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Tioconazole

Medically reviewed by Drugs.com. Last updated on Aug 13, 2020.

Pronunciation

(tye oh KONE a zole)

Dosage Forms

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

Ointment, Vaginal:

Vagistat-1: 6.5% (4.6 g [DSC])

Brand Names: U.S.

  • Vagistat-1 [OTC] [DSC]

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Vaginal

Pharmacology

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.

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 (Jones 1993)

Onset of Action

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

Use: Labeled Indications

Candidiasis, vulvovaginal: Local treatment of vulvovaginal candidiasis

Contraindications

Hypersensitivity to tioconazole or any component of the formulation

Dosing: Adult

Candidiasis, vulvovaginal: Intravaginal: Insert 1 applicatorful in vagina as a single dose at bedtime

Note: A longer duration may be necessary in patients with complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida, or infection in an immunocompromised host) (CDC [Workowski 2015]; HHS [OI adult] 2020).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing

Administration

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.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

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

Adverse Reactions

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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. May damage condoms or diaphragms.

Reproductive Considerations

This product may weaken latex condoms and diaphragms (CDC [Workowski 2015]).

Pregnancy Considerations

Following vaginal administration, small amounts of imidazoles are absorbed systemically. Single dose, topical azole regimens are not recommended for the treatment of vulvovaginal candidiasis; only topical azole products with 7-day regimens are recommended in pregnant women with vulvovaginal candidiasis.

Patient Education

What is this drug used for?

• It is used to treat vaginal infections.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Vaginal irritation, itching, or burning

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Abdominal pain

• Chills

• Nausea

• Vomiting

• Foul-smelling vaginal discharge

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.