Septodiar^® (Suspension) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Laboratories Galenica, JSC (Morocco)

ATC Code

A07AX03 (Nifuroxazide)

Active Substance

Nifuroxazide (Rec.INN registered by WHO)

Dosage Form

Septodiar®

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

Dosage Form, Packaging, and Composition

Oral suspension after shaking is a yellow liquid with uniformly distributed particles, with an orange odor.

Excipients: carbomer – 12.52 mg, sucrose – 893.84 mg, orange oil – 0.25 µl, ethanol 96% – 30.25 µl, methylparahydroxybenzoate – 5 mg, propylparahydroxybenzoate – 2.5 mg, sodium hydroxide – 1.25 mg, anhydrous citric acid – 0.62 mg, purified water – up to 5 ml.

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

Clinical-Pharmacological Group

Intestinal antiseptic. Antidiarrheal agent

Pharmacotherapeutic Group

Antimicrobial agent – nitrofuran

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 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

For oral use only. Shake the bottle vigorously immediately before each use to achieve a uniform suspension.

Administer the suspension using the supplied measuring spoon. Adhere strictly to the age-specific dosing schedule.

For adults and children over 6 years of age: administer 5 ml (200 mg) four times daily.

For children from 2 to 6 years of age: administer 2.5 ml (100 mg) three times daily.

For infants from 2 months to 2 years of age: administer 1.25 to 2.5 ml (50 to 100 mg) two to three times daily. Dose must be determined by a physician.

Do not use in newborns under 2 months of age due to immaturity of the intestinal mucosa and risk of systemic absorption.

The dosing interval should be approximately 6 hours for a four-times-daily schedule and 8 hours for a three-times-daily schedule.

The duration of treatment is typically 3 to 5 days. The maximum course of therapy must not exceed 7 days.

If symptoms persist beyond 3 days of treatment, or if high fever, blood in stools, or signs of dehydration occur, discontinue use and consult a physician immediately.

Concurrently with nifuroxazide therapy, ensure adequate fluid and electrolyte intake to prevent dehydration.

Adverse Reactions

Allergic reactions skin rash, urticaria, angioedema, anaphylactic shock.

Contraindications

Hypersensitivity to nitrofuran derivatives; pregnancy; children’s age – depending on the dosage form.

With caution liver disease, alcoholism, traumatic brain injury, brain diseases; period of breastfeeding; children’s age.

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 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.

The consumption of alcohol 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.