Terconazole

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Terconazole Recall

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Side Effects & Adverse Reactions

None.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole 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.

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History

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Other Information

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-(1H-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.

Sources

Terconazole Manufacturers

E. Fougera & Co. A Division Of Nycomed Us Inc.

Terconazole | E. Fougera & Co. A Division Of Nycomed Us Inc.

One full applicatorful (5 g) of terconazole 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 terconazole vaginal cream 0.8% is not affected by menstruation.

No Recall
Physicians Total Care, Inc.

Terconazole | Physicians Total Care, Inc.

One full applicator (5 g) of Terconazole Vaginal Cream (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 Terconazole Vaginal Cream is not affected by menstruation.

No Recall
Physicians Total Care, Inc.

Terconazole | Physicians Total Care, Inc.

One full applicatorful (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.

No Recall
Rebel Distributors Corp

Terconazole | Rebel Distributors Corp

One full applicator (5 g) of Terconazole Vaginal Cream 0.4% (20 mg terconazole) should be administered intravaginally once 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.

No Recall
Rebel Distributors Corp

Terconazole | Rebel Distributors Corp

Terconazole Vaginal Cream 0.4%:

One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.

Terconazole Vaginal Cream 0.8%:

One full applicator (5 g) of Terconazole Vaginal Cream (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 these products is not affected by menstruation.

No Recall
Dispensing Solutions, Inc.

Terconazole | Dispensing Solutions, Inc.

Terconazole Vaginal Cream 0.4%:

One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.

Terconazole Vaginal Cream 0.8%:

One full applicator (5 g) of Terconazole Vaginal Cream (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 these products is not affected by menstruation.

No Recall
H.j. Harkins Company, Inc.

Terconazole | H.j. Harkins Company, Inc.

Terconazole Vaginal Cream 0.4%:

One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.

Terconazole Vaginal Cream 0.4%:

One full applicator (5 g) of Terconazole Vaginal Cream (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 these products is not affected by menstruation.

No Recall
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

Terconazole | E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.

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.

No Recall
Actavis Pharma, Inc

Terconazole | Actavis Pharma, Inc

Terconazole Vaginal Cream 0.4%
One full applicator (5 g) of Terconazole Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
Terconazole Vaginal Cream 0.8%
One full applicator (5 g) of Terconazole Vaginal Cream (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 these products is not affected by menstruation.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Terconazole | Taro Pharmaceuticals U.s.a., Inc.

One full applicator (5 g) of terconazole vaginal cream (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 is not affected by menstruation.

No Recall
Taro Pharmaceuticals U.s.a., Inc.

Terconazole | Taro Pharmaceuticals U.s.a., Inc.

One full applicator (5 g) of terconazole vaginal cream (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 terconazole vaginal cream is not affected by menstruation.

No Recall