Clotrimazole 1% Cream 15gm
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 1% Cream is an antifungal medication used to treat various skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and certain types of yeast infections on 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
To maintain the medication's effectiveness and safety, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a secure 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 scheduled dose, skip the missed dose and resume your regular dosing 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
To maintain the medication's effectiveness and safety, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a secure 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Keep the affected area clean and dry.
- Wear loose-fitting, breathable clothing (e.g., cotton) to allow air circulation.
- 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 and surrounding healthy skin twice daily (morning and evening).
Condition-Specific Dosing:
Tinea pedis:
Apply twice daily for 4 weeks.
Tinea cruris/corporis:
Apply twice daily for 2 weeks.
Cutaneous candidiasis:
Apply twice daily for 2-4 weeks.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Apply a thin layer to the affected skin area twice daily for 2-4 weeks (consult pediatrician)
Child:
Apply a thin layer to the affected skin area twice daily for 2-4 weeks
Adolescent:
Apply a thin layer to the affected skin area twice daily 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 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
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 increased cell membrane permeability and leakage of essential intracellular components, ultimately leading to fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<0.5% (systemic after topical application)
Tmax:
Not well-defined for topical application (localized effect)
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not applicable (primarily localized to stratum corneum)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
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:
Symptomatic relief typically within a few days (e.g., 2-7 days)
PeakEffect:
Not well-defined for topical application
DurationOfAction:
Dependent on completion of treatment course and resolution of infection
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 medical attention immediately:
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 is used
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 or seek medical help.
Not all possible side effects are listed here. If you have questions or concerns about side effects, talk to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
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 attention immediately:
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 is used
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 or seek medical help.
Not all possible side effects are listed here. If you have questions or concerns about side effects, talk to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Increased redness, swelling, or irritation at the application site
- Development of hives or rash over a wider area
- Difficulty breathing or swelling of the face/throat (signs of allergic reaction)
- No improvement in symptoms after 2-4 weeks 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, 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 existing health problems
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 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 taking
Any natural products or vitamins you are using
* Your existing health problems
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 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 medication is accidentally swallowed, it can be harmful. In such cases, 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 cases, 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:
- Highly unlikely with topical application due to minimal systemic absorption. Ingestion of large quantities may cause gastrointestinal upset (nausea, vomiting).
What to Do:
For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222). For topical overdose, simply wipe off excess cream.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily
Target: Complete resolution
Action Threshold: If symptoms worsen or do not improve after 2-4 weeks of treatment, re-evaluate diagnosis.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Improvement in scaling or flaking
- Resolution of burning sensation
Special Patient Groups
Pregnancy
Clotrimazole topical is generally considered safe for use during pregnancy (Pregnancy Category B) due to minimal systemic absorption. Consult with a healthcare provider before use.
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 (Lactation Risk L2). Minimal systemic absorption makes it unlikely to pass into breast milk in significant amounts. Avoid applying to the nipple area if breastfeeding.
Infant Risk:
Low risk to infant.
Pediatric Use
Safe for use in children, including infants, under medical supervision. Dosing is generally similar to adults, but duration may vary. Always consult a pediatrician.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Ensure the affected area is clean and dry before applying the cream.
- Apply a thin layer and rub in gently until it disappears.
- Wash hands thoroughly before and after applying the cream.
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent recurrence.
- For external use only. Avoid contact with eyes, nose, mouth, and vagina (unless specifically treating vaginal candidiasis with a different formulation).
- If irritation or sensitivity develops, discontinue use and consult a healthcare professional.
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Nystatin (topical - primarily for Candida)
Cost & Coverage
Average Cost:
$5 - $20 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 (often available OTC and not covered by prescription plans, or covered as a low-cost generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.