Cormax 0.05% Topical Scalp Sol 50ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cormax 0.05% Topical Scalp Solution contains clobetasol, a very strong steroid medicine. It is used on the scalp to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis or eczema. It works by calming down the body's inflammatory response.
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.
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.
Important Application Precautions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Storage and Disposal
Store the medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposing of it.
Protect the medication from heat and open flames.
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 application 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.
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.
Important Application Precautions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Storage and Disposal
Store the medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposing of it.
Protect the medication from heat and open flames.
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 application schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply only to the affected areas of the scalp as directed by your doctor. Do not use on your face, groin, or underarms.
- Wash your hands thoroughly before and after applying the solution.
- Do not use more than the prescribed amount or for longer than 2 consecutive weeks, as this can increase the risk of side effects.
- Avoid contact with your eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or tight caps unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of solution to the affected scalp areas twice daily. Treatment should be limited to 2 consecutive weeks.
Condition-Specific Dosing:
psoriasis:
Apply twice daily to affected scalp areas for up to 2 consecutive weeks. Total dosage should not exceed 50 mL per week.
eczema:
Apply twice daily to affected scalp areas for up to 2 consecutive weeks. Total dosage should not exceed 50 mL per week.
Pediatric Dosing
Neonatal:
Not established (generally not recommended)
Infant:
Not established (generally not recommended)
Child:
Not recommended for children under 12 years of age due to increased risk of systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome). If used, extreme caution and short duration under strict medical supervision.
Adolescent:
For adolescents 12 years and older, use with caution and limit treatment duration and amount similar to adults, due to higher surface area to body weight ratio compared to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use. Monitor for systemic effects if extensive absorption occurs.
Dialysis:
No specific considerations for topical use. Systemic absorption is generally minimal.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use. Monitor for systemic effects if extensive absorption occurs, as metabolism is primarily hepatic.
Confidence:
Medium
Pharmacology
Mechanism of Action
Clobetasol propionate is a super-high potency synthetic corticosteroid. It induces phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Clobetasol also exhibits vasoconstrictive and antiproliferative actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (systemic absorption can occur, especially with prolonged use, large surface area application, or compromised skin barrier)
Tmax:
Not precisely quantified for topical application; systemic levels peak hours after application if significant absorption occurs.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; distributes throughout body tissues if systemically absorbed.
ProteinBinding:
High (to plasma proteins, if systemically absorbed)
CnssPenetration:
Limited (unless significant systemic absorption occurs)
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Renal (primarily as metabolites), some biliary.
Unchanged:
Minimal (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical improvement (e.g., reduction in inflammation, pruritus)
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; rapid recurrence of symptoms upon discontinuation if underlying condition is not resolved.
Confidence:
Medium
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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision, eye pain, or severe eye irritation
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, contact your doctor for advice:
Burning or stinging sensations
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision, eye pain, or severe eye irritation
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, contact your doctor for advice:
Burning or stinging sensations
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 skin problems like thinning skin, stretch marks, acne, or increased hair growth
- Signs of skin infection (redness, swelling, pus, fever)
- Signs of too much steroid in your body (e.g., unusual weight gain, 'moon face', increased thirst or urination, fatigue, muscle weakness)
- Blurred vision or eye pain (if applied near eyes)
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 and its symptoms.
If you have thinning skin at the site where you will be applying this medication.
* If there is an active infection at the site where this medication will be used.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have to ensure safe use.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm 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 allergic reaction and its symptoms.
If you have thinning skin at the site where you will be applying this medication.
* If there is an active infection at the site where this medication will be used.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have to ensure safe use.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm 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.
To minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking.
This medication is not intended for treating diaper rash. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth.
When applying this drug to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Before using any other drugs or products on your skin, including soaps, discuss them with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Do not use this drug for a longer duration than prescribed by your doctor.
If this medication is swallowed, it can cause harm. In such an event, immediately contact a doctor or a poison control center.
Prolonged use of this drug may increase the risk of developing cataracts or glaucoma. Consult your doctor about these potential risks.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor to discuss the potential benefits and risks.
When using this drug in children, caution is advised, as the risk of certain side effects may be higher in this population.
In some cases, this medication can affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.
