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terconazole
Overview
What is Zazole?
Zazole Vaginal Cream 0.8% (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 Zazole look like?
What are the available doses of Zazole?
Sorry No records found.
What should I talk to my health care provider before I take Zazole?
Sorry No records found
How should I use Zazole?
Zazole Vaginal Cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole Vaginal Cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
One full applicator (5 g) of Zazole Vaginal Cream 0.8% (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 Zazole Vaginal Cream 0.8% is not affected by menstruation.
What interacts with Zazole?
Patients known to be hypersensitive to terconazole or to any of the components of the cream.
What are the warnings of Zazole?
Reports in the published literature have raised a question regarding the possible association between the use of methylxanthines and development of necrotizing enterocolitis, although a causal relationship between methylxanthine use and necrotizing enterocolitis has not been established. Therefore, as with all preterm infants, patients being treated with caffeine citrate should be carefully monitored for the development of necrotizing enterocolitis.
What are the precautions of Zazole?
General:
Laboratory Tests:
Drug Interactions:
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenesis:
Mutagenicity:
in vitro
in vivo
Impairment of Fertility:
Pregnancy: Teratogenic Effects:
There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (50x 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 increase 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 vaginal cream 0.8%. 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.
Nursing Mothers:
Pediatric Use:
Geriatric Use:
What are the side effects of Zazole?
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% 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 vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% 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 vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.
What should I look out for while using Zazole?
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 Zazole?
Overdosage 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 Zazole?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Zazole Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. March 2008 PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8347C R3/08 #300Zazole Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. March 2008 PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8347C R3/08 #300Zazole Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. March 2008 PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8347C R3/08 #300Zazole Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. March 2008 PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8347C R3/08 #300Zazole Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature]. March 2008 PharmaDerm A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8347C R3/08 #300
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 x 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 concentration 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 ultra-violet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream 0.8%.
Non-Clinical Toxicology
Patients known to be hypersensitive to terconazole or to any of the components of the cream.None.
Drug Interactions:
General:
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% 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 vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% 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 vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% 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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