metronidazole vaginal (Rx)

Brand and Other Names:MetroGel Vaginal, Vandazole, more...Nuvessa
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal gel

  • 0.75% (MetroGel Vaginal, Vandazole)
  • 1.3% (Nuvessa)

Bacterial Vaginosis

0.75%: One applicatorful intravaginal qDay/BID x5 days at bedtime

1.3%: One applicatorful intravaginal once as a single-dose at bedtime

Dosage Forms & Strengths

vaginal gel

  • 0.75% (MetroGel Vaginal, Vandazole)
  • 1.3% (Nuvessa)

Bacterial Vaginosis

<12 years: Safety and efficacy not established

Adolescents aged ≥12 years

  • 0.75%: One applicatorful intravaginal qDay/BID x5 days at bedtime
  • 1.3%: One applicatorful intravaginal once as a single-dose at bedtime
Next:

Interactions

Interaction Checker

and metronidazole vaginal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (1)

            • progesterone intravaginal gel

              metronidazole vaginal, progesterone intravaginal gel. Other (see comment). Contraindicated. Comment: Do not use with other vaginal products because of potential to alter progesterone release.

            Serious - Use Alternative (1)

            • cholera vaccine

              metronidazole vaginal, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

            Monitor Closely (0)

              Minor (3)

              • disulfiram

                disulfiram increases toxicity of metronidazole vaginal by decreasing metabolism. Minor/Significance Unknown. Enhanced CNS & cardiac toxicity with oral metronidazole and disulfiram; less likely to occur with vaginal administration because of low absorption.

              • ethanol

                metronidazole vaginal will increase the level or effect of ethanol by decreasing metabolism. Minor/Significance Unknown. Disulfiram-like reaction with oral metronidazole and alcohol; less likely to occur with vaginal administration because of low absorption

              • warfarin

                metronidazole vaginal will increase the level or effect of warfarin by decreasing metabolism. Minor/Significance Unknown. Oral metronidazole potentiates the effect of warfarin; less likely to occur with vaginal administration because of low absorption

              Previous
              Next:

              Adverse Effects

              >10%

              Bacterial infection (12%)

              1-10%

              Headache (7%)

              Pruritus (6%)

              Abdominal pain (5%)

              Nausea (3%)

              Dysmenorrhea (3%)

              Pharyngitis (2%)

              Rash (1%)

              Diarrhea (1%)

              Breast pain (1%)

              Metrorrhagia (1%)

              Previous
              Next:

              Warnings

              Contraindications

              Hypersensitivity

              Psychotic reactions have been reported with coadministration disulfiram and oral metronidazole; do not administer concurrently with or within 2 weeks of disulfiram

              Disulfiram-like reactions to alcohol have been reported with coadministration of oral metronidazole; do not consume ethanol or propylene glycol, during and for at least 24 hr following treatment

              Cautions

              Psychotic reaction with disulfiram (see Contraindications)

              Interaction with alcohol (disulfiram-like reaction); abdominal cramps, nausea, vomiting, headache, flushing (see Contraindications)

              PO and IV administration associated with seizures, encephalopathy, aseptic meningitis, and peripheral neuropathy

              Carcinogenic in mice and rats; avoid unnecessary use

              May interfere with lab assessments of AST, ALT, LDH, TG, and glucose hexokinase

              Drug interaction overview

              • Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently; do not initiate metronidazole in patients who have taken disulfiram within the last 2 weeks
              • Disulfiram-like reactions reported with oral metronidazole consumed with alcohol; do not consume ethanol or propylene glycol, during and for at least 24 hr following treatment
              • Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time
              • Short-term use of oral metronidazole has been associated with elevation of serum lithium concentrations
              • Cimetidine may decrease plasma clearance and prolong metronidazole half-life
              Previous
              Next:

              Pregnancy & Lactation

              Pregnancy

              There are no data on the use of metronidazole intravaginal in pregnant women

              Human systemic data

              • Blood levels following vaginal administration are lower than those achieved with oral metronidazole; Cmax and AUC of intravaginally administered metronidazole is 2% and 4%, respectively, of those following oral administration
              • There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole systemically during pregnancy
              • Many studies included first trimester exposures
              • One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in-utero; however, these findings were not confirmed
              • In addition, >10 randomized, placebo-controlled clinical trials enrolled >5000 pregnant women to assess the use of systemic antibiotic treatment (including metronidazole) for bacterial vaginosis on the incidence of preterm delivery; most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following metronidazole exposure during pregnancy
              • Three studies conducted to assess the risk of infant cancer following systemic metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited

              Animal data

              • No adverse developmental effects were demonstrated when oral dose was administered to mice at doses up to six times the recommended human dose

              Lactation

              There is no information on the presence of metronidazole in human milk, or the effects on the breast-fed child, or the effects on milk production following intravaginal administration

              Following PO administration, concentrations in human milk are similar to concentrations in plasma; since some metronidazole is systemically absorbed following vaginal administration, excretion in human milk is possible; the published literature reports no adverse effects in infants exposed through breastmilk to maternal orally administered metronidazole

              Because of the potential for tumorigenicity shown in animal studies, breastfeeding is not recommended during treatment with metronidazole intravaginal and for 2 days after therapy ends

              Breastfeeding women may choose to pump and discard milk for the duration of therapy, and for 48 hr after therapy ends and feed her infant stored human milk or formula

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

              Previous
              Next:

              Pharmacology

              Mechanism of Action

              Antibacterial agent; active in vitro to most strains of organisms associated with bacterial vaginosis including Bacteroides spp., Gardnerella vaginalis, Mobiluncus spp., and Peptostreptococcus spp.

              Inhibits nucleic acid synthesis by disrupting DNA

              Pharmacokinetics

              Peak plasma time: 9.5 hr

              Peal plasma concentration: 281 ng/mL (2% of PO dose)

              AUC: 125,000 ng•hr/mL (5% of single oral dose)

              Previous
              Next:

              Images

              No images available for this drug.
              Previous
              Next:

              Patient Handout

              A Patient Handout is not currently available for this monograph.
              Previous
              Next:

              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
              Additional Offers
              Email to Patient

              From:

              To:

              The recipient will receive more details and instructions to access this offer.

              By clicking send, you acknowledge that you have permission to email the recipient with this information.

              Email Forms to Patient

              From:

              To:

              The recipient will receive more details and instructions to access this offer.

              By clicking send, you acknowledge that you have permission to email the recipient with this information.

              Previous
              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.