Ketoconazole 2% Shampoo 120ml
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, topical
Pharmacologic Class
Imidazole antifungal
Pregnancy Category
Category C
FDA Approved
Dec 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ketoconazole 2% shampoo is an antifungal medicine used to treat skin conditions like seborrheic dermatitis (dandruff) and tinea versicolor (a fungal skin infection). It works by stopping the growth of the fungus that causes these conditions. You apply it to your skin or scalp, lather, leave it on for a few minutes, and then rinse it off.
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 as directed, and continue to use it even if your symptoms improve.
Application Instructions
This medication is for use on your scalp and hair only. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning. To apply:
1. Wet your hair and scalp.
2. Apply enough shampoo to create a lather.
3. Lather well and leave it on for the recommended amount of time.
4. Rinse thoroughly.
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 direct light. Keep it in a dry place, and avoid storing it in the bathroom or refrigerating/freezing it.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
This medication is for use on your scalp and hair only. Avoid getting it in your mouth, nose, ears, or eyes, as it may cause burning. To apply:
1. Wet your hair and scalp.
2. Apply enough shampoo to create a lather.
3. Lather well and leave it on for the recommended amount of time.
4. Rinse thoroughly.
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 direct light. Keep it in a dry place, and avoid storing it in the bathroom or refrigerating/freezing it.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not swallow the shampoo.
- Use regularly as directed by your doctor, even if symptoms improve, to prevent recurrence.
- For seborrheic dermatitis, regular use can help control dandruff and flaking.
- For tinea versicolor, ensure the shampoo covers all affected areas.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas of the skin and scalp, lather, and leave in place for 3-5 minutes before rinsing. For seborrheic dermatitis: use twice weekly for 4 weeks, with a maintenance regimen of once every 1-2 weeks as needed. For tinea versicolor: use once daily for 5 days.
Condition-Specific Dosing:
seborrheicDermatitis:
Apply twice weekly for 4 weeks, then once every 1-2 weeks as needed for maintenance.
tineaVersicolor:
Apply once daily for 5 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established in children under 12 years of age. Use only if clearly needed and under medical supervision.
Adolescent:
Generally considered safe for use in adolescents 12 years and older, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No 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. It does this by inhibiting the cytochrome P450-dependent enzyme lanosterol 14-alpha-demethylase. This inhibition leads to increased permeability of the fungal cell membrane, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal (<5% systemically) after topical application to the skin or scalp.
Tmax:
Not applicable for topical shampoo; systemic levels are negligible.
FoodEffect:
Not applicable for topical shampoo.
Distribution:
Vd:
Not applicable for topical shampoo due to minimal systemic absorption.
ProteinBinding:
Not applicable for topical shampoo due to minimal systemic absorption.
CnssPenetration:
No (minimal to none due to negligible systemic absorption).
Elimination:
HalfLife:
Not applicable for topical shampoo due to minimal systemic absorption.
Clearance:
Not applicable for topical shampoo due to minimal systemic absorption.
ExcretionRoute:
Not applicable for topical shampoo due to minimal systemic absorption.
Unchanged:
Not applicable for topical shampoo due to minimal systemic absorption.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 weeks for seborrheic dermatitis; within 5-7 days for tinea versicolor.
PeakEffect:
Not applicable in terms of systemic drug levels; peak clinical effect depends on duration of treatment.
DurationOfAction:
Effect persists as long as the product is used as directed, with maintenance therapy often required for chronic conditions like seborrheic dermatitis.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
- 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, difficulty 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 any of the following side effects or if they persist or bother you:
- Burning
- Irritation at the site of application
- Loss of hair curl
- Hair loss
- Change in hair color
- Change in hair texture
- Itching
- Dry skin
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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
- 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, difficulty 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 any of the following side effects or if they persist or bother you:
- Burning
- Irritation at the site of application
- Loss of hair curl
- Hair loss
- Change in hair color
- Change in hair texture
- Itching
- Dry skin
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, stinging, or irritation after application
- New or worsening rash
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing or swallowing
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 assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 assess potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, such as soaps, consult with your doctor to ensure safe use. If this medication is accidentally swallowed, immediately contact a doctor or a poison control center for assistance. If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Ingestion of large amounts may cause nausea, vomiting, abdominal pain, and headache. Systemic toxicity is unlikely due to poor absorption.
- Excessive topical application may lead to increased local irritation.
What to Do:
If ingested, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). For topical irritation, discontinue use and rinse thoroughly with water. Symptomatic and supportive care.
Drug Interactions
Monitoring
Symptom Monitoring
- Resolution of scaling, itching, and redness (for seborrheic dermatitis)
- Resolution of skin discoloration (for tinea versicolor)
- Signs of local irritation (e.g., burning, stinging, itching, redness)
- Signs of allergic reaction (e.g., rash, swelling, severe itching)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with topical application, reducing the risk compared to oral ketoconazole.
Trimester-Specific Risks:
First Trimester:
Minimal systemic absorption suggests low risk, but caution is advised.
Second Trimester:
Minimal systemic absorption suggests low risk.
Third Trimester:
Minimal systemic absorption suggests low risk.
Lactation
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.
Infant Risk:
Low risk to nursing infant due to minimal maternal systemic absorption.
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 or precautions are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in metabolism or excretion are not relevant.
Clinical Information
Clinical Pearls
- Ketoconazole 2% shampoo is prescription-strength, while 1% is available OTC.
- For seborrheic dermatitis, it's often used as a 'treatment' phase (e.g., twice weekly for 4 weeks) followed by a 'maintenance' phase (e.g., once every 1-2 weeks).
- Ensure the shampoo is left on the affected area for the recommended 3-5 minutes to allow adequate contact time for the active ingredient.
- Avoid using harsh soaps or other irritants on the scalp/skin during treatment, as this can worsen irritation.
- If symptoms do not improve after the recommended treatment period, consult a healthcare professional to re-evaluate the diagnosis.
Alternative Therapies
- Selenium sulfide shampoo (e.g., Selsun Blue)
- Pyrithione zinc shampoo (e.g., Head & Shoulders, Nizoral A-D 1%)
- Ciclopirox shampoo
- Coal tar shampoo
- Topical corticosteroids (for inflammation/itching in seborrheic dermatitis)
- Topical antifungals (e.g., clotrimazole, miconazole, terbinafine creams for tinea versicolor)
Cost & Coverage
Average Cost:
$15 - $40 per 120ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most plans, especially 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 for more information. If you have any questions or concerns about this 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 happened.