Clotrimazole 1% Cream (otc) 14.17gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1970
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
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply 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 apply two doses at the same time or use 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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply 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 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 unless directed by a doctor.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Change socks and underwear daily.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Complete the full course of treatment, 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 skin and surrounding area twice 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 if indicated
Child:
Apply a thin layer to affected skin and surrounding area twice daily for 2-4 weeks, or as directed by a physician
Adolescent:
Apply a thin layer to affected skin and surrounding area twice daily for 2-4 weeks
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical)
Moderate:
No adjustment needed (topical)
Severe:
No adjustment needed (topical)
Dialysis:
No specific considerations (topical)
Hepatic Impairment:
Mild:
No adjustment needed (topical)
Moderate:
No adjustment needed (topical)
Severe:
No adjustment needed (topical)
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.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.5% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Not available (primarily local action)
CnssPenetration:
Limited (not systemically absorbed)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Biliary/fecal (if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within days (symptomatic relief), full therapeutic effect over weeks
PeakEffect:
Not applicable (local action)
DurationOfAction:
Maintained with continued application
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, talk to your doctor.
Reporting Side Effects
You can report side effects 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 answer any questions you may have.
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, talk to your doctor.
Reporting Side Effects
You can report side effects 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 answer any questions you may have.
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 2-4 weeks of use
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 treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems you have.
This information will help your doctor determine whether 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, 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 treatment, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems you have.
This information will help your doctor determine whether 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 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 an event, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
If this medication is accidentally swallowed, it can be harmful. In such an event, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic effects due to minimal absorption.
- Accidental ingestion may cause nausea, vomiting, abdominal cramps, or diarrhea.
What to Do:
For accidental ingestion, seek medical attention or call a poison control center (1-800-222-1222). Management is generally supportive.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of symptoms (itching, redness, scaling)
Frequency: Daily
Target: Improvement leading to resolution
Action Threshold: If no improvement after 2 weeks (tinea cruris/corporis) or 4 weeks (tinea pedis), or if condition worsens, consult a healthcare provider.
Skin irritation or allergic reaction
Frequency: Daily
Target: Absence of new or worsening irritation
Action Threshold: Discontinue use and consult a healthcare provider if severe irritation, rash, or signs of allergic reaction occur.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Resolution of scaling or flaking
- Healing of skin lesions
- Absence of burning or stinging
Special Patient Groups
Pregnancy
Clotrimazole topical is generally considered safe for use during pregnancy. Systemic absorption is minimal. Use only if clearly needed and under the guidance of a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic absorption.
Second Trimester:
Low risk, minimal systemic absorption.
Third Trimester:
Low risk, minimal systemic absorption.
Lactation
Clotrimazole topical is considered compatible with breastfeeding. Systemic absorption is minimal, making infant exposure unlikely. Avoid applying to the breast area if breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Generally safe for use in children over 2 years of age. For children under 2 years, consult a physician. Dosing is similar to adults for topical application. Ensure proper diagnosis as diaper rash can be confused with fungal infections.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not typically a concern for topical use.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent relapse.
- Advise patients to keep the affected area clean and dry to aid in healing and prevent recurrence.
- For athlete's foot, recommend wearing cotton socks and changing them frequently, and using antifungal powder in shoes.
- Inform patients that temporary mild burning, stinging, or irritation may occur upon application.
- Clotrimazole cream is for external use only; avoid contact with eyes, nose, mouth, and vagina (unless specifically indicated for vaginal use, which is a different formulation).
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Tolnaftate (topical)
- Ketoconazole (topical)
- Econazole (topical)
Cost & Coverage
Average Cost:
$5 - $15 per 14.17gm tube
Generic Available:
Yes
Insurance Coverage:
Not typically covered by prescription plans as it is an OTC product, but may be eligible for FSA/HSA.
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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.