Tioconazole

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Tioconazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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 and imidazole that is FDA approved for the treatment of Vaginal antifungal. Common adverse reactions include mild increase in vaginal burning, itching or irritation.

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.

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)

  • Children under 12 years of age: ask a doctor

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
When using this product
  • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
Stop use and ask a doctor if
  • symptoms do not get better after 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away.

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 (FDA):

  • ask a health professional before use.


Pregnancy Category (AUS):

  • 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

  • If swallowed, get medical help or contact a Poison Control Center right away.

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

Tioconazole.png
1 : 1 mixture (racemate)Tioconazole
Systematic (IUPAC) name
(RS)-1-[2-[(2-Chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
Identifiers
CAS number 65899-73-2
ATC code D01AC07 G01AF08 (WHO)
PubChem 5482
DrugBank DB01007
Chemical data
Formula C16H13Cl3N2OS 
Mol. mass 387.711 g/mol
Synonyms Thioconazole
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

OTC(US)

Routes Topical

Mechanism of Action

Structure

  • butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum

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

There is limited information regarding Tioconazole How Supplied in the drug label.

Storage

  • Store at 20° - 25°C (68° - 77°F)

Images

Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

Compare to 1-Day active ingredient

tioconazole 1

tioconozole ointment 6.5% - vaginal antifungal

1 dose vaginal treatment

ready-to-use prefilled applicator

cures most vaginal yeast infections

1 dose treatment

NET WT 4.6g (0.16 OZ) filled applicator

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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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