Navigation

metronidazole vaginal (MetroGel Vaginal, Vandazole, Nuvessa)

 

Classes: Antibiotics, Other; Vaginal Preparations, Other

Dosing and uses of MetroGel, Vandazole (metronidazole vaginal)

 

Adult dosage forms and strengths

vaginal geL

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

 

Bacterial Vaginosis

0.75%: One applicatorful intravaginal qDay/BID x5 days

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

 

Pediatric dosage forms and strengths

vaginal geL

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

 

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

 

MetroGel, Vandazole (metronidazole vaginal) adverse (side) 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%)

 

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

 

Pregnancy and 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.

 

Pharmacology of MetroGel, Vandazole (metronidazole vaginal)

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)