.

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 age-appropriate recommended doses and dosage forms. 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 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

Endifuril^® [Iris, LLC (Russia)]
Oral suspension 200 mg/5 ml: fl. 90 ml with meas. spoon

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Endifuril^®

Oral suspension 200 mg/5 ml: fl. 90 ml with meas. spoon

Dosage Form, Packaging, and Composition

Oral suspension yellow, homogeneous, with a characteristic odor.

	5 ml
Nifuroxazide (calculated as 100% substance)	200 mg

Excipients : sucrose – 1000 mg, carbomer – 9 mg, methylparaben – 5 mg, sodium hydroxide – 1.63 mg, anhydrous citric acid – 0.75 mg, banana flavor – 0.6 mg, purified water – to make a suspension with a volume of 5 ml.

90 ml – dark glass bottles (1) with a double-sided measuring spoon with a volume of 2.5 ml on one side and 5 ml on the other side – cardboard boxes.

Endifuril^® [Iris, LLC (Russia)]
Capsules 200 mg: 8, 10, 16, 20, 24, 30, 32, 40, 48 or 50 pcs.

Marketing Authorization Holder

Iris, LLC (Russia)

Manufactured By

Avva Rus, JSC (Russia)

Dosage Form

Endifuril^®

Capsules 200 mg: 8, 10, 16, 20, 24, 30, 32, 40, 48 or 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size 0, yellow; capsule contents – a mixture of powder and granules, yellow.

	1 caps.
Nifuroxazide	200 mg

Excipients : microcrystalline cellulose 102 – 86 mg, potato starch – 40 mg, magnesium stearate – 8 mg, sucrose – to obtain capsule contents weighing 400 mg.

Composition of the hard gelatin capsule gelatin – up to 100%, riboflavin – 0.5%, titanium dioxide – 2%.

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