TERCONAZOLE VAGINAL CREAM 0.8%

Terconazole Vaginal Cream, 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis -1-[ p [[2-(2,4-Dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4- yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows: Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol. chemical-structure

Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females. ( 1 )

The recommended dose is one applicator full of Terconazole Vaginal Cream (5 grams of cream containing 40 mg terconazole) administered intravaginally once daily at bedtime for three consecutive days. Terconazole Vaginal Cream is not for oral or ophthalmic use. • One full applicator (5 grams) of Terconazole Vaginal Cream administered intravaginally once daily at bedtime for three (3) consecutive days. ( 2 ) • Not for oral or ophthalmic use. ( 2 )

Terconazole Vaginal Cream, 0.8% is contraindicated in patients with known hypersensitivity to terconazole or to any of the components of the cream. Known hypersensitivity to terconazole or any other component of the cream ( 4 )

Most common adverse reactions (incidence ≥ 2%) were headache, dysmenorrhea, genital burning and itching, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience 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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and estimating their relative rates. During a controlled clinical trial conducted in the United States, patients with vulvovaginal candidiasis were treated with Terconazole Vaginal Cream, 0.8% for 3 days (n=231) or Terazol®3 for 3 days (n=229) [see Clinical Studies (14)]. Table 1 lists the adverse reactions occurring in ≥2% of patients receiving Terconazole Vaginal Cream in the trial. The therapy-related discontinuation rate was 2.0% for Terconazole Vaginal Cream. The adverse reaction most frequently causing discontinuation of Terconazole Vaginal Cream therapy was vulvovaginal itching (0.7%). Table 1: Adverse Reactions Occurring in ≥2% of Patients Receiving Terconazole Vaginal Cream in a Randomized, Double-Blind Active Controlled Trial Terconazole Vaginal Cream, 0.8% n=231 (%) Terazol ® 3 n=229 (%) Headache 49 (21) 37(16) Dysmenorrhea 14 (6) 5 (2) Genital Burning and Itching 12 (5) 15-21 (6-9) Abdominal Pain 8 (3.4) 2 (1) Other adverse reactions reported in less than 2% of patients receiving Terconazole Vaginal Cream was fever (1%). Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% (not an approved strength) and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions were not observed in U.S. and foreign clinical trials in patients who were treated with other terconazole formulations (i.e., terconazole suppositories or vaginal cream, 0.8%).

Oral Contraceptives: There is no known interaction with the concomitant use of this product and oral contraceptives.