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Metronidazole
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DrugPoint Summary
  Dosing & Indications
  Adult Dosing
Important Note
  • Orphan drug designation: Treatment of perioral dermatitis
  • Orphan drug designation: Treatment of acne rosacea
  • Orphan drug designation: Topical treatment of active perianal Crohn disease
  • Orphan drug designation: Treatment of pouchitis
  • Orphan drug designation: Treatment of clostridium difficile infection in pediatric patients (0 through 16 years of age)
General Dosage Information
  • safety and efficacy of extended-release tablets not established in premenarchal women [3]
Abscess, Anaerobic
  • Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose; duration 7 to 10 days or longer as clinically indicated; MAX 4 g/day [4]
  • 7.5 mg/kg orally every 6 hours for 7 to 10 days or longer as clinically indicated; maximum 4 g/day [5][6]
Amebic dysentery, acute
  • 750 mg orally 3 times daily for 5 to 10 days [5][6].
Amebic liver abscess
  • 500 to 750 mg orally 3 times daily for 5 to 10 days [5][6]
Appendectomy - Postoperative infection; Prophylaxis
  • 500 mg IV 1 hour prior to surgery; for unusually long procedures repeat dosing may be required; total treatment duration should not exceed 24 hours (guideline dosage) [7]
Bacterial meningitis
  • Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose; MAX 4 g/day [8]
  • 7.5 mg/kg orally every 6 hours; usual duration is 7 to 10 days; MAX 4g/day; for serious infections, initiate treatment with IV formulation [6].
Bacterial vaginosis
  • (Extended-release tablets) 750 mg orally once daily for 7 days (FDA dosage) [3]
  • (0.75% vaginal gel) 1 applicator (37.5 mg) intravaginally once daily for 5 days at bedtime (FDA dosage) [9]
  • (1.3% vaginal gel) 1 full applicator (65 mg) once intravaginally at bedtime (FDA dosage) [10]
  • (Oral tablets) 500 mg orally twice daily for 7 days (guideline dosage) [11]
  • (0.75% vaginal gel) 1 full applicator (37.5 mg) intravaginally once daily for 5 days (guideline dosage) [11]
Clostridium difficile diarrhea, including Pseudomembranous Colitis
  • Nonsevere, vancomycin or fidaxomicin not available, 500 mg orally 3 times a day for 10 days (guideline dosage) [12]
  • Fulminant disease, 500 mg IV every 8 hours plus vancomycin 500 mg orally/NG tube 4 times daily; if complete ileus, consider adding vancomycin retention enema (500 mg in 100 mL NS) rectally every 6 hours (guideline dosage) [12]
Giardiasis
  • 250 mg orally 3 times daily for 5 days [13]
Helicobacter pylori gastrointestinal tract infection
  • Clarithromycin triple regimen, 500 mg orally 3 times per day in combination with clarithromycin 500 mg orally twice daily and a standard-dose or double-dose proton pump inhibitor orally twice daily; treat for 14 days (guideline dosage) [14]
  • Bismuth quadruple regimen, 250 mg orally 4 times a day OR 500 mg orally 3 or 4 times per day in combination with bismuth subsalicylate 300 mg or bismuth subcitrate 120 to 300 mg orally 4 times a day, tetracycline hydrochloride 500 mg orally 4 times a day, and a standard-dose proton pump inhibitor twice daily; treat for for 10 to 14 days (guideline dosage) [14]
  • Concomitant regimen, 500 mg orally twice daily in combination with clarithromycin 500 mg orally twice daily, amoxicillin 1 g orally twice daily, and a standard-dose proton pump inhibitor twice daily; continue regimen for 10 to 14 days (guideline dosage) [14]
  • Sequential regimen, amoxicillin 1 g orally twice daily plus a standard-dose proton pump inhibitor (PPI) orally twice daily for 5 to 7 days; then follow with clarithromycin 500 mg twice daily, metronidazole 500 mg twice daily, and a standard-dose PPI twice daily for 5 to 7 days (guideline dosage) [14]
  • Hybrid regimen, amoxicillin 1 g orally twice daily plus a standard-dose proton pump inhibitor (PPI) orally twice daily for 7 days; then follow with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, metronidazole 500 mg twice daily, and a standard-dose PPI twice daily for 7 days (guideline dosage) [14]
  • Levofloxacin sequential regimen, Amoxicillin 1 g orally twice daily plus a standard-dose or double-dose proton pump inhibitor (PPI) orally twice daily for 5 to 7 days; then follow with amoxicillin 1 g orally twice daily, metronidazole 500 mg orally twice daily, a standard-dose or double-dose PPI orally twice daily, and levofloxacin 500 mg orally once daily for 5 to 7 days (guideline dosage) [14]
Infection due to anaerobic bacteria
  • Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose, for 7 to 10 days or longer as clinically indicated; MAX 4 g/day [4]
  • 7.5 mg/kg orally every 6 hours for 7 to 10 days, or longer as clinically indicated; maximum 4 g/day [5][6]
Infection of bone; Adjunct
  • Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose, for 7 to 10 days or longer as clinically indicated; MAX 4 g/day [4]
  • 7.5 mg/kg orally every 6 hours for 7 to 10 days, or longer as clinically indicated; maximum 4 g/day [5][6]
