Class: Azoles
ATC Class: D01AC07
VA Class: GU300
Chemical Name: 1-[2-[(2-Chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
Molecular Formula: C16H13Cl3N2OS
CAS Number: 65899-73-2
Brands: 1-Day, Vagistat-1
Introduction
Antifungal; azole (imidazole derivative).2 3 49 65
Uses for Tioconazole
Vulvovaginal Candidiasis
Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).1 2 108 127 128 A drug of choice.4 30 74 75 76 92 93 104 108 127 128
Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having recurrence of similar symptoms.1 108 123 124
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).108 127 128 Complicated infections generally require more prolonged treatment than uncomplicated infections.108 126 127 128
Optimal regimens for treatment of vulvovaginal candidiasis caused by Candida other than C. albicans (e.g., C. glabrata, C. krusei) not identified.108 128 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).108 128 129
Tioconazole Dosage and Administration
Administration
Intravaginal Topical Administration
Administer intravaginally as a 6.5% ointment using the prefilled applicator provided by the manufacturer.1 108 123 124
Vaginal ointment is for intravaginal administration only; do not administer orally.1 Avoid contact with the eyes.1
Administer dose intravaginally high in the vaginal vault at bedtime.1 123 124
Open applicator just prior to administration to prevent contamination.1 123 124
Dosage
Pediatric Patients
Uncomplicated Vulvovaginal Candidiasis
Intravaginal
Children ≥12 years of age: One applicatorful of 6.5% ointment (approximately 300 mg of tioconazole) as a single dose at bedtime.1 123 124 May be used for self-medication.1 123 124
If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medication and consult a clinician.1 108 123 124 Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.1 108
HIV-infected Adolescents
Intravaginal
Use same regimen recommended for other patients.108 126 Some experts recommend a duration of 3–7 days.126 Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;126 routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.126 108
Complicated Vulvovaginal Candidiasis
Recurrent Vulvovaginal Infections Caused by Candida albicans
Intravaginal
Adolescents: 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).108 127 128
Other Complicated Vulvovaginal Infections
Intravaginal
Adolescents: 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 those with underlying medical conditions.108 127
Adults
Uncomplicated Vulvovaginal Candidiasis
Intravaginal
One applicatorful of 6.5% ointment (approximately 300 mg of tioconazole) as a single dose at bedtime.1 123 124 May be used for self-medication.1 123 124
If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medication and consult a clinician.1 108 123 124 Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.1 108
HIV-infected Adults
Intravaginal
Use same regimen recommended for other patients.108 126 Some experts recommend a duration of 3–7 days.126 Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;126 routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.108 126
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).108 127 128
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.108 127
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 Tioconazole
Contraindications
Known hypersensitivity to tioconazole, other imidazoles, or any ingredient in the formulation.1 117
Warnings/Precautions
Warnings
Use of Latex or Rubber Products
Tioconazole vaginal ointment contains petroleum base that can weaken latex or rubber products (including condoms and vaginal contraceptive diaphragms).1 108 Use of such products within 72 hours following intravaginal tioconazole treatment not recommended.1 108 124
Sensitivity Reactions
Hypersensitivity Reactions
Contact dermatitis reported following topical application of tioconazole45 46 47 48 50 51 100 or other imidazole-derivative azole antifungals.47 49 113 114
Possible cross-sensitization among the imidazoles.45 46 47 48 49 50 51 100 113
General Precautions
Selection and Use of Antifungals for Vulvovaginal Candidiasis
Prior to initial use in a woman with signs and symptoms of vulvovaginal candidiasis, confirm diagnosis by direct microscopic examination of vaginal discharge (saline or potassium hydroxide [KOH] wet mount or Gram stain) and/or cultures.1 2 108
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.108
If clinical symptoms persist after treatment, repeat tests to rule out other pathogens, confirm the original diagnosis, and rule out other conditions that may predispose a patient to recurrent vaginal fungal infections (e.g., HIV infection).1 2
Do not use for self-medication in women who are or think they may be pregnant or in those with diabetes mellitus, HIV infection, or HIV exposure.1 123 124
Specific Populations
Pregnancy
Category C.1
Lactation
Not known whether tioconazole is distributed into milk after intravaginal administration; temporarily discontinue nursing during treatment.1 2 117
Pediatric Use
Safety and efficacy not established in children <12 years of age.1 123 124
Common Adverse Effects
Vulvovaginal burning,1 2 10 86 123 irritation,10 123 vaginitis,1 pruritus,1 2 10 86 123 headache.1
Interactions for Tioconazole
