Clotrimazole A/f 1% Cream 28gm
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 cream used to treat various skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and certain yeast infections. 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 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
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 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
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
- Keep the affected area clean and dry.
- Wear loose-fitting, breathable clothing.
- Change socks and underwear frequently if treating foot or groin infections.
- Avoid sharing towels 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 1-2 times daily.
Condition-Specific Dosing:
tineaPedisCrurisCorporis:
Apply twice daily for 2-4 weeks.
cutaneousCandidiasis:
Apply twice daily for 7-14 days.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician)
Infant:
Apply a thin layer to the affected area and surrounding skin 1-2 times daily (consult pediatrician)
Child:
Apply a thin layer to the affected area and surrounding skin 1-2 times daily
Adolescent:
Apply a thin layer to the affected area and surrounding skin 1-2 times daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical use)
Moderate:
No adjustment needed (topical use)
Severe:
No adjustment needed (topical use)
Dialysis:
No specific considerations (topical use)
Hepatic Impairment:
Mild:
No adjustment needed (topical use)
Moderate:
No adjustment needed (topical use)
Severe:
No adjustment needed (topical use)
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 fungal cell death. It is fungistatic at lower concentrations and fungicidal at higher concentrations.
Pharmacokinetics
Absorption:
Bioavailability:
<0.5% (systemic after topical application to intact skin)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable (topical use)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (primarily local action, minimal systemic absorption)
Clearance:
Not applicable (primarily local action)
ExcretionRoute:
Biliary and renal (if systemically absorbed)
Unchanged:
Not applicable (primarily local action)
Pharmacodynamics
OnsetOfAction:
Within days (symptomatic relief), full effect over weeks
PeakEffect:
Not applicable (local effect)
DurationOfAction:
Dependent on continued application and infection type
Safety & Warnings
Side Effects
Serious 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
+ 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.
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
+ 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
- Pus or signs of bacterial infection
- No improvement in symptoms after 2-4 weeks of consistent use
- Worsening of the condition
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.
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 combination 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 any 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 combination 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 drug is accidentally ingested, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately if swallowing occurs. If you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor, as it is necessary to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption.
- If ingested: Nausea, vomiting, abdominal cramps, dizziness, drowsiness.
What to Do:
For accidental ingestion, seek medical attention. Management is supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection
Rationale: To confirm diagnosis and determine extent of infection
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly
Target: Complete resolution
Action Threshold: Lack of improvement after 2-4 weeks or worsening symptoms
Local adverse reactions (e.g., irritation, burning, stinging)
Frequency: Daily
Target: None or mild, transient
Action Threshold: Severe or persistent irritation, allergic reaction
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Improvement in skin appearance (less scaling, cracking)
- Absence of burning or stinging sensation
Special Patient Groups
Pregnancy
Clotrimazole topical is generally considered safe for use during pregnancy (Category B) due to minimal systemic absorption. Consult with 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 (L2). Minimal systemic absorption makes it unlikely to be excreted in breast milk in significant amounts. Avoid applying to the nipple/areola area if breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Generally safe for use in children. Dosing is similar to adults. Always consult a pediatrician for use in infants and young children.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Efficacy and safety profiles are similar to younger adults.
Clinical Information
Clinical Pearls
- Ensure the affected area is clean and dry before applying the cream.
- Apply a thin layer of cream, just enough to cover the affected area and a small margin of surrounding healthy skin.
- Wash hands thoroughly before and after applying the cream.
- Complete the full prescribed course of treatment, even if symptoms improve, to prevent recurrence.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If accidental contact occurs, rinse thoroughly with water.
- For athlete's foot, apply to the feet and between the toes. Wear clean, cotton socks and well-ventilated shoes.
Alternative Therapies
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Naftifine (topical)
- Butenafine (topical)
Cost & Coverage
Average Cost:
$5 - $20 per 28gm cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 (often OTC, not covered by prescription plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.