Infectious disorder of joint; Adjunct
  • Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose, for 7 to 10 days or longer as clinically indicated; MAX 4 g/day [4]
  • 7.5 mg/kg orally every 6 hours for 7 to 10 days, or longer as clinically indicated; maximum 4 g/day [5][6]
Nongonococcal urethritis
  • Recurrent or persistent infection: 2 g orally in a single dose plus azithromycin 1 g orally in a single dose if not used for initial episode (guideline dosage) [11]
Operation on gastrointestinal tract, Colorectal - Postoperative infection; Prophylaxis
  • 1 g orally in 3 divided doses over 10 hours plus oral neomycin sulfate given the afternoon and evening prior to surgery and after completion of mechanical bowel preparation (guideline dosage) [7]
  • 500 mg IV 1 hour prior to surgery; for unusually long procedures repeat dosing may be required; total treatment duration should not exceed 24 hours (guideline dosage) [7]
  • 15 mg/kg IV over 30 to 60 minutes, complete 1 hour before surgery; follow with 7.5 mg/kg IV over 30 to 60 minutes at 6 and 12 hours after initial dose; limit treatment to day of surgery and discontinue within 12 hours following completion of surgery (manufacturer dosage) [4]
Operation on neck - Operative procedure on head - Postoperative infection; Prophylaxis
  • 500 mg IV 1 hour prior to surgery; for unusually long procedures repeat dosing may be required; total treatment duration should not exceed 24 hours (guideline dosage) [7]
Operative procedure on female genital system including obstetrics - Postoperative infection; Prophylaxis
  • 500 mg IV single dose plus single dose of either gentamicin 1.5 mg/kg IV or a quinolone (ciprofloxacin, levofloxacin, moxifloxacin) 400 mg IV [15]
  • Surgical abortion: 500 mg orally twice daily for 5 days [15]
Pelvic inflammatory disease
  • 500 mg orally twice daily for 14 days PLUS doxycycline 100 mg orally twice daily for 14 days PLUS a single IM dose of ceftriaxone 250 mg or a single IM dose of cefoxitin 2 g with probenecid 1 g given orally (guideline dosage) [11]
Rosacea
  • (1% cream) Apply a thin film topically to affected area once daily [16].
  • (0.75% lotion or gel) Apply a thin film topically and rub into affected area twice daily (morning and evening); area should be cleansed before application; cosmetics may be used after application [17][18].
  • (1% gel) Apply a thin film topically and rub into the affected area once daily; area should be cleansed before application; cosmetics may be used after application [19]
Sexually transmitted infectious disease; Prophylaxis - Victim of sexual aggression
  • 2 g orally as a single dose plus ceftriaxone 250 mg IM as a single dose and azithromycin 1 g orally as a single dose (guideline dosage) [11]
Trichomoniasis
  • (Oral tablets) 250 mg orally 3 times daily for 7 days OR 2 g orally as a single dose or divided into two 1-g doses taken on the same day (FDA dosage) [6]
  • (Oral capsules) 375 mg orally twice daily for 7 days (FDA dosage) [5]
  • 2 g orally as a single dose (preferred) OR 500 mg orally twice daily for 7 days (guideline dosage) [11]
  • HIV-infected women: 500 mg orally twice daily for 7 days (guideline dosage) [11].
  • Pregnant women: 2 g orally as a single dose at any stage of pregnancy (guideline dosage) [11].
  Pediatric Dosing
Important Note
  • Orphan drug designation: Treatment of perioral dermatitis
  • Orphan drug designation: Treatment of acne rosacea
  • Orphan drug designation: Topical treatment of active perianal Crohn disease
  • Orphan drug designation: Treatment of pouchitis
  • Orphan drug designation: Treatment of clostridium difficile infection in pediatric patients (0 through 16 years of age)
General Dosage Information
  • safety and effectiveness of immediate-release oral tablets and capsules not established in pediatric patients, except in the treatment of amebiasis [5][6]
  • safety and effectiveness of IV formulation not established in pediatric patients [4]
  • safety and efficacy of extended-release tablets not established in premenarchal women [3]
Amebic dysentery, acute
  • 35 to 50 mg/kg/day orally in 3 divided doses for 10 days; MAX 750 mg/dose [5][6]
Amebic liver abscess
  • 35 to 50 mg/kg/day orally in 3 divided doses for 10 days; MAX 750 mg/dose [5][6]
Bacterial vaginosis
  • (Post-menarche, 0.75% vaginal gel) 1 full applicator (37.5 mg) intravaginally once daily for 5 days at bedtime [9]
  • (12 years or older, 1.3% vaginal gel) 1 full applicator (65 mg) once intravaginally at bedtime [10]
Giardiasis
  • 15 mg/kg/day orally in 3 divided doses for 7 to 10 days; MAX 250 mg/dose [20]
Helicobacter pylori gastrointestinal tract infection
  • (4 to 17 years) 7.5 mg/kg 3 times daily (MAX, 400 mg/dose) in combination with omeprazole 10 to 20 mg once daily and clarithromycin 7.5 mg/kg twice daily (MAX, 250 mg/dose); treat for 7 days (off-label dosage) [21]
Infection by Dracunculus medinensis
  • 25 mg/kg orally every 24 hours; up to 750 mg/24 hours, in 3 divided doses for 10 days [20]
 
