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Pronunciation:

(me troe NI da zole)

U.S. Brand Names:

Flagyl®; Flagyl ER®; Flagyl® I.V. RTU™; MetroCream®; MetroGel®; MetroGel-Vaginal®; MetroLotion®; Noritate®; Rozex™

Synonyms:

Metronidazole Hydrochloride

Generic Available:

Yes: Cream, infusion, tablet

Canadian Brand Names:

Apo-Metronidazole®; Flagyl®; Florazole® ER; MetroCream®; Metrogel®; Nidagel™; Noritate®; Novo-Nidazol; Trikacide

Use:

Treatment of susceptible anaerobic bacterial and protozoal infections in the following conditions: Amebiasis, symptomatic and asymptomatic trichomoniasis; skin and skin structure infections; CNS infections; intra-abdominal infections (as part of combination regimen); systemic anaerobic infections; treatment of antibiotic-associated pseudomembranous colitis (AAPC), bacterial vaginosis; as part of a multidrug regimen for H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Topical: Treatment of inflammatory lesions and erythema of rosacea

Use - Dental:

Treatment of oral soft tissue infections due to anaerobic bacteria including all anaerobic cocci, anaerobic gram-negative bacilli (Bacteroides), and gram-positive spore-forming bacilli (Clostridium). Useful as single agent or in combination with amoxicillin, Augmentin®, or ciprofloxacin in the treatment of periodontitis associated with the presence of Actinobacillus actinomycetemcomitans (AA).

Use - Unlabeled/Investigational:

Crohn's disease

Pregnancy Risk Factor:

B (may be contraindicated in 1st trimester)

Pregnancy Implications:

Crosses the placenta (carcinogenic in rats); contraindicated for the treatment of trichomoniasis during the first trimester of pregnancy, unless alternative treatment is inadequate. Until safety and efficacy for other indications have been established, use only during pregnancy when the benefit to the mother outweighs the potential risk to the fetus.

Lactation:

Enters breast milk/not recommended (AAP rates "of concern")

Contraindications:

Hypersensitivity to metronidazole, nitroimidazole derivatives, or any component of the formulation; pregnancy (1st trimester - found to be carcinogenic in rats)

Warnings/Precautions:

Use with caution in patients with liver impairment due to potential accumulation, blood dyscrasias; history of seizures, CHF, or other sodium retaining states; reduce dosage in patients with severe liver impairment, CNS disease, and severe renal failure (Clcr<10 mL/minute); if H. pylori is not eradicated in patients being treated with metronidazole in a regimen, it should be assumed that metronidazole-resistance has occurred and it should not again be used; seizures and neuropathies have been reported especially with increased doses and chronic treatment; if this occurs, discontinue therapy

Adverse Reactions:

Systemic: Frequency not defined:

Cardiovascular: Flattening of the T-wave, flushing

Central nervous system: Ataxia, confusion, coordination impaired, dizziness, fever, headache, insomnia, irritability, seizure, vertigo

Dermatologic: Erythematous rash, urticaria

Endocrine & metabolic: Disulfiram-like reaction, dysmenorrhea, libido decreased

Gastrointestinal: Nausea (~12%), anorexia, abdominal cramping, constipation, diarrhea, furry tongue, glossitis, proctitis, stomatitis, unusual/metallic taste, vomiting, xerostomia

Genitourinary: Cystitis, darkened urine (rare), dysuria, incontinence, polyuria, vaginitis

Hematologic: Neutropenia (reversible), thrombocytopenia (reversible, rare)

Neuromuscular & skeletal: Peripheral neuropathy, weakness

Respiratory: Nasal congestion, rhinitis, sinusitis, pharyngitis

Miscellaneous: Flu-like syndrome, moniliasis

Topical: Frequency not defined:

Central nervous system: Headache

Dermatologic: Burning, contact dermatitis, dryness, erythema, irritation, pruritus, rash

Gastrointestinal: Unusual/metallic taste, nausea, constipation

Local: Local allergic reaction

Neuromuscular & skeletal: Tingling/numbness of extremities

Ocular: Eye irritation

Vaginal:

