Tioconazole

Mechanism-of-action class: 14-alpha Demethylase Inhibitors.

• Use • treats vaginal yeast infections

Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed 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

For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS 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 • if you do not get complete relief ask a doctor before using another product 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

• Nov 21, 2001ANDAANDA075915Perrigo

1. 1Vulvovaginal Burning Sensation52634%
2. 2Drug Ineffective44129%
3. 3Vulvovaginal Swelling29519%
4. 4Vulvovaginal Pain22915%
5. 5Condition Aggravated22615%
6. 6Vulvovaginal Pruritus19713%
7. 7Vulvovaginal Discomfort16110%
8. 8Vaginal Discharge593.8%
9. 9Underdose543.5%
10. 10Vaginal Haemorrhage543.5%
11. 11Hypersensitivity533.4%
12. 12Vulvovaginal Erythema523.4%
13. 13Off Label Use362.3%
14. 14Chemical Burn Of Genitalia291.9%
15. 15Headache241.6%

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Tioconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
  Completed · Phase 3 · Interventional · 577 enrolled · Ege University
  NCT06056947updated 2023-09-28
• Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
  Unknown · Phase 4 · Interventional · 30 enrolled · Cairo University
  NCT05999474updated 2023-08-21
• The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
  Completed · Phase 4 · Interventional · 20 enrolled · Northwestern University
  NCT02550093updated 2022-05-16
• Evaluation of Efficacy and Safety of Gynomax® XL Ovule
  Completed · Phase 4 · Interventional · 116 enrolled · Exeltis Turkey
  NCT03839875updated 2020-01-31

Frequently asked questions

How does Tioconazole work?

Mechanism-of-action class: 14-alpha Demethylase Inhibitors.

What is Tioconazole used for?

According to FDA labeling, Tioconazole carries indications including: Use • treats vaginal yeast infections. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tioconazole?

Tioconazole is classified as Imidazole and triazole derivatives, Imidazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Decreased Cell Membrane Integrity.

What are the brand names for Tioconazole?

Tioconazole is marketed under brand names including Monistat Simple Therapy, Vagistat-1.