  Dose Adjustments
  • Renal impairment, including ESRD: No adjustment necessary; metabolites may accumulate in ESRD; monitor for adverse effects [4][3][5][6]
  • Hemodialysis: Consider supplemental dose following hemodialysis, if administration cannot be separated from the dialysis session [4][3][5][6].
  • Continuous ambulatory peritoneal dialysis: No adjustment necessary [4][3][5][6]
  • Hepatic impairment (mild to moderate): No adjustment necessary [4][3][5][6]
  • Hepatic impairment, severe (Child-Pugh C): Extended-release tablets not recommended unless benefit outweighs risk [3]; reduce dose of IV or immediate-release tablets or capsules by 50% [4][6]; for treatment of trichomoniasis with 375-mg capsules, increase dosing interval to once every 24 hours [5]
  FDA-Labeled Indications
  • Abscess, AnaerobicView additional information.
  • Amebic dysentery, acuteView additional information.
  • Amebic liver abscessView additional information.
  • Bacterial meningitisView additional information.
  • Bacterial vaginosisView additional information.
  • Infection due to anaerobic bacteriaView additional information.
  • Infection of bone; AdjunctView additional information.
  • Infectious disorder of joint; AdjunctView additional information.
  • Operation on gastrointestinal tract, Colorectal - Postoperative infection; ProphylaxisView additional information.
  • RosaceaView additional information.
  • TrichomoniasisView additional information.
  Non-FDA Labeled Indications
  • Appendectomy - Postoperative infection; ProphylaxisView additional information.
  • Cesarean section - Puerperal endometritisView additional information.
  • Clostridium difficile colitis; Prophylaxis - Operation on gastrointestinal tractView additional information.
  • Clostridium difficile diarrhea, including Pseudomembranous ColitisView additional information.
  • Crohn's diseaseView additional information.
  • Entamoeba polecki infectionView additional information.
  • GiardiasisView additional information.
  • Gingival enlargementView additional information.
  • Gynecological procedure; ProphylaxisView additional information.
  • Helicobacter pylori gastrointestinal tract infectionView additional information.
  • Infection by Dracunculus medinensisView additional information.
  • Infection by FasciolaView additional information.
  • Nongonococcal urethritisView additional information.
  • Ocular rosaceaView additional information.
  • Operation on neck - Operative procedure on head - Postoperative infection; ProphylaxisView additional information.
  • Operative procedure on female genital system including obstetrics - Postoperative infection; ProphylaxisView additional information.
  • Pelvic inflammatory diseaseView additional information.
  • Periodontal infectionView additional information.
  • Preterm labor; ProphylaxisView additional information.
  • Seborrheic dermatitisView additional information.
  • Sexually transmitted infectious disease; Prophylaxis - Victim of sexual aggressionView additional information.
  Black Box Warning
 
