AMRIZOLE 125 MG/5 ML (METRONIDAZOLE) – ORAL SUSPENSION

Active Ingredient: Metronidazole 125 mg per 5 mL
Concentration: 25 mg/mL
Pharmaceutical Form: Oral suspension
Pack Size: 120 mL
Therapeutic Class: Nitroimidazole antimicrobial agent (Antibacterial and Antiprotozoal).

Product Overview

Amrizole 125 mg/5 mL is an oral suspension containing metronidazole, an antimicrobial medication used to treat infections caused by susceptible anaerobic bacteria and certain protozoa.

It is particularly useful in pediatric patients and individuals who have difficulty swallowing tablets, allowing the prescribed dose to be measured according to the patient's age, body weight, and medical condition.

Metronidazole works by entering susceptible microorganisms and interfering with their DNA, ultimately inhibiting nucleic acid synthesis and leading to microbial cell death.

Indications and Uses

Amrizole oral suspension may be prescribed for the treatment of:

• Amoebiasis: Treatment of intestinal and extraintestinal infections caused by Entamoeba histolytica.
• Giardiasis: Treatment of intestinal infections caused by Giardia duodenalis.
• Trichomoniasis: Treatment of infections caused by Trichomonas vaginalis.
• Anaerobic bacterial infections: Treatment of infections caused by susceptible anaerobic bacteria.
• Dental infections: As part of an appropriate treatment plan for infections involving susceptible anaerobic bacteria.
• Certain intra-abdominal and pelvic infections: When anaerobic bacterial coverage is clinically indicated.

Important: Metronidazole is not effective against viral infections such as the common cold or influenza, and it does not treat all bacterial infections.

Mechanism of Action

Metronidazole is activated inside susceptible anaerobic microorganisms and protozoa, producing compounds that interact with and damage microbial DNA.

This results in:

• Inhibition of DNA synthesis.
• Disruption of essential cellular functions.
• Prevention of microbial replication.
• Death of susceptible microorganisms.

Dosage and Administration

Route of Administration: Oral.

The appropriate dose depends on the patient's age, body weight, type of infection, and severity.

• Pediatric patients: Dosing is generally calculated according to body weight (mg/kg/day) and divided into appropriate doses.
• Adults: Dosage varies according to the infection being treated.
• Treatment duration: Depends on the indication and prescribed treatment regimen.

Administration Instructions:

• Shake the bottle well before each use.
• Measure the prescribed dose using an oral syringe or suitable measuring device.
• Administer with or after food if gastrointestinal discomfort occurs.
• Follow the prescribed treatment schedule.
• Complete the full treatment course as directed.

Note: Amrizole contains 125 mg of metronidazole per 5 mL, equivalent to 25 mg/mL. Do not use a fixed dose for all children; accurate weight-based dosing is essential.

Possible Side Effects

Common side effects may include:

• Nausea and vomiting.
• Diarrhea.
• Abdominal discomfort or stomach cramps.
• Metallic or unpleasant taste in the mouth.
• Loss of appetite.
• Headache.
• Dark-colored urine (usually harmless).

Rare but potentially serious adverse reactions include:

• Allergic reactions, including skin rash and swelling.
• Peripheral neuropathy (numbness or tingling).
• Seizures.
• Confusion or coordination difficulties.
• Severe skin reactions.

Seek medical attention if serious or unusual symptoms develop.

Contraindications and Precautions

Contraindications:

• Known hypersensitivity to metronidazole or other nitroimidazole derivatives.
• Recent disulfiram use (within the previous two weeks).

Precautions:

• Use cautiously in patients with severe liver impairment; dosage adjustment may be necessary.
• Patients with a history of neurological disorders should be carefully monitored.
• Inform the doctor about any history of blood disorders.
• Use during pregnancy or breastfeeding should be discussed with a healthcare professional.
• Patients taking anticoagulants, particularly warfarin, may require additional monitoring.
• Avoid unnecessary or prolonged use to reduce the risk of antimicrobial resistance.

Important Drug and Lifestyle Interactions

• Alcohol: Avoid alcoholic beverages and products containing propylene glycol during treatment and for at least 3 days after the last dose.
• Disulfiram: Concurrent use may cause serious psychiatric reactions.
• Warfarin: May increase anticoagulant activity and bleeding risk.
• Lithium: May increase lithium concentrations and the risk of toxicity.
• Phenytoin and phenobarbital: May affect metronidazole concentrations and treatment response.

Storage Conditions

• Store according to the manufacturer's recommended storage conditions.
• Protect from excessive heat and direct sunlight.
• Keep the bottle tightly closed.
• If supplied as a powder for reconstitution, follow the manufacturer's instructions regarding preparation and storage after reconstitution.
• Keep out of reach of children.
• Do not use after the expiry date.

Patient Counseling Points

• Use Amrizole only when prescribed by a healthcare professional.
• Ensure accurate measurement of each dose, especially in children.
• Do not stop treatment early without medical advice.
• Avoid alcohol during treatment and for 3 days after completing it.
• Maintain adequate fluid intake, particularly when treating gastrointestinal infections associated with diarrhea.
• Seek medical advice if symptoms persist or worsen.
• Do not use antibiotics unnecessarily or for viral infections.

Medical References

1. Egyptian Drug Authority (EDA): Egyptian Antimicrobial Formulary – Metronidazole, including 125 mg/5 mL oral suspension.
2. U.S. National Library of Medicine (DailyMed): Metronidazole Oral Suspension – Prescribing Information.
3. Centers for Disease Control and Prevention (CDC): Clinical Care of Giardia Infection.
4. Médecins Sans Frontières (MSF): Metronidazole Oral – Medical Guidelines.
5. Ethiopian Food and Drug Authority: Metronidazole 125 mg/5 mL Oral Suspension – Summary of Product Characteristics.

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. Dosage, frequency, and treatment duration must be determined according to the patient's age, body weight, medical condition, and type of infection.