>10%: Genitourinary: Vaginal discharge (12%)

1% to 10%:

Central nervous system: Headache (5%), dizziness (2%)

Gastrointestinal: Gastrointestinal discomfort (7%), nausea and/or vomiting (4%), unusual/metallic taste (2%), diarrhea (1%)

Genitourinary: Vaginitis (10%), vulva/vaginal irritation (9%), pelvic discomfort (3%)

Hematologic: WBC increased (2%)

<1%: Abdominal bloating, abdominal gas, darkened urine, depression, fatigue, itching, rash, thirst, xerostomia

Overdosage/Toxicology:

Symptoms of overdose include nausea, vomiting, ataxia, seizures, and peripheral neuropathy. Treatment is symptomatic and supportive.

Drug Interactions:

Inhibits CYP2C8/9 (weak), 3A4 (moderate)

Cimetidine may increase metronidazole levels.

Cisapride: May inhibit metabolism of cisapride, causing potential arrhythmias; avoid concurrent use

CYP3A4 substrates: Metronidazole may increase the levels/effects of CYP3A4 substrates. Example substrates include benzodiazepines, calcium channel blockers, cyclosporine, mirtazapine, nateglinide, nefazodone, sildenafil (and other PDE-5 inhibitors), tacrolimus, and venlafaxine. Selected benzodiazepines (midazolam and triazolam), cisapride, ergot alkaloids, selected HMG-CoA reductase inhibitors (lovastatin and simvastatin), and pimozide are generally contraindicated with strong CYP3A4 inhibitors.

Ethanol: Ethanol results in disulfiram-like reactions.

Lithium: Metronidazole may increase lithium levels/toxicity; monitor lithium levels.

Phenytoin, phenobarbital may increase metabolism of metronidazole, potentially decreasing its effect.

Warfarin: Metronidazole increases P-T prolongation with warfarin.

Ethanol/Nutrition/Herb Interactions:

Ethanol: The manufacturer recommends to avoid all ethanol or any ethanol-containing drugs (may cause disulfiram-like reaction characterized by flushing, headache, nausea, vomiting, sweating or tachycardia).

Food: Peak antibiotic serum concentration lowered and delayed, but total drug absorbed not affected.

Stability:

Metronidazole injection should be stored at 15°C to 30°C and protected from light. Product may be refrigerated but crystals may form; crystals redissolve on warming to room temperature. Prolonged exposure to light will cause a darkening of the product. However, short-term exposure to normal room light does not adversely affect metronidazole stability. Direct sunlight should be avoided. Stability of parenteral admixture at room temperature (25°C): Out of overwrap stability: 30 days.

Standard diluent: 500 mg/100 mL NS

Compatibility:

Stable in D5W, NS

Y-site administration: Compatible: Acyclovir, allopurinol, amiodarone, amifostine, cefepime, cisatracurium, clarithromycin, cyclophosphamide, diltiazem, docetaxel, dopamine, doxorubicin liposome, enalaprilat, esmolol, etoposide phosphate, fluconazole, foscarnet, gatifloxacin, gemcitabine, granisetron, heparin, hydromorphone, labetalol, linezolid, lorazepam, magnesium sulfate, melphalan, meperidine, methylprednisolone sodium succinate, midazolam, morphine, perphenazine, piperacillin/tazobactam, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, vinorelbine. Incompatible: Amphotericin B cholesteryl sulfate complex, aztreonam, filgrastim, meropenem, warfarin

Compatibility when admixed: Compatible: Amikacin, aminophylline, ampicillin, cefazolin, cefotaxime, cefoxitin, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, chloramphenicol, ciprofloxacin, clindamycin, disopyramide, floxacillin, fluconazole, gentamicin, heparin, hydrocortisone sodium succinate, multivitamins, netilmicin, penicillin G potassium, tobramycin. Incompatible: Aztreonam, dopamine, meropenem. Variable (consult detailed reference): Cefamandole, cefepime

Mechanism of Action:

After diffusing into the organism, interacts with DNA to cause a loss of helical DNA structure and strand breakage resulting in inhibition of protein synthesis and cell death in susceptible organisms

