Terconazole 0.4% Vaginal Crm 45gm
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
Azole 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. It comes as a cream that you insert into the vagina.
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.
What to Do If You Miss 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.
What to Do If You Miss 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.
- Avoid sexual intercourse during treatment to prevent reinfection or irritation.
- Wear cotton underwear and avoid tight-fitting clothing.
- Avoid douching or using tampons during treatment.
- Consult a healthcare provider if symptoms do not improve or worsen after treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One applicatorful (5g of 0.4% cream) intravaginally once daily at bedtime for 7 consecutive days.
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
vulvovaginal_candidiasis:
One applicatorful (5g of 0.4% cream) intravaginally once daily at bedtime for 7 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in 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 (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 an azole antifungal that inhibits fungal cytochrome P450-dependent 14-alpha-demethylase, an enzyme essential for ergosterol biosynthesis. Ergosterol is a vital component of fungal cell membranes. Inhibition of this enzyme leads to the accumulation of 14-alpha-methyl sterols and a decrease in ergosterol, disrupting the fungal cell membrane structure and increasing its permeability, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
5-8% (systemic after vaginal administration)
Tmax:
6.6 hours (after single vaginal dose)
FoodEffect:
Not applicable (vaginal administration)
Distribution:
Vd:
Not extensively studied systemically due to low absorption
ProteinBinding:
94.9%
CnssPenetration:
Limited (due to low systemic absorption)
Elimination:
HalfLife:
6.9 hours
Clearance:
Not available
ExcretionRoute:
Urine and feces
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 24-72 hours (symptomatic relief)
PeakEffect:
Not precisely defined for antifungal effect; clinical cure typically after full course
DurationOfAction:
Duration of treatment course (7 days)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
* Menstrual (period) pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
* Menstrual (period) pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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:
- Severe vaginal burning, itching, or irritation (worse than baseline)
- Hives or rash
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Fever or chills (may indicate a more serious infection)
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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, discuss your symptoms with your doctor. 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 with your doctor to discuss appropriate management.
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 balance of the vagina. Avoid scratching the affected area, as this can exacerbate irritation and potentially spread the infection. It is recommended to abstain from vaginal sex while using this medication.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Do not use this medication if you experience abdominal pain, fever, or foul-smelling vaginal discharge. Instead, discuss your symptoms with your doctor. 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 with your doctor to discuss appropriate management.
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 balance of the vagina. Avoid scratching the affected area, as this can exacerbate irritation and potentially spread the infection. It is recommended to abstain from vaginal sex while using this medication.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Not expected with vaginal administration due to minimal systemic absorption. In case of accidental oral ingestion, symptoms are unlikely to be severe but may include nausea or vomiting.
What to Do:
Call a poison control center (1-800-222-1222) or seek emergency medical attention if accidental ingestion occurs, though severe toxicity is unlikely. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of symptoms (itching, burning, discharge)
Frequency: Daily during treatment, then follow-up as needed
Target: Complete resolution
Action Threshold: If symptoms persist or worsen after completing the full course, re-evaluate diagnosis.
Symptom Monitoring
- Vaginal itching
- Vaginal burning
- Vaginal irritation
- Vaginal discharge
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption after vaginal administration is minimal.
Trimester-Specific Risks:
First Trimester:
Limited data, but low systemic absorption suggests low risk.
Second Trimester:
Low systemic absorption suggests low risk.
Third Trimester:
Low systemic absorption suggests low risk.
Lactation
Lactation Risk L3 (Moderately Safe). It is not known whether terconazole is excreted in human milk. Due to minimal systemic absorption, it is unlikely to cause adverse effects in a breastfed infant. Use with caution.
Infant Risk:
Low risk (due to minimal systemic absorption)
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age.
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, no overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Clinical Information
Clinical Pearls
- Advise patients to complete the entire 7-day course of treatment, even if symptoms resolve earlier, to prevent recurrence.
- Instruct patients on proper application technique using the provided applicator.
- Inform patients that some mild burning or itching may occur upon initial application, but severe or worsening irritation should be reported.
- Remind patients to avoid sexual intercourse and use of tampons or douches during treatment.
Alternative Therapies
- Clotrimazole vaginal cream/suppository
- Miconazole vaginal cream/suppository
- Tioconazole vaginal ointment
- Fluconazole (oral, single dose for uncomplicated VVC)
Cost & Coverage
Average Cost:
$20 - $50 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.