Terconazole
Generic: TERCONAZOLE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
VAGINAL
FDA Set ID
71c13149-396e-edc6-e053-2a95a90af50c
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, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days.
Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs.
16% with placebo) and dysmenorrhea (6% vs.
2% with placebo).
Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs.
1% with placebo) and fever (1% vs.
0.3% with placebo).
The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
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, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days.
Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs.
16% with placebo) and dysmenorrhea (6% vs.
2% with placebo).
Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs.
1% with placebo) and fever (1% vs.
0.3% with placebo).
The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
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