Version May 2024
Bacterial vaginosis:
Vaginal gel 0.75%: Adolescents: Intravaginal: One applicatorful (~37.5 mg metronidazole) intravaginally once daily at bedtime for 5 days
Vaginal gel 1.3%: Children ≥12 years and Adolescents: Intravaginal: One applicatorful (~65 mg metronidazole) intravaginally once at bedtime as a single dose
Periorificial dermatitis: Limited data available: Infants ≥6 months, Children, and Adolescents: Topical: 0.75% gel: Apply thin film once or twice daily (Ref)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution in severe hepatic impairment.
(For additional information see "Metronidazole (topical): Drug information")
Bacterial vaginosis:
Note: Treatment is generally not warranted for patients who are asymptomatic (Ref).
0.75% gel: Intravaginal: One applicatorful (5 g containing ~37.5 mg metronidazole) once daily at bedtime for 5 days (Ref). For suppressive therapy following retreatment in patients with multiple disease recurrences, give twice weekly for 3 to 6 months (Ref).
1.3% gel (alternative agent): Intravaginal: One applicatorful (5 g containing ~65 mg metronidazole) as a single dose; administer at bedtime (Ref). Note: Some experts favor multiday regimens of other formulations because of uncertain comparative efficacy with the single-dose regimen (Ref).
Rosacea:
0.75%: Topical: Apply and rub a thin film twice daily, morning and evening, to entire affected areas after washing.
1%: Topical: Apply thin film to affected area once daily.
Trichomoniasis (alternative agent): Note: Intravaginal metronidazole is not recommended because it is less effective than oral therapy (Ref).
10% (Flagyl Cream [Canadian product]): Intravaginal: Insert one applicatorful (equal to metronidazole 500 mg) intravaginally once or twice daily for 10 or 20 consecutive days (even during menses).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution in severe hepatic impairment.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Topical:
1% to 10:
Cardiovascular: Hypertension (1%)
Central nervous system: Headache (2%)
Dermatologic: Erythema (≤6%), contact dermatitis (1% to 3%), burning sensation of skin (<3%), exacerbation of acne rosacea (<3%), pruritus (<3%), skin irritation (<3%), stinging of the skin (<3%), xeroderma (≤2%)
Genitourinary: Urinary tract infection (1%)
Hypersensitivity: Local hypersensitivity reaction (3%)
Infection: Influenza (1%)
Respiratory: Upper respiratory tract infection (3%)
Frequent not defined:
Central nervous system: Metallic taste, numbness of extremities, tingling of extremities
Gastrointestinal: Nausea
Ophthalmic: Lacrimation
<1%, postmarketing, and/or case reports: Acne vulgaris, conjunctivitis, eye irritation, peripheral neuropathy, xerostomia
Vaginal:
>10%:
Genitourinary: Vaginal discharge (12%)
Infection: Fungal infection (12%)
1% to 10%:
Central nervous system: Headache (2% to 7%), dizziness (2%)
Dermatologic: Pruritus (6%), skin rash (1%)
Gastrointestinal: Gastrointestinal distress (7%), abdominal pain (5%), nausea (≤4%), vomiting (≤4%), dysgeusia (2%), abdominal cramps (1%), decreased appetite (1%), diarrhea (1%)
Genitourinary: Vulvovaginal candidiasis (6% to 10%), cervical candidiasis (≤10%), vaginitis (≤10%), vulvovaginal irritation (9%), pelvic pain (3%), dysmenorrhea (1% to 3%), vulvovaginal pruritus (2%), abnormal uterine bleeding (1%), mastalgia (1%)
Hematologic & oncologic: Abnormal white blood cell differential (2%)
Infection: Infection (1%)
Neuromuscular & skeletal: Muscle cramps (1%)
Respiratory: Pharyngitis (2%)
<1%, postmarketing, and/or case reports: Acne vulgaris, anorexia, asthma, back pain, bloating, breast hypertrophy, constipation, dark urine, depression, diaphoresis, dyspepsia, dysuria, edema (labial), fatigue, flatulence, flu-like symptoms, gingivitis, heavy menstrual bleeding, hypersensitivity reaction, increased thirst, insomnia, lactation, leukorrhea, mucous membrane disease, pain, pyelonephritis, rhinitis, salpingitis, urinary frequency, urinary tract infection, urticaria, vomiting, xerostomia
Hypersensitivity to metronidazole, parabens, or other ingredients of the formulation or other nitroimidazole derivatives; use of alcohol or propylene glycol during therapy and for up to 24 hours after therapy discontinuation (vaginal gel only); use of disulfiram within the past 2 weeks (vaginal gel only).