Black Box Warning
Intravenous (Solution)
  • Metronidazole has been shown to be carcinogenic in mice and rats. Its use, therefore, should be reserved only for conditions for which it is approved [4][23].
Oral (Capsule; Tablet; Tablet, Extended Release)
  • Metronidazole has been shown to be carcinogenic in mice and rats. Unnecessary use of the drug should be avoided. Its use should be reserved only for conditions for which it is approved [6][5][3].
  Contraindications/Warnings
 
  Do Not Confuse
  • metroNIDAZOLE - metFORMIN[1][2]
 
  Contraindications
  • alcohol (or products containing propylene glycol) use during and for at least 3 days after metronidazole use (oral, Flagyl(R) IV, vaginal gel) [6][4][5][3][22]
  • concomitant use with or within the last 2 weeks of disulfiram (oral, Flagyl(R) IV, vaginal gel) [6][4][5][3][22]
  • hypersensitivity to metronidazole or any other component of the product or to other nitroimidazole agents [6][4][5][3][22][23][24]
  • hypersensitivity to parabens (vaginal gel) [22]
  • pregnancy, first trimester, in patients being treated for trichomoniasis (immediate-release tablets, capsules) [6][5]
 
  Precautions
  • carcinogenicity has been demonstrated in mice and rats following chronic oral exposure; avoid unnecessary use and reserve only for approved indications (oral, Flagyl(R) IV, vaginal gel, cream) [6][4][5][3][22][24]
  • absence of bacterial or parasitic infection, active or suspected, or prophylactic indication; increased risk of drug-resistant bacteria or parasites (Flagyl(R) IV, oral) [6][4][5][3]
  • aseptic meningitis has been reported (injection, oral, vaginal gel) [6][4][5][3][22]; if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy (injection, oral) [6][4][5][3]; prompt discontinuation may be required (Metronidazole USP RTU(R), vaginal gel) [22][23]
  • blood dyscrasia, evidence or history of; mild leukopenia has been observed during drug administration; monitoring recommended (injection, oral, topical cream) [6][4][5][3][23][24]
  • candidiasis, known or previously unrecognized, including vaginal candidiasis; may cause more prominent symptoms during treatment (injection, oral, vaginal gel) [6][4][5][3][22][23]
  • CNS disease; may increase risk of adverse CNS effects (vaginal gel) [22]
  • concomitant use with or within the last 2 weeks of disulfiram should be avoided (Metronidazole USP RTU(R) injection) [23]
  • conjunctivitis has been reported with application to the face (topical cream) [24]
  • contact with eyes should be avoided (topical cream and vaginal gel) [22][24]
  • edema, patients who are predisposed to; may result in sodium retention (injection) [4][23]
  • encephalopathy, associated with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria, has been reported (injection, oral, vaginal gel) [6][4][5][3][22]; if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy (injection, oral) [6][4][5][3]; prompt discontinuation may be required (Metronidazole USP RTU(R), vaginal gel) [22][23]
  • hepatotoxicity and acute hepatic failure, including fatalities, have occurred in patients with Cockayne syndrome; use only after benefit-risk assessment and if no alternative treatment is available. Discontinue if elevations of liver function test occur [25]
  • hepatic disease, severe; slows the metabolism of metronidazole; dose adjustment recommended (injection, immediate-release tablets and capsules) [6][4][5][23]
  • hepatic disease, severe; use not recommended (extended-release tablets) [3]
  • laboratory test interference may occur with some serum chemistry values (eg, AST, ALT, lactate dehydrogenase, triglycerides, glucose hexokinase); values of zero may be observed (Flagyl(R) injection, oral) [6][4][5][3]; consider postponing lab tests until after metronidazole treatment (vaginal gel) [22]
  • leukopenia has been reported; monitoring recommended (Flagyl(R) injection) [4]
  • peripheral neuropathy, including optic neuropathy, has been reported (injection, oral, vaginal gel) [6][4][5][3][22]; if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy (injection, oral) [6][4][5][3]; prompt discontinuation may be required (Metronidazole USP RTU(R) injection, vaginal gel) [22][23]
  • renal disease, ESRD; drug or metabolites may be slowly excreted in urine; monitoring recommended (Flagyl(R) injection, oral) [6][4][5][3]
  • seizures, convulsive, have been reported (injection, oral, vaginal gel) [6][4][5][3][22]; if abnormal neurologic signs occur, evaluate benefit to risk ratio for continued therapy (injection, oral) [6][4][5][3]; prompt discontinuation may be required (Metronidazole USP RTU(R), vaginal gel) [22][23]
  • skin reactions, local, have been reported; use less frequently or discontinue use if skin reaction occurs (topical cream) [24]
  • report suspected adverse effects to the US Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch [22]
 
  Pregnancy Category
 
  Breast Feeding
  Drug Interactions (single)
 
Contraindicated
  • Amisulpride (theoretical)
  • Amprenavir (probable)
  • Bepridil (theoretical)
  • Cisapride (theoretical)
  • Disulfiram (probable)
  • Dronabinol (theoretical)
  • Dronedarone (theoretical)
  • Mesoridazine (established)
  • Pimozide (theoretical)
  • Saquinavir (theoretical)
  • Sparfloxacin (theoretical)
  • Terfenadine (theoretical)
  • Thioridazine (theoretical)
  • Ziprasidone (theoretical)
 
