Metronidazole (Systemic) : Introductory Information

Metronidazole (Systemic)
Introductory Information
Antibacterial and antiprotozoal;.152, 197, 430, 494, 495 nitroimidazole derivative.494
Class: 8:30.92 Antiprotozoals, Miscellaneous; am900 (VA primary); ap100 (VA primary)
Brands*: Flagyl, Helidac Therapy (combination)
*
also available generically
Generic Name: Metronidazole

CAS Number: 443-48-1
Generic Name: Metronidazole Hydrochloride
CAS Number: 69198-10-3
Boxed Warning
Carcinogenic in mice and rats.152, 156, 197, 430, 495
Avoid unnecessary use; reserve for use in approved indications.152, 156, 197, 430, 495 (See Uses.)
Uses
Bone and Joint Infections
Adjunct for treatment of bone and joint infections caused by Bacteroides, including the B.
fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus).152, 197, 495
Endocarditis
Treatment of endocarditis caused by Bacteroides (including the B. fragilis group).152, 197, 495
Gynecologic Infections
Treatment of gynecologic infections (including endometritis, endomyometritis, tubo-ovarian
abscess, postsurgical vaginal cuff infection) caused by Bacteroides (including the B. fragilis
group), Clostridium, Peptococcus niger, or Peptostreptococcus.152, 197, 495
Treatment of acute pelvic inflammatory disease (PID); used in conjunction with other antiinfectives.199, 341, 496 Metronidazole is included in PID regimens to provide coverage against
anaerobes.341
When a parenteral regimen is indicated for PID, an initial regimen of IV cefoxitin and IV or
oral doxycycline is recommended followed by oral doxycycline; if tubo-ovarian abscess is
present, some experts recommend that the oral follow-up regimen include metronidazole (or
clindamycin) in addition to doxycycline.341
When an oral regimen is indicated for PID, an single IM dose of ceftriaxone, cefoxitin (with
oral probenecid), or cefotaxime is recommended in conjunction with oral doxycycline (with
or without oral metronidazole).199, 341, 496 Alternatively, if a parenteral cephalosporin is not
feasible and the community prevalence and individual risk for gonorrhea is low, a regimen of
oral levofloxacin or oral ofloxacin (with or without oral metronidazole) may be considered.496
Intra-abdominal Infections
Treatment of intra-abdominal infections (including peritonitis, intra-abdominal abscess, liver
abscess) caused by susceptible Bacteroides (including the B. fragilis group), Clostrium,
Eubacterium, P. niger, or Peptostreptococcus.152, 197, 495
Meningitis and Other CNS Infections
Treatment of CNS infections (including meningitis, brain abscess) caused by Bacteroides
(including the B. fragilis group).152, 197, 495
Respiratory Tract Infections
Treatment of respiratory tract infections (including pneumonia) caused by Bacteroides
(including the B. fragilis group).152, 197, 495
Septicemia
Treatment of septicemia caused by Bacteroides (including the B. fragilis group) or
Clostridium.152, 197, 495
Skin and Skin Structure Infections
Treatment of skin and skin structure infections caused by Bacteroides (including the B.
fragilis group), Clostridium, Fusobacterium, P. niger, or Peptostreptococcus.152, 197, 495
Amebiasis
Treatment of acute intestinal amebiasis and amebic liver abscess caused by Entamoeba
histolytica.100, 152, 153, 197, 364, 368, 370 Oral metronidazole or oral tinidazole followed by a luminal
amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or
severe intestinal disease and for amebic hepatic abscess.100, 153, 364, 368, 370
Bacterial Vaginosis
Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella
vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in
pregnant or nonpregnant women.199, 292, 297, 298, 302, 341, 365, 366, 430
CDC recommends treatment of bacterial vaginosis in all symptomatic women (including
pregnant women).341 In addition, asymptomatic pregnant women at high risk for
complications of pregnancy should be screened (preferably at the first prenatal visit) and
treatment initiated if needed.341
Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as
those for women without HIV infection.341
Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal
clindamycin cream;341 alternative regimens are a 7-day regimen of oral clindamycin or 3-day
regimen of intravaginal clindamycin suppositories.341 The preferred regimens for pregnant
women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.341
Regardless of regimen used, relapse or recurrence is common;287, 295, 297, 298, 300, 302, 307, 341, 365 an
alternative regimen (e.g., topical therapy when oral therapy was used initially) may be used in
such situations.297, 341
Routine treatment of asymptomatic male sexual contacts of women who have relapsing or
recurrent bacterial vaginosis not recommended.341
Balantidiasis
Alternative to tetracycline for treatment of balantidiasis
caused by Balantidium
coli.100, 153
Blastocystis hominis Infections
Treatment of infections caused by Blastocystis hominis
.100, 153, 368, 371, 372 May be
effective, but metronidazole resistance may be common.153

