Nuvessa metronidazole 65 mg/5g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Metronidazole is used to treat vaginal infections such as bacterial vaginosis (an infection caused from too much harmful bacteria in the vagina). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Read the full MedlinePlus article ↗- It depends on the specific product you've been given. The topical skin gel (like Metronidazole Gel 1%) is used to treat the red bumps and pimple-like spots that come with rosacea —...
- What is metronidazole topical gel actually used for?
- First, gently cleanse the area you're treating and let it dry. Then apply a thin film of the gel and rub it in gently — you only need to do this once a day. The good news is you ca...
- You should avoid alcohol while using metronidazole and for at least 24 hours after finishing treatment. Mixing metronidazole with alcohol — even in products like mouthwash or some...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metronidazole — tap one for details:
Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII W25LM17A4W
Polycarbophil is a synthetic polymer that absorbs water and swells. It's used as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $42.998 | $214.99 / 5 g |
| Medicaid paysCMS SDUD · 12 mo | $42.51 | $212.54 / 5 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nuvessa 65 mg/5gthis 00642-7466-05 | Exeltis | 1 applicator | $42.998 | — | Availability likely | — |
| Metronidazole Vaginal Gel 65 mg/5g 21922-0046-41 | Encube | 1 applicator | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9198858 ↗ | Method of use | U-1664 | Jun 28, 2032 |
| US 8658678 ↗ | Method of use | U-1682 | Jun 27, 2028 |
| US 8946276 ↗ | Method of use | U-1664 | Jun 28, 2032 |
| US 7893097 ↗ | Drug product | — | Feb 19, 2028 |
| US 8877792 ↗ | Drug product | — | Feb 2, 2028 |
| US 10238634 ↗ | Drug product | — | Jun 28, 2032 |
| US 10596155 ↗ | Drug product | — | Jun 28, 2032 |
Is there a generic version of NUVESSA VAGINAL 1.3% GEL?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00642-7466-05 You're viewing this | 1 APPLICATOR in 1 CARTON (0642-7466-05) / 5 g in 1 APPLICATOR | $43.00 / g | $214.99 | 2018-03-10 | Active |
| 00642-7466-06 | 1 APPLICATOR in 1 CARTON (0642-7466-06) / 5 g in 1 APPLICATOR | — | — | 2018-03-10 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00642-7466-05?
What NDC number is used to bill for this package of Nuvessa metronidazole 65 mg/5g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE NUVESSA is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. NUVESSA is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND 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. A single-dose, pre-filled disposable applicator administered once intravaginally at bedtime. ( 2 ) NUVESSA is not for ophthalmic, dermal, or oral use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Vaginal gel (1.3%) containing 65 mg of metronidazole in 5 grams of gel in a pre-filled applicator. Vaginal gel: 65 mg of metronidazole in 5 grams of gel (1.3%) in a prefilled applicator ( 3 )
⛔ 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 )
4.1Hypersensitivity NUVESSA is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives.
4.2Use 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.
4.3Concomitant 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.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 ) Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values. ( 5.3 )
5.1Central 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.
5.2Carcinogenicity in Animals Metronidazole has been shown to be carcinogenic at high doses administered orally in mice and rats [see Nonclinical Toxicology ( 13.1 )] . Unnecessary use of metronidazole should be avoided. Use of NUVESSA should be reserved for the treatment of bacterial vaginosis [see Indications and Usage ( 1 )].
5.3Drug/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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions observed in adult clinical studies (incidence ≥1%) were vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, and dysmenorrhea. The most common adverse reactions observed in pediatric clinical studies (incidence ≥1%) was vulvovaginal discomfort.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc., at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Clinical Trial Experience in Adult Subjects The safety of NUVESSA was evaluated in a randomized, double-blind, vehicle-controlled study in subjects with bacterial vaginosis. A total of 321 non-pregnant females with a mean age of 33.4 years (range 18 to 67 years) received NUVESSA. Subjects were primarily Black/African American (58.3%) or White (39.3%).
Subjects administered a single dose of NUVESSA at bedtime on the first day of the study. There were no deaths or serious adverse reactions in this trial. Adverse reactions were reported by 19.0% of subjects treated with NUVESSA versus 16.1% of subjects treated with Vehicle Gel.
Adverse reactions occurring in ≥1% of subjects receiving NUVESSA were: vulvovaginal candidiasis (5.6%), headache (2.2%), vulvovaginal pruritus (1.6%), nausea (1.6%), diarrhea (1.2%), and dysmenorrhea (1.2%). No subjects discontinued treatment due to adverse reactions. Clinical Trial Experience in Pediatric Subjects The safety of NUVESSA was evaluated in a multicenter, open-label study evaluating the safety and tolerability of NUVESSA in 60 pediatric subjects between the ages of 12 and less than 18 years old all of whom were treated with a single dose of NUVESSA administered once at bedtime intravaginally.
