Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 04 January 2017

Indication(s)

INDICATIONS AND USAGE Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole 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.

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Advisory information

contraindications
CONTRAINDICATIONS Patients known to be hypersensitive to terconazole or to any of the components of the cream.
Special warnings and precautions

PRECAUTIONS General: Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.

Laboratory Tests: If there is a lack of response to terconazole, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.

Drug Interactions: The therapeutic effect of this product is not affected by oral contraceptive usage.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis: Studies to determine the carcinogenic potential of terconazole have not been performed.

Mutagenicity: Terconazole was not mutagenic when tested in_vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in_vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.

Impairment of Fertility: No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.

Pregnancy: Teratogenic Effects: Pregnancy Category C: 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: 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.

Pediatric Use: Safety and efficacy in children have not been established.

Geriatric Use: Clinical studies of terconazole 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.

Adverse reactions

ADVERSE REACTIONS 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.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION One full applicatorful (5 g) of terconazole 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 terconazole vaginal cream 0.8 % is not affected by menstruation.

Pregnancy and lactation

Nursing Mothers: 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.

Interactions

Drug Interactions: The therapeutic effect of this product is not affected by oral contraceptive usage.

More information

Category Value
Authorisation number NDA021735
Agency product number 0KJ2VE664U
Orphan designation No
Product NDC 0168-0347
Date Last Revised 28-08-2009
Type HUMAN PRESCRIPTION DRUG
RXCUI 313227
Marketing authorisation holder E. FOUGERA & CO. A division of Nycomed US Inc.