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Terconazole
Overview
What is Terconazole?
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, -1-[-[[2-(2,4-Dichlorophenyl)-2-(1-1,2,4-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.
What does Terconazole look like?
What are the available doses of Terconazole?
Sorry No records found.
What should I talk to my health care provider before I take Terconazole?
Sorry No records found
How should I use Terconazole?
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 , the
diagnosis should be confirmed by KOH smears and/or cultures.
One full applicator (5 g) of Terconazole Vaginal Cream (40 mg terconazole)
should be administered intravaginally once daily at bedtime for three
consecutive days. Before prescribing another course of therapy, the diagnosis
should be reconfirmed by smears and/or cultures and other pathogens commonly
associated with vulvovaginitis ruled out. The therapeutic effect of Terconazole
Vaginal Cream is not affected by menstruation.
What interacts with Terconazole?
Patients known to be hypersensitive to terconazole or to any of the components of the cream.
What are the warnings of Terconazole?
There have been isolated reports of hypopigmentation after use of azelaic
acid. Since azelaic acid has not been well studied in patients with dark
complexion, these patients should be monitored for early signs of
hypopigmentation.
What are the precautions of Terconazole?
Discontinue use and do not retreat with terconazole if
sensitization, irritation, fever, chills or flu-like symptoms are reported
during use.
If there is lack of response to Terconazole Vaginal Cream,
appropriate microbiologic studies (standard KOH smear and/or cultures) should be
repeated to confirm the diagnosis and rule out other pathogens.
The levels of estradiol (E2) and progesterone did not differ
significantly when 0.8% terconazole vaginal cream was administered to healthy
female volunteers established on a low dose oral contraceptive.
Studies to determine the carcinogenic potential of terconazole
have not been performed.
Terconazole was not mutagenic when tested for induction of microbial point mutations (Ames test), or for
inducing cellular transformation, or for chromosome breaks (micronucleus test) or
dominant lethal mutations in mouse germ cells.
No impairment of fertility occurred when female rats were
administered terconazole orally up to 40 mg/kg/day for a three month
period.
There was no evidence of teratogenicity when terconazole was
administered orally up to 40 mg/kg/day (50× the recommended intravaginal human
dose of the 0.8% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits,
or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there
was a delay in fetal ossification at 10 mg/kg/day in rats. There was some
evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was
reflected as a decrease in litter size and number of viable young and reduced
fetal weight. There was also delay in ossification and an increased incidence of
skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of
terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean
peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal
administration of terconazole 0.8% vaginal cream. This safety assessment does
not account for possible exposure of the fetus through direct transfer to
terconazole from the irritated vagina by diffusion across amniotic
membranes.
Since terconazole is absorbed from the human vagina, it should not be used in
the first trimester of pregnancy unless the physician considers it essential to
the welfare of the patient.
It is not known whether this drug is excreted in human milk.
Animal studies have shown that rat offspring exposed via the milk of treated (40
mg/kg/orally) dams showed decreased survival during the first few post-partum
days, but overall pup weight and weight gain were comparable to or greater than
controls throughout lactation. Because many drugs are excreted in human milk,
and because of the potential for adverse reaction in nursing infants from
terconazole, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
mother.
Safety and efficacy in children have not been established.
Clinical studies of terconazole 0.8% vaginal cream did not
include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the elderly and
younger patients.
What are the side effects of Terconazole?
During controlled clinical studies conducted in the United States, patients with
vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for
three days. Based on comparative analyses with placebo and a standard agent, the
adverse experiences considered most likely related to terconazole 0.8% vaginal
cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with
placebo). Genital complaints in general, and burning and itching in particular,
occurred less frequently in the terconazole 0.8% vaginal cream 3 day regimen (5%
vs. 6%-9% with placebo). Other adverse experiences reported with terconazole
0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1%
vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the
terconazole 0.8% vaginal cream. The adverse drug experience most frequently
causing discontinuation of therapy was vulvovaginal itching 0.7% with the
terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
What should I look out for while using Terconazole?
Patients known to be hypersensitive to terconazole or to any of the components
of the cream.
None.
What might happen if I take too much Terconazole?
Overdose of terconazole in humans has not been reported to date. In the rat, the
oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female,
respectively. The oral LD 50 values for the male and female dog were 1280 and ≥
640 mg/kg, respectively.
How should I store and handle Terconazole?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).Terconazole Vaginal Cream 0.8% is available in 20 g tubes with 3 applicators. Store at controlled room temperature 15° to 30°C (59° to 86°F).NDC 54868-5183-0Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532June 2003Relabeling of "Additional Barcode Label" by:Terconazole Vaginal Cream 0.8% is available in 20 g tubes with 3 applicators. Store at controlled room temperature 15° to 30°C (59° to 86°F).NDC 54868-5183-0Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532June 2003Relabeling of "Additional Barcode Label" by:Terconazole Vaginal Cream 0.8% is available in 20 g tubes with 3 applicators. Store at controlled room temperature 15° to 30°C (59° to 86°F).NDC 54868-5183-0Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532June 2003Relabeling of "Additional Barcode Label" by:Terconazole Vaginal Cream 0.8% is available in 20 g tubes with 3 applicators. Store at controlled room temperature 15° to 30°C (59° to 86°F).NDC 54868-5183-0Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532June 2003Relabeling of "Additional Barcode Label" by:Terconazole Vaginal Cream 0.8% is available in 20 g tubes with 3 applicators. Store at controlled room temperature 15° to 30°C (59° to 86°F).NDC 54868-5183-0Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532June 2003Relabeling of "Additional Barcode Label" by:
Clinical Information
Chemical Structure
No Image foundClinical 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 daily intravaginal administration of 0.8% terconazole 40 mg (0.8%
cream × 5 g) for seven days to normal humans, plasma concentrations were low and
gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6
hours.
Results from similar studies in patients with vulvovaginal candidiasis
indicate that the slow rate of absorption, the lack of accumulation, and the
mean peak plasma concentrations of terconazole was not different from that
observed in healthy women. The absorption characteristics of terconazole 0.8% in
pregnant or non-pregnant patients with vulvovaginal candidiasis were also
similar to those found in normal volunteers.
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,
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,
0.8%.
Terconazole exhibits fungicidal activity against Antifungal
activity also has been demonstrated against other fungi. The MIC values of
terconazole against most spp. typically
found in the human vagina were ≥ 128 mcg/mL, therefore these beneficial bacteria
are not affected by drug treatment.
The exact pharmacologic mode of action of terconazole is uncertain; however,
it may exert its antifungal activity by the disruption of normal fungal cell
membrane permeability. No resistance to terconazole has developed during
successive passages of
Non-Clinical Toxicology
Patients known to be hypersensitive to terconazole or to any of the components of the cream.None.
Drug Interactions
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.
If there is lack of response to Terconazole Vaginal Cream, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
The levels of estradiol (E2) and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.
Studies to determine the carcinogenic potential of terconazole have not been performed.
Terconazole was not mutagenic when tested for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.
No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.
There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (50× the recommended intravaginal human dose of the 0.8% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.8% vaginal cream. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.
Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and efficacy in children have not been established.
Clinical studies of terconazole 0.8% vaginal cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole 0.8% vaginal cream 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole 0.8% vaginal cream. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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