Terconazole 80mg Vaginalsupp 3's
It is used to treat vaginal infections. If this drug has been given for some other reason, talk with the doctor for more information.
Drug Class
Antifungal
Pharmacologic Class
Triazole Antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Terconazole is an antifungal medicine used to treat vaginal yeast infections. It works by stopping the growth of the yeast that causes the infection.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
This medication is for vaginal use only and should not be taken orally.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation.
Wash your hands before and after applying the medication.
For optimal results, apply the medication at bedtime.
Clean the applicator after each use.
Storing and Disposing of Your Medication
Store the medication at room temperature.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
* Consult your pharmacist for guidance on the best disposal method or to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
This medication is for vaginal use only and should not be taken orally.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation.
Wash your hands before and after applying the medication.
For optimal results, apply the medication at bedtime.
Clean the applicator after each use.
Storing and Disposing of Your Medication
Store the medication at room temperature.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
* Consult your pharmacist for guidance on the best disposal method or to inquire about drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Insert the suppository high into the vagina, preferably at bedtime.
- Complete the full course of treatment, even if symptoms improve.
- Avoid sexual intercourse during treatment to prevent reinfection and irritation.
- Avoid using tampons, douches, spermicides, or other vaginal products during treatment.
- Terconazole vaginal suppositories may weaken latex condoms and diaphragms, reducing their effectiveness. Use alternative birth control methods during treatment and for 3 days after.
- Wear cotton underwear and avoid tight-fitting clothing.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
80 mg vaginal suppository once daily at bedtime for 3 consecutive days.
Dose Range:
80 - 80 mg
Condition-Specific Dosing:
vulvovaginalCandidiasis:
80 mg vaginal suppository once daily at bedtime for 3 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for pre-pubertal girls)
Adolescent:
Safety and efficacy not established in pediatric patients under 18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Terconazole is a triazole antifungal agent that inhibits fungal cytochrome P450-dependent 14-alpha-demethylase. This enzyme is responsible for the demethylation of lanosterol to ergosterol, an essential component of the fungal cell membrane. Inhibition of this enzyme leads to the depletion of ergosterol and the accumulation of 14-alpha-methyl sterols, resulting in disruption of fungal cell membrane integrity and increased permeability, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
5-8% (systemic absorption after vaginal administration)
Tmax:
6.6 hours (after vaginal administration)
FoodEffect:
Not applicable (vaginal administration)
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
94.9% (in vitro)
CnssPenetration:
Limited (due to minimal systemic absorption)
Elimination:
HalfLife:
6.9 hours (systemic half-life after vaginal administration)
Clearance:
Not available
ExcretionRoute:
Urine (primarily as metabolites), Feces (primarily as metabolites)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief typically within 2-3 days
PeakEffect:
Not applicable (local action)
DurationOfAction:
Duration of treatment is 3 days for the 80mg suppository
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Fever or chills
Flu-like symptoms
A severe skin reaction (toxic epidermal necrolysis) may occur, which can lead to serious health problems and even death. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Menstrual (period) pain
Burning sensation
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Irritation at the site where the medication was applied
Fever or chills
Flu-like symptoms
A severe skin reaction (toxic epidermal necrolysis) may occur, which can lead to serious health problems and even death. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Menstrual (period) pain
Burning sensation
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased vaginal irritation, burning, or itching
- Rash or hives
- Abdominal cramps or pain that worsens
- Headache that is severe or persistent
- Fever or chills
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a known allergy to any type of nuts or seeds, discuss this with your doctor, as some products may contain nuts.
Do not use this medication if you experience abdominal pain, fever, or foul-smelling vaginal discharge. Instead, consult your doctor for guidance. This medication is specifically intended for the treatment of vaginal yeast infections and should not be used to address itching caused by other health issues. If you frequently experience vaginal yeast infections, consult your doctor to discuss the best course of action.
