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Tioconazole: Drug information

Tioconazole: Drug information
(For additional information see "Tioconazole: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Monistat 1-Day
Pharmacologic Category
  • Antifungal Agent, Imidazole Derivative;
  • Antifungal Agent, Vaginal
Dosing: Adult
Candidiasis, vulvovaginal

Candidiasis, vulvovaginal:

Note: A longer duration of 7 to 14 days may be necessary in patients with complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida, or infection in an immunocompromised host) (Ref). Not effective against Candida glabrata (Ref).

Ointment 6.5%: Intravaginal: Insert 1 applicatorful (~5 g) as a single dose (at bedtime) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Central nervous system: Headache

Gastrointestinal: Abdominal pain

Dermatologic: Burning sensation of skin, exfoliation of skin

Genitourinary: Dyspareunia, dysuria, nocturia, vaginal discharge, vaginal pain, vaginitis, vulvar swelling, vulvovaginal irritation, vulvovaginal pruritus

Warnings/Precautions

Concerns related to adverse effects:

• Irritation: If irritation or sensitization occurs, discontinue use.

Special populations:

• Pediatric: Vaginal products are not for OTC use in children <12 years of age.

Dosage form specific issues:

• Formulation: Petrolatum-based vaginal products may damage rubber or latex condoms or diaphragms; separate use by 3 days.

• Vaginal product: Consult with health care provider prior to self-medication (OTC use) if experiencing vaginal itching/discomfort, lower abdominal pain, back or shoulder pain, chills, nausea, vomiting, foul-smelling discharge, if this is the first vaginal yeast infection, or if exposed to HIV. Contact health care provider if symptoms do not begin to improve after 3 days or last longer than 7 days.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Ointment, Vaginal:

Monistat 1-Day: 6.5% (4.6 g)

Generic: 6.5% (4.6 g, 8 g)

Generic Equivalent Available: US

No

Pricing: US

Ointment (Vagistat-1 Vaginal)

6.5% (4.6 g): $10.79

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Administration: Adult

Intravaginal: For vaginal use only. Administer 1 applicatorful (prefilled) intravaginally. Applicator may be inserted in any comfortable position. Hold the applicator by the barrel, insert gently into the vagina as far as possible without causing discomfort. Press the plunger until it stops and withdraw the applicator. Patients should not use intravaginal products (eg, tampons, douches) or engage in vaginal intercourse for the duration of treatment. Discard applicator after use.

Administration: Pediatric

Intravaginal: For vaginal use only. Administer 1 applicatorful (prefilled) intravaginally, preferably at bedtime. Applicator may be inserted in any comfortable position. Hold the applicator by the barrel, insert gently into the vagina as far as possible without causing discomfort. Press the plunger until it stops and withdraw the applicator. Patients should not use intravaginal products (eg, tampons, douches) or engage in vaginal intercourse for the duration of treatment. Discard applicator after use.

Use: Labeled Indications

Candidiasis, vulvovaginal: Local treatment of vulvovaginal candidiasis

Medication Safety Issues
Sound-alike/look-alike issues:

Tioconazole may be confused with terconazole

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Reproductive Considerations

This product may weaken latex condoms and diaphragms (CDC [Workowski 2021]).

Pregnancy Considerations

Various tioconazole regimens have been evaluated in pregnant patients (Clissold 1986; Henderson 1983). However, only topical azole therapies with 7-day regimens are recommended in pregnant patients with vulvovaginal candidiasis (CDC [Workowski 2021]).

Mechanism of Action

A 1-substituted imidazole derivative with a broad antifungal spectrum against a wide variety of dermatophytes and yeasts, including Trichophyton mentagrophytes, T. rubrum, T. erinacei, T. tonsurans, Microsporum canis, Microsporum gypseum, and Candida albicans. Both agents appear to be similarly effective against Epidermophyton floccosum.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Some improvement: Within 24 hours; Complete relief: Within 7 days.

Absorption: Intravaginal: Systemic 10.6 to 35.8 ng/mL at 8 hours postdose; none detectable at 24 hours (Houang 1985).

