metronidazole vaginal (Rx)

Brand and Other Names:MetroGel Vaginal, Vandazole, more...Nuvessa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal gel

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

0.75%: One applicatorful intravaginal qDay/BID x5 days

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)
more...

Bacterial Vaginosis

Premenarchal: Safety and efficacy not established

Postmenarchal adolescents

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

Interaction Checker

and metronidazole vaginal

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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%)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Psychotic reaction with disulfiram

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

            Discontinue alcohol consumption during and for at least 3 days after metronidazole therapy

            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

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            Pregnancy & Lactation

            Pregnancy Category: B

            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

            Lactation: Excreted in human milk; caution advised

            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

            Potential for tumorigenicity shown in animal studies, a decision should be made whether to discontinue nursing or to discontinue metronidazole; breastfeeding women may choose to pump and discard milk for the duration of therapy, and for 24 hours 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.

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            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 Peak

            Plasma Concentration: 281 ng/mL (2% of PO dose)

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

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            Images

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            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.
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