MedPath

Tioconazole

Generic Name
Tioconazole
Brand Names
Monistat Simple Therapy, Vagistat
Drug Type
Small Molecule
Chemical Formula
C16H13Cl3N2OS
CAS Number
65899-73-2
Unique Ingredient Identifier
S57Y5X1117

Overview

Tioconazole is an imidazole antifungal used to treat fungal and yeast infections. Topical formulations are used for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". Tioconazole interacts with 14-alpha demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability.

Indication

For the local treatment of vulvovaginal candidiasis (moniliasis).

Associated Conditions

  • Fungal skin infection
  • Infection, Mixed
  • Onychomycosis
  • Vaginal Candidiasis
  • Vulvovaginal Candidiasis
  • Bacterial skin infections
  • Cutaneous dermatophyte infection
  • Superficial Fungal skin infection

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
GYNO-ELLYCIE VAGINAL OINTMENT 6.5%
N/A
bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited
N/A
N/A
6/8/2009

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
GYNECURE VAGINAL OVULE 300MG
pfizer canada inc., consumer healthcare division
02095009
Suppository - Vaginal
300 MG / SUP
12/31/1995
GYNECURE VAGINAL OINTMENT 6.5% W/W
pfizer canada inc., consumer healthcare division
02095017
Ointment - Vaginal
6.5 %
12/31/1995
TROSYD AF CREAM 1%
pfizer canada inc., consumer healthcare division
02095025
Cream - Topical
1 %
12/31/1987
GYNECURE TANDEMPK.VAG ONT6.5%/VULV.CRM1%-W/W
pfizer canada inc., consumer healthcare division
02218291
Cream ,  Ointment - Topical ,  Vaginal
1 % / KIT
3/27/1997
GYNECURE TANDEMPK.VAG ONT6.5%/VULV.CRM1%-W/W
pfizer canada inc., consumer healthcare division
02218291
Cream ,  Ointment - Topical ,  Vaginal
6.5 % / KIT
3/27/1997
GYNECURE TANDEMPK.VAG OV.300MG/VULV.CRM1%W/W
pfizer canada inc., consumer healthcare division
02218283
Cream ,  Suppository - Vaginal ,  Topical
1 % / KIT
12/2/1996
GYNECURE TANDEMPK.VAG OV.300MG/VULV.CRM1%W/W
pfizer canada inc., consumer healthcare division
02218283
Cream ,  Suppository - Vaginal ,  Topical
300 MG / KIT
12/2/1996
TROSYD J CREAM 1% W/W
pfizer canada inc., consumer healthcare division
02217406
Cream - Topical
10 MG / G
3/27/1997
GYNECURE COM.PK.VAG ONT6.5%VULVAR CRM1% W/W
pfizer canada inc., consumer healthcare division
02171902
Cream ,  Ointment - Topical ,  Vaginal
6.5 %
12/31/1995
GYNECURE COM.PK.VAG ONT6.5%VULVAR CRM1% W/W
pfizer canada inc., consumer healthcare division
02171902
Cream ,  Ointment - Topical ,  Vaginal
1 %
12/31/1995

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
SERNAX 280 mg/ml SOLUCION CUTANEA EFG
Laboratorios Serra Pamies S.A.
70801
SOLUCIÓN CUTÁNEA
Medicamento Sujeto A Prescripción Médica
Commercialized
TROSID 280 mg/ml BARNIZ DE UÑAS MEDICAMENTOSO
Pfizer S.L.
58758
BARNIZ DE UÑAS MEDICAMENTOSO
Medicamento Sujeto A Prescripción Médica
Commercialized
TIOCONAZOL KORHISPANA 280 mg/ml BARNIZ DE UÑAS MEDICAMENTOSO EFG
Korhispana S.L.
67439
BARNIZ DE UÑAS MEDICAMENTOSO
Medicamento Sujeto A Prescripción Médica
Commercialized
TIOCONAZOL ABAMED 28% SOLUCION CUTANEA
Abamed Pharma S.L.
67470
BARNIZ DE UÑAS MEDICAMENTOSO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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