Metronidazole


Generic Medicine Info
Indications and Dosage
Intravenous
Prophylaxis of postoperative anaerobic bacterial infections
Adult: 1,000-1,500 mg as a single dose given 30-60 minutes before surgery or 500 mg infused before, during and after surgery. Followed by 500 mg 8 hourly for Max of 48 hours. Continue with oral therapy as soon as possible. Alternatively, 15 mg/kg infused over 30-60 minutes given 1 hour prior to procedure, followed by 7.5 mg/kg infused over 30-60 minutes at 6 and 12 hours after initial dose.
Child: <12 years 20-30 mg/kg as a single dose given 1-2 hours prior to surgery.

Intravenous
Anaerobic bacterial infections
Adult: 1,000-1,500 mg once daily as a single dose or 500 mg 8 hourly via infusion at a rate of 5 mL/min over 20-60 minutes usually for about 7 days. Max: 4,000 mg daily. Alternatively, 15 mg/kg over 1 hour, followed by 7.5 mg/kg 6 hourly over 1 hour given 6 hours after loading dose. Max: 4,00 mg daily.
Child: Infants <8 weeks 15 mg/kg once daily or divided into 7.5 mg/kg 12 hourly; >8 weeks to 12 years 20-30 mg/kg as a single dose or divided into 7.5 mg/kg 8 hourly. Treatment duration: Usually, 7 days. Daily dose may be increased to 40 mg/kg based on the severity of the infection.

Oral
Eradication of Helicobacter pylori associated with peptic ulcer disease
Adult: In combination with another antibacterial and PPI: 400 mg bid. In combination with omeprazole and amoxicillin: 400 mg tid. Treatment duration: 7-14 days. Consult official guidelines before initiating therapy.
Child: In combination with another antibacterial and PPI: 20 mg/kg daily in divided doses for 7-14 days. Max: 500 mg bid.

Oral
Anaerobic bacterial infections
Adult: Initially, 800 mg followed by 400 mg 8 hourly usually for about 7 days.
Child: <8 weeks 15 mg/kg once daily or divided into 7.5 mg/kg 12 hourly; >8 weeks to 12 years 20-30 mg/kg as a single dose or divided into 7.5 mg/kg 8 hourly for 7 days. Daily dose may be increased to 40 mg/kg depending on the severity of the infection.

Oral
Bacterial vaginosis
Adult: 400-500 mg bid for 5-7 days. Alternatively, 2,000 mg as a single dose.

Oral
Giardiasis
Adult: 2,000 mg once daily for 3 days, or 400 mg tid for 5 days, or 500 mg bid for 7-10 days.
Child: 1-2 years 500 mg once daily for 3 days; 3-6 years 600-800 mg once daily for 3 days; 7-9 years 1,000 mg once daily for 3 days; ≥10 years Same as adult dose. Alternatively, 15 mg/kg daily in 3 divided doses.

Oral
Leg ulcer, Pressure sore
Adult: 400 mg tid for 7 days.
Child: >10 years Same as adult dose.

Oral
Acute dental infections
Adult: 200 mg tid for 3-7 days.
Child: >10 years Same as adult dose.

Oral
Trichomoniasis
Adult: 2,000 mg as a single dose or 200 mg 8 hourly for 7 days. Alternatively, 400-500 mg 12 hourly for 5-7 days. Sexual partners should also be treated.
Child: 40 mg/kg as a single dose or 15-30 mg/kg daily in 2-3 divided doses. Max: 2,000 mg/dose. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Prophylaxis of postoperative anaerobic bacterial infections
Adult: 400 mg 8 hourly in the 24 hours before surgery followed by IV or rectal dosage post-operatively until oral therapy is possible. Max: 4,000 mg daily.
Child: <12 years 20-30 mg/kg as a single dose given 1-2 hours before surgery.

Oral
Amoebiasis
Adult: 800 mg 8 hourly for 5 days (intestinal infection); 400-800 mg 8 hourly for 5-10 days (extra-intestinal infection). Alternatively, 35-50 mg/kg daily in 3 divided doses for 5-10 days or 500-750 mg 8 hourly for 7-10 days (intestinal or extraintestinal infection). Max: 2,400 mg daily.
Child: 1-3 years 100-200 mg tid; 3-7 years 100-200 mg 4 times daily; 7-10 years 200-400 mg tid. Alternatively, 35-50 mg/kg daily in 3 divided doses. Max: 2,400 mg daily. All doses are given for 5-10 days. >10 years Same as adult dose.

Oral
Acute ulcerative gingivitis
Adult: 200 mg 8 hourly for 3 days.
Child: 1-2 years 50 mg tid for 3 days; 3-6 years 100 mg bid for 3 days; 7-9 years 100 mg tid for 3 days; ≥10 years Same as adult dose.

Rectal
Anaerobic infections
Adult: As supp: 1,000 mg 8 hourly for 3 days, if needs to continue for more than 3 days, reduce dose to 1 g 12 hourly. Substitute oral therapy as soon as possible.
Child: <1 year 125 mg; 1-4 years 250 mg; 5-9 years 500 mg. All doses are to be given 8 hourly for 3 days, then 12 hourly until oral medication is possible. ≥10 years Same as adult dose.

