A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Vagistat-1 Indications, Dosage, Storage, Stability - Tioconazole
Vagistat-1 Indications, Dosage, Storage, Stability - Tioconazole
INDICATIONS
VAGISTAT-1 is indicated for the local
treatment of vulvovaginal
candidiasis (moniliasis). As
VAGISTAT-1 has been shown to be effective only for candidal vulvovaginitis,
the diagnosis should
be confirmed by KOH smears
and/or cultures. Other pathogens commonly associated with vulvovaginitis
should be ruled out by appropriate
methods.
Studies have shown that women taking oral
contraceptives have a cure rate similar to those not taking such
agents when treated with VAGISTAT-1.
Safety and effectiveness
in pregnant and diabetic
patients have not been established (see PRECAUTIONS).
DOSAGE AND ADMINISTRATION
VAGISTAT-1 has been found to be effective as a single- dose
treatment for vulvovaginal
candidiasis. Using the prefilled applicator, insert one applicator-
full intravaginally. Administration of VAGISTAT-1 just prior to
bedtime may be preferred.
HOW SUPPLIED
VAGISTAT-1 is supplied in a ready-to-use, prefilled, single-dose
vaginal applicator (NDC 0087-0657-40). Each applicator-full will
deliver approximately
4.6 grams of VAGISTAT-1 containing 65 mg
of tioconazole per gram
of ointment.
Storage: Store at controlled room
temperature 15°-30°
C (59°-86° F).
WARNING: Manufactured with 1,1,1-trichloroethane, a substance
which harms public health
and environment
by destroying ozone in
the upper atmosphere.
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