Pharmacodynamics/Kinetics:

Absorption: Oral: Well absorbed; Topical: Concentrations achieved systemically after application of 1 g topically are 10 times less than those obtained after a 250 mg oral dose

Distribution: To saliva, bile, seminal fluid, breast milk, bone, liver, and liver abscesses, lung and vaginal secretions; crosses placenta and blood-brain barrier

CSF:blood level ratio: Normal meninges: 16% to 43%; Inflamed meninges: 100%

Protein binding: <20%

Metabolism: Hepatic (30% to 60%)

Half-life elimination: Neonates: 25-75 hours; Others: 6-8 hours, prolonged with hepatic impairment; End-stage renal disease: 21 hours

Time to peak, serum: Oral: Immediate release: 1-2 hours

Excretion: Urine (20% to 40% as unchanged drug); feces (6% to 15%)

Dosage:

Infants and Children:

Amebiasis: Oral: 35-50 mg/kg/day in divided doses every 8 hours for 10 days

Trichomoniasis: Oral: 15-30 mg/kg/day in divided doses every 8 hours for 7 days

Anaerobic infections:

Oral: 15-35 mg/kg/day in divided doses every 8 hours

I.V.: 30 mg/kg/day in divided doses every 6 hours

Clostridium difficile (antibiotic-associated colitis): Oral: 20 mg/kg/day divided every 6 hours

Maximum dose: 2 g/day

Adults:

Amebiasis: Oral: 500-750 mg every 8 hours for 5-10 days

Trichomoniasis: Oral: 250 mg every 8 hours for 7 days or 375 mg twice daily for 7 days or 2 g as a single dose

Anaerobic infections: Oral, I.V.: 500 mg every 6-8 hours, not to exceed 4 g/day

Antibiotic-associated pseudomembranous colitis: Oral: 250-500 mg 3-4 times/day for 10-14 days

Helicobacter pylori eradication: Oral: 250-500 mg with meals and at bedtime for 14 days; requires combination therapy with at least one other antibiotic and an acid-suppressing agent (proton pump inhibitor or H2 blocker)

Bacterial vaginosis:

Oral: 750 mg (extended release tablet) once daily for 7 days

Vaginal: 1 applicatorful (~37.5 mg metronidazole) intravaginally once or twice daily for 5 days; apply once in morning and evening if using twice daily, if daily, use at bedtime

Acne rosacea: Topical:

0.75%: Apply and rub a thin film twice daily, morning and evening, to entire affected areas after washing. Significant therapeutic results should be noticed within 3 weeks. Clinical studies have demonstrated continuing improvement through 9 weeks of therapy.

1%: Apply thin film to affected area once daily

Elderly: Use lower end of dosing recommendations for adults, do not administer as a single dose

Dosing adjustment in renal impairment: Clcr<10 mL/minute: Administer 50% of dose or every 12 hours

Hemodialysis: Extensively removed by hemodialysis and peritoneal dialysis (50% to 100%); administer dose posthemodialysis

Peritoneal dialysis: Dose as for Clcr<10 mL/minute

Continuous arteriovenous or venovenous hemofiltration: Administer usual dose

Dosing adjustment/comments in hepatic disease: Unchanged in mild liver disease; reduce dosage in severe liver disease

Administration:

Oral: May be taken with food to minimize stomach upset. Extended release tablets should be taken on an empty stomach (1 hour before or 2 hours after meals).

I.V.: Avoid contact between the drug and aluminum in the infusion set.

Topical: No disulfiram-like reactions have been reported after topical application, although metronidazole can be detected in the blood. Apply to clean, dry skin. Cosmetics may be used after application (wait at least 5 minutes after using lotion).

Test Interactions:

May interfere with AST, ALT, triglycerides, glucose, and LDH testing

Dietary Considerations:

Take on an empty stomach. Drug may cause GI upset; if GI upset occurs, take with food. Extended release tablets should be taken on an empty stomach (1 hour before or 2 hours after meals). Sodium content of 500 mg (I.V.): 322 mg (14 mEq). The manufacturer recommends that ethanol be avoided during treatment and for 3 days after therapy is complete.

