Clotrimazole 1% Cream (otc) 14gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole antifungal
Pregnancy Category
B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clotrimazole 1% cream is an antifungal medication used to treat common skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and certain yeast infections of the skin. It works by stopping the growth of the fungus.
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 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 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 resume your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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 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 resume your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash the affected area and dry thoroughly before applying the cream.
- Apply a thin layer of cream to the affected area and surrounding skin.
- Wash hands thoroughly after applying the cream.
- Do not cover the treated area with bandages or dressings unless directed by a doctor.
- Wear loose-fitting, breathable clothing (e.g., cotton) to allow air circulation.
- Keep the affected area clean and dry.
- Change socks and underwear frequently if treating foot or groin infections.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
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 the affected skin area twice daily (morning and evening)
Condition-Specific Dosing:
tineaPedis:
Apply for 4 weeks
tineaCruris:
Apply for 2 weeks
tineaCorporis:
Apply for 2 weeks
cutaneousCandidiasis:
Apply for 2 weeks
Pediatric Dosing
Neonatal:
Not established (use with caution and physician consultation)
Infant:
Not established (use with caution and physician consultation)
Child:
Apply a thin layer to the affected skin area twice daily (morning and evening) for 2-4 weeks, or as directed by a physician.
Adolescent:
Apply a thin layer to the affected skin area twice 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 inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.5% (systemic absorption after topical application)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Biliary/fecal (if systemically absorbed)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1 week, but full course of treatment is necessary.
PeakEffect:
Full therapeutic effect observed after completing the recommended treatment duration (2-4 weeks).
DurationOfAction:
Effect persists as long as the drug is applied; residual effect after cessation depends on the fungal burden and host factors.
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or 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. 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 have side effects that bother you or do not go away, contact your doctor for advice. Note that this list may not include all possible side effects. If you have questions or concerns about side effects, your doctor is available to provide guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for discussing any side effects and providing medical advice.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, or 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. 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 have side effects that bother you or do not go away, contact your doctor for advice. Note that this list may not include all possible side effects. If you have questions or concerns about side effects, your doctor is available to provide guidance.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also a valuable resource for discussing any side effects and providing medical advice.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site
- Swelling or blistering of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
- No improvement in symptoms after 1-2 weeks of treatment
- Worsening of the 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 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 currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 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 currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 drug is ingested, it may cause harm, so it is crucial to contact a doctor or a poison control center immediately if accidental ingestion occurs. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to local skin irritation (redness, burning, stinging).
What to Do:
If accidentally ingested, contact a poison control center immediately. For topical overdose, wash the area with soap and water. If irritation persists, seek medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- None known for topical application
Major Interactions
- None known for topical application
Moderate Interactions
- None known for topical application
Minor Interactions
- None known for topical application
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To confirm fungal infection and establish baseline severity (e.g., redness, itching, scaling, lesions).
Timing: Prior to initiation of treatment
Routine Monitoring
Resolution of symptoms (e.g., itching, burning, 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, warrants re-evaluation.
Adverse skin reactions (e.g., irritation, rash, blistering)
Frequency: Daily by patient
Target: Absence of new or worsening reactions
Action Threshold: Development of severe irritation, allergic reaction, or worsening of existing symptoms requires discontinuation and medical advice.
Symptom Monitoring
- Itching
- Redness
- Scaling
- Burning sensation
- Cracking of skin
- Blistering
Special Patient Groups
Pregnancy
Clotrimazole topical cream is generally considered safe for use during pregnancy (Pregnancy Category B) due to minimal systemic absorption. However, use only if clearly needed and after consulting with 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 cream is considered compatible with breastfeeding (Lactation Risk L3) due to minimal systemic absorption. It is unlikely to cause adverse effects in a breastfed infant. Avoid applying to the breast or nipple area to prevent direct infant ingestion.
Infant Risk:
Low risk
Pediatric Use
Safe for use in children over 2 years of age. For children under 2 years, consult a physician before use. Dosing is similar to adults, but duration may vary based on physician's advice. Ensure proper diagnosis as other skin conditions can mimic fungal infections.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Use as directed for adults.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent recurrence.
- Advise patients to keep the affected area clean and dry to aid healing and prevent reinfection.
- Remind patients that clotrimazole cream is for external use only and should not be used in the eyes, mouth, or vagina (unless specifically formulated for vaginal use).
- Educate on hygiene practices to prevent spread of infection (e.g., hand washing, not sharing personal items).
- If symptoms do not improve after the recommended treatment period (e.g., 2-4 weeks), advise patients to consult a healthcare professional for re-evaluation and alternative diagnosis/treatment.
Alternative Therapies
- Miconazole 2% cream (e.g., Micatin, Desenex)
- Terbinafine 1% cream (e.g., Lamisil AT)
- Ketoconazole 2% cream (prescription)
- Tolnaftate 1% cream/solution (e.g., Tinactin)
Cost & Coverage
Average Cost:
$5 - $20 per 14gm tube
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC) products are generally not covered by prescription drug plans unless specifically prescribed by a physician and covered under a flexible spending account (FSA) or health savings account (HSA).
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.