Tioconazole
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Tioconazole is a antifungal , anti-Infective agent that is FDA approved for the treatment of Vaginal antifungal. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Treats vaginal yeast infections
DIRECTIONS
- before using this product read the enclosed brochure and instructions on foil packet for complete directions and information
- adults and children 12 years and over:
- open the foil packet just before use and remove purple cap
- insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.
- children under 12 years of age: ask a doctor
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tioconazole in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tioconazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Tioconazole in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tioconazole in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tioconazole in pediatric patients.
Contraindications
There is limited information regarding Contraindications of Tioconazole in pediatric patients.
Warnings
- For vaginal use only
Do not use
- if you have never had a vaginal yeast infection diagnosed by a doctor
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Tioconazole in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Tioconazole in the drug label.
Drug Interactions
There is limited information regarding Drug Interactions of Tioconazole in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tioconazole in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tioconazole during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tioconazole with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Tioconazole with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Tioconazole with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Tioconazole with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tioconazole with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tioconazole in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tioconazole in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tioconazole in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tioconazole in patients who are immunocompromised.
Administration and Monitoring
Administration
- Topical
Monitoring
There is limited information regarding Monitoring of Tioconazole in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Tioconazole in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Tioconazole in the drug label.
Pharmacology
There is limited information regarding Tioconazole Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Tioconazole in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Tioconazole in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Tioconazole in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Tioconazole in the drug label.
How Supplied
Storage
There is limited information regarding Tioconazole Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
PRINCIPAL DISPLAY PANEL
1-dose treatment
tioconazole 1
tioconazole ointment 6.5%
vaginal antifungal
Compare to active ingredient in 1-Day™
cures most vaginal yeast infections
1 ready-to-use prefilled applicator
educational brochure enclosed
1 DOSE {{#ask: Label Page::Tioconazole |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Tioconazole in the drug label.
Precautions with Alcohol
- Alcohol-Tioconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®
Look-Alike Drug Names
There is limited information regarding Tioconazole Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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