terconazole
Terazol 3, Terazol 7

Pharmacologic classification: triazole derivative
Therapeutic classification: antifungal
Pregnancy risk category C


Available forms
Available by prescription only
Vaginal cream: 0.4% in 45-g tube, 0.8% in 20-g tube with applicator
Vaginal suppositories: 80 mg

Indications and dosages
 Local treatment of vulvovaginal candidiasis. Adults: For 0.4% strength-1 full applicator (5 g) intravaginally once daily h.s. for 7 consecutive days. For 0.8% strength-1 full applicator (5 g) intravaginally once daily h.s. for 3 consecutive days. Or, insert 1 suppository vaginally h.s. for 3 consecutive days.

Pharmacodynamics
Antifungal action: Exact mechanism of action is unknown. Terconazole may disrupt fungal cell membrane permeability.

Pharmacokinetics
Absorption: Minimally absorbed, about 5% to 16%.
Distribution: Effect is mainly local.
Metabolism: Metabolized mainly by oxidative N- and O-dealkylation, dioxolane ring cleavage, and conjugation pathways.
Excretion: Following oral administration of terconazole, 32% to 56% of dose is excreted in urine and 47% to 52% is excreted in feces within 24 hours.

Route Onset Peak Duration
Intra-vaginal Unknown Unknown Unknown


Contraindications and precautions
Contraindicated in patients hypersensitive to drug or its components.

Interactions
None reported.

Adverse reactions
CNS: headache, fever.
GU: dysmenorrhea, genitalia pain, vulvovaginal burning.
Skin: irritation, pruritus, photosensitivity.
Other: chills, body aches.

Effects on lab test results
None reported.

Overdose and treatment
None reported.

Special considerations
• Drug is only effective against vulvovaginitis caused by Candida organisms. Confirm diagnosis by cultures or potassium hydroxide smears.
• Intractable candidiasis may be a sign of diabetes mellitus. Obtain blood and urine glucose tests to rule out undiagnosed diabetes mellitus.
• A persistent infection may be caused by reinfection. Evaluate patient for possible sources.
Pregnant patients
• There are no adequate and controlled studies regarding use of drug during first trimester. Drug was used during second and third trimesters in at least 100 women without adverse effects on the outcome of pregnancy.
Breast-feeding patients
• Safety hasn’t been established. Breast-feeding isn’t recommended during therapy with terconazole.

Patient education
• Instruct patient to insert cream high into the vagina.
• Tell patient to complete full course of therapy and to use it continuously, even during menstrual period. The therapeutic effect of terconazole isn’t affected by menstruation.
• Inform patient to report burning or irritation.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use