Metronidazole Vaginal Gel 65 mg/5g
Metronidazole vaginal gel, 1.3 % · GEL · Encube Ethicals, Inc.
Metronidazole Vaginal Gel is a gel containing metronidazole vaginal gel, 1.3 % at 65 mg/5g, taken vaginal. Manufactured by Encube Ethicals, Inc..
Key Facts
- Brand Name
- Metronidazole Vaginal Gel
- Generic Name
- Metronidazole vaginal gel, 1.3 %
- NDC Code (Product)
21922-046- Manufacturer
- Encube Ethicals, Inc.
- Strength
- 65 mg/5g
- Dosage Form
- GEL
- Route
- VAGINAL
- Marketing Status
- Application #
- ANDA216795
- Drug Class
- Nitroimidazole Antimicrobial [EPC]
- Marketing Start
- 03/19/2024
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. Metronidazole vaginal gel is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. ( 1 )
Dosage & 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. Metronidazole vaginal gel should be administered at bedtime. Metronidazole vaginal gel, 1.3% is not for ophthalmic, dermal or oral use. • A single-dose, pre-filled disposable applicator administered once intravaginally at bedtime. (2) • Metronidazole vaginal gel is not for ophthalmic, dermal, or oral use. (2)
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 ) 4.1 Hypersensitivity Metronidazole vaginal gel 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.
Drug Interactions
7 DRUG INTERACTIONS The intravaginal administration of a single dose of metronidazole vaginal gel 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. Metronidazole vaginal gel 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…
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. Encube Ethicals Private Limited, at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Clinical Trial Experience in Adult Patients The safety of metronidazole vaginal gel 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 metronidazole vaginal gel. Subjects were primarily Black/African American (58.3%) or White (39.3%).Subjects administered a single dose of me…
Frequently Asked Questions
What is Metronidazole Vaginal Gel used for?
Metronidazole Vaginal Gel contains Metronidazole vaginal gel, 1.3 %. It is a gel taken vaginal. Consult your doctor for specific uses.
Is Metronidazole Vaginal Gel a controlled substance?
Metronidazole Vaginal Gel is not classified as a controlled substance by the DEA.
What is the generic name for Metronidazole Vaginal Gel?
The generic name for Metronidazole Vaginal Gel is Metronidazole vaginal gel, 1.3 %. There are no other listed brand versions of Metronidazole vaginal gel, 1.3 %.
What is the NDC code for Metronidazole Vaginal Gel 65 mg/5g?
The NDC (National Drug Code) for Metronidazole Vaginal Gel 65 mg/5g is 21922-046, listed by Encube Ethicals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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