Major
  • Alfuzosin (theoretical)
  • Amiodarone (theoretical)
  • Amitriptyline (theoretical)
  • Anagrelide (theoretical)
  • Apomorphine (theoretical)
  • Aripiprazole (theoretical)
  • Aripiprazole Lauroxil (theoretical)
  • Arsenic Trioxide (theoretical)
  • Asenapine (theoretical)
  • Astemizole (theoretical)
  • Atazanavir (theoretical)
  • Azithromycin (theoretical)
  • Bedaquiline (theoretical)
  • Buprenorphine (theoretical)
  • Bupropion (theoretical)
  • Buserelin (theoretical)
  • Busulfan (probable)
  • Capecitabine (theoretical)
  • Chloroquine (theoretical)
  • Chlorpromazine (theoretical)
  • Cholera Vaccine, Live (theoretical)
  • Ciprofloxacin (theoretical)
  • Citalopram (theoretical)
  • Clarithromycin (theoretical)
  • Clomipramine (theoretical)
  • Clozapine (theoretical)
  • Crizotinib (theoretical)
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  • Dasatinib (theoretical)
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  • Delamanid (theoretical)
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  • Deslorelin (theoretical)
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  • Dofetilide (theoretical)
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  • Droperidol (theoretical)
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  • Encorafenib (theoretical)
  • Eribulin (theoretical)
  • Erythromycin (theoretical)
  • Escitalopram (theoretical)
  • Famotidine (theoretical)
  • Felbamate (theoretical)
  • Fingolimod (theoretical)
  • Flecainide (theoretical)
  • Fluconazole (theoretical)
  • Fluorouracil (theoretical)
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  • Formoterol (theoretical)
  • Foscarnet (theoretical)
  • Fosphenytoin (theoretical)
  • Galantamine (theoretical)
  • Gatifloxacin (theoretical)
  • Gemifloxacin (theoretical)
  • Glasdegib (theoretical)
  • Gonadorelin (theoretical)
  • Goserelin (theoretical)
  • Granisetron (theoretical)
  • Halofantrine (theoretical)
  • Haloperidol (theoretical)
  • Histrelin (theoretical)
  • Hydroquinidine (theoretical)
  • Hydroxychloroquine (probable)
  • Hydroxyzine (theoretical)
  • Ibutilide (theoretical)
  • Iloperidone (theoretical)
  • Imipramine (theoretical)
  • Inotuzumab Ozogamicin (theoretical)
  • Itraconazole (theoretical)
  • Ivabradine (theoretical)
  • Ivosidenib (theoretical)
  • Ketoconazole (theoretical)
  • Lapatinib (theoretical)
  • Leuprolide (theoretical)
  • Levofloxacin (theoretical)
  • Lofexidine (probable)
  • Lumefantrine (theoretical)
  • Macimorelin (theoretical)
  • Mebendazole (established)
  • Mefloquine (theoretical)
  • Methadone (theoretical)
  • Mifepristone (theoretical)
  • Mizolastine (theoretical)
  • Moxifloxacin (theoretical)
  • Mycophenolate Mofetil (established)
  • Mycophenolic Acid (established)
  • Nafarelin (theoretical)
  • Nelfinavir (theoretical)
  • Nilotinib (theoretical)
  • Norfloxacin (theoretical)
  • Octreotide (theoretical)
  • Ofloxacin (theoretical)
  • Olanzapine (theoretical)
  • Ondansetron (theoretical)
  • Osimertinib (theoretical)
  • Paliperidone (theoretical)
  • Panobinostat (theoretical)
  • Papaverine Hydrochloride (theoretical)
  • Paroxetine (theoretical)
  • Pasireotide (theoretical)
  • Pazopanib (theoretical)
  • Pentamidine (theoretical)
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  • Pimavanserin (theoretical)
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  • Pitolisant (theoretical)
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  • Procainamide (theoretical)
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  • Promethazine (theoretical)
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  • Quetiapine (theoretical)
  • Quinidine (theoretical)
  • Quinine (theoretical)
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  • Ribociclib (theoretical)
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  • Ritonavir (theoretical)
  • Sertindole (theoretical)
  • Sertraline (theoretical)
  • Sevoflurane (theoretical)
  • Sodium Phosphate (theoretical)
  • Sodium Phosphate, Dibasic (theoretical)
  • Sodium Phosphate, Monobasic (theoretical)
  • Solifenacin (theoretical)
  • Sorafenib (theoretical)
  • Sotalol (theoretical)
  • Sulpiride (theoretical)
  • Sunitinib (theoretical)
  • Tacrolimus (probable)
  • Tamoxifen (theoretical)
  • Tegafur (theoretical)
  • Telaprevir (theoretical)
  • Telavancin (theoretical)
  • Telithromycin (theoretical)
  • Tetrabenazine (theoretical)
  • Tizanidine (theoretical)
  • Tolterodine (theoretical)
  • Toremifene (theoretical)
  • Trazodone (theoretical)
  • Trimipramine (theoretical)
  • Triptorelin (theoretical)
  • Vandetanib (theoretical)
  • Vardenafil (theoretical)
  • Vemurafenib (theoretical)
  • Venlafaxine (theoretical)
  • Vilanterol (theoretical)
  • Vinflunine (theoretical)
  • Voriconazole (theoretical)
  • Vorinostat (theoretical)
  • Warfarin (probable)
  • Zuclopenthixol (theoretical)
 
Moderate
  • Carbamazepine (probable)
  • Cholestyramine (probable)
  • Cyclosporine (probable)
  • Lithium (probable)
  • Milk Thistle (probable)
  Adverse Effects
   
Common
  • Gastrointestinal: Abdominal discomfort (4% to 7% ), Abnormal taste in mouth (2% to 9% ), Diarrhea (1% to 4% ), Nausea (1.6% to 10% )
  • Immunologic: Jarisch Herxheimer reaction
  • Neurologic: Dizziness (1% to 4% ), Headache (Vaginal gel, 2.2% to 5%; extended-release tablets, 18% )
  • Reproductive: Candida infection of genital region, Vaginal discharge (12% ), Vaginal irritation (9% ), Vaginitis (15% )
   
Serious
  • Dermatologic: Stevens-Johnson syndrome, Toxic epidermal necrolysis
  • Hematologic: Leukopenia
  • Hepatic: Hepatic failure, acute, Hepatotoxicity
  • Neurologic: Aseptic meningitis, Encephalopathy, Peripheral neuropathy, Seizure
  • Ophthalmic: Disorder of optic nerve
  • Otic: Ototoxicity
  • Renal: Hemolytic uremic syndrome
  Name Info
 
Drug Images
   More images...
   