To minimize the risk of staining, take precautions to protect your clothing and fabrics. Additionally, avoid using tampons during treatment. After showering, bathing, or swimming, thoroughly dry the external vaginal area to prevent moisture buildup. Change out of wet bathing suits or damp workout clothes as soon as possible to reduce the risk of infection.
Unless advised by your doctor, refrain from using douches, as this may disrupt the natural balance of the vagina. Avoid scratching the affected area, as this can lead to increased irritation and potentially spread the infection. It is also recommended to abstain from vaginal sex while using this medication.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby. When using this medication, avoid contact between the drug and latex products, such as condoms or diaphragms, as it may cause damage to the latex and compromise the effectiveness of these products.
Do not use this medication if you experience abdominal pain, fever, or foul-smelling vaginal discharge. Instead, consult your doctor for guidance. This medication is specifically intended for the treatment of vaginal yeast infections and should not be used to address itching caused by other health issues. If you frequently experience vaginal yeast infections, consult your doctor to discuss the best course of action.
To minimize the risk of staining, take precautions to protect your clothing and fabrics. Additionally, avoid using tampons during treatment. After showering, bathing, or swimming, thoroughly dry the external vaginal area to prevent moisture buildup. Change out of wet bathing suits or damp workout clothes as soon as possible to reduce the risk of infection.
Unless advised by your doctor, refrain from using douches, as this may disrupt the natural balance of the vagina. Avoid scratching the affected area, as this can lead to increased irritation and potentially spread the infection. It is also recommended to abstain from vaginal sex while using this medication.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby. When using this medication, avoid contact between the drug and latex products, such as condoms or diaphragms, as it may cause damage to the latex and compromise the effectiveness of these products.
Overdose Information
Overdose Symptoms:
- Overdose with vaginal administration is highly unlikely due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidental oral ingestion occurs, contact a poison control center immediately. For local irritation, discontinue use and consult a healthcare professional. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of vulvovaginal candidiasis
Rationale: To confirm appropriate indication for therapy.
Timing: Prior to initiation of treatment
Routine Monitoring
Resolution of symptoms (itching, burning, discharge)
Frequency: Daily during treatment and post-treatment
Target: Complete resolution or significant improvement
Action Threshold: If symptoms worsen or do not improve after 3 days, re-evaluate diagnosis and consider alternative treatment.
Symptom Monitoring
- Vaginal itching
- Vaginal burning
- Vaginal discharge
- Vaginal irritation
- Abdominal pain
- Headache
Special Patient Groups
Pregnancy
Terconazole is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data are available on use in pregnant women.
Trimester-Specific Risks:
First Trimester:
Use only if clearly needed and potential benefits outweigh risks.
Second Trimester:
Use only if clearly needed and potential benefits outweigh risks.
Third Trimester:
Use only if clearly needed and potential benefits outweigh risks.
Lactation
It is not known whether terconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when terconazole is administered to a nursing woman. Due to minimal systemic absorption, infant exposure is expected to be low.
Infant Risk:
Low risk, but caution advised due to lack of data.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Generally not recommended for pre-pubertal girls.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic changes are unlikely to be clinically significant.
Clinical Information
Clinical Pearls
- Advise patients to complete the entire 3-day course of therapy, even if symptoms improve earlier, to prevent recurrence.
- Inform patients that terconazole vaginal suppositories contain ingredients that may damage latex or rubber products, such as condoms and diaphragms. Advise them to use alternative birth control methods during treatment and for at least 3 days after.
- Administer at bedtime to allow the medication to remain in the vagina for an extended period.
- If symptoms persist or worsen after completing the course, advise the patient to consult their healthcare provider for re-evaluation.
Alternative Therapies
- Miconazole (vaginal cream/suppository)
- Clotrimazole (vaginal cream/suppository)
- Tioconazole (vaginal ointment)
- Fluconazole (oral tablet, single dose)
Cost & Coverage
Average Cost:
$30 - $60 per 3 vaginal suppositories
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.