TERCONAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Terconazole Vaginal Cream 0.8% is available in 20 gram (NDC 51672-1302-0) tubes with 3 measured-dose applicators. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERCONAZOLE- TERCONAZOLE CREAM
REMEDYREPACK INC.
----------
TERCONAZOLE
VAGINAL CREAM 0.8%
RX ONLY
DESCRIPTION
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, purified water, and
stearyl alcohol.
The structural formula of terconazole is as follows:
TERCONAZOLE
C
H
Cl
N
O
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 to 76%) of terconazole
remains in the vaginal area
during the suppository retention period (16 hours); approximately 10%
(range: 5 to 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
similar in patients with vulvovaginal
candidiasis (pregnant or non-pregnant) and healthy subjects.
DIS TRIBUTION
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 mcg/mL.
METABOLIS M
26
31
2
5
3
14
Systemically absorbed terconazole is extensively metabolized (>95%).
ELIMINATION
Across various studies in healthy women, after single or multiple
intravaginal administration of
terconazole as the cream or su