TERCONAZOLE suppository

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Padagis Israel Pharmaceuticals Ltd

INN (שם בינלאומי):

TERCONAZOLE

הרכב:

TERCONAZOLE 80 mg

מסלול נתינה (של תרופות):

VAGINAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Terconazole Vaginal Suppositories, 80 mg are 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 suppositories.

leaflet_short:

Terconazole Vaginal Suppositories, 80 mg are available as follows: Carton containing 3 suppositories (NDC 45802-717 -08)

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TERCONAZOLE- TERCONAZOLE SUPPOSITORY
PADAGIS ISRAEL PHARMACEUTICALS LTD
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TERCONAZOLE VAGINAL SUPPOSITORIES, 80 MG
RX ONLY
DESCRIPTION
Terconazole Vaginal Suppositories, 80 mg 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 532.47. It is insoluble in water; sparingly soluble in
ethanol; and soluble in
butanol.
CLINICAL PHARMACOLOGY
ABSORPTION - 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 suppository.
Systemic exposure
to terconazole is approximately proportional to the applied dose. The
rate and extent of
absorption of terconazole are similar in patients with vulvovaginal
candidiasis (pregnant
or non-pregnant) and healthy subjects.
DISTRIBUTION - Terconazole is highly protein bound (94.9%) in human
plasma and the
degree of binding is independent of drug concentration over the range
of 0.01 to 5.0
mcg/mL.
METABOLISM - Systemically absorbed terconazole is extensively
metabolized (>95%).
14
ELIMINATION - Across various studies in healthy women, after single or
multiple
intravaginal administration of terconazole, the mean elimination
half-life of unchanged
terconazole ranged from 6.4 to 8.5 hours. Following a single
intravaginal adm