Rectal
Prophylaxis of postoperative anaerobic bacterial infections
Adult: As supp: 1,000 mg 2 hours before surgery, repeated 8 hourly until oral doses can be given to complete the 7-day treatment course.
Child: As supp: 5-9 years 500 mg; ≥10 years 1,000 mg. All doses are given 2 hours before surgery, then repeated 8 hourly for up to 3 further doses (in high-risk procedures).

Topical/Cutaneous
Rosacea
Adult: For the treatment of inflammatory papules and pustules of rosacea: As 0.75% gel/cream/lotion: Apply thinly onto affected areas bid. Average treatment period: 3-4 months, may be continued for further 3-4 months if necessary, depending on the severity of the infection.

Vaginal
Bacterial vaginosis
Adult: As 0.75% gel: 1 applicator-full (approx 5 g gel containing 37.5 mg metronidazole) once daily at bedtime for 5 days. Alternatively, as 1.3% gel: 1 applicator-full (approx 5 g gel containing 65 mg metronidazole) as a single dose given at bedtime.
Hepatic Impairment
Oral:
Severe: Dose reduction may be needed. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Intravenous:
Dose reduction may be necessary.
Administration
tab: Should be taken with food.
susp: Should be taken on an empty stomach. Take at least 1 hr before meals.
Contraindications
Hypersensitivity to metronidazole and other nitroimidazoles. Concomitant use with disulfiram within the last 14 days. Coadministration with alcohol or propylene glycol-containing products during or within 3 days of therapy discontinuation. Pregnancy during the 1st trimester in the treatment of trichomoniasis.
Special Precautions
Patient with active or chronic severe peripheral and CNS disease; current or history of seizure disorder, blood dyscrasias; Cockayne syndrome, hepatic encephalopathy. Renal and hepatic impairment. Neonates and children. Pregnancy and lactation.
Adverse Reactions
Significant: Bacterial or fungal superinfection (e.g. Clostridium difficile-associated diarrhoea and pseudomembranous colitis); gonococcal infection (after treatment of Trichomonas vaginalis); leucopenia; central, peripheral, or optic neuropathy; aseptic meningitis, ataxia, neurocerebellar toxicity, encephalopathy, seizures, confusion, dysarthria, vertigo; Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis. Candida vaginitis (vaginal gel).
Blood and lymphatic system disorders: Aplastic anaemia.
Ear and labyrinth disorders: Hearing loss or impairment (including sensorineural), tinnitus.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, taste disorders, furred tongue, glossitis, stomatitis, eructation with bitter taste, metallic taste, epigastric pain, dysphagia.
General disorders and administration site conditions: Fever; vein irritations including thrombophlebitis (IV).
Immune system disorders: Angioedema.
Metabolism and nutrition disorders: Anorexia.
Nervous system disorders: Headache.
Psychiatric disorders: Depression, insomnia.
Skin and subcutaneous tissue disorders: Erythema multiforme, urticaria. Pruritus, dry skin, burning or stinging of the skin, skin irritation, worsening of rosacea (topical).
Potentially Fatal: Severe hepatotoxicity/acute hepatic failure (patients with Cockayne syndrome).
IV/Parenteral/PO/Topical/Vag: B
Patient Counseling Information
This drug may cause drowsiness, confusion, dizziness, vertigo, hallucinations, convulsions, or transient visual disorders, if affected, do not drive or operate machinery. As an alternative option, nursing mothers may stop breastfeeding during and for 12-24 hours after stopping treatment. Topical: Avoid exposure of treated areas to ultraviolet or strong sunlight during treatment.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor CBC with differential (baseline, during, and after repeated or prolonged treatment); LFTs before treatment initiation, during, and after treatment until liver function is within the normal range or until baseline values are reached (in patients with Cockayne syndrome). Assess for neurologic symptoms.
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, anorexia, metallic taste, ataxia, dizziness, headache, insomnia, drowsiness; transient epileptiform seizures (with intensive or prolonged therapy); peripheral motor neuropathy, blood dyscrasias, liver damage. Rarely, transient increase in liver enzyme. Management: Symptomatic and supportive treatment. Administer IV fluids and plasma expanders to treat disulfiram-type reactions. Control frequent or prolonged convulsions with IV diazepam or lorazepam. Provide oxygen, and correct acid-base and metabolic disturbance as necessary.
Drug Interactions
Psychotic reactions with disulfiram. May potentiate the anticoagulant effects of warfarin. May retain lithium and increase the risk of renal damage. Decreased serum concentration with phenobarbital, phenytoin, or primidone. Increased serum concentration with cimetidine. May increase serum concentration and risk of toxicity of 5-fluorouracil. May increase the serum concentration of ciclosporin and busulfan. Increased risk of QT prolongation and torsades de pointes with amiodarone.
Food Interaction
May cause disulfiram-like reactions with alcohol.
Lab Interference
May interfere with AST, ALT, triglycerides, glucose hexokinase, and LDH testing.
Action
Description:
Mechanism of Action: Metronidazole interacts with the microbial DNA to break its strand and helical structure leading to inhibition of protein synthesis, degradation, and cell death.
Pharmacokinetics:
Absorption: Readily and almost completely absorbed from the gastrointestinal tract. Food delays absorption. Time to peak plasma concentration: Within 1-2 hours (oral); 5-12 hours (rectal); 8 hours (intravaginal gel). Bioavailability: 60-80% (rectal); 20-25% (vaginal pessaries); 56% (intravaginal gel).
Distribution: Widely distributed in body tissues and fluids such as bile, bone, liver and liver abscesses, seminal fluid, lung and vaginal secretions, saliva, cerebral abscesses, and CSF. Crosses blood-brain barrier and the placenta; enters breast milk at concentrations similar to maternal plasma concentrations. Plasma protein binding: <20%.
Metabolism: Metabolised in the liver via side-chain oxidation and glucuronide formation into active hydroxyl and several other metabolites.
Excretion: Mainly via urine (60-80% as unchanged drug and metabolites; approx 20% of total as unchanged drug); faeces (6-15%). Elimination half-life: Approx 8 hours.
Chemical Structure

