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)

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
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Interactions

Interaction Checker

and metronidazole vaginal

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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%)

            Postmarketing Reports

            Severe irreversible hepatotoxicity/acute liver failure (patients with Cockayne syndrome)

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            Warnings

            Contraindications

            Hypersensitivity

            Patients with Cockayne syndrome

            Within 2 weeks of taking disulfiram

            Consumption of alcohol or products containing propylene glycol within least three days of receiving metronidazole

            Cautions

            Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes reported after initiation of metronidazole, another nitroimidazole drug, structurally related to benznidazole in patients with Cockayne syndrome

            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
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            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

            • In animal reproduction studies, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rats and rabbits, during organogenesis, at up to 30 times and 60 times the recommended human dose based on body surface area comparison, respectively

            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

            Metronidazole is present in human milk following oral metronidazole administration, at concentrations similar to those found in plasma; metronidazole vaginal gel achieves 2% of the mean maximum serum concentration of a 500 mg oral metronidazole

            Animal studies have shown the potential for tumorigenicity after oral metronidazole administered chronically to rats and mice; the clinical relevance of these findings is unclear

            The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy, and any potential adverse effects on breastfed child from the drug or from underlying maternal condition

            Alternatively, a lactating patient may interrupt breastfeeding and choose to pump and discard breastmilk during treatment and for 48 hours after last dose and feed her infant previously 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

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

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

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            Patient Handout

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            Formulary

            FormularyPatient Discounts

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