Cormax 0.05% Topical Scalp Sol 25ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
C
FDA Approved
Aug 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cormax 0.05% Topical Scalp Solution contains a very strong steroid called clobetasol. It is used on the scalp to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis. It works by calming down the immune response in the skin.
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's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and make sure it's dry.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using coverings such as bandages, dressings, or makeup on the treated area unless advised by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when necessary.
Protect the medication from heat and open flames.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's 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's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and make sure it's dry.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using coverings such as bandages, dressings, or makeup on the treated area unless advised by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when necessary.
Protect the medication from heat and open flames.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's 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
- Use exactly as directed by your doctor. Do not use more often or for longer than prescribed (typically no more than 2 weeks continuously).
- Apply a thin layer only to the affected areas of the scalp. Do not use on your face, groin, or armpits unless specifically instructed by your doctor.
- Wash your hands before and after applying the solution.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or tight caps unless your doctor tells you to, as this can increase absorption and side effects.
- Do not use on broken, infected, or irritated skin without consulting your doctor.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected scalp areas twice daily, once in the morning and once at night, for up to 2 consecutive weeks. Total dosage should not exceed 50 g (or 50 mL of solution) per week.
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to the affected scalp areas twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement is seen after 2 weeks. Do not use for more than 2 weeks continuously without a treatment-free period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
For adolescents 12 years and older, use with caution and for limited periods, similar to adult dosing but with close monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Dialysis:
No specific adjustment needed for topical application.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency topical corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids bind to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). This results in reduced inflammation, edema, and pruritus in the skin.
Pharmacokinetics
Absorption:
Bioavailability:
Low, but variable; systemic absorption can occur, especially with prolonged use, application to large surface areas, occlusive dressings, or compromised skin barrier. Absorption is higher in areas with thinner skin (e.g., scalp, face).
Tmax:
Not well-defined for topical application; systemic levels are generally low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical application; if absorbed systemically, distributes widely.
ProteinBinding:
Highly protein-bound (primarily to albumin) if absorbed systemically.
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life not precisely defined for topical application due to variable absorption; generally short for corticosteroids.
Clearance:
Primarily hepatic metabolism followed by renal excretion.
ExcretionRoute:
Renal (metabolites) and biliary.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within days of initiation of therapy for local effects.
PeakEffect:
Within 1-2 weeks of continuous use for maximal local effect.
DurationOfAction:
Effects persist as long as applied; local effects may linger for a few days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
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 upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Burning or stinging
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
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 upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Burning or stinging
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:
- Signs of skin infection (e.g., increased redness, swelling, pus, warmth)
- Severe burning, itching, or irritation that worsens after application
- Thinning of the skin, easy bruising, or stretch marks in the treated area
- Unusual hair growth in the treated area
- Acne-like breakouts
- Signs of systemic absorption (rare but serious): unusual tiredness, weight gain, swelling in the face, muscle weakness, or vision problems. Contact your doctor immediately if these occur.
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 you experienced, including any symptoms that occurred.
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 of this medication.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one, to avoid potential interactions with other drugs or health conditions.
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 you experienced, including any symptoms that occurred.
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 of this medication.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one, to avoid potential interactions with other drugs or health conditions.
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, follow these precautions:
- Keep this medication away from open flames or sparks, as it is flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- Do not use this medication to treat acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds. Consult your doctor before doing so.
- Before using any other skin products or medications, including soaps, discuss them with your doctor to ensure safe use.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- The use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this risk with your doctor.
- This medication may not be suitable for children of all ages. Consult your doctor before administering it to a child.
- When used in children, this medication requires careful monitoring due to a higher risk of certain side effects.
- 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 medication directly on the nipple or the surrounding area.
Pregnancy and breastfeeding:
- If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best outcome for both you and your baby.
To minimize risks, follow these precautions:
- Keep this medication away from open flames or sparks, as it is flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- Do not use this medication to treat acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds. Consult your doctor before doing so.
- Before using any other skin products or medications, including soaps, discuss them with your doctor to ensure safe use.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- The use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this risk with your doctor.
- This medication may not be suitable for children of all ages. Consult your doctor before administering it to a child.
- When used in children, this medication requires careful monitoring due to a higher risk of certain side effects.
- 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 medication directly on the nipple or the surrounding area.
Pregnancy and breastfeeding:
- If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, striae, muscle weakness, hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Moderate Interactions
- Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, leading to potential systemic corticosteroid effects. Use with caution and monitor for adverse effects.
Monitoring
Baseline Monitoring
Skin condition and extent of affected area
Rationale: To establish baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, scaling)
Frequency: Weekly during treatment period.
Target: Significant improvement or resolution of symptoms.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: Weekly during treatment period and at follow-up.
Target: Absence or minimal signs of adverse effects.
Action Threshold: If severe or persistent local reactions occur, discontinue use and reassess.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Absence of systemic effects.
Action Threshold: If suspected, perform appropriate diagnostic tests (e.g., ACTH stimulation test, plasma cortisol levels) and discontinue or taper therapy.
Symptom Monitoring
- Increased redness, swelling, or pus (signs of infection)
- Severe burning, itching, or irritation at application site
- Thinning of skin, easy bruising, or stretch marks (striae)
- Increased hair growth in treated areas
- Acne-like eruptions
- Unusual fatigue, weight gain, moon face, or muscle weakness (signs of systemic absorption)
Special Patient Groups
Pregnancy
Pregnancy Category C. Clobetasol propionate 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 low.
Second Trimester:
Risk generally considered low with limited topical use.
Third Trimester:
Risk generally considered low with limited topical use; however, high doses or prolonged use near term could theoretically affect fetal adrenal function.
Lactation
Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemically administered corticosteroids appear in human milk. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Low risk with limited topical use, but avoid applying to areas that may come into direct contact with the infant during feeding.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression and Cushing's syndrome have been reported in children receiving topical corticosteroids.
Geriatric Use
Use with caution. Elderly patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Use the lowest effective dose for the shortest duration necessary.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super high-potency topical corticosteroid. It should be used for short durations (typically up to 2 weeks) to minimize the risk of local and systemic side effects.
- Avoid abrupt discontinuation after prolonged use, especially if used on large areas, as this can lead to a rebound flare of the underlying skin condition.
- Educate patients on proper application technique: apply a thin layer, do not use more than prescribed, and avoid occlusive dressings.
- Monitor for signs of skin atrophy (thinning, shiny skin, visible blood vessels) and HPA axis suppression, especially in children or with extensive use.
- Not for use on the face, groin, or axillae unless specifically directed by a specialist due to increased risk of side effects in these sensitive areas.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas or for long-term use.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Coal tar preparations for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions not responsive to topical treatment.
Cost & Coverage
Average Cost:
$50 - $150 per 25ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most insurance plans, especially generics)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 emergency 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.