ANTINAL (NIFUROXAZIDE) – 200 MG CAPSULES & 220 MG/5 ML ORAL SUSPENSION

Product Presentations

1. ANTINAL 200 MG (NIFUROXAZIDE) – 24 CAPSULES

• Active Ingredient: Nifuroxazide 200 mg per capsule.
• Pharmaceutical Form: Hard capsules.
• Pack Size: 24 capsules.

2. ANTINAL 220 MG/5 ML (NIFUROXAZIDE) – 60 ML ORAL SUSPENSION

• Active Ingredient: Nifuroxazide 220 mg per 5 mL.
• Concentration: 44 mg/mL.
• Pharmaceutical Form: Oral suspension.
• Pack Size: 60 mL.

Therapeutic Class: Intestinal anti-infective agent (Nitrofuran derivative).

Product Overview

Antinal contains nifuroxazide, an intestinal antimicrobial agent belonging to the nitrofuran class. It is used for the treatment of suspected acute diarrhea of bacterial origin when there are no signs suggesting invasive or systemic infection.

Nifuroxazide has very limited absorption from the gastrointestinal tract when the intestinal mucosa is intact, allowing it to act primarily within the intestinal lumen.

Mechanism of action:

• Interferes with essential bacterial metabolic processes.
• Disrupts the activity of susceptible intestinal bacteria.
• Helps control diarrhea associated with susceptible bacterial infections.

The capsule and suspension formulations provide alternative administration options for suitable patients, with the suspension offering easier administration when swallowing capsules is difficult.

Indications and Uses

Antinal may be prescribed as an adjunct to rehydration for:

• Acute bacterial diarrhea: Suspected non-invasive bacterial diarrhea without signs of systemic infection.
• Infectious gastroenteritis: Selected cases of gastrointestinal infection associated with susceptible bacteria.
• Traveler's diarrhea: Selected cases when bacterial infection is suspected and local treatment is considered appropriate.

►Important: Antinal is not a universal treatment for all causes of diarrhea. It does not replace oral rehydration therapy (ORS), dietary management, or medical evaluation when necessary.

Mechanism of Action

Nifuroxazide acts locally in the gastrointestinal tract through antimicrobial activity against susceptible intestinal bacteria.

Its proposed actions include:

• Interference with bacterial enzyme systems.
• Disruption of essential bacterial metabolic processes.
• Inhibition of bacterial growth and activity.

Its limited gastrointestinal absorption allows most of the administered medication to remain within the intestinal lumen.

Dosage and Administration

Route of Administration: Oral.

A. Antinal 200 mg Capsules

• Adults: One 200 mg capsule four times daily.
• Swallow the capsule with sufficient water.
• The treatment duration should not exceed 3 days without medical reassessment.

B. Antinal 220 mg/5 mL Suspension

• Children over 2 years: 5 mL three times daily.
• Shake the bottle well before each use.
• Measure each dose using an appropriate measuring device.
• The treatment duration should not exceed 3 days without medical reassessment.

Important precautions:

• The suspension is not recommended for children under 2 years according to the referenced product information.
• The capsule formulation should only be used by patients for whom the dosage form and age restrictions are appropriate.
• Do not exceed the recommended dose.
• If diarrhea persists beyond 3 days, medical reassessment is necessary.

Possible Side Effects

Antinal is generally associated with limited systemic exposure because nifuroxazide is minimally absorbed through an intact intestinal mucosa.

Possible adverse reactions include:

• Skin rash.
• Itching.
• Urticaria (hives).
• Allergic reactions.
• Angioedema (swelling of the face, lips, or tongue).
• Rarely, severe allergic reactions, including anaphylaxis.

Discontinue treatment and seek immediate medical attention if signs of a serious allergic reaction occur.

Contraindications and Precautions

Contraindications:

• Known hypersensitivity to nifuroxazide, nitrofuran derivatives, or any product component.
• Children under 2 years of age for the referenced suspension formulation.

Precautions:

• Antinal should not replace fluid and electrolyte replacement.
• Use caution in patients with persistent diarrhea or suspected severe gastrointestinal infection.
• Patients with fever, blood in the stool, severe abdominal pain, or signs of systemic infection require medical evaluation.
• If symptoms persist after 3 days, reassess the diagnosis and treatment.
• Nifuroxazide should be avoided during pregnancy as a precaution because adequate safety data are unavailable.
• Breastfeeding may generally continue during short-term treatment according to the referenced product information.

Important Drug and Lifestyle Interactions

• Alcohol: Check the product leaflet and avoid alcohol during treatment.
• Alcohol-deterrent medications: Concomitant use with medicines that produce disulfiram-like reactions is not recommended.
• Central nervous system depressants: Concomitant use is not recommended according to the product information.
• Inform your healthcare professional about all medications being taken before starting treatment.

Storage Conditions

• Store below 30°C.
• Protect from excessive heat and direct sunlight.
• Keep the bottle tightly closed.
• Keep out of reach of children.
• Do not use after the expiry date.

For the suspension, follow any additional storage instructions printed on the manufacturer's packaging.

Patient Counseling Points

• Maintain adequate fluid intake throughout the treatment period.
• Use oral rehydration solution (ORS) to replace fluids and electrolytes lost through diarrhea.
• Continue appropriate nutrition and feeding.
• Shake the suspension well before administration.
• Measure the suspension accurately.
• Do not exceed the recommended treatment duration.
• Seek medical attention if diarrhea is accompanied by fever, blood in the stool, severe abdominal pain, or signs of dehydration.
• Do not use Antinal routinely for every episode of diarrhea, as many cases are viral or self-limiting.

►Clinical note: The WHO 2024 guideline recommends against routine antibiotic treatment for acute watery diarrhea in children up to 10 years of age, regardless of etiology. Rehydration remains the cornerstone of management. Nifuroxazide should therefore not be presented as a routine treatment for all childhood diarrhea.

References

1. Antinal – Summary of Product Characteristics: Composition, indications, dosage, contraindications, precautions, adverse reactions, and storage. View Antinal product information.
2. World Health Organization (WHO): Guideline on Management of Pneumonia and Diarrhoea in Children up to 10 Years of Age (2024). View WHO guidelines.
3. Egyptian Drug Authority / EIPICO clinical product information: Nifuroxazide – therapeutic indications for suspected acute bacterial diarrhea. View product information.
4. Infectious Diseases Society of America (IDSA): Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. View clinical guidelines.

Patient Disclaimer: This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before using this medication, especially in children, pregnant women, or breastfeeding mothers. Appropriate treatment depends on the cause and severity of diarrhea. Oral rehydration and correction of fluid and electrolyte losses remain essential components of management.