Clotrimazole 1% Cream 30gm

Manufacturer TARO Active Ingredient Clotrimazole Cream, Ointment, and Solution(kloe TRIM a zole) Pronunciation kloe TRIM a zole
It is used to treat fungal infections of the skin.
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Drug Class
Antifungal
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Pharmacologic Class
Imidazole Antifungal
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Pregnancy Category
Category B
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FDA Approved
Jan 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clotrimazole cream is an antifungal medicine used on the skin to treat various fungal infections like athlete's foot, jock itch, ringworm, and yeast infections of the skin. It works by stopping the growth of the fungus.
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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

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 irritation or 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 application. Clean the affected area before use and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.

Unless instructed by your doctor to do so, do not cover the treated area with bandages or dressings.

Storage and Disposal

To maintain the medication's effectiveness, store it at room temperature in a dry location, avoiding bathrooms. Keep the container tightly closed and out of reach of children and pets.

Missed Dose Instructions

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 continue with your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
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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 the affected skin and surrounding area.
  • Do not cover the treated area with bandages unless directed by a doctor.
  • Wear loose-fitting clothing and breathable fabrics (e.g., cotton) to keep the area dry.
  • 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.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected area and surrounding skin 1-2 times daily.
Dose Range: 1 - 2 mg

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.
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Pediatric Dosing

Neonatal: Not established, consult pediatrician.
Infant: Apply a thin layer to the affected area and surrounding skin 1-2 times daily, under medical supervision.
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.
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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

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal (<0.5% systemic absorption after topical application).
Tmax: Not applicable (minimal systemic absorption).
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not applicable (minimal systemic absorption).
ProteinBinding: Not applicable (minimal systemic absorption).
CnssPenetration: No (minimal systemic absorption).

Elimination:

HalfLife: Not applicable (minimal systemic absorption).
Clearance: Not applicable (minimal systemic absorption).
ExcretionRoute: Primarily fecal and renal if systemically absorbed, but systemic absorption is minimal.
Unchanged: Not applicable (minimal systemic absorption).
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically seen within 1 week.
PeakEffect: Full therapeutic effect usually within 2-4 weeks of consistent application.
DurationOfAction: Maintained as long as treatment continues; residual effect after cessation depends on infection severity and duration of treatment.

Safety & Warnings

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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
+ 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 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
You can report any side effects 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 answering any questions you may have.
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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, swelling of face/lips/tongue/throat)
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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 treatment, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

This will enable your doctor and pharmacist to assess potential interactions and determine the safety of taking this medication with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
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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.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is highly unlikely due to minimal systemic absorption. Ingestion of a large amount may cause nausea, vomiting, or abdominal discomfort.

What to Do:

If accidentally ingested, seek medical attention. For topical irritation, discontinue use and wash the area. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Routine Monitoring

Clinical signs and symptoms of fungal infection (e.g., redness, itching, scaling)

Frequency: Daily by patient, weekly by clinician if needed

Target: Resolution of symptoms

Action Threshold: Lack of improvement after 1-2 weeks or worsening symptoms

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Symptom Monitoring

  • Reduction in itching
  • Decrease in redness
  • Resolution of scaling or rash
  • Healing of skin lesions

Special Patient Groups

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Pregnancy

Clotrimazole topical is generally considered safe for use during pregnancy (Pregnancy Category B) due to minimal systemic absorption. Use only if clearly needed and under medical advice.

Trimester-Specific Risks:

First Trimester: Low risk, but use with caution and only if necessary.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Clotrimazole topical is considered low risk during breastfeeding (Lactation Risk L2) due to minimal systemic absorption. Avoid applying to the breast area if breastfeeding to prevent infant ingestion.

Infant Risk: Low risk of adverse effects in breastfed infants.
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Pediatric Use

Generally safe for use in pediatric patients for appropriate indications. Dosing is similar to adults. Always consult a pediatrician for infants and young children.

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Geriatric Use

No specific dose adjustments or precautions are necessary for geriatric patients. Efficacy and safety are similar to younger adults.

Clinical Information

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Clinical Pearls

  • Clotrimazole is effective for common superficial fungal infections of the skin, including tinea (ringworm, athlete's foot, jock itch) and cutaneous candidiasis.
  • Patients should be advised to complete the full course of treatment, even if symptoms improve, to prevent relapse.
  • Proper hygiene, such as keeping the affected area clean and dry, is crucial for successful treatment and prevention of recurrence.
  • Topical clotrimazole has an excellent safety profile due to its very low systemic absorption.
  • If no improvement is seen after 2-4 weeks of treatment, re-evaluate the diagnosis.
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Alternative Therapies

  • Miconazole (topical)
  • Terbinafine (topical)
  • Ketoconazole (topical)
  • Econazole (topical)
  • Nystatin (topical, for Candida only)
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Cost & Coverage

Average Cost: $5 - $20 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.