Ketoconazole 2% Cream 15gm
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 medicine used to treat skin infections caused by fungi, such as athlete's foot, jock itch, ringworm, and a skin condition called seborrheic dermatitis (dandruff-like rash). 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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you are treating a skin condition on your hand, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it well. Then, gently rub a thin layer of the medication onto the affected skin. Unless your doctor advises otherwise, 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 damaged skin.
Storage and Disposal
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze it, and keep it out of the bathroom. 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. However, 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 once or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you are treating a skin condition on your hand, do not wash your hand after application.
Before applying the medication, clean the affected area and dry it well. Then, gently rub a thin layer of the medication onto the affected skin. Unless your doctor advises otherwise, 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 damaged skin.
Storage and Disposal
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze it, and keep it out of the bathroom. 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. However, 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 once or use extra doses to make up for a missed dose.
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.
- Keep the affected area clean and dry.
- Wear loose-fitting clothing and breathable footwear (for foot infections).
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area once daily for tinea corporis, tinea cruris, tinea pedis, and tinea versicolor. Apply to affected area twice daily for seborrheic dermatitis.
Condition-Specific Dosing:
tinea_corporis_cruris_pedis_versicolor:
Apply once daily for 2-4 weeks.
seborrheic_dermatitis:
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:
Apply as for adults, typically once daily for tinea infections and twice daily for seborrheic dermatitis.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due0 to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Ketoconazole is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to increased permeability of the cell membrane, leakage of cellular contents, and ultimately, fungal cell death. It also inhibits other fungal enzyme systems.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5%) after topical application.
Tmax:
Not clinically relevant for topical application.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not clinically relevant for topical application.
ProteinBinding:
Not clinically relevant for topical application.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically relevant for topical application.
Clearance:
Not clinically relevant for topical application.
ExcretionRoute:
Not clinically relevant for topical application; primarily fecal if systemically absorbed.
Unchanged:
Not clinically relevant for topical application.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within days to 1-2 weeks.
PeakEffect:
Full therapeutic effect may take 2-4 weeks depending on the condition.
DurationOfAction:
Effect persists as long as treatment is continued; recurrence possible after cessation if underlying conditions persist.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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, or 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. Contact your doctor or seek medical help if you experience:
- Burning
- Irritation at the site where the medication was applied
These are not all the possible side effects of this medication. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
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 attention 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, or 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. Contact your doctor or seek medical help if you experience:
- Burning
- Irritation at the site where the medication was applied
These are not all the possible side effects of this medication. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
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, stinging, or irritation at the application site.
- Rash, hives, or swelling (signs of an allergic reaction).
- Worsening of the skin condition.
- Signs of a secondary bacterial infection (e.g., pus, increased pain, fever).
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current 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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current 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 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. 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 infant.
Before using any other medications or products on your skin, including soaps, discuss this with your doctor. 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 infant.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion of a large amount may cause nausea, vomiting, abdominal pain.
What to Do:
If accidentally ingested, contact a poison control center immediately (e.g., 1-800-222-1222 in the US). For topical overdose, simply wipe off excess cream.
Drug Interactions
Contraindicated Interactions
- None known for topical application due to minimal systemic absorption.
Major Interactions
- None known for topical application due to minimal systemic absorption.
Moderate Interactions
- None known for topical application due to minimal systemic absorption.
Minor Interactions
- None known for topical application due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Clinical assessment of affected skin area
Rationale: To establish baseline severity and extent of fungal infection or seborrheic dermatitis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical assessment of affected skin area
Frequency: Periodically (e.g., weekly) during treatment, or as needed.
Target: Reduction in erythema, scaling, pruritus, and lesion size.
Action Threshold: If no improvement or worsening after 2-4 weeks, re-evaluate diagnosis and treatment.
Local skin reactions (e.g., irritation, burning, itching)
Frequency: Daily, or as needed.
Target: Absence or mildness of reactions.
Action Threshold: If severe irritation or allergic reaction occurs, discontinue use.
Symptom Monitoring
- Resolution of itching
- Reduction in redness and inflammation
- Decrease in scaling or flaking
- Clearing of skin lesions
- Absence of new lesions
- Monitoring for signs of local irritation (burning, stinging, pruritus, erythema)
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, 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
L3 (Moderately Safe). It is not known whether topical ketoconazole is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is unlikely to be clinically significant. Use with caution; avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age. Use in children should be under medical supervision. Generally considered safe for older children and adolescents when used as directed.
Geriatric Use
No specific dosage adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no differences in safety or effectiveness have been observed.
Clinical Information
Clinical Pearls
- Topical ketoconazole is for external use only. Avoid contact with eyes, mouth, and other mucous membranes.
- It is crucial to complete the full course of treatment, even if symptoms improve, to prevent relapse.
- For seborrheic dermatitis, maintenance therapy (e.g., 1-2 times per week) may be needed to prevent recurrence after initial clearing.
- Distinguish between topical and oral ketoconazole; their safety profiles and indications are vastly different.
- If irritation or sensitization occurs, discontinue treatment and consult a healthcare professional.
Alternative Therapies
- Other topical azole antifungals (e.g., clotrimazole, miconazole, econazole, oxiconazole, sulconazole)
- Topical allylamine antifungals (e.g., terbinafine, naftifine, butenafine)
- Topical ciclopirox
- Topical nystatin (for Candida infections only)
- Selenium sulfide shampoo or pyrithione zinc shampoo (for seborrheic dermatitis)
Cost & Coverage
Average Cost:
$15 - $40 per 15gm 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 information. 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 details about the medication taken, the amount, and the time it occurred.