TERCONAZOLE- terconazole cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Actavis Pharma, Inc

INN (Nome Internazionale):

TERCONAZOLE

Composizione:

TERCONAZOLE 4 mg in 1 g

Via di somministrazione:

VAGINAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is 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.

Dettagli prodotto:

Terconazole Vaginal Cream 0.4% is available in 45 g (NDC 0591-3196-89) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15°–30°C (59°–86°F). Terconazole Vaginal Cream 0.8% is available in 20 g (NDC 0591-3197-52) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15°–30°C (59°–86°F).

Stato dell'autorizzazione:

New Drug Application Authorized Generic

Scheda tecnica

TERCONAZOLE- TERCONAZOLE CREAM
ACTAVIS PHARMA, INC
----------
TERCONAZOLE VAGINAL CREAM 0.4%
7-DAY REGIMEN
TERCONAZOLE VAGINAL CREAM 0.8%
3-DAY REGIMEN
DESCRIPTION
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.
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.
CLINICAL PHARMACOLOGY
ABS ORPTION
Following a single intravaginal application of a suppository
containing 240 mg
C-terconazole to
healthy women, approximately 70% (range: 64–76%) of terconazole
remains in the vaginal area during
the suppository retention period (16 hours); approximately 10% (range:
5–16%) of the administered
radioactivity was absorbed systemically over 7 days. Maximum plasma
concentrations of terconazole
occur 5 to 10 hours after intravaginal application of the cream or
suppository. Systemic exposure to
terconazole is approximately proportional to the applied dose, whether
as the cream or suppository.
The rate and extent of absorption of terconazole are