Terconazole: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag={{Ammu}} | |||
|genericName=Terconazole | |||
|aOrAn=a | |||
|drugClass=antifungals | |||
|indicationType=treatment | |||
|indication=Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). | |||
|adverseReactions=vulvovaginal burning, itching and irritation have also been reported, headache and dysmenorrhea, [[abdominal pain]], [[asthenia]], Influenza-Like Illness consisting of multiple listed reactions including [[fever]] and [[chills]], [[nausea]], [[vomiting]], [[myalgia]], [[arthralgia]], [[malaise]], [[hypersensitivity]], [[anaphylaxis]], [[face edema]], [[bronchospasm]], [[rash]], [[toxic epidermal necrolysis]], urticaria | |||
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | |blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content) | ||
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|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Terconazole in pediatric patients. | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Terconazole in pediatric patients. | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Terconazole in pediatric patients. | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Terconazole in pediatric patients. | ||
|clinicalTrials======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. | |||
======Terconazole Vaginal Cream 0.4%====== | |||
* 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. | |||
======Terconazole Vaginal Cream 0.8%====== | |||
* 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. | |||
|postmarketing=* 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 | |||
|alcohol=Alcohol-Terconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Terconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 19:06, 2 December 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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Overview
Terconazole is a antifungals that is FDA approved for the treatment of Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis).. Common adverse reactions include vulvovaginal burning, itching and irritation have also been reported, headache and dysmenorrhea, abdominal pain, asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise, hypersensitivity, anaphylaxis, face edema, bronchospasm, rash, toxic epidermal necrolysis, urticaria.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Terconazole FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terconazole in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Terconazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Terconazole FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terconazole in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Terconazole in pediatric patients.
Contraindications
There is limited information regarding Terconazole Contraindications in the drug label.
Warnings
There is limited information regarding Terconazole Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
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.
Terconazole Vaginal Cream 0.4%
- 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.
Terconazole Vaginal Cream 0.8%
- 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.
Postmarketing 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
Drug Interactions
There is limited information regarding Terconazole Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Terconazole in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Terconazole in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Terconazole during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Terconazole in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Terconazole in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Terconazole in geriatric settings.
Gender
There is no FDA guidance on the use of Terconazole with respect to specific gender populations.
Race
There is no FDA guidance on the use of Terconazole with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Terconazole in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Terconazole in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Terconazole in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Terconazole in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Terconazole Administration in the drug label.
Monitoring
There is limited information regarding Terconazole Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Terconazole and IV administrations.
Overdosage
There is limited information regarding Terconazole overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Terconazole Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Terconazole Mechanism of Action in the drug label.
Structure
There is limited information regarding Terconazole Structure in the drug label.
Pharmacodynamics
There is limited information regarding Terconazole Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Terconazole Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Terconazole Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Terconazole Clinical Studies in the drug label.
How Supplied
There is limited information regarding Terconazole How Supplied in the drug label.
Storage
There is limited information regarding Terconazole Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Terconazole |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Terconazole |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Terconazole Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Terconazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Terconazole Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Terconazole Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
For patient information, click here.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]
Overview
Category
Antifungal
US Brand Names
TERAZOL 7® (cream),TERAZOL 3® (suppository)
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages