AMRIZOLE 500mg/100ml Infusion/Solution for

What is AMRIZOLE 500mg/100ml

AMRIZOLE 500mg/100ml is a sterile solution for intravenous infusion containing Metronidazole, an antibiotic and antiprotozoal agent. It is primarily used to treat and prevent infections caused by anaerobic bacteria and certain parasites. AMRIZOLE is essential in surgical prophylaxis, particularly for gastrointestinal, gynecological, and orthopedic procedures where anaerobic infections are a risk.

• Generic Name: Metronidazole
• Form: Solution for Infusion
• Indications: Treatment of anaerobic bacterial infections, intra-abdominal infections, pelvic infections, skin and soft tissue infections, and certain protozoal infections like amoebiasis.
• Key Benefits: Rapid onset of action, effective broad-spectrum anaerobic coverage, and excellent tissue penetration.

AMRIZOLE 500mg/100ml is often reserved for hospital use under medical supervision, ensuring the management of severe infections efficiently and safely.

How to use AMRIZOLE 500mg/100ml

Proper administration of AMRIZOLE is crucial for its efficacy and patient safety:

• Administration Route: Intravenous infusion.
• Infusion Time: Infuse slowly over a period of approximately 30 to 60 minutes.
• Preparation: Use the vial directly. Do not mix with incompatible solutions. Follow aseptic techniques.
• Monitoring: Monitor the patient for signs of hypersensitivity, adverse effects, and response to therapy during infusion.
• Duration: As prescribed by the physician, typically until the infection resolves or when the patient can switch to oral therapy.

Always inspect the solution visually for particulate matter and discoloration before administration. Only clear and colorless to slightly yellow solutions should be used.

Mode of Action AMRIZOLE 500mg/100ml

Metronidazole works through a distinct mechanism targeting anaerobic organisms:

• Penetration: Easily diffuses into cells of susceptible organisms.
• Reductive Activation: In anaerobic environments, the drug undergoes chemical reduction to produce reactive intermediates.
• DNA Disruption: These reactive metabolites interact with DNA, inhibiting nucleic acid synthesis and leading to the death of bacteria and protozoa.
• Selective Toxicity: Metronidazole selectively targets anaerobes without significant effects on human cells.

This unique mode of action makes AMRIZOLE highly effective against a broad range of anaerobic pathogens and specific protozoal infections.

AMRIZOLE 500mg/100ml Interactions AMRIZOLE 500mg/100ml

Metronidazole can interact with a range of other drugs, influencing its effectiveness and risk of side effects:

• Alcohol: Can cause a disulfiram-like reaction (flushing, nausea, vomiting, headache).
• Warfarin and Anticoagulants: May enhance anticoagulant effects, increasing bleeding risk; monitor INR closely.
• Phenytoin and Phenobarbital: May reduce Metronidazole levels by enhancing its metabolism.
• Cyclosporine: Risk of elevated cyclosporine levels; monitor serum levels carefully.
• Lithium: May increase serum lithium levels leading to toxicity; monitor lithium concentrations closely.

Before starting AMRIZOLE, patients should inform their healthcare provider about all current medications to avoid potential interactions.

Dosage of AMRIZOLE 500mg/100ml

Dosage regimens must be carefully tailored depending on the type and severity of infection:

• Adults: Typically, 500mg every 8 hours by IV infusion over 30-60 minutes.
• Severe Infections: Higher or more frequent dosing may be needed under hospital monitoring.
• Prophylaxis (Surgery): 500mg IV infusion 1 hour before surgery, with additional doses post-operatively if needed.
• Children: Dose is adjusted based on body weight and clinical condition, usually 7.5mg/kg every 8 hours.

Dosage adjustment may be necessary in patients with severe liver dysfunction. Always follow the exact dosing instructions given by the physician.

Possible side effects of AMRIZOLE 500mg/100ml

Although generally safe under medical supervision, AMRIZOLE can cause side effects:

• Common Side Effects: Nausea, metallic taste, loss of appetite, diarrhea, headache, dizziness.
• Infusion Reactions: Pain, redness, or swelling at the infusion site.
• Serious Side Effects: Seizures, peripheral neuropathy (tingling/numbness), severe allergic reactions, liver toxicity.
• Hematologic Effects: Rare cases of blood dyscrasias like leukopenia.

Promptly report any unusual symptoms to a healthcare provider, particularly neurological changes or allergic symptoms, during or after therapy.

AMRIZOLE 500mg/100ml Contraindications AMRIZOLE 500mg/100ml

AMRIZOLE should not be used in certain individuals:

• Hypersensitivity: Allergy to Metronidazole, other nitroimidazole derivatives, or any component of the formulation.
• First Trimester of Pregnancy: Avoid unless absolutely necessary; use only if benefits outweigh risks.
• Alcohol Consumption: Contraindicated during and for at least 48 hours after treatment due to risk of severe reactions.
• Severe Central Nervous System Diseases: Such as epilepsy or active brain disease, due to risk of neurological side effects.

Careful evaluation is necessary before starting AMRIZOLE therapy, particularly in high-risk patients.

Storage of AMRIZOLE 500mg/100ml

Proper storage is essential to maintain the sterility and effectiveness of AMRIZOLE:

• Temperature: Store at 20°C to 25°C (68°F to 77°F); brief excursions allowed between 15°C to 30°C (59°F to 86°F).
• Protection: Protect from freezing and avoid excessive heat.
• Light Sensitivity: Protect from direct light; keep the vial in its original outer carton until ready for use.
• Handling: Discard unused portions after opening the vial; do not reuse partially used vials.
• Expiration: Do not use beyond the expiration date indicated on the vial.

Strict adherence to storage conditions ensures the safety and efficacy of AMRIZOLE 500mg/100ml throughout its use.