TERCONAZOLE (terconazole)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal vaginal bleeding Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Toxic epidermal necrolysis Urticaria

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysmenorrhea Fever Genital organ pruritus Vaginal discharge

Rare/Very Rare
Acute abdominal pain Chills Contact dermatitis Cystitis Dizziness Facial edema Flu-like symptoms General weakness Headache disorder Nausea Pruritus of skin Skin rash Vaginal burning Vaginal irritation Vaginitis Vulvovaginal pain

Reproduction studies in rats using oral terconazole dosages up to 40 mg/kg daily (up to 100 times the usual recommended vaginal human dose of the 0.4% vaginal cream) or in rabbits using oral dosages up to 20 mg/kg daily have not revealed evidence of teratogenicity. In addition, there was no evidence of teratogenicity when the drug was given subcutaneously to rats in dosages up to 20 mg/kg daily. However, there was some evidence of embryotoxicity in rats and rabbits that received the drug in an oral dosage of 20-40 mg/kg daily prior to mating and throughout gestation.

At this dosage in rats, there was a decreased litter size and number of viable young, reduced fetal weight, delayed ossification, and an increased incidence of skeletal variants. Terconazole does not appear to affect parturition in animals since there was no evidence of prolonged gestation or dystocia. There generally was no evidence of embryotoxicity at dosages of 10 mg/kg daily or less; however, there was a delay in fetal ossification in rats that received 10 mg/kg daily.

In pregnant rats, oral administration of terconazole in a dosage 10 mg/kg daily results in mean peak plasma concentrations of 176 ng/mL which is 44 times greater than mean peak plasma concentration (4 ng/mL) attained in healthy adults following intravaginal administration of the 0.4% cream. There are no adequate and controlled studies to date using intravaginal terconazole in women during the first trimester of pregnancy.

The drug has been used intravaginally during the second and third trimester of pregnancy in at least 100 women without adverse effects on the outcome of pregnancy. However, because small amounts of terconazole are absorbed from the vagina, the manufacturer states that terconazole should be used during the first trimester of pregnancy only when considered essential to the welfare of the patient. The CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for the treatment of vulvovaginal candidiasis in pregnant women.

It is not known whether terconazole is distributed into human milk; however, the drug is distributed into milk in rats. In a study in lactating rats receiving oral terconazole in a dosage of 40 mg/kg daily, there was decreased survival in their nursing offspring during the first few postpartum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. The manufacturer states that because of the potential for adverse effects of terconazole in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.