US Trade Names
  • Flagyl
  • Flagyl ER
  • Flagyl I.V. RTU
  • Metrocream
  • Metrogel
  • Metrogel-Vaginal
  • Metrolotion
  • Noritate
All Trade Names
 
  Class
  • Antiacne Antibacterial
  • Antibacterial
  • Antibiotic
  • Nitroimidazole
   
Regulatory Status
  • RX
   
Generic Availability
  • Yes
  Mechanism of Action/Pharmacokinetics
 
  Mechanism of Action
  • Metronidazole is a nitroimidazole and works by passive diffusion into the cytoplasm of anaerobic bacteria where transport proteins such ferredoxin transfer electrons to the nitro group of metronidazole forming a nitroso free radical. This creates a concentration gradient for intracellular transport of metronidazole where the free radical of metronidazole interacts with intracellular DNA resulting in the inhibition of DNA synthesis and degradation and ultimately bacterial death [27]. Topical application of metronidazole exerts an antiinflammatory effect in the treatment of rosacea [17].
  Pharmacokinetics
  Absorption
  • Tmax, IV: end of infusion [28]
  • Tmax, Oral: 1 to 2 hours [29]
  • Tmax, Rectal: 3 hours [30]
  • Tmax, Topical: 8 to 12 hours [31]
  • Bioavailability, systemic: 80% [32][33]
  • Bioavailability, Topical: minimal [34]
  • Bioavailability, Vaginal cream or tablets: 20%; Vaginal gel: 56% [35][36][37][38]
  • Effects of food, regular release: lower Cmax, delayed Tmax; absorption not affected [29]
  • Effects of food, extended-release: increased rate of absorption; altered extended-release characteristics [39]
  Distribution
  • Vd, adults: 0.55 L/kg; neonates: 0.54 to 0.81 L/kg [32][40][41]
  • Protein binding: less than 20% [29]
  Metabolism
  • Hepatic: extensive [42]
  • hydroxymethyl metabolite: active [42] 1-[2-hydroxyethyl]-2-hydroxymethyl-5-nitroimidazole and 1-acetic acid-2-methyl-5-nitroimidazole (vaginal): active [43][44]
  Excretion   Elimination Half Life
  • 8 hours (range 6 to 12 hours) [46][40][41]
  • 75 hours, adults; 35 hours, neonates 28 to 30 weeks; 25 hours, neonates 32 to 40 weeks [40][41]
  Administration/Monitoring
  Administration
Intravenous
  • administer by slow IV drip infusion only, either as a continuous or intermittent infusion[4]
  • reconstituted solution must be further diluted to a final concentration of 5 to 8 mg/mL; do NOT administer reconstituted solution as an IV bolus [4]
  • do not introduce additives into injection; if used with a primary IV fluid system, discontinue the primary solution during infusion [4]
  • do NOT use equipment containing aluminum (eg, needles, cannulae) that would come in contact with the drug solution [4]
  • (surgical prophylaxis) administration of the initial preoperative dose must be completed approximately 1 hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision [4]
Oral
  • (extended-release tablets) do not crush, split, or chew [3]
  • (extended-release tablets) take under fasting conditions, at least 1 hour before or 2 hours after meals [3]
 
  Monitoring
  • culture and susceptibility information; before treatment initiation and with therapy modifications [4][6][3][5]
  • prevention or improvement of susceptible anaerobic bacterial or parasitic infections indicates efficacy
  • trichomoniasis: trichomonad wet smears, cultures, or both; before and after treatment and before repeated therapy [6][5]
  • total and differential leukocyte counts; before and after therapy in patients with current or past blood dyscrasias [6][5][3], or who require prolonged or repeated treatment [6][4][5]
  • drug-associated adverse events in geriatric patients and patients with ESRD or hepatic impairment [6][4][3][5]
  • liver function tests: In patients with Cockayne syndrome prior to therapy initiation, within 2 to 3 days of therapy initiation, frequently during therapy and after discontinuation of therapy [25]
  • signs and symptoms of liver injury (eg, abdominal pain, nausea, change in stool color or jaundice): In patients with Cockayne syndrome [25]
  How Supplied
 