Most subjects in this study were either Black/African-American, non-Hispanic (47%) or Hispanic (35%). Safety in pediatric female subjects aged 12 to less than 18 years old was comparable to adult women. No deaths occurred and no subjects discontinued treatment due to adverse reactions.
Adverse reactions occurring in ≥ 1% of pediatric subjects included: vulvovaginal discomfort (2%).
6.2Other Metronidazole Formulations Other Vaginal Formulations Other reactions that have been reported in association with the use of other formulations of metronidazole vaginal gel include: unusual taste and decreased appetite. Topical (Dermal) Formulations Other reactions that have been reported in association with the use of topical (dermal) formulations of metronidazole include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse reactions exceeded an incidence of 2% of patients.
Oral and Parenteral Formulations The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of metronidazole: Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings. Nervous System: The most serious adverse reactions reported in patients treated with oral metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity.
In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia [see Warnings and Precautions ( 5.1 )]. Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, "furry" tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages. Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctiti…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The intravaginal administration of a single dose of NUVESSA 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.
( 7.3 ) Lithium: Elevated plasma lithium concentrations have been reported with oral metronidazole. ( 7.4 )
7.1Disulfiram 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 ( 4.2 )] .
7.2Alcoholic 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 ( 4.3 )].
7.3Coumarin and Other Oral Anticoagulants Use of oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when NUVESSA is prescribed for patients on this type of anticoagulant therapy.
7.4Lithium Short-term use of oral metronidazole has been associated with elevation of plasma lithium concentrations and, in a few cases, signs of lithium toxicity in patients stabilized on relatively high doses of lithium.
7.5Cimetidine Use of oral metronidazole with cimetidine may prolong the half-life and decrease plasma clearance of metronidazole. No dose adjustment of NUVESSA is necessary.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: A lactating patient may pump and discard breast milk during treatment and for 48 hours after the last dose. ( 8.2 )
8.1Pregnancy Risk Summary There are no data available on the use of NUVESSA 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, during organogenesis to pregnant rats and rabbits 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 NUVESSA vaginal administration are lower than those achieved with oral metronidazole. Following a single intravaginal 5 g dose of NUVESSA, mean maximum concentration (C max ) and total exposure (AUC 0 -∞ ) 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 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 metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited.
Animal Data No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rabbits at up to 200 mg/kg (about 60 times the maximum human dose based on body surface area comparison). Similarly, no fetotoxic or teratogenic effects were observed in five studies in rats where dosing was administered orally in the diet or by gastric intubation at doses up to 200 mg/kg (about 30 times the maximum human dose based on body surface area comparison). As well, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at doses up to 100 mg/kg (about 7 times the maximum human dose based on body surface area comparison).
However, some intrauterine deaths were observed in Swiss Webster mice administered metronidazole intraperitoneally at doses up to 15 mg/kg (about 1 times the maximum human dose based on body surface area comparison). The relationship of these intraperitoneal findings in mice to the vaginal use of NUVESSA is unknown.
8.2Lactation 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 ( 12.3 )] .
The published literature repor…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data available on the use of NUVESSA 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, during organogenesis to pregnant rats and rabbits 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 NUVESSA vaginal administration are lower than those achieved with oral metronidazole. Following a single intravaginal 5 g dose of NUVESSA, mean maximum concentration (C max ) and total exposure (AUC 0 -∞ ) 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 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 metronidazole exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited.
Animal Data No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rabbits at up to 200 mg/kg (about 60 times the maximum human dose based on body surface area comparison). Similarly, no fetotoxic or teratogenic effects were observed in five studies in rats where dosing was administered orally in the diet or by gastric intubation at doses up to 200 mg/kg (about 30 times the maximum human dose based on body surface area comparison). As well, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at doses up to 100 mg/kg (about 7 times the maximum human dose based on body surface area comparison).
However, some intrauterine deaths were observed in Swiss Webster mice administered metronidazole intraperitoneally at doses up to 15 mg/kg (about 1 times the maximum human dose based on body surface area comparison). The relationship of these intraperitoneal findings in mice to the vaginal use of NUVESSA is unknown.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of NUVESSA have been established in pediatric subjects between the ages of 12 and less than 18 years old. Use of NUVESSA in this age group is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis [see Adverse Reactions ( 6.1 )] and, evidence from adequate and well-controlled studies in adult women. The safety and effectiveness of NUVESSA in pediatric subjects below the age of 12 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies with NUVESSA did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied NUVESSA could be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6.2 )].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Metronidazole is an antimicrobial drug [see Microbiology ( 12.4 )].
