Clotrimazole 1% Vaginal Cream 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
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clotrimazole vaginal cream is an antifungal medication used to treat vaginal yeast infections. It works by stopping the growth of the yeast that causes the infection.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. For best results, apply the medication at bedtime.
Before and after use, wash your hands thoroughly. 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.
To prevent irritation and ensure effective use, dry the outside vaginal area completely after showering, bathing, or swimming. Change out of wet clothing, such as bathing suits or workout clothes, as soon as possible. Avoid having vaginal sex while using this medication.
If you are applying the cream to the skin outside the vagina, squeeze a small amount onto your fingertip and gently apply it to the affected area.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, 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 correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. For best results, apply the medication at bedtime.
Before and after use, wash your hands thoroughly. 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.
To prevent irritation and ensure effective use, dry the outside vaginal area completely after showering, bathing, or swimming. Change out of wet clothing, such as bathing suits or workout clothes, as soon as possible. Avoid having vaginal sex while using this medication.
If you are applying the cream to the skin outside the vagina, squeeze a small amount onto your fingertip and gently apply it to the affected area.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, 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 of partner and allow medication to work.
- Wear cotton underwear and avoid tight-fitting clothing.
- Avoid douching or using tampons during treatment.
- Keep the vaginal area clean and dry.
- Avoid using perfumed soaps, bubble baths, or feminine hygiene sprays.
Available Forms & Alternatives
Available Strengths:
- Clotrimazole 1% Cream 15gm
- Clotrimazole 1% Cream 30gm
- Clotrimazole 1% Cream 45gm
- Clotrimazole 1% Solution 30ml
- Clotrimazole 1% Vaginal Cream 45gm
- Clotrimazole 10mg Lozenge
- Clotrimazole 10mg Lozenge
- Clotrimazole 1% Solution 10ml
- Clotrimazole 1% Cream (otc) 30gm
- Clotrimazole 2% 3 Day Vag Crm 21gm
- Clotrimazole 1% Cream 2x45gm
- Clotrimazole 1% Solution 10ml
- Clotrimazole 1% Cream (otc) 14gm
- Clotrimazole 1% Cream (otc) 14.17gm
- Clotrimazole A/f 1% Cream 28gm
Dosing & Administration
Adult Dosing
Standard Dose:
One applicatorful (approximately 5 grams) intravaginally at bedtime for 7 consecutive days.
Dose Range:
5 - 5 mg
Condition-Specific Dosing:
vulvovaginal_candidiasis:
One applicatorful (approximately 5 grams) intravaginally at bedtime for 7 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use; consult specialist for specific cases (e.g., immunocompromised).
Adolescent:
Same as adult dosing for post-menarcheal adolescents with vulvovaginal candidiasis.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Clotrimazole inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the cytoplasmic membrane, resulting in leakage of cellular contents and ultimately fungal cell death. It also inhibits the activity of oxidative and peroxidative enzymes, leading to intracellular accumulation of toxic peroxides.
Pharmacokinetics
Absorption:
Bioavailability:
< 10% (systemic after vaginal administration)
Tmax:
Not clinically relevant for vaginal cream due to minimal systemic absorption.
FoodEffect:
Not applicable for vaginal cream.
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption.
ProteinBinding:
Not clinically relevant due0 to minimal systemic absorption.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not clinically relevant for vaginal cream due to minimal systemic absorption.
Clearance:
Not clinically relevant for vaginal cream due to minimal systemic absorption.
ExcretionRoute:
Biliary/Fecal (after systemic absorption)
Unchanged:
Not clinically relevant for vaginal cream due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Symptomatic relief may begin within 2-3 days.
PeakEffect:
Full therapeutic effect typically seen after completion of the 7-day course.
DurationOfAction:
Effects persist as long as the fungus is eradicated; treatment course is designed for eradication.
Safety & Warnings
Side Effects
Serious 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 application site
Blisters or sores that ooze, drain, or crust over
Burning sensation
Swelling at the application site
Upset stomach or vomiting
Bad-smelling vaginal discharge
Stomach pain
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 have side effects that bother you or do not go away, contact your doctor or seek medical help.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
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 application site
Blisters or sores that ooze, drain, or crust over
Burning sensation
Swelling at the application site
Upset stomach or vomiting
Bad-smelling vaginal discharge
Stomach pain
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 have side effects that bother you or do not go away, contact your doctor or seek medical help.