Weak inducer of CYP450 isoenzymes.61 63
Drugs Metabolized by Hepatic Microsomal Enzymes
Potential pharmacokinetic interaction with drugs metabolized by CYP450 isoenzymes;61 63 interaction unlikely with usual single-dose intravaginal tioconazole regimen117 since only low amounts of the drug absorbed systemically.1 2
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Oral contraceptives | Efficacy of intravaginal tioconazole not affected by concomitant oral contraceptives1 |
Tioconazole Pharmacokinetics
Absorption
Bioavailability
Following intravaginal administration, only small amounts absorbed systemically;1 2 3 18 84 peak plasma concentrations usually attained within 2–24 hours.84
Distribution
Extent
Unabsorbed drug persists in vaginal fluid for 24–72 hours following an intravaginal dose.2 18 84 87
Not known whether tioconazole is distributed into milk.1
Elimination
Elimination Route
Does not appear to be metabolized in vaginal fluid.2 After oral administration of radiolabeled tioconazole, systemically absorbed drug excreted in urine as metabolites (25–27% of the oral dose) and in feces as unchanged drug (59% of the oral dose).2 6
Stability
Storage
Intravaginal
Ointment
15–30°C;1 123 124 expires 3 years following the date of manufacture.91
Actions and SpectrumActions
Imidazole-derivative azole antifungal.2 3 49 65
Usually fungistatic in action; can be fungicidal at high concentrations or against very susceptible organisms (e.g., Candida).2 7 8 37 39 59 81
Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.59 62 68 69 77 81 90 111 Interferes with ergosterol synthesis probably via inhibition of C-14 demethylation of sterol intermediates (e.g., lanosterol).12 59 62 68 69 77 81 90 111
Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.1 3 64 Also has in vitro activity against some gram-positive and gram-negative bacteria,3 53 87 Trichomonas,3 22 and Chlamydia.22
Candida: Active in vitro and in vivo against C. albicans,2 23 24 25 43 44 62 C. glabrata (formerly Torulopsis glabrata),2 24 101 C. krusei,2 24 C. parapsilosis,2 24 C. pseudotropicalis,2 24 and C. tropicalis.2
Dermatophytes and other fungi: Active in vitro against Epidermophyton floccosum,3 43 44 53 64 E. stockdaleae,53 Microsporum canis,3 23 44 64 M. gypseum,3 23 64 Trichophyton mentagrophytes,3 23 43 44 64 T. rubrum,3 23 43 44 54 103 T. tonsurans.3 64 Also active against Aspergillus3 23 87 and Cryptococcus neoformans.3 23 24 64
Bacteria: Active in vitro against Corynebacterium minutissimum, Enterococcus faecalis (formerly Streptococcus faecalis),87 Gardnerella vaginalis (formerly Haemophilus or Corynebacterium vaginalis),3 87 H. ducreyi ,87 Helicobacter pylori,52 , Mobiluncus,87 Moraxella catarrhalis (formerly Branhamella catarrhalis),87 Neisseria gonorrhoeae,87 N. meningitidis,87 Staphylococcus aureus,87 S. epidermidis,87 and some streptococci.3 87
Other organisms: Active against Chlamydia trachomatis,3 Lymphogranuloma venereum,3 and Trichomonas vaginalis.3 22
C. albicans, C. glabrata, C. krusei, C. tropicalis, and C. parapsilosis with reduced susceptibility to tioconazole reported.2 31 32 34 90 101 111
Cross-resistance can occur among the azole antifungals.31 32 34 90 111
Advice to Patients
Importance of reading and understanding manufacturer’s patient instructions regarding use of applicator for intravaginal administration.117 123 124
Not for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician.1 123 124
Not for self-medication in women who think they are pregnant or have been exposed to HIV.1 123 124
Importance of discontinuing self-medication of vulvovaginal candidiasis and consulting clinician if fever, abdominal pain, or foul-smelling discharge develops; if symptoms do not improve within 3 days, if condition persists beyond 7 days, or if symptoms recur within 2 months.1 72 108 123 124
Importance of informing clinicians if irritation, sensitization, fever, chills, or flu-like symptoms occur.1 123 124
Advise patients that a single intravaginal dose of tioconazole 6.5% ointment generally is effective,1 2 3 108 but complete relief may not occur on the day of treatment.123 124 Most women experience some relief of symptoms within 1 day and complete relief within 7 days.123 124
Importance of not using latex or rubber products such as condoms or vaginal contraceptive diaphragms within 72 hours following tioconazole treatment.1 108 124
Importance of not having vaginal intercourse, douching, using spermicides, or other vaginal products after an intravaginal dose of tioconazole.10 123 124
If used during menstruation,1 56 72 117 importance of using sanitary napkins instead of vaginal tampons.1 56 72 123 124
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, including diabetes mellitus and HIV infection.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 123 124
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 | Ointment | 6.5%* | 1-Day (available in prefilled, disposable applicators) | Personal Products |
Tioconazole Vaginal Ointment (available in prefilled, disposable applicators) | Perrigo | |||
Vagistat-1 (available in prefilled, disposable applicators) | Novartis |
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.
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