Terconazole

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

• Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.ICD-10: B37.9

• Patients known to be hypersensitive to terconazole or to any of the components of the cream.contraindicated

One full applicator (5 g) of terconazole vaginal cream 0.4% (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of terconazole vaginal cream 0.4% is not affected by menstruation.

Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.

Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching. Post-marketing Experience The following adverse drug reactions have been first identified during post-marketing experience with terconazole vaginal cream 0.4%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Pregnancy Teratogenic Effects, Pregnancy Category C: There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (100x the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats. Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20 to 40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increase incidence of skeletal variants. The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.4%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.

In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively. In the event of oral ingestion of the cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

• Apr 6, 2004ANDAANDA075953Sun Pharma Canada
• Oct 1, 2004NDANDA021735Fougera Pharms Inc
• Jan 19, 2005ANDAANDA076043Sun Pharma Canada
• Feb 18, 2005ANDAANDA076712Fougera Pharms
• Mar 17, 2006ANDAANDA077149Padagis Israel
• Mar 9, 2007ANDAANDA077553Sun Pharma Canada

1. 1Pain9312%
2. 2Chronic Kidney Disease688.4%
3. 3Drug Ineffective546.7%
4. 4Anxiety486.0%
5. 5Nausea475.8%
6. 6Headache445.5%
7. 7Urinary Tract Infection435.3%
8. 8Fatigue384.7%
9. 9Acute Kidney Injury374.6%
10. 10Product Quality Issue374.6%
11. 11Emotional Distress364.5%
12. 12Pain In Extremity334.1%
13. 13Renal Failure334.1%
14. 14Diarrhoea303.7%
15. 15Dyspnoea303.7%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Terconazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
  Completed · Interventional · 572 enrolled · Padagis LLC
  NCT00803738updated 2021-10-13
• Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
  Completed · Phase 4 · Interventional · 140 enrolled · Peking University Shenzhen Hospital
  NCT02180100updated 2020-10-23
• Multi-Center Study of New Medications to Treat Vaginal Infections
  Completed · Phase 3 · Interventional · 475 enrolled · Curatek Pharmaceuticals, LLC
  NCT02308007updated 2020-08-04
• Multi-Center Study of New Medications to Treat Vaginal Infections
  Completed · Phase 3 · Interventional · 204 enrolled · Curatek Pharmaceuticals, LLC
  NCT02308033updated 2020-07-27
• Multi-Center Study of New Medications to Treat Vaginal Infections
  Completed · Phase 3 · Interventional · 212 enrolled · Curatek Pharmaceuticals, LLC
  NCT02308046updated 2020-07-27
• Comparison of Boric Acid vs. Terconazole in Treatment of RVVC
  Unknown · Interventional · 76 enrolled · Hatem AbuHashim
  NCT04208555updated 2019-12-24
• Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis
  Unknown · Phase 3 · Interventional · 69 enrolled · Assiut University
  NCT03473418updated 2018-03-22
• In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products
  Completed · Phase 1 · Interventional · 101 enrolled · CONRAD
  NCT01813162updated 2015-05-22
• Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network
  Completed · Early phase 1 · Interventional · 46 enrolled · Agency for Healthcare Research and Quality (AHRQ)
  NCT00503542updated 2014-01-08
• A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
  Completed · Phase 3 · Interventional · 160 enrolled · Janssen-Cilag, S.A.
  NCT01867164updated 2013-12-24

Frequently asked questions

How does Terconazole work?

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

What is Terconazole used for?

According to FDA labeling, Terconazole carries indications including: Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Terconazole?

Terconazole is classified as Triazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Decreased Cell Membrane Integrity.

What are the contraindications for Terconazole?

Terconazole labeling lists contraindications including: Patients known to be hypersensitive to terconazole or to any of the components of the cream.. Always consult the full prescribing information and a clinician.