Revision Year: 2021
Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
One full applicator (5 g) of terconazole vaginal cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal cream 0.4% is not affected by menstruation.
In the rat, the oral LD50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively.
In the event of oral ingestion of the cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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