How Supplied
Generic
  • Intravenous Solution: 500 MG/100 ML
  • Oral Capsule: 375 MG
  • Oral Tablet: 250 MG, 500 MG
  • Topical Cream: 0.75 %
  • Topical Gel/Jelly: 0.75 %, 1 %
  • Topical Lotion: 0.75 %
  • Vaginal Gel/Jelly: 0.75 %
Flagyl 375
  • Oral Capsule: 375 MG
Flagyl
  • Oral Tablet: 250 MG, 500 MG
Metrocream
  • Topical Cream: 0.75 %
Metrogel
  • Topical Gel/Jelly: 1 %
MetroGel-Vaginal
  • Vaginal Gel/Jelly: 0.75 %
Metrolotion
  • Topical Lotion: 0.75 %
metroNIDAZOLE Novaplus
  • Intravenous Solution: 500 MG/100 ML
Noritate
  • Topical Cream: 1 %
Nuvessa
  • Vaginal Gel/Jelly: 1.3 %
PremierPro Rx metroNIDAZOLE
  • Intravenous Solution: 500 MG/100 ML
Rosadan Gel
  • Topical Gel/Jelly: 0.75 %
Rosadan
  • Topical Cream: 0.75 %
Vandazole
  • Vaginal Gel/Jelly: 0.75 %
  Toxicology
 
Clinical Effects
METRONIDAZOLE AND RELATED AGENTS
  • USES: Metronidazole is a synthetic 5-nitroimidazole compound. Secnidazole and tinidazole are related compounds and are long-acting 5-nitroimidazole derivatives. These drugs have antiprotozoal and antibacterial activity and are used in the treatment of protozoal and anaerobic bacterial infections. Metronidazole and tinidazole are used for the treatment of trichomoniasis, amebic liver abscesses, intestinal amebiasis, pelvic inflammatory disease, bacterial vaginosis, giardiasis, and Clostridium difficile-associated diarrhea, as well as for perioperative prophylaxis. Secnidazole is used to treat giardiasis, intestinal amebiasis, bacterial vaginosis, and vaginal trichomoniasis, but secnidazole is not currently available in the United States. PHARMACOLOGY: These chemicals are reduced in a process unique to anaerobic metabolism; the short-lived metabolite disrupts DNA and inhibits nucleic acid synthesis. TOXICOLOGY: Mechanism is not known. EPIDEMIOLOGY: Metronidazole is commonly prescribed. Acute toxicity is rare. MILD TO MODERATE TOXICITY: METRONIDAZOLE: Most patients remain asymptomatic. Dark (green/black) urine and increased liver enzymes have been reported. TINIDAZOLE: At the time of this review, there are no reports of human overdose with tinidazole. SEVERE TOXICITY: CNS depression and seizures have been reported rarely. Dizziness, diplopia, disorientation, ataxia, and sensory neuropathy have been reported with chronic overdose. ADVERSE EFFECTS: METRONIDAZOLE: Characteristic adverse effects include nausea, vomiting, anorexia, headache, and vertigo. Peripheral neuropathy has been reported in children receiving chronic therapy. Leukopenia has been reported in approximately 1% of patients receiving therapeutic dosing. In 2 patients, sensorineural hearing loss occurred within 48 hours of use. An expected reaction in a patient who takes metronidazole and drinks ethanol is a disulfiram-like reaction; patients taking these agents should avoid ingestion of ethanol during treatment and for 3 days after cessation of treatment. Nausea, vomiting, abdominal cramps, flushing, anxiety, confusion, vertigo, and headache may occur. In severe reactions, patients may become hypotensive. TINIDAZOLE: Overall the adverse effects reported with tinidazole are similar to those of metronidazole. In clinical studies, adverse effects were mild and self-limited with therapy.
 
Treatment
METRONIDAZOLE AND RELATED AGENTS
  • Support: MILD TO MODERATE TOXICITY: Patients may only need observation. SEVERE TOXICITY: Treatment is symptomatic and supportive. Orotracheal intubation for airway protection should be performed early in cases of CNS depression or repeated seizure activity. DISULFIRAM-LIKE REACTION: Manage hypotension with IV fluids. If hypotension persists, use direct-acting vasopressors such as epinephrine or norepinephrine. Benzodiazepines may be used for associated agitation or anxiety. Fomepizole inhibits alcohol dehydrogenase, preventing the formation of acetaldehyde, and could theoretically be useful in treating severe disulfiram-like reactions, although there is limited experience with this therapy.
  • Decontamination: PREHOSPITAL: Most patients remain asymptomatic; prehospital decontamination is not routinely recommended. HOSPITAL: Consider decontamination if a patient presents promptly after a large oral overdose, is not vomiting, and does not have CNS depression or seizures.
  • Airway management: Perform early in patients with CNS depression or seizures.
  • Antidote: None.
  • Nausea: Antiemetics may be used to control nausea.
  • Tachycardia: If the patient cannot tolerate fluids, IV fluids can be given. If anxiety from a disulfiram-like reaction is present, a benzodiazepine can be given.
  • Hypotensive episode: If patient is hypotensive, it is either from a disulfiram-like reaction or a co-ingestant. Secure intravenous access and put patient in supine position. Initiate treatment with IV fluids. Initiate pressors if necessary and titrate to a mean arterial pressure of at least 60 mmHg. If a pressor is needed to increase blood pressure, a direct-acting agent such as norepinephrine or epinephrine is best. Insert foley bladder catheter and monitor urine output.
  • Headache: Oral analgesics can be given if tolerated. If the patient is nauseated, IV analgesics can be given.
  • Seizure: Seizures are rare and often self-limited but may be a result of CNS stimulation. Treatment includes IV benzodiazepines. If seizures persist, use propofol or barbiturates.
  • Monitoring of patient: Monitor vital signs and mental status. Metronidazole plasma concentrations are not clinically useful or readily available. A CBC should be obtained if leukopenia is suspected clinically. Monitor serum electrolytes and glucose, and liver enzymes in symptomatic patients. No specific lab work is needed in most patients but may be helpful in ruling out other causes of altered mental status or seizures if they occur. Consider head CT and lumbar puncture to rule out intracranial mass, bleeding or infection for patients with CNS manifestations. Acute toxicity has not been reported with this drug. However, standard treatment measures may be indicated in ingestions of greater than 1 to 2 grams.
  • Enhanced elimination procedure: Hemodialysis and hemoperfusion are UNLIKELY to be of value for metronidazole.
  • Patient disposition: HOME CRITERIA: Asymptomatic patients with unintentional ingestions can be monitored at home. OBSERVATION CRITERIA: Patients with deliberate ingestions should be sent to a healthcare facility for observation for at least 4 hours. Any patient with symptoms should be sent to a healthcare facility and observed until symptoms improve or resolve. ADMISSION CRITERIA: Patients with significant seizure activity, marked disulfiram-like reaction and/or persistent abnormal vital signs should be admitted. Patients with seizures, severe hypotension or any other life-threatening result of toxicity should be admitted to an intensive care setting. CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
 
