Ketoconazole 2% Cream 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Jun 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole 2% Cream is an antifungal medicine applied to 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 only as directed.
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.
Continue using the medication as instructed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that 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.
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on damaged skin.
Storage and Disposal
Store the medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
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. It is essential to use this medication only as directed.
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.
Continue using the medication as instructed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that 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.
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
If your skin is broken or swollen, consult your doctor before using this medication, as some medications are not suitable for use on damaged skin.
Storage and Disposal
Store the medication at room temperature, away from refrigeration and freezing.
Keep the medication in a dry place, avoiding storage in a bathroom.
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 hands thoroughly before and after applying the cream.
- Clean and dry the affected skin area before application.
- Apply a thin layer of cream to the affected skin and the immediate surrounding area.
- 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.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Wear loose-fitting clothing and breathable footwear (for foot infections) to help keep the area dry.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once daily for tinea corporis, tinea cruris, and tinea pedis. Apply to affected area twice daily for seborrheic dermatitis.
Condition-Specific Dosing:
tineaCorporis_Cruris:
Apply once daily for 2 weeks.
tineaPedis:
Apply once daily for 6 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 for children under 12 years of age. Use with caution and under medical supervision if prescribed.
Adolescent:
For adolescents 12 years and older, dosing is generally similar to adults for approved indications.
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 agent that inhibits the cytochrome P450-dependent 14-alpha-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. This leads to an accumulation of 14-alpha-methyl sterols and a decrease in ergosterol, which impairs the fungal cell membrane's permeability and function, ultimately inhibiting fungal growth.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic absorption from topical application)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
No (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:
Days to weeks (clinical improvement)
PeakEffect:
Weeks (full therapeutic effect)
DurationOfAction:
Dependent on completion of treatment course
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
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Burning
- Irritation at the site where the medication 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, 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
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Burning
- Irritation at the site where the medication 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, 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:
- Severe burning, itching, or irritation 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/lips/tongue, severe rash)
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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, 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
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, 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
* Existing health problems or conditions
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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 known allergy to sulfites, consult with your doctor, as some formulations of this product 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 you or someone else swallows it, immediately contact a doctor or a poison control center for assistance.
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 exposure to the infant.
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 you or someone else swallows it, immediately contact a doctor or a poison control center for assistance.
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 exposure to the infant.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of large quantities may lead to nausea, vomiting, and abdominal pain.
What to Do:
If accidentally ingested, seek medical attention. For topical overdose, simply wipe off excess cream. Call 1-800-222-1222 (Poison Control) for advice if concerns arise.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity and type of fungal infection.
Timing: Prior to initiation of treatment
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Weekly or as clinically indicated
Target: Progressive improvement
Action Threshold: Lack of improvement or worsening of symptoms after appropriate treatment duration may indicate treatment failure, incorrect diagnosis, or adverse reaction.
Local skin reactions (e.g., irritation, burning, pruritus)
Frequency: Daily, during application
Target: Absence or mild, transient reactions
Action Threshold: Severe or persistent irritation, burning, or allergic reactions warrant discontinuation and medical evaluation.
Symptom Monitoring
- Redness
- Itching
- Burning sensation
- Stinging
- Dryness
- Peeling
- Swelling
- Blistering
- Hives
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from topical application is minimal, suggesting low risk.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Considered low risk. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Apply to areas not in direct contact with the infant's skin or mouth.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy have not been fully established in children under 12 years of age. Use in this population should be under the guidance of a healthcare professional, weighing potential benefits against risks.
Geriatric Use
No specific dose adjustments or precautions are generally required 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
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent recurrence of the infection.
- Advise patients that improvement may not be seen for several days to weeks, depending on the infection type.
- For seborrheic dermatitis, treatment may need to be intermittent or prolonged to control symptoms.
- Inform patients that topical ketoconazole is for external use only and should not be used in the eyes, mouth, or vagina.
Alternative Therapies
- Clotrimazole topical
- Miconazole topical
- Terbinafine topical
- Econazole topical
- Ciclopirox topical
- Sertaconazole topical
Cost & Coverage
Average Cost:
$15 - $50 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.