Chemical Structure Image
Metronidazole

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4173, Metronidazole. https://pubchem.ncbi.nlm.nih.gov/compound/Metronidazole. Accessed Aug. 17, 2023.

Storage
Tab/topical cream/gel/lotion: Store between 15-25°C. Protect from light. IV: Store between 20-25°C. Protect from light. Do not refrigerate. Vaginal gel: Store between 15-30°C. Do not freeze. Protect from heat. Rectal supp: Store below 20°C. Protect from light.
MIMS Class
Antiamoebics / Other Antibiotics / Preparations for Vaginal Conditions / Topical Antibiotics
ATC Classification
G01AF01 - metronidazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
P01AB01 - metronidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
J01XD01 - metronidazole ; Belongs to the class of imidazole derivative antibacterials. Used in the systemic treatment of infections.
References
Committee on Infectious Diseases, American Academy of Pediatrics, Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH. "Tables of Antibacterial Drug Dosages", Red Book: 2021-2024 Report of the Committee on Infectious Diseases. American Academy of Pediatrics [online]. Accessed 12/04/2023.

Anon. Metronidazole (Systemic) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/04/2023.

Anon. Metronidazole (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/04/2023.

Anon. Metronidazole (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/04/2023.

Anon. Metronidazole. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 12/04/2023.

Baxter Healthcare Ltd. Metronidazole 500 mg/100 mL Solution for Infusion data sheet 8 September 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2023.

Buckingham R (ed). Metronidazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/04/2023.

Healthcare Logistics. Rozex Cream data sheet 19 November 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2023.

Healthcare Logistics. Rozex Gel data sheet 19 November 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2023.

Joint Formulary Committee. Metronidazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/04/2023.

Metrogyl Injection 5 mg/mL (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2023.

Metrogyl Suspension 200 mg/5 mL (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2023.

Metrogyl Tablets 200 mg and 400 mg (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2023.

Metrolyl Suppositories 1 g (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Metronidazole 200 mg/5 mL Oral Suspension (Dawa Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Metronidazole 400 mg Tablets (Genethics Europe Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Metronidazole 500 mg/100 mL Solution for Infusion (B. Braun Melsungen AG). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Metronidazole Capsule (Alembic Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Cream (Cosette Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Gel (Alembic Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Injection, Solution (Sun Pharmaceutical Industries, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Lotion (Fougera Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Tablet (Alembic Labs LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Tablet, Film Coated, Extended Release (Alembic Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Metronidazole Tablets 500 mg (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Nuvessa Gel (Exeltis USA, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/04/2023.

Paediatric Formulary Committee. Metronidazole. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 12/04/2023.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Flagyl 500 mg Suppositories and Flagyl-S 200 mg/5 mL Oral Suspension data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2023.

Rozex 0.75% w/w Cream (Galderma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Rozex 0.75% w/w Gel (Galderma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Rozex Topical Gel (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 12/04/2023.

Viatris Ltd. Metrogyl 200 mg and 400 mg Tablets data sheet 8 September 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 12/04/2023.

Zidoval 7.5 mg/g Vaginal Gel (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 12/04/2023.

Disclaimer: This information is independently developed by MIMS based on Metronidazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
  • Anmerob
  • Corsagyl
  • Dimedazol
  • Fladex
  • Flagyl IV
  • Flagyl/Flagyl Forte
  • Grafazol
  • Metrofusin
  • Metrolet
  • Metronidazole Fima
  • Metronidazole Fresenius
  • Metronidazole Ikapharmindo
  • Metronidazole OGB Dexa
  • Molazol 500
  • Nidazole
  • Progyl/Progyl IV
  • Promuba
  • Sotroz
  • Supplin
  • Tismazol
  • Trogiar
  • Trogyl
  • Vadazol
  • Vagizol
  • Velazol
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in