Clinical importance of B. hominis as a cause of GI pathology is controversial;100, 153, 368, 371, 372
unclear when treatment is indicated.100, 368, 371 Some clinicians suggest treatment be reserved
for certain individuals (e.g., immunocompromised patients) when symptoms persist and no
other pathogen or process is found to explain their GI symptoms.100, 368
Clostridium difficile-associated Diarrhea and Colitis
Treatment of Clostridium difficile-associated diarrhea and colitis
(CDAD; also
known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis,

and pseudomembranous colitis).100, 125, 126, 127, 128, 129, 131, 132, 312, 313, 314, 315, 316, 344, 345, 443, 444, 445, 446,
447
Drugs of choice are metronidazole and vancomycin; 100, 312, 313, 314, 315, 316 metronidazole
generally preferred and vancomycin reserved for those with severe or potentially lifethreatening colitis, patients in whom metronidazole-resistant C. difficile is suspected, patients
in whom metronidazole is contraindicated or not tolerated, or those who do not respond to
metronidazole.100, 126, 127, 312, 313, 314, 315, 316, 322, 323, 406, 443, 444, 445, 446, 447, 448
Crohn's Disease
Mangement of Crohn's disease
as an adjunct to conventional therapies.101, 102, 103, 104
Has been used with467, 468, 471, 475, 476, 477, 485 or without ciprofloxacin;101, 102, 103, 104, 105, 469, 470, 471,
472, 473, 474, 478, 479, 484, 485, 486
for induction of remission of mildly to moderately active Crohn's
disease
.101, 102, 103, 104, 105, 467, 468, 469, 471, 472, 473, 474, 475, 476, 477, 478, 479, 484
.102, 104, 105, 470, 471, 474, 478, 479, 485, 486
Has been used for refractory perianal Crohn's disease
Dientamoeba fragilis Infections

.153 Drugs of choice are
Treatment of infections caused by Dientamoeba fragilis
iodoquinol, paromomycin, tetracycline, or metronidazole.153

Dracunculiasis
Treatment of dracunculiasis
caused by Dracunculus medinensis (guinea worm
disease).153
Treatment of choice is slow extraction of worm combined with wound care.153 Metronidazole
is not curative, but decreases inflammation and facilitates worm removal.153
Giardiasis
Treatment of giardiasis
.100, 153, 367, 452 Drugs of choice are metronidazole, tinidazole, or
nitazoxanide;100, 153, 367, 452 alternatives are paromomycin, furazolidone (no longer
commercially available in the US), or quinacrine (not commercially available in the US).100,
153, 367
Treatment of asymptomatic carriers of giardiasis
.100, 367 Treatment of such carriers not
generally recommended, except possibly in patients with hypogammaglobulinemia or cystic

fibrosis or in an attempt to prevent household transmission of the disease from toddlers to
pregnant women.100
Helicobacter pylori Infection and Duodenal Ulcer Disease
Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or a history of
duodenal ulcer); eradication of H. pylori has been shown to reduce the risk of duodenal ulcer
recurrence.
Used in a multiple-drug regimen that includes metronidazole, tetracycline, and bismuth

subsalicylate and a histamine H2-receptor antagonist.455 If initial 14-day regimen does not
eradicate H. pylori, a retreatment regimen that does not include metronidazole should be
used.455
Nongonococcal Urethritis
Treatment of recurrent and persistent urethritis
in patients with nongonococcal
urethritis who have already been treated with a recommended regimen (i.e., azithromycin,
doxycycline, erythromycin, ofloxacin or levofloxacin).341
Oral metronidazole or oral tinidazole used in conjunction with oral azithromycin (if
azithromycin was not used in the initial regimen) is the regimen recommended by CDC for
recurrent and persistent urethritis in patients who were compliant with their initial regimen
and have not been re-exposed.341
Rosacea
Treatment of inflammatory lesions (papules and pustules) and erythema associated with
rosacea
(acne rosacea).137, 139, 145, 146, 148, 168, 180, 181 Topical metronidazole may be
preferred to oral metronidazole.137, 181

Tetanus
Adjunct in treatment of tetanus caused by C. tetani.100, 489
Trichomoniasis
Treatment of symptomatic and asymptomatic trichomoniasis when Trichomonas vaginalis
has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or
culture, OSOM Trichomonas Rapid Test, Affirm VP III).100, 152, 153, 197, 199, 297, 298, 302, 337, 338, 339,
341
Drug of choice is metronidazole or tinidazole.100, 153, 199, 297, 302, 337, 338, 339, 341 Goal of treatment
is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission; to
achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be
treated.153, 199, 297, 302, 339, 341
If treatment failure occurs with initial metronidazole treatment and reinfection is excluded,
alternative regimens using metronidazole or tinidazole can be used.153, 199, 341 If retreatment is
ineffective, consultation with an expert (available through CDC) is recommended.341
Perioperative Prophylaxis
Perioperative prophylaxis to reduce the incidence of postoperative anaerobic bacterial
infections in patients undergoing colorectal surgery.109, 110, 111, 112, 156, 495 Preferred regimens are
IV cefoxitin alone; IV cefazolin and IV metronidazole; oral erythromycin and oral neomycin;
or oral metronidazole and oral neomycin.110, 112, 490
Perioperative prophylaxis in patients undergoing appendectomy
;109, 111, 110, 112, 113 used
in conjunction with cefazolin.110 Preferred regimens for appendectomy (nonperforated) are IV

cefoxitin alone or IV cefazolin and IV metronidazole.110
Prophylaxis in Sexual Assault Victims
Empiric anti-infective prophylaxis in sexual assault victims
; used in conjunction
with IM ceftriaxone and oral azithromycin or doxycycline.199, 341

