Clotrimazole 1% Cream (otc) 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clotrimazole cream is an antifungal medicine used on the skin to treat common fungal infections like athlete's foot, jock itch, ringworm, and yeast infections of the skin. It works by stopping the growth of the fungus.
How to Use This Medicine
Using 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 closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
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.
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 dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use 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 closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
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.
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 dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Clean and dry the affected area thoroughly before applying the cream.
- Wash hands before and after applying the cream.
- Do not cover the treated area with bandages or dressings unless directed by a doctor.
- Wear loose-fitting clothing and breathable footwear (e.g., cotton socks) to keep the area dry.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Continue using the cream for the full recommended duration, even if symptoms improve, to prevent recurrence.
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:
Apply a thin layer to affected area and surrounding skin 2 times daily (morning and evening)
Condition-Specific Dosing:
tineaPedis:
Apply twice daily for 4 weeks
tineaCruris:
Apply twice daily for 2 weeks
tineaCorporis:
Apply twice daily for 2 weeks
cutaneousCandidiasis:
Apply twice daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Consult physician; generally similar to child dosing for topical use if indicated
Child:
Apply a thin layer to affected area and surrounding skin 2 times daily (morning and evening) for 2-4 weeks, or as directed by physician. Safety and efficacy in children under 2 years of age have not been established.
Adolescent:
Apply a thin layer to affected area and surrounding skin 2 times daily (morning and evening) for 2-4 weeks.
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 adjustment needed (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
Clotrimazole is an imidazole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death. It exhibits fungistatic activity at lower concentrations and fungicidal activity at higher concentrations against susceptible organisms.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.5% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1 week
PeakEffect:
Full therapeutic effect within 2-4 weeks of consistent application
DurationOfAction:
Maintained as long as applied; residual effect for a short period after cessation
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
Blisters or sores that ooze, drain, or crust over
Burning sensation
* Swelling at the site where the medication was applied
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 any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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 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
Blisters or sores that ooze, drain, or crust over
Burning sensation
* Swelling at the site where the medication was applied
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 any side effects that bother you or do not go away, contact your doctor for advice. Not all possible side effects are listed here. If you have questions or concerns about side effects, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Increased redness or irritation at the application site
- Severe burning or stinging
- Swelling or blistering
- Signs of allergic reaction (e.g., rash, hives, difficulty breathing - seek immediate medical attention)
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 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 your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist. This will help determine whether it is safe to take this medication in combination 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, 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 your safety, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist. This will help determine whether it is safe to take this medication in combination 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 of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
Before taking this medication, notify your doctor if you are pregnant, planning to become pregnant, or are currently breast-feeding. Your doctor will discuss the potential benefits and risks of using this medication during pregnancy or breast-feeding to ensure the best possible outcome for you and your baby.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
Before taking this medication, notify your doctor if you are pregnant, planning to become pregnant, or are currently breast-feeding. Your doctor will discuss the potential benefits and risks of using this medication during pregnancy or breast-feeding to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Local irritation may occur.
What to Do:
If accidentally ingested, contact a poison control center immediately. For topical overuse, wash the area with soap and water. Call 1-800-222-1222
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of affected area
Rationale: To establish baseline severity and type of fungal infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily by patient, weekly by healthcare provider if needed
Target: Progressive improvement
Action Threshold: Lack of improvement after 1-2 weeks or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local skin reactions (e.g., irritation, burning, stinging)
Frequency: Daily by patient
Target: None to mild
Action Threshold: Severe or persistent irritation may warrant discontinuation.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Reduction in scaling or flaking
- Improvement in skin appearance
- Absence of new lesions
Special Patient Groups
Pregnancy
Clotrimazole topical is generally considered safe for use during pregnancy (Category B) due to minimal systemic absorption. However, use only if clearly needed and after consulting a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Clotrimazole topical is considered compatible with breastfeeding (L3). Systemic absorption is minimal, making infant exposure unlikely. Avoid applying to the breast area if breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy in children under 2 years of age have not been fully established; consult a physician. For children 2 years and older, dosing is generally similar to adults, but duration may vary. Supervise application to ensure proper use.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in organ function are not expected to significantly impact safety or efficacy.
Clinical Information
Clinical Pearls
- Clotrimazole 1% cream is a widely available and effective OTC treatment for common superficial fungal infections.
- Emphasize the importance of completing the full course of treatment (typically 2-4 weeks) even if symptoms improve earlier, to prevent relapse.
- Advise patients on good hygiene practices, such as keeping affected areas clean and dry, and wearing breathable clothing, to aid treatment and prevent recurrence.
- Inform patients that improvement is usually seen within 1 week, but full resolution may take longer.
- Not for ophthalmic, oral, or intravaginal use (unless specifically formulated for those uses, e.g., vaginal cream).
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Tolnaftate (topical)
- Ketoconazole (topical)
- Econazole (topical)
Cost & Coverage
Average Cost:
$5 - $20 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
OTC (Over-the-Counter), generally not covered by prescription insurance unless prescribed by a physician and submitted for reimbursement, but inexpensive enough for most to purchase out-of-pocket.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.