Adisord^® (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. 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, elevated body temperature, 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 dosage and the appropriate pharmaceutical form.

For Adisord^® Capsules (200 mg): Adults and children over 6 years: take 2 capsules four times daily. Maintain regular intervals between doses, approximately every 6 hours.

For Adisord^® Suspension (220 mg/5 ml): Children from 2 to 6 months: administer 2.5 ml two or three times daily. Children from 6 months to 6 years: administer 5 ml three times daily. Children over 6 years and adults: administer 5 ml four times daily.

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

The total duration of treatment must not exceed 7 days. If symptoms persist beyond this period, discontinue use and consult a physician.

Initiate oral rehydration therapy concurrently to prevent fluid and electrolyte loss.

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, elevated body temperature, 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

Adisord^® [Kronopharm, LLC (Russia)]
Oral suspension 200 mg/5 ml: 90 ml bottle with a measuring spoon

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Manufactured By

AVZ S-P. LLC (Russia)

PharmVILAR NPO, LLC (Russia)

Dosage Form

Adisord^®

Oral suspension 200 mg/5 ml: 90 ml bottle with a measuring spoon

Dosage Form, Packaging, and Composition

Oral suspension yellow, homogeneous, with a banana aroma.

	5 ml
Nifuroxazide	200 mg

Excipients : banana flavor (banana essence) – 0.6 mg, carbomer 971P – 9 mg, anhydrous citric acid – 0.75 mg, methylparaben – 5 mg, sodium hydroxide – 2 mg, sucrose – 1000 mg, ethanol 96% – 0.05 ml, purified water – up to 5 ml.

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

Adisord^® [Kronopharm, LLC (Russia)]
Capsules 100 mg: 14, 20, 21, 28, 30, 40, 45 or 60 pcs.

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Dosage Form

Adisord^®

Capsules 100 mg: 14, 20, 21, 28, 30, 40, 45 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 2, with a dark yellow body and cap; the capsule contents are a mixture of granules and yellow powder, inclusions of a compressed yellow mass that crumbles with light pressure are allowed.

	1 caps.
Nifuroxazide	100 mg

Excipients : calcium hydrogen phosphate dihydrate – 25 mg, pregelatinized corn starch – 33 mg, mannitol – 20 mg, magnesium stearate – 1 mg, talc – 1 mg.

Composition of gelatin shell No. 2 body – titanium dioxide – 0.3811 mg, gelatin – 37.3478 mg, iron oxide yellow dye – 0.3811 mg; cap – titanium dioxide – 0.2289 mg, gelatin – 22.4322 mg, iron oxide yellow dye – 0.2289 mg.

7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – 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.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (3) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.

Adisord^® [Kronopharm, LLC (Russia)]
Capsules 200 mg: 14, 20, 21, 28, 30, 40, 45 or 60 pcs.

Marketing Authorization Holder

Kronopharm, LLC (Russia)

Dosage Form

Adisord^®

Capsules 200 mg: 14, 20, 21, 28, 30, 40, 45 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, with a yellow body and cap; the capsule contents are a mixture of granules and yellow powder, inclusions of a compressed yellow mass that crumbles with light pressure are allowed.

	1 caps.
Nifuroxazide	200 mg

Excipients : calcium hydrogen phosphate dihydrate – 50 mg, pregelatinized corn starch – 66 mg, mannitol – 40 mg, magnesium stearate – 2 mg, talc – 2 mg.

Composition of gelatin shell No. 0 body – titanium dioxide – 0.7867 mg, gelatin – 57.6681 mg, quinoline yellow dye – 0.5426 mg, sunset yellow FCF dye – 0.0026 mg; cap – titanium dioxide – 0.4933 mg, gelatin – 36.1648 mg, quinoline yellow dye – 0.3403 mg, sunset yellow FCF dye – 0.0016 mg