Dosage and Administration
Administration
Administer orally152, 197, 430 or by continuous or intermittent IV infusion.156, 495 Do not
administer by rapid IV injection because of the low pH of the reconstituted product.156, 495
In the treatment of serious anaerobic infections, parenteral route usually is used initially and
oral metronidazole substituted when warranted by patient's condition.152, 197
Oral Administration
Administer extended-release tablets at least 1 hour before or 2 hours after meals.430
IV Infusion
For solution and drug compatibility information, see Compatibility under Stability.
Commercially available metronidazole injection for IV infusion does not need to be diluted
or neutralized prior to IV administration.156, 495
Metronidazole hydrochloride powder for injection must by reconstituted, diluted, and then
neutralized prior to IV administration.156
Reconstitution and Dilution
Reconstitute metronidazole hydrochloride powder for injection by adding 4.4 mL of sterile or
bacteriostatic water for injection, 0.9% sodium chloride injection, or bacteriostatic sodium
chloride injection to the vial containing 500 mg of metronidazole.156 The reconstituted
solution contains approximately 100 mg of metronidazole/mL and has a pH of 0.5-2.156
The reconstituted metronidazole hydrochloride solution must be further diluted with 0.9%
sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection to a
concentration of 8 mg/mL.156
The reconstituted and diluted metronidazole hydrochloride solution must then be neutralized
by adding approximately 5 mEq of sodium bicarbonate injection for each 500 mg of
metronidazole.156 The addition of sodium bicarbonate to the metronidazole hydrochloride
solution may generate carbon dioxide gas and it may be necessary to relieve gas pressure in
the container.156
Rate of Administration
IV infusions usually are infused over 1 hour.156, 495
Dosage
Available as metronidazole152, 156, 197, 430, 495 and metronidazole hydrochloride;156 dosage
expressed in terms of metronidazole.156
Pediatric Patients
General Dosage in Neonates
>Oral or IV
Neonates <1 week of age: AAP recommends 7.5 mg/kg every 24-48 hours in those weighing
<1.2 g, 7.5 mg/kg every 24 hours in those weighing 1.2-2 kg, or 7.5 mg/kg every 12 hours in
those weighing >2 kg.100
Neonates 1-4 weeks of age: AAP recommends 7.5 mg/kg every 24-48 hours in those
weighing <1.2 kg, 7.5 mg/kg every 12 hours in those weighing 1.2-2 kg, and 15 mg/kg every
12 hours in those weighing >2 kg.100
General Dosage in Children 1 Month of Age
Oral: 15-35 mg/kg daily in 3 divided doses.100 AAP states oral route inappropriate for severe
infections.100
Amebiasis
>Entamoeba histolytica Infections
Oral: 35-50 mg/kg daily in 3 divided doses given for 7-10 (usually 10) days;152, 153, 197, 370
follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin).153
Bacterial Vaginosis
Oral: Children weighing <45 kg: 15 mg/kg daily (up to 1 g) in 2 divided doses given for 7
days.100
Adolescents: 500 mg twice daily for 7 days.100
Balantidiasis
Oral: 35-50 mg/kg daily in 3 divided doses given for 5 days.153
Oral: 20-35 mg/kg daily in 3 divided doses given for 10 days may improve symptoms in
some patients.100
Crohn's Disease
Oral: 10-20 mg/kg daily (up to 1 g daily) has been recommended for children with mild
perianal Crohn's disease
or those intolerant to sulfasalazine or mesalamine.487

Oral: 30-50 mg/kg daily in 3 or 4 equally divided doses given for 7-10 days (not to exceed
adult dosage).100, 445, 446
Oral: 20-40 mg/kg daily in 3 divided doses given for 10 days.153
Dracunculiasis
Oral: 25 mg/kg daily (up to 750 mg) in 3 divided doses given for 10 days.153 Is not curative,
but may decrease inflammation and facilitate worm removal.153
Giardiasis
Oral: 15 mg/kg daily in 3 divided doses given for 5-7 days.153, 367, 452
Oral: Recurrent or persistent urethritis in adolescents: A single 2-g dose given in conjunction
with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341
Tetanus
Oral: 30 mg/kg daily (up to 4 g daily) in 4 doses given for 10-14 days.100
>IV
30 mg/kg daily (up to 4 g daily) in 4 doses given for 10-14 days.100
Trichomoniasis
Oral: Prepubertal children weighing <45 kg: 15 mg/kg daily in 3 divided doses (up to 2 g
daily) given for 7 days.100, 153
Adolescents: A single 2-g dose or 500 mg twice daily for 7 days.100
Oral: Preadolescent children weighing <45 kg: 15 mg/kg daily given in 3 divided doses for 7
days given in conjunction with IM ceftriaxone and either oral azithromycin or oral
erythromycin.100, 341
Adolescents and preadolescent children weighing 45 kg: A single 2-g dose given in
conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.100, 341
Adults
Anaerobic Bacterial Infections
>Serious Infections
Oral: 7.5 mg/kg every 6 hours (up to 4 g daily).152, 156, 197
IV, then Oral: An initial IV loading dose of 15 mg/kg followed by IV maintenance doses of
7.5 mg/kg every 6 hours.156, 495 After clinical improvement occurs, switch to oral
metronidazole (7.5 mg/kg every 6 hours).156, 495
Total duration of treatment usually is 7-10 days, but infections of bone and joints, lower
respiratory tract, or endocardium may require longer treatment.156, 495
Gynecologic Infections
>Pelvic Inflammatory Disease
Oral: 500 mg twice daily given for 14 days; used in conjunction with a single IM dose of
ceftriaxone (250 mg), cefoxitin (2 g with oral probenecid 1 g), or another parenteral
cephalosporin (e.g., cefotaxime) and 14-day regimen of oral doxycycline (100 mg twice
daily).341, 496
Alternatively, 500 mg twice daily given for 14 days; used in conjunction with a 14-day
regimen of oral ofloxacin (400 mg twice daily) or levofloxacin (500 mg once daily).199, 341, 496
Regimens containing a fluoroquinolone should only be considered when a parenteral
cephalosporin is not feasible and the community prevalence and individual risk of gonorrhea
is low.496
Amebiasis
>Entamoeba histolytic Infections
Oral: 750 mg 3 times daily given for 5-10 (usually 10) days for intestinal amebiasis152, 153, 197,
364, 368, 370
or 500-750 mg 3 times daily given for 5-10 (usually 10) days for amebic liver
abscess.152, 197, 364, 368, 370 Alternatively, amebic liver abscess has been treated with 2.4 g once
daily given for 1 or 2 days.364
Follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin) after metronidazole.153,
364, 368, 370
IV: 500 mg every 6 hours for 10 days.364