Range of Toxicity
METRONIDAZOLE AND RELATED AGENTS
  • TOXICITY: METRONIDAZOLE: ADULT: Single doses up to 15 g have been tolerated well. Seizures and peripheral neuropathy have occurred after 5 to 7 days of doses of 6 to 10.4 g every other day. Encephalopathy has been reported in patients taking metronidazole with cumulative doses from 0.25 g to 182 g. Patients may present with cerebellar dysfunction, altered mental status, and seizures. Most patients recover following the discontinuation of metronidazole. PEDIATRIC: Not well established. However, peripheral neuropathy has been reported in children taking a mean dose of 19 mg/kg/day of metronidazole for 4 to 11 months. THERAPEUTIC DOSES: METRONIDAZOLE: ADULT: Varies according to indication. Typical doses range from 250 to 2000 mg once to three times daily. INTRAVENOUS: Loading dose, 15 mg/kg IV over 1 hour; maintenance dose, 7.5 mg/kg IV every 6 hours, starting 6 hours after loading dose; duration 7 to 10 days or longer as clinically indicated; MAX 4 g/day. 7.5 mg/kg orally every 6 hours for 7 to 10 days or longer as clinically indicated; maximum 4 g/day. VAGINAL: VANDAZOLE(R): 0.75% VAGINAL GEL: 1 applicator (37.5 mg) intravaginally once daily for 5 days at bedtime. NUVESSA(TM): 1.3% VAGINAL GEL: 1 full applicator (65 mg) once intravaginally at bedtime. PEDIATRIC: Varies according to indication. Typical doses range from 7.5 to 30 mg/kg/day divided every 8 hours. VAGINAL: VANDAZOLE(R): POST-MENARCHE, 0.75% VAGINAL GEL: 1 full applicator (37.5 mg) intravaginally once daily for 5 days at bedtime. NUVESSA(TM): 12 YEARS OR OLDER, 1.3% VAGINAL GEL: 1 full applicator (65 mg) once intravaginally at bedtime. SECNIDAZOLE: ADULT: 1 packet (2 g) orally once daily. PEDIATRIC: Safety and efficacy in the pediatric or adolescent population have not been established. TINIDAZOLE: ADULT: A single 2 g oral dose. CHILDREN (3 YEARS OF OLDER): 50 mg/kg/day up to 3 days.
  Clinical Teaching
   
Clinical Teaching
  • Warn patient to immediately report symptoms of aseptic meningitis, encephalopathy, or peripheral neuropathy [5][3][4][6][22][52].
  • Side effects may include seizures, nausea, diarrhea, headaches, dizziness, metallic taste, rash, pruritus, or leukopenia (mild) [5][3][4][6].
  • Topical side effects may include local reactions (dryness, scaling, pruritus, stinging, burning) or contact dermatitis. Face exposure may cause conjunctivitis and eye irritation [52][24].
  • Vaginal side effects may include vaginal candidiasis, headaches, pruritus, abdominal pain, nausea, dysmenorrhea, or rash [22].
  • Advise patient to take extended-release tablet at least 1 hour before or 2 hours after a meal [3].
  • Tell patient to avoid alcohol with drug due to disulfiram-like reaction [5][3][4][6][22].
  • Metronidazole (Oral route, Capsule, Tablet, Tablet, Extended Release)Metronidazole (Intravenous route, Powder for Solution, Solution)Metronidazole (Topical route, Cream, Gel/Jelly, Emulsion, Lotion)Metronidazole (Vaginal route, Gel/Jelly)
  References
 
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