Patient Education:

Take exactly as directed. May take with or without food. Take with food if medication causes upset stomach. Avoid alcohol during and for 72 hours after last dose. With alcohol you may experience severe flushing, headache, nausea, vomiting, or chest and abdominal pain. May discolor urine (brown/black/dark) (normal). You may experience "metallic" taste disturbance or nausea or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Refrain from intercourse or use a barrier contraceptive if being treated for trichomoniasis. Report unresolved or severe fatigue; weakness; fever or chills; mouth or vaginal sores; numbness, tingling, or swelling of extremities; respiratory difficulty; or lack of improvement or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Breast-feeding is not recommended.

Topical: Wash hands and area before applying. Apply medication thinly. Wash hands after applying. Avoid contact with eyes. Do not cover with occlusive dressing. Report severe skin irritation or if condition does not improve.

Anesthesia and Critical Care Concerns/Other Considerations:

Metronidazole may have effects similar to that of disulfiram (Antabuse®). If ethanol is taken during and within 24 hours of the last dose of metronidazole, patients may have severe flushing, headache, nausea, vomiting, or chest and abdominal pain.

Cardiovascular Considerations:

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Unusual/metallic taste, glossitis, stomatitis, and xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

Dizziness is common; case reports of depression, insomnia, confusion, panic, delusions, hallucinations, exacerbation of schizophrenia

Mental Health: Effects on Psychiatric Treatment:

May rarely cause leukopenia; use caution with clozapine and carbamazepine; may decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Oncology: Emetic Potential:

Low (10% to 30%)

Oncology: Vesicant:

Dosage Forms:

[DSC] = Discontinued product

Capsule (Flagyl®): 375 mg

Cream, topical: 0.75% (45 g)

MetroCream®: 0.75% (45 g) [contains benzyl alcohol]

Noritate®: 1% (60 g)

Emulsion, topical (Rozex™): 0.75% (60 g) [contains benzyl alcohol]

Gel, topical (MetroGel®): 0.75% (45 g)

Gel, vaginal (MetroGel-Vaginal®): 0.75% (70 g)

Infusion (Flagyl® I.V. RTU™) [premixed iso-osmotic sodium chloride solution]: 500 mg (100 mL) [contains sodium 14 mEq]

Injection, powder for reconstitution, as hydrochloride (Flagyl®): 500 mg [DSC]

Lotion, topical (MetroLotion®): 0.75% (60 mL) [contains benzyl alcohol]

Tablet (Flagyl®): 250 mg, 500 mg

Tablet, extended release (Flagyl® ER): 750 mg

Extemporaneously Prepared:

A 20 mg/mL oral suspension can be prepared by crushing ten 250 mg tablets in a mortar, and then adding 10 mL purified water USP to create a uniform paste. Add a small quantity of syrup, then transfer to a graduate and add a sufficient quantity of syrup to make 125 mL. Label "shake well" and "refrigerate." Refrigerated stability is 10 days.

Irwin DB, Dupuis LL, Prober CG, et al, "The Acceptability, Stability, and Relative Bioavailability of an Extemporaneous Metronidazole Suspension,"Can J Hosp Pharm, 1987, 40:42-6.

Nahata MC, Morosco RS, and Hipple TF, 4th ed, Pediatric Drug Formulations, Cincinnati, OH: Harvey Whitney Books Co, 2000.

International Brand Names:

