Ekofuril® capsules 100 mg

Instructions for Use of Ekofuril® capsules 100 mg

Trade Name of the Drug: Ekofuril^®

International Nonproprietary Name: nifuroxazide

Dosage Form: capsules

Composition per one capsule

for 100 mg dosage:

Active substance: nifuroxazide 100.0 mg.

Excipients: lactitol - 300.0 mg, microcrystalline cellulose - 23.0 mg, potato starch - 9.0 mg, magnesium stearate - 4.0 mg, sucrose up to the content weight of 460.0 mg.

Hard gelatin capsules No. 0 [gelatin (up to 100 %, water (14-15 %), colour quinoline yellow (0.9197 %), colour sunset yellow (0.0044 %), titanium dioxide (1.3333 %)];

for 200 mg dosage:

Active substance: nifuroxazide 200.0 mg.

Excipients: lactitol - 300.0 mg, microcrystalline cellulose - 58.0 mg, potato starch - 18.0 mg, magnesium stearate - 6.0 mg, sucrose up to the content weight of 630.0 mg.

Hard gelatin capsules No. 00 [gelatin (up to 100 %), water (14-15 %), cap: ,
body: colour quinoline yellow (0.3497 %), colour sunset yellow (0.0116 %), titanium dioxide (0.8742 %)].

Description

Hard gelatin capsules No. 0, yellow in colour (for 100 mg and 200 mg dosages). The capsule contents are a granulated yellow powder with white specks.

Pharmacotherapeutic Group: antimicrobial agent - nitrofuran

ATC Code: A07AX03

Pharmacological Properties

A broad-spectrum antimicrobial agent, a derivative of 5-nitrofuran. It is used for the treatment of gastrointestinal infections. Nifuroxazide blocks the activity of dehydrogenases and inhibits the respiratory chain, the tricarboxylic acid cycle, and other biochemical processes in the bacterial cell. It disrupts the membranes of susceptible bacteria and reduces toxin production by microorganisms. It activates immunity, increasing phagocyte activity and complement titer.

Effective against Gram-positive microorganisms:

• Staphylococcus spp.;
• Streptococcus spp.

and Gram-negative microorganisms:

• Salmonella spp.;
• Klebsiella spp.;
• Enterobacter spp.;
• Escherichia coli;
• Shigella spp.;
• Proteus spp.;
• Haemophilus influenzae;
• Campylobacter spp.;
• Edwardsiella spp.;
• Citrobacter spp.;
• Vibrio cholerae;
• Yersinia enterocolitica.

Nifuroxazide does not affect the normal intestinal microflora. In acute bacterial diarrhea, it restores gut eubiosis. In case of 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 has no systemic effects. It exerts its antibacterial activity against susceptible bacteria solely within the intestinal lumen. It is excreted unchanged via the intestines. The elimination rate depends on the dose and gastrointestinal motility.

Indications for Use

Acute and chronic diarrhea of infectious origin (without signs of helminthic infestation).

Chronic colitis and enterocolitis.

Contraindications

Hypersensitivity to nifuroxazide, other components of the drug, or other 5-nitrofuran derivatives. Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Children under 3 years of age (for this dosage form).

Use During Pregnancy and Breastfeeding.

There are no data on adverse effects on the fetus during pregnancy. If necessary, the drug may be prescribed with caution to pregnant women and breastfeeding women.

Dosage and Administration

For oral administration.

Adults and children over 7 years: 2 capsules of 100 mg or 1 capsule of 200 mg, 4 times a day (800 mg/day).

Children 3-7 years: 2 capsules of 100 mg or 1 capsule of 200 mg, 3 times a day (600 mg/day).

The duration of therapy with nifuroxazide should not exceed 7 days.

Overdose

No specific symptoms of overdose have been described. Standard emergency measures are recommended.

Side Effects

Allergic reactions.

Drug Interactions

No data on the interaction of nifuroxazide with other medicinal products have been published.

Special Precautions

When treating diarrhea, rehydration therapy (oral or intravenous) should be conducted concurrently with nifuroxazide therapy, according to the patient's condition and the duration of diarrhea. Alcohol consumption is not permitted during nifuroxazide therapy.

Effect on Ability to Drive Vehicles and Operate Machinery

The drug does not negatively affect the ability to drive vehicles and/or operate machinery.

Packaging

Capsules 100 mg and 200 mg. 10 capsules (100 mg dosage) or 5, 7, 8 capsules (200 mg dosage) are placed in a blister strip made of polyvinyl chloride film and printed lacquered aluminum foil. 30 capsules (100 mg dosage) or 16, 28, or 30 capsules (200 mg dosage) in a plastic bottle with a screw cap or a polymer jar with a screw cap. 3 blister strips (for 100 mg dosage) or 2 blister strips of 8 capsules, 4 blister strips of 7 capsules, or 6 blister strips of 5 capsules (for 200 mg dosage), or 1 bottle, or 1 jar, together with the instructions for use, are placed in a cardboard carton.

Storage Conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf Life

5 years. Do not use after the expiration date.

Supply Terms

Over-the-counter

Name and Address of the Legal Entity in whose name the Marketing Authorization is issued / Organization handling complaints:

JSC "AVVA RUS", Russia, 121614, Moscow, ul. Krylatskie Kholmy, 30, bld. 9.

Manufacturing Site Address:

JSC "AVVA RUS", Russia, 610044, Kirov, ul. Luganskaya, 53a.