Metronidazole 0.75% Vag prep

Metronidazole 0.75% Vag prep is used for: Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or gardnerella vaginitis).

Topical/Cutaneous Bacterial vaginosis Adult: As 0.75% gel: Apply to affected area intravaginally one applicatorful once daily or bid for 5 days.

Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Metronidazole should be given with caution in the following conditions- anaemia or other blood disorders, liver disease, disease of the nervous system, seizures etc. Lactation: Excreted in human milk; caution advised

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 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 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 24 hr after therapy ends and feed her infant stored human milk or formula

Concurrent use w/ disulfiram may produce psychotic reactions. May potentiate the effect of oral anticoagulants. May increase risk of lithium toxicity. May reduce the renal clearance resulting to increased toxicity of 5-fluorouracil. May increase serum levels of ciclosporin. May increase plasma levels of busulfan resulting to severe busulfan toxicity. Enhanced metabolism w/ phenobarbital and phenytoin resulting to decreased serum concentrations.

Side effects of Metronidazole 0.75% Vag prep : >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%)

Metronidazole is converted to reduction products that interact w/ DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.