Cormax 0.05% Cream 30gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
May 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong (potent) corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like psoriasis and eczema. 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 dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this 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.
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.
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 take 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 dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this 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.
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.
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 take extra doses.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the cream, unless your hands are the treated area.
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid using this medicine on your face, groin, or armpits unless your doctor tells you to, as these areas are more sensitive to side effects.
- Do not use for longer than 2 weeks continuously, or exceed 50 grams per week, unless directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on broken, infected, or irritated skin without consulting your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice daily, once in the morning and once at night.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
Eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
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. If used, limit to the smallest amount for the shortest duration.
Adolescent:
For adolescents 12 years and older, use with caution and limit treatment duration to 2 weeks, not exceeding 50 g per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids bind to cytoplasmic glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene expression. This leads to the synthesis of lipocortins, which inhibit phospholipase A2, thereby preventing the release of arachidonic acid and the subsequent formation of inflammatory mediators like prostaglandins and leukotrienes. They also suppress the immune response by inhibiting the migration of macrophages and leukocytes to the inflamed area, and by reversing capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (systemic absorption is generally low but can increase with prolonged use, large surface area application, occlusion, or compromised skin barrier)
Tmax:
Not precisely quantifiable for topical application due to variable absorption; systemic effects can manifest over days to weeks of continuous use.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantifiable for topical application; systemically absorbed clobetasol is distributed throughout the body.
ProteinBinding:
Approximately 97% (for systemically absorbed portion)
CnssPenetration:
Limited (for topical application, systemic levels are usually too low to cause significant CNS penetration)
Elimination:
HalfLife:
Approximately 3-5 hours (for systemically absorbed portion)
Clearance:
Not precisely quantifiable for topical application.
ExcretionRoute:
Renal (primarily as metabolites), some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (e.g., reduction in redness, itching)
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; HPA axis suppression can persist for some time after discontinuation.
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 or seek medical attention immediately:
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. 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 symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all 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 or seek medical attention immediately:
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. 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 symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all 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 where the medicine is applied.
- New or worsening skin rash or infection.
- Skin thinning, easy bruising, or stretch marks appearing.
- Changes in skin color.
- Unusual hair growth.
- Signs of systemic absorption: unusual tiredness, weakness, nausea, vomiting, dizziness, weight gain, swelling in the face or ankles, or blurred vision (rare).
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 existing health problems you have. Your doctor will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 existing health problems you have. Your doctor will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.
Before using other skincare products or medications, including soaps, consult your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond the duration prescribed by your doctor.
If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.
Before using other skincare products or medications, including soaps, consult your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond the duration prescribed by your doctor.
If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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, buffalo hump, central obesity, skin thinning, easy bruising, striae, muscle weakness, fatigue, hypertension, hyperglycemia, and HPA axis suppression.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 for Poison Control Center assistance.
Drug Interactions
Moderate Interactions
- Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to systemic corticosteroid effects. Use with caution.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Area of body surface area (BSA) affected
Rationale: To estimate potential for systemic absorption and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms and appearance of skin lesions.
Action Threshold: If no improvement after 2 weeks, reassess diagnosis and treatment plan. If worsening, discontinue.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching)
Frequency: At each follow-up visit.
Target: Absence of or minimal local adverse effects.
Action Threshold: If significant local adverse effects occur, reduce frequency, switch to lower potency, or discontinue.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusion.
Target: Absence of signs/symptoms.
Action Threshold: If suspected, perform ACTH stimulation test. If confirmed, gradually withdraw clobetasol and manage HPA axis suppression.
Symptom Monitoring
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching that worsens
- Skin thinning or bruising easily
- Development of stretch marks (striae)
- Appearance of small red lines (telangiectasias)
- Signs of skin infection (pus, fever, spreading redness)
- Unusual fatigue or weakness
- Weight gain or swelling (especially in face/neck)
- Blurred vision (rare, with prolonged systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption of topical clobetasol is low, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low.
Second Trimester:
Risk generally considered low with limited topical use.
Third Trimester:
Risk generally considered low with limited topical use; however, potential for HPA axis suppression in the neonate with extensive maternal use near term.
Lactation
L3 (Moderately Safe). It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is low, so infant exposure is likely minimal. Use with caution. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use. Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression).
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Not recommended for children under 12 years of age. If used in adolescents, limit treatment duration and amount. Monitor closely for signs of HPA axis suppression, Cushing's syndrome, and growth retardation.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy and purpura. Monitor for these effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% is a super-high potency topical corticosteroid; it should be used for short durations (typically no more than 2 consecutive weeks) to minimize the risk of local and systemic side effects.
- Total weekly dosage should generally not exceed 50 grams.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically prescribed.
- Patients should be educated on proper application technique (thin layer, gentle rub) and the importance of not exceeding the prescribed duration or amount.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone dipropionate, fluocinonide for high potency; triamcinolone acetonide for medium potency)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like eczema, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses not responsive to topical treatment.
Cost & Coverage
Average Cost:
$20 - $100 per 30g tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.