Flagyl cream [Canadian product]: Additional contraindications: Active neurological disorders; history of blood dyscrasia, hypothyroidism or hypoadrenalism.
Nidagel [Canadian product]: Additional contraindications: Use during the first trimester of pregnancy.
Concerns related to adverse effects:
• Carcinogenic: Possibly carcinogenic based on animal data. Unnecessary use should be avoided.
• CNS effects: Aseptic meningitis, encephalopathy, seizures, and neuropathies (peripheral and optic) have been reported with systemic metronidazole, especially with increased doses and chronic treatment; peripheral neuropathy has also been reported with topical products; monitor and consider discontinuation of therapy if signs/symptoms occur. Use with caution in patients with CNS diseases. Discontinue immediately if abnormal neurologic signs develop.
• Eye irritation: May cause tearing of the eye; avoid contact with the eyes. In the event of accidental contact, wash out immediately.
• Hepatic impairment: Use with caution in patients with severe liver impairment due to potential accumulation.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. Approximately 6% to 10% of women treated with the vaginal gel developed Candida vaginitis during or immediately after treatment.
Disease-related concerns:
• Blood dyscrasias: Use with caution in patients with or history of blood dyscrasias.
Dosage form related concerns:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
• Vaginal gel: Disulfiram-like reaction to ethanol has been reported with systemic metronidazole and may occur with the vaginal gel; consumption of alcoholic beverages during therapy with vaginal gel is contraindicated during and for up to 72 hours after therapy. Do not administer the vaginal gel to patients who have taken disulfiram within the past 2 weeks. Patients should avoid vaginal intercourse during treatment.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
MetroCream: 0.75% (45 g) [contains benzyl alcohol]
Noritate: 1% (60 g) [contains methylparaben, propylparaben, trolamine (triethanolamine)]
Rosadan: 0.75% (45 g [DSC]) [contains benzyl alcohol]
Generic: 0.75% (45 g)
Gel, External:
Metrogel: 1% (55 g [DSC], 60 g) [contains methylparaben, propylparaben]
Rosadan: 0.75% (45 g [DSC]) [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Generic: 0.75% (45 g); 1% (55 g, 60 g)
Gel, Vaginal:
Nuvessa: 1.3% (5 g) [contains benzyl alcohol, methylparaben, propylene glycol, propylparaben]
Vandazole: 0.75% (70 g) [contains methylparaben, propylparaben]
Generic: 0.75% (70 g)
Kit, External:
Rosadan: 0.75% [DSC] [contains benzyl alcohol]
Rosadan: 0.75% [DSC] [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Lotion, External:
MetroLotion: 0.75% (59 mL) [contains benzyl alcohol]
Generic: 0.75% (59 mL)
May be product dependent
Cream (MetroCream External)
0.75% (per gram): $16.68
Cream (metroNIDAZOLE External)
0.75% (per gram): $1.90 - $12.22
Cream (Noritate External)
1% (per gram): $39.13
Gel (Metrogel External)
1% (per gram): $7.53
Gel (metroNIDAZOLE External)
0.75% (per gram): $3.64 - $7.10
1% (per gram): $5.04
Gel (metroNIDAZOLE Vaginal)
0.75% (per gram): $2.18 - $2.28
Gel (Nuvessa Vaginal)
1.3% (per gram): $48.73
Gel (Vandazole Vaginal)
0.75% (per gram): $2.33
Lotion (MetroLotion External)
0.75% (per mL): $14.62
Lotion (metroNIDAZOLE External)
0.75% (per mL): $4.19 - $4.85
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Noritate: 1% (45 g) [contains methylparaben, propylparaben, trolamine (triethanolamine)]
Cream, Vaginal:
Flagyl: 10% (60 g) [contains methylparaben, propylparaben, trolamine (triethanolamine)]
Gel, External:
Metrogel: 0.75% (3 g, 60 g); 1% (3 g, 60 g) [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Gel, Vaginal:
Nidagel: 0.75% (70 g) [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
Intravaginal: Use only vaginal gel intravaginally; fill applicator with medication; insert the applicator high into the vagina and press the plunger to release the medication; clean the applicator with warm soapy water and rinse well. Do not apply to the eye
Topical: For topical use only. Wash affected areas with a mild cleanser; then apply a thin film of drug to the affected area and rub in. Cosmetics may be used after application (wait at least 5 minutes after using lotion). Do not apply to the eye.