Bacterial Vaginosis
>Nonpregnant Women
Oral: Conventional tablets: 500 mg twice daily given for 7 days.100, 199, 286, 297, 298, 300, 301, 302, 341,
366
A single 2-g dose has been used (e.g., for patients who may be noncompliant with the
multiple-dose regimen),120, 122, 199, 292, 297 but appears to be less effective than other regimens
and is no longer recommended by CDC.341
Extended-release tablets: 750 mg once daily given for 7 days.199, 341, 416, 417, 430
>Pregnant Women
Oral: Conventional tablets: 500 mg twice daily or 250 mg 3 times daily given for 7 days.341,
416, 417
Contraindicated during first trimester of pregnancy.152, 197, 430 In addition, single-dose regimens
not recommended in pregnant women because of the slightly higher serum concentrations
attained, which may reach fetal circulation.152
Balantidiasis
Oral: 750 mg 3 times daily given for 5 days.153
Oral: 750 mg 3 times daily given for 10 days may improve symptoms in some patients.100, 153
Crohn's Disease
Oral: 400 mg twice daily101, 103, 105 or 1 g daily has been effective for treatment of active
Crohn's disease
.467, 472, 473, 475, 476, 482 For treatment of refractory perineal disease, 20
mg/kg (1-1.5 g) given in 3-5 divided doses daily has been employed.102, 103, 104, 105, 478, 486
Oral: 750 mg to 2 g daily in 3 or 4 divided doses given for 7-14 days.125, 126, 129, 131, 132, 133, 313,
314
Dose-ranging studies to determine comparative efficacy have not been performed; most
commonly employed regimens are 250 mg 4 times daily or 500 mg 3 times daily given for 10
days.443, 444, 445, 446
>IV
500-750 mg every 6-8 hours; use when oral therapy is not feasible.134, 161, 162, 313, 342, 343, 445
Oral: 500-750 mg 3 times daily given for 10 days.153
Dracunculiasis
Oral: 250 mg 3 times daily given for 10 days.153 Is not curative, but may decrease
inflammation and facilitate worm removal.153
Giardiasis
Oral: 250 mg 3 times daily given for 5-7 days.153, 367, 452
Helicobacter pylori Infection and Duodenal Ulcer Disease
Oral: 250 mg in conjunction with tetracycline (500 mg) and bismuth subsalicylate (525 mg)
4 times daily (at meals and at bedtime) for 14 days; these drugs should be given
concomitantly with an H2-receptor antagonist in recommended dosage.455
Oral: Recurrent or persistent urethritis: A single 2-g dose given in conjunction with a single
1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341
Tetanus
>IV
500 mg every 6 hours given for 7-10 days.489
Trichomoniasis
>Initial Treatment
Oral: 2 g as a single dose152, 153, 199, 341 or in 2 divided doses.152 Alternatively, 500 mg twice
daily given for 7 days153, 199, 341 or 375 mg twice daily given for 7 days.199, 197 Manufacturer
also recommends 250 mg 3 times daily given for 7 days.152
>Retreatment
Oral: 500 mg twice daily given for 7 days.297, 341 If repeated failure occurs, CDC recommends
2 g once daily given for 5 days.297, 341 Others recommend retreatment with 2-4 g daily for 7-14
days if metronidazole-resistant strains are involved.153, 199
Do not administer repeat courses of treatment unless presence of T. vaginalis is confirmed by
wet smear and/or culture and an interval of 4-6 weeks has passed since the initial course.152,
197
If treatment of resistant infection is guided by in vitro susceptibility testing under aerobic

