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])
Pharmacology
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/Pharmacodynamics
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
Dosage and Administration
Dosing: Adult
Candidiasis, vulvovaginal: Intravaginal: Insert 1 applicatorful in vagina as a single dose at bedtime
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.
Pregnancy
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. This product may weaken latex condoms and diaphragms (CDC [Workowski 2015]).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience vaginal irritation, itching, or burning. Have patient report immediately to prescriber abdominal pain, chills, nausea, vomiting, or foul-smelling vaginal discharge (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