12.3Pharmacokinetics Following a single, intravaginal 5 g dose of NUVESSA (equivalent to 65 mg of metronidazole) to 20 healthy female subjects, a mean maximum serum metronidazole concentration (C max ) of 239 ng/mL was observed (range: 114 to 428 ng/mL). The average time to achieve this C max was 7.3 hours (range: 4 to 18 hours). This C max is approximately 2% of the mean maximum serum concentration reported in healthy subjects administered a single, oral 500 mg dose of metronidazole tablets (mean C max = 12,785 ng/mL).
The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 g dose of NUVESSA (equivalent to 65 mg of metronidazole), was 5,434 ng∙hr/mL (range: 1382 to 12744 ng∙hr/mL). This AUC 0-∞ is approximately 4% of the reported AUC of metronidazole following a single oral 500 mg dose of metronidazole (approximately 125,000 ng∙hr/mL).
12.4Microbiology Mechanism of Action Metronidazole is a nitroimidazole antimicrobial agent that acts primarily against anaerobic bacteria and selected protozoa. The 5-nitro group on the metronidazole molecule is reduced by metabolically active anaerobes to its active state by the bacterial nitro-reductase enzyme after it diffuses into the bacterial cell. This results in the production of cytotoxic compounds that disrupt the helical structure of bacterial DNA thereby inhibiting bacterial nucleic acid synthesis which leads to cell death.
Resistance The mechanism of resistance, like for other nitroimidazoles, appears to be multifactorial that include decreased uptake of the drug, higher efflux activity, and/or altered nitroreductase activity. Antibacterial Activity Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Clinical Studies ( 14 )] . The following in vitro data are available, but their clinical significance is unknown.
Metronidazole is active in vitro against most isolates of the following organisms reported to be associated with bacterial vaginosis: Bacteroides spp. Gardnerella vaginalis Mobiluncus spp. Peptostreptococcus spp.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Metronidazole is an antimicrobial drug [see Microbiology ( 12.4 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING NUVESSA is available in cartons containing one single-dose, prefilled disposable applicator delivering 5 g of vaginal gel containing approximately 65 mg of metronidazole: 5 g disposable applicator (NDC 0642-7466-05). Store at 20-25°C (68-77°F); excursions permitted to 15°-30°C (59°-86°F) [ see USP Controlled Room temperature ]. Do not freeze. Do not refrigerate.
📦 Storage and Handling ▾
Store at 20-25°C (68-77°F); excursions permitted to 15°-30°C (59°-86°F) [ see USP Controlled Room temperature ]. Do not freeze. Do not refrigerate.
📋 Description ▾
11 DESCRIPTION NUVESSA contains 1.3% metronidazole, USP in a single-dose prefilled disposable applicator. It is intended for intravaginal use. Metronidazole is a nitroimidazole antimicrobial.
Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. Its structural formula is: The molecular formula is C 6 H 9 N 3 O 3 with a molecular weight of 171.16. NUVESSA is an aqueous gel containing metronidazole at a concentration of 13 mg/g (1.3%).
The gel is formulated at pH 4.0. The gel also contains benzyl alcohol, methylparaben, polycarbophil, polyethylene glycol 400, propylene glycol, propylparaben, and purified water. Each applicator contains approximately 65 mg of metronidazole in 5 g of vaginal gel.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Interaction with Alcohol Instruct the patient not to consume alcoholic beverages and preparations containing ethanol or propylene glycol during and for at least 24 hours after treatment with NUVESSA [see Contraindications ( 4.3 ) and Drug Interactions ( 7.2 )]. Drug Interactions Instruct the patient not to use NUVESSA if disulfiram had been used within the last two weeks [see Contraindications ( 4.2 )] , and to inform their healthcare provider if they are taking oral anticoagulants, or lithium [see Drug Interactions ( 7.3 , 7.4 )].
Vaginal Intercourse and Use with Vaginal Products Instruct the patient not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) following the single administration of NUVESSA. Lactation A patient may choose to pump and discard breast milk during treatment with NUVESSA and for 48 hours after last dose, and feed her infant previously stored human milk or formula [see Use in Specific Populations ( 8.2 )]. Vaginal Irritation Inform the patient to discontinue use and consult a healthcare provider if vaginal irritation occurs with use of NUVESSA.
Administration of Drug Instruct the patient that NUVESSA is supplied as a single dose in a pre-filled applicator.