TERCONAZOLE- terconazole cream

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Termékjellemzők Termékjellemzők (SPC)
30-05-2018

Aktív összetevők:

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

Beszerezhető a:

Actavis Pharma, Inc

INN (nemzetközi neve):

TERCONAZOLE

Összetétel:

TERCONAZOLE 4 mg in 1 g

Az alkalmazás módja:

VAGINAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

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).

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

                                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
                                
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