7
Other effects 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 events exceeded an incidence of 2% of patients.
Oral and Parenteral Formulations
Metronidazole vaginal gel results in minimal peak serum levels and systemic exposure (AUC) of
metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of
exposure are less likely to produce the common reactions seen with oral metronidazole, the
possibility of these and other reactions cannot be excluded presently. Data from well-controlled
trials directly comparing metronidazole administered orally to metronidazole administered
vaginally are not available.
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.
Central Nervous System: (See WARNINGS.) Headache, dizziness, syncope, ataxia,
confusion, convulsive seizures, peripheral neuropathy, vertigo, incoordination,
irritability, depression, weakness, insomnia.
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; flushing; nasal congestion;
dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.
Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened
urine.
OVERDOSAGE
There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied
metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects.
(See WARNINGS.)
DOSAGE AND ADMINISTRATION
The recommended dose is one applicator full of metronidazole vaginal gel, (approximately 5
grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day
for 5 days. For once a day dosing, metronidazole vaginal gel should be administered at bedtime.
HOW SUPPLIED