Clotrimazole 1% Cream 45gm
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 medication used to treat skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and certain types of diaper rash. 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 your skin. 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. Before applying, clean the affected area and dry it thoroughly. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
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 one.
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 your skin. 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. Before applying, clean the affected area and dry it thoroughly. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
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 one.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Clean and dry the affected area thoroughly before application.
- Apply a thin layer of cream to cover the entire affected area and a small portion of the surrounding healthy skin.
- Do not cover the treated area with an occlusive dressing unless directed by a doctor.
- Wear loose-fitting clothing and breathable fabrics (e.g., cotton) to keep the affected area dry.
- Change socks and underwear daily if treating foot or groin infections.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- 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 area and surrounding skin twice daily (morning and evening).
Condition-Specific Dosing:
Tinea pedis, tinea cruris, tinea corporis:
Apply twice daily for 2-4 weeks.
Cutaneous candidiasis:
Apply twice daily for 2-4 weeks.
Tinea versicolor:
Apply twice daily for 2-4 weeks.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Apply a thin layer to the affected area and surrounding skin twice daily (morning and evening) for 2-4 weeks, or as directed by physician.
Child:
Apply a thin layer to the affected area and surrounding skin twice daily (morning and evening) for 2-4 weeks, or as directed by physician.
Adolescent:
Apply a thin layer to the affected area and surrounding skin 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 cell death. It also inhibits the transformation of blastospores of Candida albicans into the invasive mycelial form.
Pharmacokinetics
Absorption:
Bioavailability:
<0.5% (systemic absorption after topical application)
Tmax:
Not clinically relevant for topical application (minimal systemic absorption)
FoodEffect:
Not applicable for topical application
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
Limited (not clinically relevant for topical application)
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Biliary and renal (for systemically absorbed portion, but clinically insignificant for topical use)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1 week.
PeakEffect:
Full therapeutic effect usually within 2-4 weeks.
DurationOfAction:
Maintained as long as treatment continues; resolution of infection after completion.
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 application site
Blisters or sores that ooze, drain, or crust over
Burning sensation
Swelling at the application site
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may 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.
Reporting Side Effects
If you have questions about side effects or want to report any, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
Note: This is not an exhaustive list of all possible side effects. If you have concerns about side effects, consult your doctor.
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 application site
Blisters or sores that ooze, drain, or crust over
Burning sensation
Swelling at the application site
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may 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.
Reporting Side Effects
If you have questions about side effects or want to report any, you can:
Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch
Note: This is not an exhaustive list of all possible side effects. If you have concerns about side effects, consult your doctor.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site.
- Swelling or blistering of the skin.
- Signs of a new skin infection (e.g., pus, fever).
- No improvement in symptoms after 1-2 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 symptoms you experienced.
If you have nail or scalp infections, as this medication is not effective in treating these conditions.
Additionally, to ensure safe use, you must:
Provide your doctor and pharmacist with a comprehensive list of all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about any health problems you have, as this medication may interact with other drugs or 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. This will help prevent potential interactions or adverse effects.
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 symptoms you experienced.
If you have nail or scalp infections, as this medication is not effective in treating these conditions.
Additionally, to ensure safe use, you must:
Provide your doctor and pharmacist with a comprehensive list of all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about any health problems you have, as this medication may interact with other drugs or 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. This will help prevent potential interactions or adverse effects.
Precautions & Cautions
It is essential to inform all 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. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Topical overdose is highly unlikely due to minimal systemic absorption. Ingestion of large amounts may cause nausea, vomiting, or abdominal discomfort, but is generally not life-threatening.
What to Do:
For accidental ingestion, contact a poison control center immediately (e.g., 1-800-222-1222 in the US). For topical irritation, discontinue use and wash the area with soap and water. Symptomatic and supportive care.
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 clinician if needed.
Target: Progressive reduction in symptoms.
Action Threshold: Lack of improvement after 1-2 weeks or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Appearance of affected skin area
Frequency: Daily by patient, weekly by clinician if needed.
Target: Return to normal skin appearance.
Action Threshold: Persistent rash, increased irritation, or signs of secondary infection.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Reduction in scaling or flaking
- Healing of skin lesions
- Absence 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 (L3) due to very low systemic absorption and minimal excretion into breast milk. Apply carefully to avoid direct contact with the infant's mouth or skin.
Infant Risk:
Low risk; unlikely to cause adverse effects in a breastfed infant.
Pediatric Use
Clotrimazole cream is generally safe and effective for use in pediatric patients, including infants, for appropriate fungal skin infections. Dosing is typically similar to adults. Always consult a pediatrician for use in very young children or infants.
Geriatric Use
No specific dose adjustments or precautions are generally necessary 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
- Ensure the affected area is clean and dry before applying the cream to maximize efficacy.
- Advise patients to continue treatment for the full recommended duration, even if symptoms improve, to prevent relapse.
- Topical clotrimazole is for external use only; avoid contact with eyes, nose, mouth, and vagina (unless specifically for vaginal candidiasis with a different formulation).
- If irritation or sensitization occurs, discontinue use and consult a healthcare professional.
- For athlete's foot, advise patients to wear clean, dry socks and well-ventilated shoes.
- For jock itch, advise patients to wear loose-fitting cotton underwear.
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Tolnaftate (topical)
- Nystatin (topical, for Candida only)
Cost & Coverage
Average Cost:
$5 - $20 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC) or as a Tier 1 generic prescription. Coverage varies by plan.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.