Cormax 0.05% Ointment 45gm
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 Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cormax 0.05% Ointment contains clobetasol, a very strong corticosteroid medicine. It is used on the skin to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis and eczema. It works by calming down the body's 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 is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after use.
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 disposal.
Keep all medications in a safe location, out of the reach of children and pets.
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, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after use.
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 disposal.
Keep all medications in a safe location, out of the reach of children and pets.
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 a very thin layer of ointment to the affected skin area(s) only, as directed by your doctor. Do not use more than prescribed.
- Wash your hands before and after applying the ointment, unless your hands are the treated area.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the ointment to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- Do not use for longer than 2 consecutive weeks, or more than 50 grams per week, unless advised 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
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
Pediatric Dosing
Neonatal:
Not established. Use generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established. Use generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Child:
Not established. Use generally not recommended due to increased risk of systemic absorption and HPA axis suppression. If used, limit to smallest amount for shortest duration, and avoid occlusion.
Adolescent:
Similar to adult dosing, but with extreme caution and limited duration due to potential for systemic absorption and HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
Severe:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
Dialysis:
No specific adjustment needed for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
Severe:
No specific adjustment needed for topical use, as systemic absorption is generally limited.
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. These effects are mediated by the induction of phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Corticosteroids also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on vehicle, skin integrity, area of application, duration of exposure, and use of occlusive dressings). Systemic absorption can occur, especially with prolonged use, large surface areas, or compromised skin barrier.
Tmax:
Not precisely quantifiable for topical application due to variable absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantifiable for topical application; if absorbed systemically, distributes widely throughout the body.
ProteinBinding:
Approximately 90% (if absorbed systemically, similar to other corticosteroids).
CnssPenetration:
Limited (if absorbed systemically, similar to other corticosteroids).
Elimination:
HalfLife:
Not precisely quantifiable for topical application; systemic half-life of absorbed drug is similar to other corticosteroids (e.g., 4-6 hours).
Clearance:
Not precisely quantifiable for topical application.
ExcretionRoute:
Metabolites primarily excreted by the kidneys, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours to days for anti-inflammatory and antipruritic effects).
PeakEffect:
Within days to 2 weeks of continuous use.
DurationOfAction:
Effects persist as long as applied; residual effects may last for days 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 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
+ 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 at the site 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 have mild 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 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
+ 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 at the site 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 have mild 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:
- Increased redness, itching, or irritation at the application site
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like breakouts or hair growth in the treated area
- Changes in skin color (lightening)
- Signs of skin infection (pus, worsening pain, fever)
- Unusual tiredness, weakness, nausea, or dizziness (rare, but can indicate systemic absorption and adrenal suppression)
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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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 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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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.
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 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. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, immediately contact a doctor or a poison control center, as it can cause harm. Additionally, long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.
This medication may not be suitable for children of all ages, so it is crucial to consult with your doctor before administering it to a child. When used in children, this medication requires careful monitoring, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both 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 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. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, immediately contact a doctor or a poison control center, as it can cause harm. Additionally, long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.
This medication may not be suitable for children of all ages, so it is crucial to consult with your doctor before administering it to a child. When used in children, this medication requires careful monitoring, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- Adrenal suppression (fatigue, weakness, nausea, vomiting, hypotension)
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression), especially with prolonged or extensive use.
Monitoring
Baseline Monitoring
Assessment of skin condition (type, severity, extent of lesion)
Rationale: To establish baseline for treatment efficacy and identify contraindications.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Weekly or as clinically indicated
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 2 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse effects (skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection)
Frequency: Weekly or as clinically indicated
Target: Absence of new or worsening adverse effects
Action Threshold: Development of significant local adverse effects requires discontinuation or reduction in frequency/potency.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Normal adrenal function
Action Threshold: Suspicion of HPA axis suppression warrants laboratory testing (e.g., ACTH stimulation test) and gradual withdrawal of the corticosteroid.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Irritation
- Dryness
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy (thinning)
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Signs of secondary infection (redness, swelling, pus, fever)
- Unusual fatigue or weakness (potential HPA axis suppression)
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 can occur, especially with high potency topical steroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical clobetasol is limited. Avoid if possible.
Second Trimester:
Use with caution; systemic absorption could affect fetal development.
Third Trimester:
Use with caution; potential for HPA axis suppression in the neonate if used extensively or for prolonged periods near term.
Lactation
Corticosteroids are excreted in breast milk following systemic administration. It is not known whether topical administration of clobetasol could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Higher risk with extensive use, prolonged use, or application to areas where infant could ingest.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use should be limited to the least amount compatible with an effective therapeutic regimen and for the shortest possible duration. Not recommended for children under 12 years of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy and other local side effects. Use with caution and monitor for adverse 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 dosage should not exceed 50 grams per week.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy, telangiectasias, and other side effects.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided.
- Patients should be educated on the proper application technique (thin layer, gentle rub) and the importance of not exceeding the prescribed duration or amount.
- Rebound flares can occur if potent topical corticosteroids are stopped abruptly after prolonged use; gradual tapering may be necessary for some conditions.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, betamethasone, triamcinolone, hydrocortisone) of varying potencies depending on the condition and location.
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Topical retinoids (e.g., tazarotene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory skin conditions.
Cost & Coverage
Average Cost:
$30 - $100 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic clobetasol propionate)
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 happened.