Terconazole
Generic: TERCONAZOLE
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
2b3923b5-0a97-428c-b8d2-4a3ceb3447a1
Indications & Usage
INDICATIONS AND USAGE Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis).
As terconazole vaginal cream is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
As terconazole vaginal cream is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
Warnings
WARNINGS Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy.
Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
Adverse Reactions
ADVERSE REACTIONS 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% 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:.
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.
General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise Immune: Hypersensitivity, Anaphylaxis, Face Edema Nervous: Dizziness Respiratory: Bronchospasm Skin: Rash, Toxic Epidermal Necrolysis, Urticaria
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% 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:.
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.
General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise Immune: Hypersensitivity, Anaphylaxis, Face Edema Nervous: Dizziness Respiratory: Bronchospasm Skin: Rash, Toxic Epidermal Necrolysis, Urticaria