Metronidazole Vaginal

Metronidazole Vaginal is a prescription medication used to treat the symptoms of Bacterial Vaginosis. 

• Metronidazole Vaginal is available under the following different brand names: MetroGel Vaginal, Vandazole, Nuvessa

Adult and pediatric dosage

Vaginal gel

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

Bacterial Vaginosis

Adult dosage

• 0.75%: One applicatorful intraVaginal once a day/two times a day for 5 days at bedtime
• 1.3%: One applicatorful intraVaginal once as a single dose at bedtime

Pediatric dosage

• Children below 12 years: Safety and efficacy not established
• Adolescents aged above 12 years
• 0.75%: One applicatorful intraVaginal once a day/two times a day for 5 days at bedtime
• 1.3%: One applicatorful intraVaginal once as a single dose at bedtime

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Metronidazole Vaginal include:

• vaginal itching or discharge,
• menstrual pain,
• breast pain,
• headache,
• rash,
• nausea,
• diarrhea, and
• cold symptoms such as stuffy nose, sneezing, or sore throat

Serious side effects of Metronidazole Vaginal include:

• convulsions (seizures),
• hives,
• difficulty breathing,
• swelling of the face, lips, tongue or throat, and
• numbness, burning, pain, or tingly feeling in the hands or feet

Rare side effects of Metronidazole Vaginal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Metronidazole Vaginal has severe interactions with the following drug:
  • progesterone intravaginal gel
• Metronidazole Vaginal has serious interactions with the following drug:
  • cholera vaccine
• Metronidazole Vaginal has moderate interactions with no other drugs.
• Metronidazole Vaginal has minor interactions with the following drugs:
  • disulfiram
  • ethanol

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Pregnancy and Lactation

• 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 are 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, more than 10 randomized, placebo-controlled clinical trials enrolled above 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, 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 is 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 the breastfed child from the drug or the underlying maternal condition
  • Alternatively, a lactating patient may interrupt breastfeeding and choose to pump and discard breastmilk during treatment and for 48 hours after the last dose and feed her infant previously-stored human milk or formula