conditions, some clinicians recommend that T. vaginalis strains exhibiting low-level
resistance (minimum lethal concentration [MLC] <100 mcg/mL) be treated with 2 g daily for
3-5 days, those with moderate (intermediate) resistance (MLC 100-200 mcg/mL) be treated
with 2-2.5 g daily for 7-10 days, and those with high-level resistance (MLC >200 mcg/mL)
be treated with 3-3.5 g daily for 14-21 days.124, 302, 338, 340 Because strains with high-level
resistance are difficult to treat,124, 297, 302, 338, 340 CDC recommends that patients with culturedocumented infection who do not respond to repeat regimens at dosages up to 2 g daily for 35 days and in whom the possibility of reinfection has been excluded should be managed in
consultation with an expert (available through CDC).297, 341
Perioperative Prophylaxis
>Colorectal Surgery
IV: 0.5 g given at induction of anesthesia (within 0.5-1 hour prior to incision); used in
conjunction with IV cefazolin (1-2 g).110
Manufacturer recommends 15 mg/kg by IV infusion over 30-60 minutes 1 hour prior to the
procedure and, if necessary, 7.5 mg/kg by IV infusion over 30-60 minutes at 6 and 12 hours
after the initial dose.156, 495 The initial preoperative dose must be completely infused
approximately 1 hour prior to surgery to ensure adequate serum and tissue concentrations of
metronidazole at the time of incision.156, 495 Prophylactic use of metronidazole should be
limited to the day of surgery and should not be continued for more than 12 hours after
surgery.156, 495
Oral: 2 g with oral neomycin sulfate (2 g) given at 7 p.m. and 11 p.m. on day before surgery;
used in conjunction with appropriate diet and catharsis.110
Oral: A single 2-g dose given in conjunction with IM ceftriaxone and either oral
azithromycin or oral doxycycline.100, 341
Special Populations
Hepatic Impairment
Decrease dosage in patients with severe hepatic impairment and monitor plasma
concentrations of the drug.152, 156, 160, 197, 430, 495
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic function.152, 197, 430
Cautions
Contraindications
Hypersensitivity to metronidazole or other nitroimidazole derivatives.152, 156, 197, 430, 495 Cautious
desensitization has been used in some situations when use of metronidazole was considered
necessary.341, 436 (See Hypersensitivity Reactions and Desensitization under Cautions.)
First trimester of pregnancy.152, 197, 430
Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate)
contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or
renal impairment, patients with known allergy to aspirin or salicylates, and those with known
hypersensitivity to any component of the kit.455
Warnings/Precautions
Warnings
Seizures and Peripheral Neuropathy
Seizures and peripheral neuropathy (characterized by numbness or paresthesia of an
extremity) reported with metronidazole.152, 156, 197, 430, 495
Persistent peripheral neuropathy reported in some patients receiving prolonged therapy.430 If
abnormal neurologic signs develop, promptly discontinue drug.152, 156, 197, 430
Use with caution in those with CNS diseases.152, 197, 430
Sensitivity Reactions
Hypersensitivity Reactions and Desensitization
Hypersensitivity reactions, including urticaria, pruritus, erythematous rash, flushing, nasal
congestion, fever, and fleeting joint pains sometimes resembling serum sickness, have been
reported with metronidazole.152, 156, 197, 430, 495
Because there are no effective alternatives to metronidazole in the US for treatment of
trichomoniasis, CDC states that desensitization can be attempted in patients with
metronidazole hypersensitivity.341 The possibility that desensitization may be hazardous
should be considered435 and adequate procedures (e.g., established IV access, BP monitoring)

and therapies (e.g., epinephrine, corticosteroids, antihistamines, oxygen) for management of
an acute hypersensitivity reaction should be readily available.435 Pretreatment (e.g., with an
antihistamine and/or corticosteroid) also should be considered.435
Desensitization has been performed by administering increasing doses of IV metronidazole
incrementally until a therapeutic dose was achieved, at which time oral dosing was
initiated.435 In this regimen, an initial 5-mcg dose of IV metronidazole was given and the dose
increased at 15- to 20-minute intervals to 15, 50, 150, and 500 mcg and then to 1.5, 5, 15, 30,
60, and 125 mg.435 After the 125-mg IV dose, dosing was switched to oral metronidazole and
doses of 250, 500, and 2 g were given at 1-hour intervals.435 For trichomoniasis,
desensitization dosing can be stopped after the 2-g dose.435 Patient should be monitored for 4
hours after the last dose (24 hours if there was any evidence of a reaction).435
General Precautions
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of metronidazole
and other antibacterials, use only for treatment or prevention of infections proven or strongly
suspected to be caused by susceptible bacteria.152, 197, 430, 495
When selecting or modifying anti-infective therapy, use results of culture and in vitro
susceptibility testing.152, 197, 430, 495 In the absence of such data, consider local epidemiology
and susceptibility patterns when selecting anti-infectives for empiric therapy.152, 197, 430, 495
Surgical procedures should be performed in conjunction with metronidazole therapy when
indicated.152, 156, 197, 430, 495
In mixed aerobic and anaerobic infections, anti-infectives appropriate for treatment of aerobic
bacteria should be used in conjunction with metronidazole.152, 156, 197, 430, 495
History of Blood Dyscrasia
Use with caution in patients with evidence or history of blood dyscrasias.152, 156, 197, 430, 495
Mild leukopenia has been reported, but persistent hematologic abnormalities do not occur.152,
156, 197, 430, 495
Perform total and differential leukocyte counts before and after metronidazole treatment,
especially when repeated courses are necessary.152, 156, 197, 430, 495
Sodium Content
Metronidazole injection contains approximately 28 mEq of sodium per g of metronidazole.156,
495
Use with caution in patients receiving corticosteroids and in those predisposed to
edema.156, 495
Candidiasis
Known or previously unrecognized candidiasis may present more prominent symptoms
during metronidazole therapy; treatment with an appropriate antifungal is required.152, 156, 197,
430, 495
Helidac Therapy
When the kit containing tetracycline, metronidazole, and bismuth subsalicylate (Helidac
Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the
cautions, precautions, and contraindications associated with tetracycline and bismuth

