Uses
Vulvovaginal Candidiasis
Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women). A drug of choice.
Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy). Complicated infections generally require more prolonged treatment than uncomplicated infections.
Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified. CDC and others state these infections may respond to an intravaginal azole antifungal given for 7–14 days or to a 14-day regimen of intravaginal boric acid (not commercially available in the US).
Dosage and Administration
Administration
Intravaginal Topical Administration
Administer intravaginally as a cream or suppository.
Interruption or discontinuance of terconazole therapy during a prescribed regimen, even during menstruation or in response to symptomatic relief, is not advised.
Dosage
Adults
Uncomplicated Vulvovaginal Candidiasis
Intravaginal
Cream: one applicatorful of 0.4% cream once daily at bedtime for 7 consecutive days or one applicatorful of 0.8% cream once daily at bedtime for 3 consecutive days.
Suppository: one 80-mg vaginal suppository once daily at bedtime for 3 consecutive days.
Complicated Vulvovaginal Candidiasis
Recurrent Vulvovaginal Infections Caused by Candida albicans
Intravaginal
CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).
Other Complicated Vulvovaginal Infections
Intravaginal
CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.
HIV-infected patients: Use same regimen recommended for other patients. Some experts recommend a duration of 3–7 days. Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes; routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.
Special Populations
Dosage in Hepatic Impairment
No specific dosage recommendations at this time.
Dosage in Renal Impairment
No specific dosage recommendations at this time.
Geriatric Patients
No specific dosage recommendations at this time.
Cautions
Contraindications
Warnings/Precautions
Sensitivity Reactions
Allergic Reactions
Possible flu-like syndrome, characterized by fever, chills, headache, and/or hypotension and occasionally by vertigo and nausea. May be immunoallergenic or may be a reaction to the dying fungi (similar to the Jarisch-Herxheimer reaction observed during penicillin therapy for syphilis).
If irritation, sensitization, fever, chills, or flu-like symptoms occur and appear to be drug related, discontinue and do not reinstitute terconazole therapy.
Photosensitivity Reactions
Photosensitivity reactions reported following repeated topical application to the skin of 0.8 or 2% terconazole cream and exposure to filtered artificial ultraviolet light; not reported to date following intravaginal administration of 0.4 or 0.8% cream or 80-mg suppositories.
General Precautions
Use of Latex/Rubber Contraceptive Diaphragms
Hydrogenated vegetable oil base contained in terconazole vaginal suppositories may interact with certain rubber or latex products such as vaginal contraceptive diaphragms; concurrent use not recommended. Consider use of terconazole vaginal cream as an alternative to the suppositories.
Selection and Use of Antifungals for Vulvovaginal Candidiasis
Prior to initial use of terconazole in a woman with signs and symptoms of vulvovaginal candidiasis, confirm the diagnosis by demonstrating yeast or pseudohyphae with direct microscopic examination of vaginal discharge (saline or 10% potassium hydroxide [KOH] wet mount or Gram stain) or by culture.
Candida identified by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10–20% of women harbor Candida or other yeasts in the vagina.
If clinical symptoms persist, tests should be repeated to rule out other pathogens and to confirm the original diagnosis.
Specific Populations
Pregnancy
Category C.
Because terconazole is absorbed systemically following intravaginal administration, manufacturer states the drug should not be used during the first trimester of pregnancy unless the clinician considers it essential to the welfare of the patient. CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.
Lactation
Distributed into milk in rats; not known whether distributed into human milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
Insufficient experience from clinical studies to determine whether patients ≥65 years of age respond differently than younger adults. Other clinical experience has not identified age-related differences in response.
Common Adverse Effects
Headache, vulvovaginal itching/burning or pain, dysmenorrhea, abdominal pain.
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