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Terconazole (Monograph)

Brand name: Terazol
Drug class: Azoles
VA class: GU300
Chemical name: cis-1-[4-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-(1-methylethyl)piperazine
Molecular formula: C26H31Cl2N5O3
CAS number: 67915-31-5

Medically reviewed by Drugs.com on Jun 21, 2023. Written by ASHP.

Introduction

Antifungal; azole (triazole derivative).1 3 7 8 11 25 28 31

Uses for Terconazole

Vulvovaginal Candidiasis

Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).1 3 5 15 16 17 18 19 20 21 22 23 24 27 33 37 47 49 65 67 68 A drug of choice.37 47 51 52 53 54 56 57 58 65 67 68

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).47 53 54 56 57 58 67 68 Complicated infections generally require more prolonged treatment than uncomplicated infections.47 66 67 68

Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified.47 68 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).47 68 69

Terconazole Dosage and Administration

Administration

Intravaginal Topical Administration

Administer intravaginally as a cream or suppository.1

Interruption or discontinuance of terconazole therapy during a prescribed regimen, even during menstruation or in response to symptomatic relief, is not advised.1 43 44

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.1 3 15 47

Suppository: one 80-mg vaginal suppository once daily at bedtime for 3 consecutive days.1 47

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).47 52 54 58 64 67 68

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.47 67

HIV-infected patients: Use same regimen recommended for other patients.47 66 Some experts recommend a duration of 3–7 days.66 Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;66 routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.47 66

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.a

Renal Impairment

No specific dosage recommendations at this time.a

Geriatric Patients

No specific dosage recommendations at this time.a

Detailed Terconazole topical dosage information

Cautions for Terconazole

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.45 May be immunoallergenic45 or may be a reaction to the dying fungi (similar to the Jarisch-Herxheimer reaction observed during penicillin therapy for syphilis).46

If irritation, sensitization, fever, chills, or flu-like symptoms occur and appear to be drug related, discontinue and do not reinstitute terconazole therapy.1

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.1 3

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.1 Consider use of terconazole vaginal cream as an alternative to the suppositories.43 44

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.1 47

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.47

If clinical symptoms persist, tests should be repeated to rule out other pathogens and to confirm the original diagnosis.1

Specific Populations

Pregnancy

Category C.1

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.1 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.47 67

Lactation

Distributed into milk in rats;1 not known whether distributed into human milk.1 43 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children1 <18 years of age.43

Geriatric Use

Insufficient experience from clinical studies to determine whether patients ≥65 years of age respond differently than younger adults.1 Other clinical experience has not identified age-related differences in response.1

Common Adverse Effects

Headache,1 3 vulvovaginal itching/burning or pain,1 3 dysmenorrhea,1 abdominal pain.1

Drug Interactions

Oral Contraceptives

Terconazole efficacy not affected by concomitant oral contraceptives; terconazole has no effect on estradiol or progesterone concentrations in women receiving low-dose oral contraceptives.1 5

Terconazole Pharmacokinetics

Absorption

Small amounts of terconazole (about 5–16% of a dose) are slowly absorbed systemically following intravaginal administration.1 3 14 The amount of drug absorbed is proportional to the dose (regardless of dosage form)3 14 and absorption is similar in women with or without vulvovaginal candidiasis.3

Distribution

Extent

Distribution into body tissues and fluids following intravaginal administration has not been determined.a

Not known whether terconazole crosses the placenta43 or is distributed into milk.1

Elimination

Metabolism

The metabolic fate of terconazole following intravaginal administration has not been fully characterized, but systemically absorbed drug appears to be rapidly and extensively metabolized.1 3

Elimination Route

Following oral administration, 32–56% of the dose excreted in urine and 47–52% excreted in feces1 within 24 hours.43

Half-life

Following oral administration, half-life is 6.9 hours.1

Stability

Storage

Cream

15–30°C.1

Suppository

15–30°C.1

Actions

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Terconazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Vaginal

Cream

0.4%*

Terazol 7 (with propylene glycol; with applicator)

Ortho-McNeil

Terconazole Vaginal Cream

Taro

0.8%*

Terazol 3 (with propylene glycol; with applicator)

Ortho-McNeil

Terconazole Vaginal Cream

Taro

Suppositories

80 mg*

Terazol 3 (in a hydrogenated vegetable oil base; with applicator)

Ortho-McNeil

Terconazole Vaginal Suppositories (in a hydrogenated vegetable oil base; with applicator)

Perrigo

AHFS DI Essentials™. © Copyright 2024, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Ortho-McNeil Pharmaceutical, Inc. Terazol 7 (terconazole) vaginal cream 0.4%, Terazol 3 (terconazole) vaginal cream 0.8%, and Terazol 3 (terconazole) vaginal suppositories prescribing information. Raritan, NJ; 2003 Apr.

3. Ortho Pharmaceutical Corporation. Terazol (terconazole 0.4% cream/80 mg suppositories) clinical monograph. Raritan, NJ; 1988 Jun.

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a. AHFS drug information 2003. McEvoy GK, ed. Terconazole. Bethesda, MD: American Society of Health-System Pharmacists; 2003:3365-69.

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