subsalicylate must be considered in addition to those associated with metronidazole.455
Specific Populations
Pregnancy
Category B.152, 156, 197, 430, 495 Contraindicated during the first trimester of pregnancy.100, 152, 197,
341, 430, 442
Lactation
Distributed into milk;152, 156, 197, 430, 495 discontinue nursing or the drug.152, 156, 197, 430, 495
If a single 2-g dose of metronidazole is indicated in the mother, AAP states that breastfeeding should be interrupted for 12-24 hours following the dose.100
Pediatric Use
Except for oral treatment of amebiasis, safety and efficacy not established in pediatric
patients.152, 156, 197, 430, 495
Metronidazole has been used and is recommended for use in pediatric patients for various
indications other than amebiasis (e.g., trichomoniasis, giardiasis).100, 153 Unusual adverse
effects have not been reported in pediatric patients.100
Safety and efficacy of the kit containing metronidazole, tetracycline, and bismuth
subsalicylate (Helidac Therapy) for treatment of H. pylori infection and duodenal ulcer
disease have not been established in pediatric patients.455
Geriatric Use
Because of age-related decreases in hepatic function, monitor serum metronidazole
concentrations and adjust dosage accordingly.152, 197, 430
Insufficient experience in those 65 years of age to determine whether they respond
differently than younger adults to concomitant use of metronidazole, tetracycline, and
bismuth subsalicylate (Helidac Therapy) for treatment of H. pylori infection and duodenal
ulcer disease.455 Age-related decreases in hepatic, renal, and/or cardiac function and
concomitant disease and drug therapy should be considered.455
Hepatic Impairment
Patients with severe hepatic impairment metabolize metronidazole more slowly, and
increased concentrations of the drug and metabolites may occur.152, 156, 197, 430, 495
Use with caution, monitor plasma metronidazole concentrations, and reduce dosage in
patients with severe hepatic impairment.152, 156, 197, 430, 495
Common Adverse Effects
Nausea, headache, anorexia, dry mouth, unpleasant metallic taste.152, 156, 197, 430, 495
Interactions
Specific Drugs
Drug
Interaction
Comments
Alcohol
Alcohol should not be consumed

Mild disulfiram-like reactions
during or for at least 1 day
(flushing, headache, nausea, vomiting,
following completion of
abdominal cramps, sweating) may
metronidazole therapy (at least 3
occur if alcohol is ingested while
days after oral capsules or
receiving metronidazole139, 152, 156, 157,
extended-release tablets)152, 156, 197,
187, 196, 197, 430, 495
430, 495
Monitor PT and adjust

Anticoagulants, Prolonged PT152, 156, 191, 192, 193, 194, 195, 197,
anticoagulant dosage as needed191,
oral (warfarin) 430, 495
192, 193, 194, 195
Cimetidine
Possible prolonged half-life and

decreased clearance of
metronidazole106, 152, 156, 197, 430, 495
Disulfiram
Acute psychoses and confusion with

concomitant use152, 156, 197, 430, 495
Lithium
Phenobarbital
Phenytoin
Increased lithium concentrations

resulting in lithium toxicity;151, 152, 155,
197, 430, 495
renal toxicity (elevated
serum creatinine, hypernatremia,
abnormally dilute urine) reported151
Decreased serum half-life and
increased metabolism of
metronidazole116, 117, 152, 197, 430, 495
Decrased serum concentration and
increased metabolism of
metronidazole; decreased clearance of
phenytoin152, 156, 197, 430, 495
If used concomitantly, consider

possibility of increased
metronidazole adverse effects106
Avoid concomitant use; do not
initiate metronidazole therapy until
2 weeks after discontinuance of
disulfiram152, 156, 197, 430, 495
Use concomitantly with caution;
monitor serum lithium and
creatinine concentrations during
concomitant use151, 152, 155, 197, 430, 495
Pharmacokinetics
Absorption
Bioavailability
80% of an oral dose is absorbed from the GI tract.g Following oral administration of
conventional tablets or capsules, peak plasma concentrations of unchanged drug and active
metabolites attained within 1-3 hours.g
Following oral administration of metronidazole extended-release tablets for 7 consecutive
days under fasting conditions, steady-state peak plasma concentrations attained an average of
6.8 hours after the dose.430
Food
Conventional tablets or capsules: Food decreases the rate of absorption and peak plasma
concentrations; total amount of drug not affected.g
Extended-release tablets: Food increases rate of absorption and peak plasma
concentrations.430
Distribution
Extent
Widely distributed into most body tissues and fluids, including bone, bile, saliva, pleural
fluid, peritoneal fluid, vaginal secretions, seminal fluid, and cerebral and hepatic abscesses.g
Distributed into CSF; CSF concentrations are 43% of concurrent plasma concentrations in
patients with uninflamed meninges and equal to or greater than concurrent plasma
concentrations in patients with inflamed meninges.g
Readily crosses the placenta and is distributed into milk.g
Plasma Protein Binding
<20%.g
Elimination
Metabolism
Approximately 30-60% of an oral or IV dose is metabolized in the liver by hydroxylation,
side-chain oxidation, and glucuronide conjugation.g The major metabolite, 2-hydroxy
metronidazole, has some antibacterial and antiprotozoal activity.g
Elimination Route
Metronidazole and its metabolites are excreted principally in urine (60-80%) and to a lesser
extent in feces (6-15%).152, 197, 430, g
Half-life
Adults with normal renal and hepatic function: 6-8 hours.430, g
Special Populations
Half-life may be prolonged in patients with impaired hepatic function.g In adults with
alcoholic liver disease and impaired hepatic function, half-life averages 18.3 hours.160
Pharmacokinetics not affected by renal impairment.430, g
Stability
Storage
Oral
Capsules
15-25C.197 Dispense in well-closed container with child-resistant closure.197
Tablets
Conventional tablets: <25C.152
Extended-release tablets: 25C (may be exposed to 15-30C).430 Dispense in well-closed
container with child-resistant closure.430
Metronidazole Combinations
Kit containing tetracycline, metronidazole, and bismuth subsalicylate: 20-25C.455
Parenteral
Injection for IV infusion
15-30C; protect from light.156, 495 Do not refrigerate.156
Powder for IV infusion
<25C; protect from light.156 After reconstitution, dilution, and neutralization, use within 24
hours; do not refrigerate.156
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Drug Compatibility (Metronidazole)
>Admixture Compatibilitya
Compatible
Amikacin sulfate
Cefazolin sodium
Cefotaxime sodium
Ceftazidime
Ceftizoxime sodium
Ceftriaxone sodium
Cefuroxime sodium
Chloramphenicol sodium succinate
Ciprofloxacin
Clindamycin phosphate
Fluconazole
Gentamicin sulfate
Midazolam HCl
Tobramycin sulfate
Incompatible
Amoxicillin sodium-clavulanate potassium
Aztreonam
Variable
Ampicillin sodium
Cefepime HCl
Cefoxitin sodium
Hydrocortisone sodium succinate
Penicillin G potassium
>Y-Site Compatibilitya
Compatible
Acyclovir sodium
Allopurinol sodium
Amifostine
Bivalirudin
Cefepime HCl
Cisatracurium besylate
Clarithromycin
Cyclophosphamide
Dexmedetomidine HCl
Diltiazem HCl
Dimenhydrinate
Docetaxel
Dopamine HCl
Doxapram HCl
Doxorubicin HCl liposome injection
Enalaprilat
Esmolol HCl
Etoposide phosphate
Fenoldopam mesylate
Fluconazole
Foscarnet sodium
Gatifloxacin
Gemcitabine HCl
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Labetalol HCl
Linezolid
Lorazepam
Magnesium sulfate
Melphalan HCl
Meperidine HCl
Methylprednisolone sodium succinate
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nicardipine HCl
Perphenazine
Piperacillin sodium-tazobactam sodium
Remifentanil HCl
Sargramostim
Tacrolimus
Teniposide
Theophylline
Thiotepa
Vinorelbine tartrate
Incompatible
Amphotericin B cholesteryl sulfate complex
Aztreonam
Drotrecogin alfa (activated)