Acromona® (EC); Acsacea-Creme® (AT); Adco-Metronidazole® (ZA); Amebicur® (EC); Ameblin® (MX); Amevan (EC); Amobin® (BD); Amodis® (BD); Amotein® (ES); Amotrex® (BD); Amrizole® (RO); Anabact® (GB, IE); Anaerobex® (AT); Anaerobil-Gold® (ZA); Anaeromet® (BE, LU); Anamet® (BD); Anmerob® (ID); Apo-Metronidazole® (CA, SG); Arcazol® (HK); Arilin® (CH, DE); Aristogyl® (IN); Asiazole® (TH); Bemetrazole® (ZA); Benmet® (BD); Bexon® (AR); Biogyl® (TH); Clont® (DE); Colpocin T® (RO, YU); Compu Metronidazole® (ZA); Corsagyl® (ID); Dazotron® (AR); Deflamon® (CZ, RO, RU); Deprocid® (CL); Dilan® (YU); Dirozyl® (BD); Dumozol® (ID, PT); Efloran® (CZ, HR, PL, RU, SI); Elyzol® (AT, CH, CY, DE, DK, EG, FI, FR, GB, IL, IT, JO, KW, LB, NL, NO, TH); Entizol® (CZ); Epaq® (CR, DO, GT, HN, PA, SV); Etron® (EC); Etronil® (AR); Farnat® (ID); Filmet® (BD); Fladex® (ID, SG); Flagemona® (AR); Flagenase® [syrup] (MX); Flagyl® (AR, AU, BD, BE, BR, CA, CH, CL, CR, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GT, HK, HN, HR, ID, IE, IL, IN, IT, LU, MX, NL, NO, NZ, PA, PT, RO, RU, SE, SG, SI, SV, TH, TR, ZA); Flagyl S® (AU, GB); Flagyl Vaginal® (ES); Flametia® (ID); Flanizol® (JO, RO); Florazole® ER (CA); Format® (AR); Fortagyl® (ID); Fresenizol® [inj.] (MX); Ginkan® (AR); G-Metronidazole® (BD); Grinazole® (PL); H.G. Metronidazol® (EC); Infectoclont® (DE); Kemet® (BD); Klion® (BD, CZ, HU, RO, RU, YU); Klion INF® (RO); Konicasol® (CL); Librazol® (BD); Mebadiol® (EC); Mecozol® (BD); Medamet® (ZA); Medazol® (HR, RU); Medazyl® (TH); Medizol® (BD); Med-Tricocide® (TH); Mefiron® (TH); Menilet® (BD); Menisole® (TH); Mepagyl® (TH); Merck-Metronidazole® (ZA); Mesolex® (TH); Metagyl® (ZA); Metason® (BD); Metazol® (ZA); Metodan® (HK); Metrajil® (TR); Metral® (AR); Metrazole® (TH, ZA); Metrazol® (TR); Metricin® (BR); Metrid® (RO); Metrion® (BD); Metro® (BD); Metrocide® (TH); MetroCream™ (CA); Metrocream® (CL); Metrocreme® (DE); Metroderme® (PT); Metrofusin® (ID); Metrogel® (CA); MetroGel® (CL, CR, DE, DK, GB, IE, MX); Metrogyl® (AU, IL, IN, RU, TH); Metrolex® (TH); Metrol® (ID); Metrolyl® (GB); Metronidazol AL® (DE); Metronidazol Alpharma® (CH, DK, FI, SE); Metronidazol Arcana® (AT); Metronidazol Artesan® (DE); Metronidazol AZU® (DE); Metronidazol Baxter® (SE); Metronidazol® (BG, BR, CL, CO, EC, NO, PL, RO, RU, SI, TR); Metronidazol Bieffe Medital® (ES); Metronidazol Biochemie® (AT); Metronidazol Biocrom® (AR); Metronidazol Biol® (AR); Metronidazol Braun® (CH, CZ, DE, ES, RU); Metronidazol CEPA® (ES); Metronidazol Dak® (DK); Metronidazol Delta-Select® (DE); Metronidazol Denver® (AR); Metronidazol Drawer® (AR); Metronidazol Duncan® (AR); Metronidazole® (AR, BE, CL, CY, GB, IL, NO, NZ, RU); Metronidazole Bioren® (CH); Metronidazole Braun® (FI, LU); Metronidazol Ecar® (CO); Metronidazole-Fandre® (LU, RO); Metronidazole Fresenius® (TR); Metronidazole Intravenous Infusion® (AU); Métronidazole