(Metronidazole)

Form: Sterile, isotonic solution for intravenous infusion, free from bacterial endotoxins.

pH: 4.5–6.0

Composition

Each 100ml contains:

Metronidazole……………………500mg

Product Description 

Metronidazole Injectable 500mg/100ml is a sterile, clear, and colorless solution for intravenous infusion. It contains metronidazole, a potent nitroimidazole antimicrobial agent, effective against anaerobic bacteria and certain protozoa. This formulation is designed for patients requiring intravenous therapy for severe infections.

Indications

- Prevention: Postoperative infections in abdominal and gynaecological surgeries.

-Treatment: Severe abdominal and gynaecological infections caused by susceptible anaerobic bacteria.

Dosage and Administration

Administration

 - Intravenous infusion at approximately 5 ml/minute (one bag over 20–60 minutes).

  - Infuse over 30–60 minutes

  - Switch to oral medication as soon as possible 

-Must be diluted in compatible IV solutions (e.g., 0.9% sodium chloride or 5% glucose).

Dosage 

Dosage, rate, and duration should be individualized based on the patient’s age, weight, clinical condition, and response to treatment.

-Adults and children over 12 years:500 mg every 8 hours.

-Children under 12 years: 1.5 mL (7.5 mg) per kg of body weight.

-Elderly: Use with caution, considering potential hepatic or renal impairment.

-Maximum dose: Do not exceed 4 g in a 24-hour period.

-Recommendations: In patients with severe hepatic impairment, the dose should be reduced, and plasma levels should be monitored.

Contraindications

-Allergy to metronidazole or any excipients.

- Avoid alcohol during treatment and for 72 hours post-treatment.

Pregnancy and Lactation

-Pregnancy (Category B2): Metronidazole crosses the placenta and should be used with caution, especially in the first trimester. In the second and third trimesters, it should only be used if clearly needed after assessing risks and benefits.

- Lactation: Metronidazole is excreted in breast milk. Due to its mutagenic and tumorigenic potential, breastfeeding is not recommended during treatment.

Precaution

Metronidazole may cause neurological side effects such as seizures and neuropathy. In patients with hepatic or renal impairment, dosage adjustments and plasma level monitoring are required. Alcohol should be avoided 72 hours before and after treatment.             

Drug Interactions 

-Avoid concurrent use with: Warfarin, disulfiram, lithium, phenobarbital, phenytoin, ciclosporin, and other interacting medications.

- Monitor for interactions with blood thinners, muscle relaxants, and anticonvulsants.

Side Effects

-Common: Nausea, vomiting, headache, metallic taste, dizziness.

-Severe (Rare): Allergic reactions, neurological effects (e.g., seizures), pancreatitis, severe skin reactions, blood disorders.

Storage and Handling 

-Store in original packaging, protected from light.

-Use only if the solution is clear and the container is intact. 

- Discard unused portions immediately.

Manufacturer Information 

Name of Company: Parsawa parenteral fluids manufacturing factory     

Add: Afghanistan, Herat, Industrial Town, Phase3, Susan5