Registered Rwanda · Rwanda FDA

METRONIDAZOLE INTRAVENOUS INFUSION BP 5G/100ML

Metranidazole BP 5g/100ml

Rwanda FDA-HMP-MA-1360 Solution for infusion 5g/100ml

What it does

Metronidazole is an antibiotic used to treat infections caused by bacteria and parasites.

Commonly used for: bacterial infections, parasitic infections, infections of the stomach (gastritis), certain types of vaginal infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1360
Registration date
18/05/2024
Expiry date
17/05/2029
Status
Registered
Active ingredient
Metranidazole BP 5g/100ml
Dosage form
Solution for infusion
Strength
5g/100ml
Pack size
100 ml bottle
Therapeutic class
-
Manufacturer / MAH
Amanta Healthcare
Country of origin
INDIA
Manufacturer location
8th Floor, Shaligram Corporates, Chhanalal Joshi Marg, Ambli, Ahmedabad, Gujarat 380058, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:14 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Metronidazole is an antibiotic used to treat infections caused by bacteria and parasites.

What it treats

  • bacterial infections
  • parasitic infections
  • infections of the stomach (gastritis)
  • certain types of vaginal infections

How it works

It works by stopping the growth of the harmful bacteria and parasites causing the infection.

Who it's for

This medicine is for adults and children who have specific infections that can be treated with metronidazole.

Cautions

  • • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
  • • Inform your doctor about any other medicines you are taking.
  • • Avoid alcohol during treatment and for at least 48 hours after finishing the medicine.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: metranidazole

Metronidazole is an antibiotic and antiprotozoal medication primarily used to treat infections caused by anaerobic bacteria and certain protozoa. It is effective against conditions such as bacterial vaginosis, trichomoniasis, and gastrointestinal infections like amoebiasis. Metronidazole is commonly administered orally, topically, or intravenously, depending on the type and severity of the infection.

Indications

  • Bacterial vaginosis
  • Trichomoniasis
  • Amoebiasis
  • Clostridium difficile infection
  • Anaerobic bacterial infections

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on the condition being treated.

Adults: Refer to the BNF for specific dosing recommendations based on the condition being treated.

Mechanism of action

Metronidazole exerts its antimicrobial effect by diffusing into the microbial cell and undergoing reduction of its nitro group, leading to the formation of reactive intermediates that damage DNA and inhibit nucleic acid synthesis. This mechanism is particularly effective against anaerobic organisms and certain protozoa.

Pharmacodynamics

Metronidazole demonstrates concentration-dependent activity against susceptible microorganisms. It has a broad spectrum of action, being effective against anaerobic bacteria and protozoa. Resistance is uncommon but may occur due to decreased uptake or enzymatic inactivation of the drug within the microorganism.

Pharmacokinetics

Metronidazole is well absorbed following oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It is widely distributed throughout the body, including the central nervous system and tissues, and has a volume of distribution of approximately 0.5 to 1 L/kg. Metronidazole is metabolized in the liver, primarily via oxidation and glucuronidation, and is eliminated predominantly through urine. The elimination half-life ranges from 6 to 8 hours.

Contra-indications

  • Hypersensitivity to metronidazole or any component of the formulation
  • First trimester of pregnancy for non-life-threatening infections
  • Severe liver impairment

Adverse effects

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Metallic taste
  • Peripheral neuropathy
  • Disulfiram-like reaction with alcohol
  • Seizures (rare)

Interactions

  • Alcohol - can cause disulfiram-like reaction
  • Warfarin - may enhance anticoagulant effect
  • Lithium - may increase lithium levels
  • CYP3A4 inducers or inhibitors - may affect metronidazole metabolism

Precautions

  • Use with caution in patients with central nervous system disorders
  • Monitor for signs of peripheral neuropathy
  • Caution in patients with hepatic dysfunction
  • Discontinue if neurological symptoms develop

Pregnancy

Not recommended during the first trimester, but may be used in later trimesters if benefits outweigh risks.

Breast-feeding

Metronidazole is excreted in breast milk; caution is advised, and breastfeeding may be interrupted during treatment.

Storage

Store at room temperature, away from moisture and heat. Protect from light.

Formulations

  • Oral tablets
  • Topical gel
  • Intravenous injection
  • Vaginal gel

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.