Terconazole 0.8% Vaginal Crm 20gm
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 vaginal cream 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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after using the medication.
For best results, use 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 safe place, out of the 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.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not use two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after using the medication.
For best results, use 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 safe place, out of the 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.
Check with your pharmacist for guidance on the best way to dispose of medications. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Complete the full course of treatment, even if symptoms improve.
- Administer at bedtime to allow the medication to remain in the vagina.
- Avoid sexual intercourse during treatment to prevent reinfection or irritation.
- Avoid douching or using tampons during treatment.
- Wear cotton underwear and loose-fitting clothing to promote air circulation.
- This cream may weaken latex condoms and diaphragms; use alternative birth control methods during treatment and for 72 hours after.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One applicatorful (5g of 0.8% cream) intravaginally once daily at bedtime for 3 consecutive days.
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
vulvovaginal_candidiasis:
One applicatorful (5g of 0.8% cream) intravaginally once daily at bedtime for 3 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
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 (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 ergosterol synthesis by interfering with cytochrome P450-dependent 14-alpha-demethylase. This leads to a disruption of the fungal cell membrane, increasing its permeability and ultimately causing fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 5-8% (systemic absorption after vaginal administration)
Tmax:
6.6 hours (after vaginal administration)
FoodEffect:
Not applicable (topical vaginal administration)
Distribution:
Vd:
Not widely distributed systemically due to minimal absorption
ProteinBinding:
Not available
CnssPenetration:
Limited (due to minimal systemic absorption)
Elimination:
HalfLife:
6.9 hours (systemic half-life of absorbed drug)
Clearance:
Not available
ExcretionRoute:
Primarily renal and fecal excretion of metabolites
Unchanged:
Less than 1% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief typically within a few days
PeakEffect:
Not precisely defined for topical antifungal effect; clinical cure usually after full course
DurationOfAction:
Duration of treatment is 3 days for 0.8% cream
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
+ Difficulty 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 potentially 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Headache
* Menstrual (period) pain
Note: This is not an exhaustive list of 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. Your doctor can provide medical advice on managing side effects.
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
+ Difficulty 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 potentially 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Headache
* Menstrual (period) pain
Note: This is not an exhaustive list of 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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Worsening of vaginal irritation, itching, or burning
- Development of new symptoms (e.g., rash, hives, swelling)
- Signs of an allergic reaction (e.g., difficulty breathing, severe rash, swelling of face/tongue/throat)
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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
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.
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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
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.
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, consult 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 with your doctor for proper evaluation and guidance. This medication is specifically intended for the treatment of vaginal yeast infections and should not be used to treat itching caused by other health issues. If you frequently experience vaginal yeast infections, discuss this with your doctor to determine the best course of action.
To minimize the risk of staining, take precautions to protect your clothing and fabrics. Avoid using tampons during treatment. After showering, bathing, or swimming, thoroughly dry the external vaginal area to prevent moisture buildup. Change into dry clothing as soon as possible, especially after wearing wet bathing suits or damp workout clothes.
Unless advised by your doctor, refrain from using douches, as this may disrupt the natural vaginal balance. Avoid scratching the affected area, as this can lead to increased irritation and potentially spread the infection. It is recommended to abstain from vaginal sex while using this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Do not use this medication if you experience abdominal pain, fever, or foul-smelling vaginal discharge. Instead, consult with your doctor for proper evaluation and guidance. This medication is specifically intended for the treatment of vaginal yeast infections and should not be used to treat itching caused by other health issues. If you frequently experience vaginal yeast infections, discuss this with your doctor to determine the best course of action.
To minimize the risk of staining, take precautions to protect your clothing and fabrics. Avoid using tampons during treatment. After showering, bathing, or swimming, thoroughly dry the external vaginal area to prevent moisture buildup. Change into dry clothing as soon as possible, especially after wearing wet bathing suits or damp workout clothes.
Unless advised by your doctor, refrain from using douches, as this may disrupt the natural vaginal balance. Avoid scratching the affected area, as this can lead to increased irritation and potentially spread the infection. It is recommended to abstain from vaginal sex while using this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical vaginal application due to minimal systemic absorption. Ingestion of the cream may cause gastrointestinal upset.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For U.S., call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Diagnosis of vulvovaginal candidiasis
Rationale: To confirm the fungal infection and rule out other causes of vaginitis.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (itching, burning, discharge)
Frequency: Daily during treatment, and at follow-up if symptoms persist
Target: Complete resolution or significant improvement
Action Threshold: If symptoms worsen or do not improve after completing the course, re-evaluate diagnosis.
Symptom Monitoring
- Vaginal itching
- Vaginal burning
- Vaginal discharge
- Vaginal irritation
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited data available.
Trimester-Specific Risks:
First Trimester:
Limited data; use with caution and only if clearly needed.
Second Trimester:
Limited data; use with caution and only if clearly needed.
Third Trimester:
Limited data; use with caution and only if clearly needed.
Lactation
Minimal systemic absorption suggests that terconazole is unlikely to be excreted in breast milk in clinically significant amounts. Use with caution, but generally considered compatible with breastfeeding.
Infant Risk:
Low risk to infant due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in children under 12 years of age.
Geriatric Use
No specific dose adjustment is necessary for geriatric patients. Systemic absorption is minimal, and no age-related differences in safety or efficacy have been observed.
Clinical Information
Clinical Pearls
- Advise patients to complete the entire 3-day course of treatment, even if symptoms improve earlier, to ensure eradication of the infection.
- Inform patients that the cream may cause temporary burning, itching, or irritation upon application.
- Counsel patients on proper administration technique, emphasizing insertion at bedtime.
- Warn patients that terconazole cream contains mineral oil and white petrolatum, which can weaken latex condoms and diaphragms. Advise using alternative birth control methods during treatment and for at least 72 hours after.
- If symptoms persist or recur frequently, advise patients to consult their healthcare provider for further evaluation to rule out other conditions or resistant infections.
Alternative Therapies
- Clotrimazole vaginal cream/suppository
- Miconazole vaginal cream/suppository
- Tioconazole vaginal ointment
- Fluconazole (oral, for complicated or recurrent cases)
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 20gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the overdose, including the medication taken, the amount, and the time it occurred.