Filgrastim
Lansoprazole
Pantoprazole sodium
Pemetrexed disodium
Metronidazole HCla
>Solution Compatibility
Incompatible
Amino acids 10%
Drug Compatibility (Metronidazole HCl)
>Admixture Compatibilitya
Compatible
Amikacin sulfate
Aminophylline
Cefazolin sodium
Cefotaxime sodium
Cefoxitin sodium
Chloramphenicol sodium succinate
Clindamycin phosphate
Disopyramide phosphate
Gentamicin sulfate
Heparin sodium
Hydrocortisone sodium succinate
Multielectrolyte concentrate
Multivitamins
Penicillin G potassium
Tobramycin sulfate
Incompatible
Ciprofloxacin
Dopamine HCl
Meropenem
Variable
Ampicillin sodium
Cefepime HCl
Ceftriaxone sodium
>Y-Site Compatibilitya
Compatible
Amiodarone HCl
Diltiazem HCl
Incompatible
Meropenem
Warfarin sodium
Actions and Spectrum
Bactericidal, amebicidal, and trichomonacidal in action.g
Un-ionized at physiologic pH and readily taken up by anaerobic organisms or cells.g In
susceptible organisms or cells, metronidazole is reduced by low-redox-potential electron
transport proteins (e.g., nitroreductases such as ferredoxin); the reduction product(s)
apparently are responsible for the cytotoxic and antimicrobial effects of the drug (e.g.,
disruption of DNA, inhibition of nucleic acid synthesis).g
Has direct anti-inflammatory effects137, 139, 148, 166, 167 and effects on neutrophil motility,
lymphocyte transformation, and some aspects of cell-mediated immunity.148, 168, 169, 170, 171, 172
Spectrum of activity includes most obligately anaerobic bacteria and many protozoa.g Inactive
against fungi and viruses and most aerobic or facultatively anaerobic bacteria.g
Gram-positive anaerobes: Clostridium,148, 152, 156, 164, 174, 176 C. difficile,175, 176 C. perfringens,164, 176
Eubacterium,148, 152, 156, 164, 174, 175 Peptococcus,148, 152, 156, 164, 174, 175, 176 and
Peptostreptococcus.148, 152, 156, 164, 174, 176, 177, 275, 278
Gram-negative anaerobes: Active against Bacteroides fragilis,148, 152, 156, 164, 173, 174, 175, 176, 275, 277,
280
B. distasonis,152, 156, 175, 176, 275 B. ovatus,152, 156, 176, 275 B. thetaiotaomicron,152, 156, 175, 176, 275 B.
vulgatus,152, 156, 175, 176, 275 B. ureolyticus,275, 277Fusobacterium,148, 152, 156, 164, 174, 176, 177 Prevotella
bivia,174, 275, 277, 278, 279 P. buccae,494 P. disiens,175, 278 P. intermedia,177, 275 P. melaninogenica,164,
175, 275, 277, 278, 279
P. oralis,175, 275, 277, 279 Porphyromonas,177, 275, 494 and Veillonella.175, 176, 177
Active against Helicobacter pylori,164 Entamoeba histolytica, Trichomonas vaginalis, Giardia
lamblia, and Balantidium coli.g Acts principally against the trophozoite forms of E.
histolytica and has limited activity against the encysted form.g
Resistance has been reported in some Bacteroides and T. vaginalis.g
Advice to Patients
Advise patients that antibacterials (including metronidazole) should only be used to treat
bacterial infections and not used to treat viral infections (e.g., the common cold).152, 197, 430
Importance of completing full course of therapy, even if feeling better after a few days.152, 197,
430
Advise patients that skipping doses or not completing the full course of therapy may decrease
effectiveness and increase the likelihood that bacteria will develop resistance and will not be
treatable with metronidazole or other antibacterials in the future.152, 197, 430
Metronidazole extended-release tablets should be taken at least 1 hour before or 2 hours after
meals; optimum absorption occurs under fasting conditions.430
Advise patients to avoid alcohol during and for at least 1 day after conventional tablets152 or at
least 3 days after receiving metronidazole capsules or extended-release tablets.197, 430
Advise patients to promptly discontinue metronidazole and contact clinician if abnormal
neurologic signs occur.152, 197, 430
Importance of informing clinicians of existing or contemplated therapy, including prescription
and OTC drugs.152, 197, 430
Importance of women informing clinician if they are or plan to become pregnant or plan to
breast-feed.152, 197, 430
Importance of advising patients of other important precautionary information.152, 197, 430 (See
Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects
in some individuals; consult specific product labeling for details.
Metronidazole
Routes
Dosage Forms
Oral
Capsules
Tablets
Strengths
375 mg
250 mg*
500 mg*
Tablets, extendedrelease, film750 mg

