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 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
- ask a health professional before use.
- 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
This article relies largely or entirely on a single source. (May 2014) |
| |
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 | |
| ATC code | D01 G01AF08 (WHO) |
| PubChem | |
| DrugBank | |
| 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 | |
| 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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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
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Patient Counseling Information
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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