nuvessa
Nuvessa (Metronidazole) is a nitroimidazole antimicrobial used to treat Abscess, Amebiasis, Bacteroides Infections, Bacterial Endocarditis.
Metronidazole · by Chemo Research Sl
Available as a generic: Metronidazole
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Metronidazole
- Drug class
- Nitroimidazole Antimicrobial
- Form
- Topical
- Strength
- Metronidazole 1.3%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- abscess, amebiasis, bacteroides infections
- Manufacturer
- Chemo Research Sl
- Half-life
- about 8 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.10 per gm — not your price
- FDA application
- NDA205223
What is Nuvessa?
From the FDA label: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
How to use
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 )
Side effects
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. 6.1 Clinical 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…
Warnings
Important safety information
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 ) 5.1 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. 5.2 Carcinogenicity 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 )]. 5.3 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.
Who should not take Nuvessa
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 NUVESSA 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.
Overdose — what happens if you take too much
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 )].
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 ) 7.1 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 ( 4.2 )] . 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 ( 4.3 )]. 7.3 Coumarin 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. 7.4 Lithium 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. 7.5 Cimetidine Use of oral metronidazole with cimetidine may prolong the half-life and decrease plasma clearance of metronidazole. No dose adjustment of NUVESSA is necessary.
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Alcohol
Watch out for: beer, wine, spirits, and other products containing alcohol.
Combining alcohol with this antibiotic can cause a disulfiram-like reaction — flushing, nausea, vomiting, headache, and a fast heartbeat.
What to do: Avoid alcohol while taking it and for a few days after your last dose, as your prescriber or the label directs. Alcohol can hide in some liquid medicines and mouthwashes.
Source: Metronidazole — MedlinePlus (U.S. National Library of Medicine)
How long does Metronidazole stay in your body?
The elimination half-life of metronidazole is about 8 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the average for healthy adults with normal kidney and liver function; the half-life is much longer in newborns (roughly 22 to 109 hours, longer the more premature the baby). Metronidazole has an active metabolite (hydroxy-metronidazole) whose levels build up in older adults (40-80% higher) and in severe kidney disease, though the label does not give a separate half-life for it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: FLAGYL (metronidazole) label, DailyMed.
Drug class
How this class works, per Metronidazole - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- abscess
- amebiasis
- bacteroides infections
- bacterial endocarditis
- pseudomembranous enterocolitis
- giardiasis
See how Nuvessa ranks — best-rated nitroimidazole antimicrobial for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Nuvessa treat?
- Nuvessa (Metronidazole) may be used to treat abscess, amebiasis, bacteroides infections, bacterial endocarditis, pseudomembranous enterocolitis, giardiasis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Nuvessa work?
- Nuvessa is a nitroimidazole antimicrobial. Nitroimidazole antibiotics (such as metronidazole) are activated inside oxygen-free bacteria and parasites, where they turn into reactive forms that break and destabilize the microbe's DNA. This kills the germ while largely sparing the body's own cells.
- How much does Nuvessa cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.10 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Nuvessa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nuvessa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nuvessa?
- Nuvessa is marketed by Chemo Research Sl. You can see Chemo Research Sl's full profile, rating, and other products on pharmaranks.
- Is Nuvessa a brand-name or generic drug?
- Nuvessa is a brand-name product with the active ingredient Metronidazole. Lower-cost generic equivalents containing Metronidazole are available — ask your pharmacist.
- Is Nuvessa available over the counter?
- No. Nuvessa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nuvessa come in?
- Nuvessa is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Nuvessa?
- Nuvessa is classified as nitroimidazole antimicrobial, per the FDA's Established Pharmacologic Class.
- Is Nuvessa FDA-registered?
- Nuvessa is on record with the U.S. FDA under application number NDA205223. You can verify this on its official FDA label.
- Is Nuvessa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Nuvessa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Nuvessa?
- Nuvessa's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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