TERAZOL® 7 VAGINAL CREAM 0.4% (terconazole) TERAZOL® 3 VAGINAL CREAM 0.8% (terconazole) TERAZOL® 3 VAGINA

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U)

Mevcut itibaren:

Janssen Pharmaceuticals, Inc.

INN (International Adı):

TERCONAZOLE

Kompozisyon:

TERCONAZOLE 4 mg in 1 g

Uygulama yolu:

VAGINAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

TERAZOL® 7 (terconazole) Vaginal Cream 0.4%, TERAZOL® 3 (terconazole) Vaginal Cream 0.8% and TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures. Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.

Ürün özeti:

TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is available in 45 g (NDC 50458-535-01) tubes with an ORTHO1 Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F). TERAZOL® 3 (terconazole) Vaginal Cream 0.8% is available in 20 g (NDC 50458-536-01) tubes with an ORTHO1 Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F). TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are available as 2.5 g, elliptically-shaped white to off-white suppositories in packages of three (NDC 50458-531-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

TERAZOL 7- TERCONAZOLE CREAM
TERAZOL 3- TERCONAZOLE CREAM
TERAZOL 3- TERCONAZOLE SUPPOSITORY
JANSSEN PHARMACEUTICALS, INC.
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TERAZOL 7 VAGINAL CREAM 0.4%
_(TERCONAZOLE) _
TERAZOL 3 VAGINAL CREAM 0.8%
_(TERCONAZOLE) _
TERAZOL 3 VAGINAL SUPPOSITORIES 80 MG
_(TERCONAZOLE)_
DESCRIPTION
TERAZOL 7 (terconazole) Vaginal Cream 0.4% is a white to off-white,
water washable cream for
intravaginal administration containing 0.4% 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.
TERAZOL 3 (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.
TERAZOL 3 (terconazole) Vaginal Suppositories are white to off-white
suppositories for
intravaginal administration containing 80 mg 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, in triglycerides derived from coconut and/or palm
kernel oil (a base of
hydrogenated vegetable oils) and butylated hydroxyanisole.
The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder
with a molecular weight of
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532.47. It is insoluble in water; sparingly soluble in ethanol; and
soluble in butanol.
CLINICAL PHARMACOLOGY
ABS ORPTION
Following a single intravaginal application o