Metronidazole Vaginal Gel
Generic: METRONIDAZOLE VAGINAL GEL, 1.3 %
Basic Information
Manufacturer
Encube Ethicals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
585d2553-e19f-4227-82db-e4c2034863bf
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 )
Metronidazole vaginal gel is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older.
( 1 )
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 metronidazole vaginal gel 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 metronidazole vaginal gel versus 16.1% of subjects treated with Vehicle Gel.
Adverse reactions occurring in ≥1% of subjects receiving metronidazole vaginal gel 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 Patients The safety of metronidazole vaginal gel was evaluated in a multicenter, open-label study evaluating the safety and tolerability of metronidazole vaginal gel 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 metronidazole vaginal gel 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 patients aged 12 to less than 18 years old was comparable to adult women.
No deaths occurred and no subjects discontinued 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.
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 metronidazole vaginal gel 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 metronidazole vaginal gel versus 16.1% of subjects treated with Vehicle Gel.
Adverse reactions occurring in ≥1% of subjects receiving metronidazole vaginal gel 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 Patients The safety of metronidazole vaginal gel was evaluated in a multicenter, open-label study evaluating the safety and tolerability of metronidazole vaginal gel 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 metronidazole vaginal gel 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 patients aged 12 to less than 18 years old was comparable to adult women.
No deaths occurred and no subjects discontinued 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.