Nuvessa (Metronidazole)

Check Drug InteractionsCheck known drug interactions.

Dosage & administration

A single-dose, pre-filled disposable applicator (which delivers approximately 5 g of gel containing 65 mg of metronidazole) administered once intravaginally. NUVESSA should be administered at bedtime.

NUVESSA is not for ophthalmic, dermal or oral use.

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Nuvessa prescribing information

Lactation: A lactating patient may pump and discard breast milk during treatment and for 48 hours after the last dose. (

8.2 Lactation

Risk Summary

There are no data on the presence of metronidazole in human milk following intravaginal administration. Metronidazole is present in human milk following oral metronidazole administration, at concentrations similar to those found in plasma (

see Data

). The metronidazole vaginal gel achieves 2% of the mean maximum serum concentration of a 500 mg oral metronidazole dose

[see Clinical Pharmacology ]

. The published literature reports no adverse effects in infants exposed through breastmilk to maternal orally administered metronidazole. There are no data on the effects on milk production.

Animal studies have shown the potential for tumorigenicity after oral metronidazole was administered chronically to rats and mice

[see Nonclinical Toxicology ]

. 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 NUVESSA, and any potential adverse effects on the breastfed child from NUVESSA or from the underlying maternal condition. Alternatively, a lactating patient may interrupt breastfeeding and choose to pump and discard breastmilk during treatment with NUVESSA and for 48 hours after the last dose and feed her infant previously stored human milk or formula.

Data

In a study of lactating women receiving oral metronidazole 600 mg (n=11) or 1200 mg (n=4) daily, mean maternal plasma concentrations were 5.0 and 12.5 mcg/mL respectively, within 2 hours following administration; the milk: maternal plasma ratio was approximately 1.

)

History of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives (
4.1 Hypersensitivity
NUVESSA is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.
)
Concomitant use of disulfiram or within 2 weeks of disulfiram (
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.
,
7.1 Disulfiram
Use of oral metronidazole has been associated with psychotic reactions in alcoholic patients who are using disulfiram concurrently. NUVESSA should not be used by patients who have taken disulfiram within the last two weeks
[see Contraindications ]
.
)
Concomitant use of alcohol (
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.
,
7.2 Alcoholic Beverages
Use of oral metronidazole has been associated with a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) to alcohol. Alcoholic beverages and preparations containing ethanol or propylene glycol should not be consumed during and for at least 24 hours after NUVESSA therapy
[see Contraindications ].
)

Central and peripheral nervous system effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole. Discontinue promptly if abnormal neurologic signs develop (
5.1 Central and Peripheral Nervous System Effects
Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. NUVESSA should be administered with caution to patients with central nervous system diseases. Discontinue promptly if abnormal neurologic signs develop.
)
Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values. (
5.3 Drug/Laboratory Test Interactions
Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation reduction of nicotinamide-adenine dinucleotides (NAD + NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.
)

Nuvessa (Metronidazole)

Dosage & administration

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