Nuvessa

Nuvessa is an FDA-registered drug product whose active ingredient is METRONIDAZOLE. It is labelled by Exeltis USA, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 0642-7466, application NDA205223, label effective 20231110. It is one of 53 FDA drug label records sharing the active ingredient METRONIDAZOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METRONIDAZOLE are most often described in connection with: treatment bacterial, vaginosis females, years age, usage nuvessa, nitroimidazole antimicrobial. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )​

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 )

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 ) 4.1 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.

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. 6.1 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 ≥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%). 6.2 Other 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, proctitis. Hematopoietic: Reversible neutropenia, reversible thrombocytopenia. Hypersensitivity Reactions: Urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains [see Contraindications ( 4 )]. Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.

FDA lists 53 drug label records with METRONIDAZOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Nuvessa used for?
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 )​

Who makes Nuvessa?
Exeltis USA, Inc. is the labeler of record for Nuvessa. 53 FDA label records share the active ingredient METRONIDAZOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Nuvessa come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Nuvessa prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METRONIDAZOLE?
Yes. 53 FDA drug label records list METRONIDAZOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Nuvessa been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.