Distribution: Vaginal fluid: 24 to 72 hours (Clissold 1986; Jones 1993).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Trosyd;
  • (AR) Argentina: Tiomicol | Trosyd;
  • (AT) Austria: Trosyd;
  • (BD) Bangladesh: Tycon;
  • (BR) Brazil: Gino-tralen | Neo tionazol | Tioconax | Tioconazol | Tionazen | Tralen;
  • (CH) Switzerland: Trosyd;
  • (CL) Chile: Telset | Trosyd;
  • (CO) Colombia: Gyno trosyd | Tioconazol | Trosyd;
  • (DE) Germany: Fungibacid | Mykontral;
  • (DO) Dominican Republic: Tiomicol | Trosyd;
  • (EC) Ecuador: Gino trosyd | Tioconazol | Trosyd;
  • (EG) Egypt: Gyno Premazole | Gyno trosyd | Mipazole | Tiocon | Topzol | Trosyd | Trozal;
  • (ES) Spain: Trosid;
  • (FI) Finland: Gyno trosyd | Trosyd;
  • (FR) France: Trosyd;
  • (GB) United Kingdom: Trosyl;
  • (GR) Greece: Cotinazin;
  • (HK) Hong Kong: Gyno trosyd | Trosyd;
  • (ID) Indonesia: Prodermal | Trosyd;
  • (IT) Italy: Ginotrosyd | Trosyd;
  • (JO) Jordan: Trosyd;
  • (JP) Japan: Straitus | Trosy;
  • (KR) Korea, Republic of: Tiosil | Tiozol;
  • (MA) Morocco: Trosyd;
  • (MY) Malaysia: Trosyd;
  • (NZ) New Zealand: Trosyd;
  • (PE) Peru: Epizol | Gino-trosyd | Telset | Tioconazol Genfar | Trosyd;
  • (PH) Philippines: Trosyd;
  • (PK) Pakistan: Trosyd;
  • (PL) Poland: Gyno trosyd;
  • (PR) Puerto Rico: Vagistat 1;
  • (PT) Portugal: Gino trosyd | Tioconazol | Trosyd;
  • (SG) Singapore: Gyno trosyd | Trosyd;
  • (TH) Thailand: Trosyd;
  • (TN) Tunisia: Trosyd;
  • (TR) Turkey: Dermo trosyd | Dermo Trosyl | Dermo-rest | Gyno trosyd | Tiocan | Tiocell | Tiocure | Trosyd;
  • (UA) Ukraine: Dermo-rest | Thiomex;
  • (UY) Uruguay: Trosyd;
  • (VE) Venezuela, Bolivarian Republic of: Gino-tralen | Tralen;
  • (ZA) South Africa: Gyno trosyd | Trosyd
  1. Clissold SP, Heel RC. Tioconazole. A review of its antimicrobial activity and therapeutic use in superficial mycoses. Drugs. 1986;31(1):29-51. doi:10.2165/00003495-198631010-00003 [PubMed 3510114]
  2. Henderson JT, Neilson W, Wilson AB, Jevons S. Tioconazole in the treatment of vaginal candidiasis. An international clinical research program. Gynakol Rundsch. 1983;23(suppl 1):42-60. doi:10.1159/000269570 [PubMed 6873747]
  3. Houang ET, Lawrence AG. Systemic absorption and persistence of tioconazole in vaginal fluid after insertion of a single 300-mg tioconazole ovule. Antimicrob Agents Chemother. 1985;27(6):964-965. [PubMed 4026270]
  4. Jones RN, Bale MJ, Hoban D, Erwin ME. In vitro antimicrobial activity of tioconazole and its concentrations in vaginal fluids following topical (vagistat-1 6.5%) application. Diagn Microbiol Infect Dis. 1993;17(1):45-51. [PubMed 8359005]
  5. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guidelines for the management of candidiasis: 2016 update by the Infectious Disease Society of America. Clin Infect Dis. 2016;62(4):409-417. doi:10.1093/cid/civ1194 [PubMed 26810419]
  6. Tioconazole [prescribing information]. Allegan, MI: Perrigo; March 2016.
  7. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed May 5, 2020.
  8. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
  9. Workowski KA, Bolan GA; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2015 [published correction appears in MMWR Recomm Rep. 2015;64(33):924]. MMWR Recomm Rep. 2015;64(RR-03):1-137. [PubMed 26042815]
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