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).
Intravaginal: For vaginal use only. Applicator may be inserted in any comfortable position. Hold the applicator by the barrel, gently insert into the vagina as far as possible without causing discomfort. Press the plunger until it stops and withdraw the applicator. Patients should not use intravaginal products (eg, tampons, douches) or engage in vaginal intercourse for the duration of treatment. Discard applicator after single use or if applicator will be re-used, clean applicator with warm soapy water and rinse well.
10% (Flagyl cream [Canadian product]): Do not use applicator after the 7th month of pregnancy.
Topical cream, gel, lotion: Store at 20°C to 25°C (68°F to 77°F).
Vaginal gel: Store at 15°C to 30°C (59°F to 86°F); do not refrigerate or freeze. Avoid exposure to extreme heat.
Topical: Note: Approved uses for generic products may vary; consult labeling for specific information:
MetroCream, MetroLotion (0.75%): Treatment of inflammatory lesions (papules and pustules) of rosacea (FDA approved in adults)
Metrogel (1%): Treatment of inflammatory lesions of rosacea (FDA approved in adults)
Noritate (1%): Treatment of inflammatory lesions and erythema of rosacea (FDA approved in adults)
Vaginal gel: Note: Approved ages and uses for generic products may vary; consult labeling for specific information:
Metrogel-Vaginal (0.75%): Treatment of bacterial vaginosis (FDA approved in adults)
Nuvessa (1.3%): Treatment of bacterial vaginosis (FDA approved in ages ≥12 years and adults)
Vandazole (0.75%): Treatment of bacterial vaginosis (FDA approved in nonpregnant, postmenarchal females)
MetroNIDAZOLE may be confused with metFORMIN
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Alcohol (Ethyl). A disulfiram-like reaction may occur. Management: Warn patients and monitor for signs and symptoms of a disulfiram-like reaction if patients consume alcohol while using topical metronidazole. Some manufacturers of vaginal metronidazole products list alcohol use within 24 to 72 hours as a contraindication Risk D: Consider therapy modification
Disulfiram: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Disulfiram. In particular, the risk for CNS toxicities such as psychosis may be increased. Management: Warn patients and monitor for the development of serious CNS toxicity if topical metronidazole is used in a patient taking disulfiram. Some manufacturers of vaginal metronidazole products list disulfiram use within 2 weeks as a contraindication. Risk D: Consider therapy modification
Lopinavir: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Lopinavir. Specifically, the use of topical metronidazole with lopinavir/ritonavir solution (which contains 42% alcohol) may result in a disulfiram-like reaction. Risk C: Monitor therapy
Tipranavir: MetroNIDAZOLE (Topical) may enhance the adverse/toxic effect of Tipranavir. Risk C: Monitor therapy
Metronidazole crosses the placenta and rapidly distributes into the fetal circulation following oral administration. The amount of metronidazole available systemically following topical application is less in comparison to oral doses. Most studies have not shown an increased risk of adverse events to the fetus following maternal use during pregnancy (CDC [Workowski 2021]).
Bacterial vaginosis has been associated with adverse pregnancy outcomes; current guidelines recommend metronidazole for the treatment of symptomatic bacterial vaginosis in pregnancy. Pregnant patients may be treated with any regimens approved for nonpregnant patients; however, use of the metronidazole 1.3% vaginal gel should be avoided (insufficient data for efficacy) (CDC [Workowski 2021]). When used for the treatment of inflammatory lesions and erythema of rosacea, topical antibiotics, including metronidazole, are considered compatible with pregnancy (Murase 2014).
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
Absorption:
Topical: Concentrations achieved systemically after application of the 1 g topical gel and cream are <1% of those obtained after a 250 mg oral dose
Vaginal gel: Concentrations achieved systemically after application of 5 g vaginal gel (containing either 37.5 mg or 65 mg metronidazole) are ~2 % of those obtained after a 500 mg oral dose
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