Please note that this list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch to report side effects online.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain
- Fever or chills
- Foul-smelling vaginal discharge (may indicate a different infection)
- Hives or rash (signs of allergic reaction)
- Worsening of symptoms or no improvement after 3-4 days of treatment
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
Additionally, to ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
Additionally, to ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 accidentally swallow this drug, immediately contact a doctor or a poison control center, as it may cause harm.
If you experience frequent vaginal yeast infections, consult your doctor to discuss the best course of action.
To prevent staining, take precautions to protect your clothing and fabrics.
Do not use this medication if you have abdominal pain, fever, or a foul-smelling vaginal discharge. Instead, consult your doctor for guidance.
This drug is specifically designed to treat vaginal yeast infections. Do not use it to treat itching caused by other health issues. If you are unsure, consult your doctor.
While using this medication and for a period after stopping it, condoms and diaphragms may not be effective in preventing pregnancy or protecting against sexually transmitted diseases. You will need to use an alternative form of birth control for a certain period after the last dose. Be sure to understand how long you need to continue using this alternative method.
Avoid douching or using other vaginal products, such as tampons, during treatment with this medication and for some time after the last dose. If you have questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
If you accidentally swallow this drug, immediately contact a doctor or a poison control center, as it may cause harm.
If you experience frequent vaginal yeast infections, consult your doctor to discuss the best course of action.
To prevent staining, take precautions to protect your clothing and fabrics.
Do not use this medication if you have abdominal pain, fever, or a foul-smelling vaginal discharge. Instead, consult your doctor for guidance.
This drug is specifically designed to treat vaginal yeast infections. Do not use it to treat itching caused by other health issues. If you are unsure, consult your doctor.
While using this medication and for a period after stopping it, condoms and diaphragms may not be effective in preventing pregnancy or protecting against sexually transmitted diseases. You will need to use an alternative form of birth control for a certain period after the last dose. Be sure to understand how long you need to continue using this alternative method.
Avoid douching or using other vaginal products, such as tampons, during treatment with this medication and for some time after the last dose. If you have questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with vaginal application due to minimal systemic absorption. Ingestion of the cream may cause nausea, vomiting, or abdominal discomfort.
What to Do:
For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention. Treatment is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of symptoms (itching, burning, discharge)
Frequency: Daily during treatment, then as needed
Target: Complete resolution
Action Threshold: If symptoms worsen or do not improve after 3-4 days of treatment, or recur shortly after treatment completion, re-evaluate diagnosis.
Symptom Monitoring
- Vaginal itching
- Vaginal burning
- Vaginal discharge (change in consistency or odor)
- Vaginal irritation
- Abdominal cramps (rare)
Special Patient Groups
Pregnancy
Clotrimazole vaginal cream is generally considered safe for use during pregnancy, particularly after the first trimester. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk due to minimal systemic absorption. Use only if clearly needed and benefits outweigh potential risks.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Minimal systemic absorption makes it unlikely to be excreted in breast milk in clinically significant amounts. Considered compatible with breastfeeding.
Infant Risk:
Low risk to infant.
Pediatric Use
Not recommended for use in girls under 12 years of age unless directed by a physician, as symptoms may indicate other conditions. For post-menarcheal adolescents, dosing is similar to adults.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Use with caution if underlying conditions affect vaginal health or ability to self-administer.
Clinical Information
Clinical Pearls
- Advise patients to complete the entire 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 local irritation (burning, itching) may occur, but severe reactions should prompt discontinuation and medical advice.
- Differentiate between yeast infection symptoms and other vaginal infections (e.g., bacterial vaginosis, trichomoniasis) which require different treatments.
- Suggest applying at bedtime to allow the cream to remain in place and work effectively overnight.
Alternative Therapies
- Miconazole (vaginal cream/suppository)
- Tioconazole (vaginal ointment)
- Terconazole (vaginal cream/suppository)
- Fluconazole (oral tablet, single dose for uncomplicated cases)
Cost & Coverage
Average Cost:
$15 - $40 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 (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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.