Zazole label

Zazole

Zazole Recall

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Side Effects & Adverse Reactions

None.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Zazole® Vaginal Cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole® Vaginal Cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

History

There is currently no drug history available for this drug.

Other Information

Zazole® 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:Structural Formula

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.

Zazole Manufacturers

  • Pharmaderm, A Division Of Nycomed Us Inc.
    Zazole | Pharmaderm, A Division Of Nycomed Us Inc.
    No Recall

    Zazole | Pharmaderm, A Division Of Nycomed Us Inc.

    Zazole | Pharmaderm, A Division Of Nycomed Us Inc.

    One full applicator (5 g) of Zazole® Vaginal Cream 0.8% (40 mg terconazole) should be administered intravaginally once daily at bedtime for three 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 Zazole® Vaginal Cream 0.8% is not affected by menstruation.

  • Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    No Recall

    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    One full applicator (5 g) of Zazole® 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 Zazole® Vaginal Cream 0.4% is not affected by menstruation.

  • Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
    No Recall

    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    Zazole | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

    One Zazole® Vaginal Suppository (terconazole vaginal suppositories, 80 mg) should be administered intravaginally once daily at bedtime for three 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 suppositories is not affected by menstruation.