Clotrimazole 1% Cream 2x45gm
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 medicine used to treat skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and certain types of 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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Keep all medications in a safe location, 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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store this medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Keep all medications in a safe location, 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
- Wash the affected area and dry thoroughly before applying the cream.
- Apply a thin layer of cream to the affected skin and surrounding area, rubbing it in gently.
- Wash hands thoroughly after applying the cream.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Wear loose-fitting clothing and breathable fabrics (e.g., cotton) to help keep the affected area dry.
- Change socks and underwear daily if treating athlete's foot or jock itch.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to ensure the infection is completely cleared and 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 of 1% cream to the affected area and surrounding skin twice daily (morning and evening). Continue treatment for 2-4 weeks, or as directed by a healthcare professional, even if symptoms improve.
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 (consult physician)
Infant:
Not established (consult physician for children under 2 years)
Child:
For children 2 years and older, apply a thin layer to the affected area twice daily for 2-4 weeks, similar to adult dosing, or as directed by a physician.
Adolescent:
Apply a thin layer to the affected area twice daily for 2-4 weeks, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to 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 altered permeability and leakage of essential intracellular components, ultimately causing fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 0.5% systemically absorbed after topical application to intact skin.
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantifiable for topical due to minimal systemic absorption; systemic half-life is approximately 3.5-5 hours.
Clearance:
Not precisely quantifiable for topical due to minimal systemic absorption.
ExcretionRoute:
Biliary and renal (for the minimal systemically absorbed portion).
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Symptom relief may begin within a few days; mycological cure typically requires 2-4 weeks of treatment.
PeakEffect:
Full therapeutic effect observed after completion of the recommended treatment duration.
DurationOfAction:
Duration of treatment is typically 2-4 weeks to ensure mycological cure and prevent recurrence.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
- 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 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 side effects that bother you or do not go away, contact your doctor or seek medical help. It's essential to note that this list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 help right away:
- 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 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 side effects that bother you or do not go away, contact your doctor or seek medical help. It's essential to note that this list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 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 the symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
To ensure your safety, 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 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.
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 the symptoms that occurred.
If you have nail or scalp infections, as this medication is not effective in treating these types of infections.
To ensure your safety, 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 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.
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 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 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 toxicity due to minimal absorption. Excessive application may lead to local irritation.
What to Do:
If accidentally ingested, seek medical attention. For topical irritation, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control Center) for advice if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (e.g., rash, itching, scaling)
Rationale: To confirm diagnosis and establish baseline severity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly by patient, periodically by clinician
Target: Complete resolution of signs and symptoms.
Action Threshold: If symptoms worsen or do not improve after 2-4 weeks of treatment, re-evaluate diagnosis and treatment plan.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Resolution of scaling or flaking
- Improvement in skin appearance
Special Patient Groups
Pregnancy
Clotrimazole topical is generally considered safe for use during pregnancy (Category B) due to minimal systemic absorption. Consult a healthcare professional 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 safe for use during lactation (L2) due to minimal systemic absorption, making it unlikely to pass into breast milk in significant amounts. Avoid applying to the nipple or areola area to prevent infant ingestion.
Infant Risk:
Low risk
Pediatric Use
Safe for use in children 2 years of age and older. For children under 2 years, use only under the supervision of a physician. Dosing is similar to adults, but treatment duration may vary based on the specific infection and physician's guidance.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Efficacy and safety profiles are similar to those in younger adults.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms resolve, to prevent recurrence.
- Advise patients to keep the affected area clean and dry to aid in healing and prevent reinfection.
- For athlete's foot, recommend wearing cotton socks and changing them frequently, and wearing well-ventilated shoes.
- For jock itch, suggest wearing loose-fitting cotton underwear.
- Clotrimazole cream is for external use only; avoid contact with eyes, nose, mouth, and vagina (unless specifically treating a vaginal yeast infection 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)
- Tolnaftate (topical)
Cost & Coverage
Average Cost:
$10 - $30 per 45gm tube of 1% cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.