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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{AJ}}
|OTC=Yes
|genericName=tioconazole
|aOrAn=a
|aOrAn=a
|hasBlackBoxWarning=Yes
|drugClass=antifungal ,  anti-Infective agent and imidazole
|adverseReactions=<!--Black Box Warning-->
|indicationType=treatment
|indication=[[Vaginal antifungal]]
|adverseReactions=mild increase in vaginal burning, [[itching]] or irritation
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 16:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=* Treats vaginal yeast infections


* Dosing Information
====DIRECTIONS====


:* Dosage
* 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.


=====Condition2=====
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=* Children under 12 years of age: ask a doctor
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Dosing Information
<!--Contraindications-->
|contraindications=There is limited information regarding <i>Contraindications</i> of {{PAGENAME}} in pediatric patients.
|warnings=* For vaginal use only


:* Dosage
=====Do not use=====


=====Condition2=====
* if you have never had a vaginal yeast infection diagnosed by a doctor


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
=====When using this product=====


<!--Contraindications-->
* 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).
|contraindications=* Condition1
* do not have vaginal intercourse
 
* mild increase in vaginal burning, itching or irritation may occur
<!--Warnings-->
|warnings=* Description
 
====Precautions====


* Description
=====Stop use and ask a doctor if=====


<!--Adverse Reactions-->
* 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


<!--Clinical Trials Experience-->
=====Keep out of reach of children=====
* If swallowed, get medical help or contact a Poison Control Center right away.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=There is limited information regarding <i>Drug Interactions</i> of {{PAGENAME}} in the drug label.
|useInPregnancyFDA=* ask a health professional before use.


=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


Line 255: Line 74:
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=* If swallowed, get medical help or contact a Poison Control Center right away.
 
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
Line 264: Line 84:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Topical
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


Line 275: Line 93:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


====Signs and Symptoms====
<!--Pharmacology-->


* Description
<!--Drug box 2-->
 
|drugBox={{one source|date=May 2014}}
====Management====
{{Drugbox2
 
| Verifiedfields = changed
* Description
| verifiedrevid = 415485693
| IUPAC_name = (''RS'')-1-[2-[(2-Chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1''H''-imidazole
| image = Tioconazole.png
| imagename = 1 : 1 mixture (racemate)
| drug_name = Tioconazole


===Chronic Overdose===
<!--Clinical data-->
| tradename = Vagistat-1
| Drugs.com = {{drugs.com|monograph|tioconazole}}
| pregnancy_category =
| legal_US= OTC
| routes_of_administration = Topical


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetic data-->
| bioavailability = 
| protein_bound = 
| metabolism = 
| elimination_half-life = 


<!--Pharmacology-->
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 65899-73-2
| ATC_prefix = D01
| ATC_suffix = AC07
| ATC_supplemental =  {{ATC|G01|AF08}}
| PubChem = 5482
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB01007
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = 5282
| UNII_Ref = {{fdacite|changed|FDA}}
| UNII = S57Y5X1117
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00890
| ChEBI_Ref = {{ebicite|changed|EBI}}
| ChEBI = 9604
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1200438


<!--Drug box 2-->
<!--Chemical data-->
|drugBox=<!--Mechanism of Action-->
| C=16 | H=13 | Cl=3 | N=2 | O=1 | S=1
| molecular_weight = 387.711 g/mol
| synonyms = Thioconazole
}}
|mechAction=*  
|mechAction=*  


<!--Structure-->
<!--Structure-->
|structure=*  
|structure=* butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
Line 313: Line 165:


<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|storage=* Store at 20° - 25°C (68° - 77°F)
|packLabel=<!--Patient Counseling Information-->
|packLabel======PRINCIPAL DISPLAY PANEL=====
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
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
 
[[File:TIOCONAZOLE drug lable01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
[[File:TIOCONAZOLE drug lable02.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=[[File:TIOCONAZOLE consumer info 01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:TIOCONAZOLE consumer info 02.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:TIOCONAZOLE consumer info 03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:TIOCONAZOLE consumer info 04.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:TIOCONAZOLE consumer info 05.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:TIOCONAZOLE consumer info 06.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
|brandNames=* ®
 
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Latest revision as of 17:17, 20 August 2015

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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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

Template:Px
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 Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
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

{{#ask: Page Name::Tioconazole |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

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.

{{#ask: Label Page::Tioconazole |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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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