TERCONAZOLE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

TERCONAZOLE

Composition:

TERCONAZOLE 4 mg in 1 g

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% 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 0.4% is available NDC  54868-6160-0      45 gram tubes with a measured dose applicator. Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature], E. FOUGERA & CO A division of Nycomed US Inc.                                    I2346 Melville, New York 11747                                            R4/08                                                                                          #22 Relabeling of "Additional Barcode Label" by: Physicians Total Care, Inc. Tulsa, OK     74146 Remove this portion before dispensing --------------------------------------------------------------------------------------------------------------------------------------------

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERCONAZOLE - TERCONAZOLE CREAM
PHYSICIANS TOTAL CARE, INC.
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TERCONAZOLE VAGINAL CREAM 0.4%
RX ONLY
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-isopropy-Ipiperazine
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
Following intravaginal administration of terconazole in humans,
absorption ranged from 5-8% in three
hysterectomized subjects and 12-16% in two non-hysterectomized
subjects with tubal ligations.
Following oral (30 mg) administration of
C-labelled terconazole, the harmonic half-life of elimination
from the blood for the parent terconazole was 6.9 hours (range
4.0-11.3). Terconazole is extensively
metabolized; the plasma AUC for terconazole compared to the AUC for
total radioactivity was 0.6%.
Total radioactivity was eliminated from the blood with a harmonic
half-life of 52.2 hours (range 44-
60). Excretion of radioactivity was both by renal (32-56%) and fecal
(47-52%) routes.
_In vitro,_ terconazole is highly protein bound (94.9%) and the degree
of binding is independent of drug
concentration.
Photosensitivity reactions were observed in some normal volunteers
following repeated dermal
application of terconazole 2.0% and 0.8% creams under conditions of
filtered artificial ultraviolet light.
Photosensitivity reactions have not been observed in U.S. and foreign
clinical trials in patients who
were treated with terconazole vaginal cream 0.4%.
MICROBIOLOGY: Terconazole e