coated
Tablets, film250 mg*
coated
500 mg*
Injection, for IV 5
Parenteral
infusion only
mg/mL*
Brand Names
Flagyl 375
Metronidazole Tablets
Metronidazole Tablets
Manufacturer
Pfizer
Mutual, Teva
Mutual, Teva
Flagyl ER
Pfizer
Flagyl
Pfizer
Flagyl
Pfizer
Flagyl I.V. RTU (Viaflex
SCS
[Baxter])
Pharmaceuticals
Metronidazole Injection (PAB Various

[Braun])
Manufacturers
Metronidazole Injection
(available in LifeCare and glass Abbott
containers)
Metronidazole Injection RTU Various
(Viaflex [Baxter])
Manufacturers
* available from one or more manufacturer, distributor, and/or repackager by generic
(nonproprietary) name
Metronidazole Combinations
Dosage
Routes
Strengths
Forms
4 Capsules, Tetracycline
Hydrochloride 500 mg
4 Tablets, Metronidazole 250
Oral Kit
mg (with povidone)
8 Tablets, chewable, Bismuth
Subsalicylate 262.4 mg (with
povidone)
Metronidazole Hydrochloride
Routes
Dosage Forms
Strengths
For injection, for IV 500 mg (of
Parenteral
infusion only
metronidazole)
Comparative Pricing
Brand Names
Manufacturer
Helidac Therapy
(combination) (available as Prometheus
14 blister cards)
Brand Names
Flagyl I.V. (with
mannitol 415 mg)
Manufacturer
SCS
Pharmaceuticals
This pricing information is subject to change at the sole discretion of DS Pharmacy. This
pricing information was updated 03/2011. For the most current and up-to-date pricing
information, please visit www.drugstore.com. Actual costs to patients will vary depending on
the use of specific retail or mail-order locations and health insurance copays.
Flagyl 250MG Tablets (PFIZER U.S.): 30/$99.99 or 90/$275.98
Flagyl 375MG Capsules (PFIZER U.S.): 30/$136 or 90/$390.97
Flagyl 500MG Tablets (PFIZER U.S.): 30/$180 or 90/$510
Flagyl ER 750MG 24-hr Tablets (PFIZER U.S.): 30/$365.98 or 90/$1066.01
MetroNIDAZOLE 250MG Tablets (TEVA PHARMACEUTICALS USA): 90/$15.98 or
180/$17.97
MetroNIDAZOLE 500MG Tablets (TEVA PHARMACEUTICALS USA): 30/$12.99 or
90/$27.97
Use is not currently included in the labeling approved by the US Food and Drug
Administration.
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Metronidazole (Systemic)

also available generically

Generic Name: Metronidazole

.100, 153, 368, 371, 372 May be

effective, but metronidazole resistance may be common.153

known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis,

as an adjunct to conventional therapies.101, 102, 103, 104

Has been used for refractory perianal Crohn's disease

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis

iodoquinol, paromomycin, tetracycline, or metronidazole.153

caused by Dracunculus medinensis (guinea worm

.100, 153, 367, 452 Drugs of choice are metronidazole, tinidazole, or

Treatment of asymptomatic carriers of giardiasis

.100, 367 Treatment of such carriers not

generally recommended, except possibly in patients with hypogammaglobulinemia or cystic

Used in a multiple-drug regimen that includes metronidazole, tetracycline, and bismuth

in patients with nongonococcal

preferred to oral metronidazole.137, 181

;109, 111, 110, 112, 113 used

in conjunction with cefazolin.110 Preferred regimens for appendectomy (nonperforated) are IV

with IM ceftriaxone and oral azithromycin or doxycycline.199, 341

Clostridium difficile-associated Diarrhea and Colitis

IV: 500 mg every 6 hours for 10 days.364

If treatment of resistant infection is guided by in vitro susceptibility testing under aerobic

should be considered435 and adequate procedures (e.g., established IV access, BP monitoring)

cautions, precautions, and contraindications associated with tetracycline and bismuth

Alcohol should not be consumed

Monitor PT and adjust

Possible prolonged half-life and

Acute psychoses and confusion with

Increased lithium concentrations

If used concomitantly, consider

Drotrecogin alfa (activated)

Tablets, extendedrelease, film750 mg

Metronidazole Injection (PAB Various

154. Ludwig E, Csiba A, Magyar T et al. Age-associated pharmacokinetic changes of

201. Baxter Healthcare Corporation. Descriptive information on premixed liquid products.

333. Handwerger S, Raucher B, Altarac D et al. Nosocomial outbreak due to Enterococcus

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