Brand names: Metronidazole Vaginal Gel
Nitroimidazole Antimicrobial
Route: Vaginal
Contraindications
4 CONTRAINDICATIONS • History of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives (4.1) • Concomitant use of disulfiram or within 2 weeks of disulfiram ( 4.2 , 7.1 ) • Concomitant use of alcohol ( 4.3 , 7.2 ) 4.1 Hypersensitivity Metronidazole vaginal gel is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives. 4.2 Use of Disulfiram Psychotic reactions have been reported with co-administration of disulfiram and oral metronidazole. Do not administer concurrently with or within 2 weeks of disulfiram. 4.3 Concomitant Alcohol Disulfiram-like reactions to alcohol have been reported with co-administration of oral metronidazole; do not consume ethanol or propylene glycol, during and for at least 24 hours following treatment.
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no data available on the use of metronidazole vaginal gel in pregnant women. Metronidazole usage in pregnancy has been associated with certain congenital anomalies (see 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 (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Blood levels following metronidazole vaginal administration are lower than those achieved with oral metronidazole. Following a single intravaginal 5 g dose of metronidazole vaginal gel, mean maximum concentration (Cmax) and total exposure (AUC0-∞) are approximately 2% and 4%, respectively, of those following a single oral 500 mg dose of metronidazole tablets [see Clinical Pharmacology ( 12.3 )] . Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole 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, more than ten randomized placebo-controlled clinical trials enrolled more than 5000 pregnant women to assess the use of antibiotic treatment (including metronidazole) for bacterial vaginosis on the inciden
6 interactions on record
Psychotic reactions reported in alcoholic patients using disulfiram concurrently with oral metronidazole. Should not be used within two weeks of disulfiram.
Source: NLP:metronidazole vaginal gel, 1.3 %
Elevation of plasma lithium concentrations and signs of lithium toxicity reported with oral metronidazole use.
Source: NLP:metronidazole vaginal gel, 1.3 %
Prolonged anticoagulant effects reported with oral metronidazole co-administration, resulting in prothrombin time prolongation.
Source: NLP:metronidazole vaginal gel, 1.3 %
Prolonged anticoagulant effects and prothrombin time prolongation reported with oral metronidazole co-administration.
Source: NLP:metronidazole vaginal gel, 1.3 %
May prolong metronidazole half-life and decrease plasma clearance; no dose adjustment of metronidazole vaginal gel necessary.
Source: NLP:metronidazole vaginal gel, 1.3 %
7 DRUG INTERACTIONS The intravaginal administration of a single dose of metronidazole vaginal gel results in lower systemic exposure to metronidazole that is approximately 2% to 4% of that achieved following oral administration of 500 mg metronidazole tablets [see Clinical Pharmacology ( 12.3 )]. The following drug interactions were reported for oral metronidazole. • Warfarin and other coumarin anticoagulants: Prolonged anticoagulant effects of warfarin and other coumarin anticoagulants have been reported with co-administration of oral metronidazole.
Source: FDA drug label - metronidazole vaginal gel, 1.3 %