Lavoisier® (FR); Metronidazole Meiji® (TH); Metronidazole Merck® (IL); Metronidazole Nycomed® (RU); Metronidazole-Polpharma® (CZ); Metronidazol Fabra® (AR); Metronidazol Fada® (AR); Metronidazol Fresenius® (DE, ID); Metronidazol Genericon® (AT, HR); Metronidazol Genfar® (EC); Metronidazol Grifols® (ES); Metronidazol Heumann® (DE); Metronidazol HMW® (AT); Metronidazol-Human® (HU); Metronidazol Jenapharm® (DE); Metronidazol Lando® (AR); Metronidazol L.CH.® (CL); Metronidazol Lindopharm® (DE); Metronidazol Lisan® (CR); Metronidazol Llorente® (ES); Metronidazol MK® (CO, CR, DO, GT, HN, PA, SV); Metronidazol Normon® (ES); Metronidazolo Bieffe® (IT); Metronidazolo® (IT); Metronidazolo PH&T® (IT); Metronidazolo Same® (IT); Metronidazol Ovulos® (AR); Metronidazol Ratiopharm® (DE); Metronidazol Richet® (AR); Metronidazol Roux-Ocefa® (AR); Metronidazol SAD® (DK); Metronidazol Sandoz® (DE); Metronidazol-Serag® (CZ, DE); Metronidazol Stada® (DE); Metronidazol Vannier® (AR); Metronidazol Vinas® (ES); metronidazol von ct® (DE); Metronidazol Waldheim® (AT); Metronid® (BD); Metronide® (AU, IE); Metronidil® (CO); Metronid-Puren® (DE); Metronimerck® (DE); Metronour® (DE); Metront® (DE); Metropast® (CL); Metropill® (BD); Metrosept® (PL); Metroson® (BD); Metrostat® (ZA); Metrotop® (GB, IE); Metrozin® (CO); Metrozine® (HK); Metrozol® (BR, DO); Metrozole® (BD); Metryl® (BD); Metsina® (BD); Midazole® (RO); Milanidazole® (TH); MND® (SG); Monizole® (IN); Nalox® (AR); Narobic® (ZA); Neoclis® (AR); Neopenil® (AR); Nidagel™ (CA); Nidazole Infusion® (EG, JO, KW, LB, SY); Nidazole® (JO, SY); Nidazol® (ID, TR); Nidazol Solüsyon® (TR); Nidazyl® (BD); Nidrozol® [syrup] (MX); Nizole® (SG); Noritate® (AR, CA, CL, GB, IL); Nor-Metrogel® (DO, GT, PA, SV); Novo-Nidazol (CA); Omnes® (BD); Orvagil® (YU); Otrozol® (CO, EC); Perilox® (CH); Pharmaflex® (BE, LU); Promuba® (ID); Protec® (BD); Protogyl® (HK); Protozol® (BG, JO, KW, LB, MA, MY, SY); Remagyl® (BD); Remet® (BD); Rivozol® (CH); Robaz® (TH); Rolab-Metronidazole® (ZA); Rosalox® (CH, CZ); Rosased® (IT); Rosazol® (FI); Rosiced® (FR); Rozacrème® (FR); Rozagel® (FR); Rozamet® (HR, SI); Rozex® (AR, AT, AU, BE, BR, CH, CZ, DK, ES, FI, FR, GB, HK, IE, IL, IT, LU, NL, NO, NZ, PL, SE, SG, ZA); Rupezol® (AR); Selegil® [syrup] (MX); Servizol® [liqu. oral] (MX); Servizol® (MX); Somet® (BD); Supplin® (CY, HU, JO, KW, LB, RO); Tarozole® (IL); Tismazol® (ID); Trichazole® (ZA); Trichex® (AT); Trichodazol® (ID); Trichomonacid® (BG); Trichonazole® (IL); Trichopol® (RU); Trichozole® (NZ); Tricofin® (AR); Tricomed® (TH); Tricowas B® (ES); Tricoxin® (EC); Trikacide (CA); Trikozol® (FI); Trogiar® (ID); Trogyl® (ID); Unimezol® (IN); Vagilen® (IT); Vagil® (TH); Vagimid® (DE); Vaginyl® (GB); Vagyl® (TH); Venogyl® (IL); Vertisal® (MX); Vetisol® (EC); Zagyl® (ZA); Zidoval® (DK, GB, IL, NO, SE); Zobacide® (ZA); Zyomet® (GB)

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