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
Brands: Terazol
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
Cautions for Terconazole
Contraindications
Known hypersensitivity to terconazole or any ingredient in the formulation.1
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
Interactions for Terconazole
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
ActionsActions
Triazole-derivative azole antifungal.1 3 5 7 8 10 11 12 14 15 18 19 21 25 27 28 29 31 33 34 35
Usually fungicidal in action.1 3 7 11
Presumably exerts its antifungal activity by altering cellular membranes resulting in increased membrane permeability, leakage of essential elements (e.g., amino acids, potassium), and impaired uptake of precursor molecules (e.g., purine and pyrimidine precursors to DNA).3 4 8 12 34 Inhibits cytochrome P-450 14-α-desmethylase in susceptible fungi, which leads to accumulation of C-14 methylated sterols (e.g., lanosterol) and decreased concentrations of ergosterol.3 4 6 8 12 28 34
Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.3 7 8 10 11 12 14 15 31 At high concentrations, has some in vitro activity against gram-positive and -negative bacteria.7 11 25 31 34
Candida: Active in vitro and in vivo against C. albicans,3 8 11 31 32 C. krusei,3 8 11 C. parapsilosis,8 C. pseudotropicalis,8 C. stellatoidea,8 and C. tropicalis.3 8 11 31
Dermatophytes and other fungi: Active in vitro against Trichophyton mentagrophytes,3 11 31 T. rubrum,3 11 31 T. tonsurans,3 11 T. verrucosum,3 11 and Epidermophyton floccosum.3 11 Also active against Cryptococcus neoformans.3 11 31
Cross resistance can occur among the azole antifungals (e.g., clotrimazole, ketoconazole, miconazole).9 47 Azole-resistant Candida have been reported.9 47
Advice to Patients
Importance of reading and understanding manufacturer’s patient instructions regarding use of applicator for intravaginal administration.1
Importance of not interrupting or discontinuing the drug and completing full course of therapy, even during menstruation or in response to symptomatic relief.1 43 44
Importance of informing clinicians if irritation, sensitization, fever, chills, or flu-like symptoms occur.1
Importance of women following clinician's advice regarding sexual intercourse and informing partner to seek medical advice if penile itching, redness, or discomfort occurs.1
Importance of not using rubber or latex products such as vaginal contraceptive diaphragms when using terconazole vaginal suppositories;1 use of terconazole vaginal cream should be considered as an alternative.43 44
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Vaginal | Cream | 0.4%* | Terazol 7 (with propylene glycol; with applicator) | Ortho-McNeil |
Terconazole Vaginal Cream | Taro, Watson | |||
0.8%* | Terazol 3 (with propylene glycol; with applicator) | Ortho-McNeil | ||
Terconazole Vaginal Cream | Taro, Watson | |||
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 |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Terazol 3 0.8% Cream (ORTHO-MCNEIL PHARMACEUTICAL): 20/$51.99 or 60/$149.98
Terazol 3 80MG Suppositories (ORTHO-MCNEIL PHARMACEUTICAL): 3/$53.99 or 9/$149.98
Terazol 7 0.4% Cream (ORTHO-MCNEIL PHARMACEUTICAL): 45/$53.99 or 135/$147.98
Terconazole 0.4% Cream (WATSON LABS): 45/$39.99 or 135/$109.97
Terconazole 0.8% Cream (WATSON LABS): 20/$34.99 or 60/$94.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
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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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