If you are breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to ensure the health and safety of both you and your baby.
To minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking.
This medication is not intended for treating diaper rash. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth.
When applying this drug to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Before using any other drugs or products on your skin, including soaps, discuss them with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Do not use this drug for a longer duration than prescribed by your doctor.
If this medication is swallowed, it can cause harm. In such an event, immediately contact a doctor or a poison control center.
Prolonged use of this drug may increase the risk of developing cataracts or glaucoma. Consult your doctor about these potential risks.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor to discuss the potential benefits and risks.
When using this drug in children, caution is advised, as the risk of certain side effects may be higher in this population.
In some cases, this medication can affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.
If you are breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to ensure the health and safety of both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects such as Cushing's syndrome (e.g., weight gain, moon face, central obesity, hypertension, hyperglycemia), adrenal suppression (fatigue, weakness, low blood pressure), and growth retardation in children.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. In case of suspected acute overdose or significant systemic absorption, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Systemic Corticosteroids (additive risk of HPA axis suppression)
- CYP3A4 Inhibitors (e.g., ritonavir, itraconazole - theoretical increase in systemic exposure if significant absorption occurs, but generally not clinically significant for topical use)
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin integrity issues.
Timing: Prior to initiation of therapy.
HPA axis function (e.g., morning cortisol, ACTH stimulation test)
Rationale: Consider for patients at high risk of systemic absorption (e.g., extensive body surface area, prolonged use, pediatric patients, occlusive dressings) to establish baseline.
Timing: Prior to initiation of therapy for high-risk patients.
Routine Monitoring
Clinical response and local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, irritation)
Frequency: Weekly during treatment, then as needed.
Target: Improvement in dermatosis symptoms without significant local adverse effects.
Action Threshold: Discontinue if severe irritation, infection, or signs of skin atrophy develop.
Signs and symptoms of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged or extensive use.
Target: Absence of systemic effects.
Action Threshold: Investigate HPA axis function if signs/symptoms appear; consider discontinuation or dose reduction.
Intraocular pressure (IOP)
Frequency: Periodically, if applied near eyes or for prolonged periods.
Target: Normal IOP.
Action Threshold: Refer to ophthalmologist if elevated.
Symptom Monitoring
- Increased redness, itching, or burning at application site
- Development of new skin lesions (e.g., pimples, thinning skin, stretch marks)
- Signs of skin infection (pus, fever)
- Increased thirst or urination (signs of hyperglycemia)
- Unusual fatigue, weakness, weight gain, 'moon face' (signs of Cushing's syndrome or HPA axis suppression)
- Blurred vision or eye pain (if applied near eyes)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Clobetasol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with high doses of corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction or other developmental effects with significant systemic exposure.
Third Trimester:
Risk of fetal growth restriction or other developmental effects with significant systemic exposure; potential for adrenal suppression in the neonate if used extensively near term.
Lactation
Caution is advised. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Low risk with limited, short-term use on small areas, but potential for systemic effects in infant if significant absorption occurs in mother and drug is excreted in milk. Avoid applying to breast area to prevent direct infant exposure.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Use in children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatric Use
No specific dose adjustments are recommended. However, elderly patients may have thinner skin and be more susceptible to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor closely for skin integrity and systemic effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids available. Use it sparingly and only for the prescribed duration.
- Limit treatment to 2 consecutive weeks for scalp solutions to minimize the risk of HPA axis suppression and other systemic side effects.
- The total dosage should not exceed 50 mL (or 50 grams for other formulations) per week.
- Do not use on the face, groin, or axillae due to increased risk of skin atrophy, striae, and other adverse effects in these sensitive areas.
- If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
- Patients should be advised to wash their hands after applying the solution to avoid accidental transfer to other body parts or eyes.
Alternative Therapies
- Calcipotriene solution (e.g., Dovonex, Sorilux) for psoriasis
- Tazarotene gel/foam (e.g., Tazorac, Fabior) for psoriasis
- Coal tar shampoos/solutions
- Salicylic acid preparations
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema (off-label for scalp)
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
Cost & Coverage
Average Cost:
$50 - $200 per 50ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 (generic) or Tier 2/3 (brand) depending on insurance plan formulary.
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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.