Mycelex 1% Solution 30ml
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 is an antifungal medicine used to treat skin infections like athlete's foot, jock itch, ringworm, and certain yeast infections. It works by stopping the growth of the fungus.
How to Use This Medicine
Using Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication 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 that 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 your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss 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 continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication 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 that 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 your medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss 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 continue with 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
- Clean and dry the affected area thoroughly before applying the solution.
- Wash hands before and after applying the medication.
- Do not cover the treated area with bandages or dressings unless directed by a doctor.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Change socks and underwear daily.
- Continue using the medication for the full prescribed duration, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected area(s) twice daily
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:
Apply twice daily for 2-4 weeks, consult physician
Child:
Apply twice daily for 2-4 weeks
Adolescent:
Apply 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 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.
Pharmacokinetics
Absorption:
Bioavailability:
<0.5% (systemic after topical application)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
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:
Clinical improvement typically within 1 week
PeakEffect:
Full therapeutic effect within 2-4 weeks of consistent use
DurationOfAction:
Maintained as long as treatment continues
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While 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 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, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them 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 offer medical advice.
While 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 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, discuss them with your doctor.
Reporting Side Effects
If you experience any side effects, you can report them 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 offer medical advice.
Seek Immediate Medical Attention If You Experience:
- Increased redness or irritation at the application site
- Swelling or blistering
- Severe itching or burning
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing)
- 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 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.
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.
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 drug is accidentally ingested, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This discussion will help you understand 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:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large amounts may cause nausea, vomiting, or abdominal discomfort.
What to Do:
If ingested, seek medical attention. For topical overdose, wipe off excess medication. Call 1-800-222-1222 (Poison Control) for advice if concerned.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of infection (e.g., redness, itching, scaling)
Frequency: Daily by patient, weekly by clinician if severe
Target: Resolution of symptoms
Action Threshold: Worsening symptoms, no improvement after 1-2 weeks, or signs of allergic reaction
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Healing of skin lesions
- Absence of new lesions
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy (Category B) due to minimal systemic absorption. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk, but use only if clearly needed.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Considered low risk (L3) for nursing infants due to minimal systemic absorption. Apply carefully to avoid infant ingestion from treated areas, especially the breast.
Infant Risk:
Low risk of adverse effects to the infant.
Pediatric Use
Generally safe for use in children. Dosing is similar to adults for most indications. Always consult a pediatrician for use in infants and young children.
Geriatric Use
No specific dose adjustments or precautions are necessary for geriatric patients. Efficacy and safety are similar to 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 treatment.
- Topical clotrimazole is for external use only; avoid contact with eyes, nose, mouth, and vagina (unless specifically indicated for vaginal candidiasis with a different formulation).
- Inform patients that improvement may be seen within a week, but full resolution can take 2-4 weeks.
- If no improvement or worsening of symptoms occurs after 1-2 weeks, advise the patient to consult their healthcare provider for re-evaluation.
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Tolnaftate (topical)
Cost & Coverage
Average Cost:
$10 - $30 per 30ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Brand)
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 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.