Ketoconazole 2% Cream 60gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
C
FDA Approved
Jun 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole cream is an antifungal medication used on the skin to treat various fungal infections like athlete's foot, jock itch, ringworm, and a skin condition called seborrheic dermatitis. 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. It is essential to use this 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.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
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 by your doctor, do not cover the treated area with bandages or dressings.
If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on broken or swollen skin.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Ensure all medications are kept 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. It is essential to use this 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.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
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 by your doctor, do not cover the treated area with bandages or dressings.
If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on broken or swollen skin.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
Ensure all medications are kept 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 and dry the affected area thoroughly before applying the cream.
- Apply a thin layer of cream to the affected skin and surrounding area.
- Wash hands immediately after applying the cream.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to prevent recurrence.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Keep the affected area clean and dry.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once daily for 2-4 weeks for tinea corporis, tinea cruris, tinea pedis. For seborrheic dermatitis, apply to affected area twice daily for 4 weeks or until clinical clearing.
Condition-Specific Dosing:
tineaCorporis_Cruris_Pedis:
Apply once daily for 2-4 weeks.
seborrheicDermatitis:
Apply twice daily for 4 weeks or until clinical clearing.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established in children under 12 years of age. Use with caution and under medical supervision.
Adolescent:
Dosing similar to adults for those 12 years and older.
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
Ketoconazole is an imidazole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to increased permeability of the fungal cell membrane, leakage of cellular contents, and ultimately, fungal cell death. It also inhibits other fungal enzymes, contributing to its fungistatic and fungicidal activity.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption (less than 5%) after topical application.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local concentration peaks rapidly.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not applicable (minimal systemic distribution).
ProteinBinding:
Not applicable (minimal systemic distribution).
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic elimination).
Clearance:
Not applicable (minimal systemic clearance).
ExcretionRoute:
Not applicable (minimal systemic excretion).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within days to 1-2 weeks.
PeakEffect:
Full therapeutic effect usually observed after 2-4 weeks of consistent application.
DurationOfAction:
Effect persists as long as treatment continues; recurrence possible if treatment is stopped prematurely.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Burning
- Irritation at the site where the drug was applied
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a serious allergic reaction:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin, with or without fever
- Wheezing
- Tightness in the chest or throat
- Difficulty breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Burning
- Irritation at the site where the drug was applied
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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:
- Severe burning, itching, or stinging at the application site
- New or worsening rash
- Swelling or blistering of the skin
- Signs of an allergic reaction (e.g., difficulty breathing, swelling of face/tongue/throat, severe rash)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all prescription and over-the-counter medications, natural products, and vitamins you are currently taking to your doctor and pharmacist.
All existing health problems, as they may affect the safety and efficacy of this medication.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all prescription and over-the-counter medications, natural products, and vitamins you are currently taking to your doctor and pharmacist.
All existing health problems, as they may affect the safety and efficacy of this medication.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this drug.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you have a sulfite allergy, consult your doctor, as some formulations of this drug may contain sulfites.
Before using any other medications or products on your skin, including soaps, discuss this with your doctor to ensure safe use. Accidental ingestion of this drug can be harmful, so if it is swallowed, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of using this medication to you and your baby. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area to prevent potential harm to your baby.
Before using any other medications or products on your skin, including soaps, discuss this with your doctor to ensure safe use. Accidental ingestion of this drug can be harmful, so if it is swallowed, immediately contact a doctor or a poison control center.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of using this medication to you and your baby. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area to prevent potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic symptoms due to minimal absorption. Excessive application may lead to increased local irritation.
What to Do:
If accidentally ingested, contact a poison control center (1-800-222-1222) or seek medical attention. For excessive topical application, wipe off excess cream and monitor for local irritation.
Drug Interactions
Monitoring
Routine Monitoring
Clinical response (resolution of symptoms, clearing of lesions)
Frequency: Weekly during treatment, then at end of treatment period
Target: Complete resolution of fungal infection or seborrheic dermatitis symptoms
Action Threshold: Lack of improvement after 2-4 weeks, or worsening of condition
Local skin reactions (e.g., irritation, burning, itching, redness)
Frequency: Daily during treatment
Target: Minimal to no local irritation
Action Threshold: Severe or persistent local irritation, signs of allergic reaction
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Stinging
- Dryness
- Peeling
- Swelling
- Blistering
- Signs of worsening infection (e.g., increased spread, pus formation)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with topical application.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic absorption is minimal.
Second Trimester:
Limited data, but systemic absorption is minimal.
Third Trimester:
Limited data, but systemic absorption is minimal.
Lactation
Considered low risk. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Use with caution, avoid applying to areas that may come into direct contact with the infant's mouth or skin.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children should be under medical supervision.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact safety or efficacy.
Clinical Information
Clinical Pearls
- Topical ketoconazole is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use occlusive dressings unless specifically instructed by a healthcare professional.
- Patients should be advised to complete the full course of treatment, even if symptoms improve, to prevent relapse.
- For seborrheic dermatitis, maintenance therapy (e.g., twice weekly) may be considered after initial clearing to prevent recurrence, as directed by a physician.
- Differentiate topical ketoconazole from oral ketoconazole, which has significant systemic risks and drug interactions.
Alternative Therapies
- Clotrimazole cream
- Miconazole cream
- Terbinafine cream
- Econazole cream
- Ciclopirox cream
- Selenium sulfide shampoo (for seborrheic dermatitis)
- Pyrithione zinc shampoo (for seborrheic dermatitis)
Cost & Coverage
Average Cost:
$15 - $50 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.