Cormax 0.05% Ointment 15gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid, synthetic; Anti-inflammatory agent
Pregnancy Category
Category C
FDA Approved
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cormax Ointment contains clobetasol, a very strong steroid medicine applied to the skin. It is used to treat severe skin conditions like psoriasis and eczema by reducing redness, swelling, and itching. It should only be used for short periods, usually no more than two weeks, and in small amounts, as directed by your doctor.
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 specifically instructed to do so by your doctor.
Do not cover the treated area with bandages, dressings, or makeup unless advised by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the duration for which it can be stored before disposal.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled 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 make up for a missed dose.
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 specifically instructed to do so by your doctor.
Do not cover the treated area with bandages, dressings, or makeup unless advised by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the duration for which it can be stored before disposal.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled 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 make up for a missed dose.
Lifestyle & Tips
- Apply a very thin layer of ointment only to the affected skin areas.
- Wash your hands before and after applying the ointment.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption.
- Avoid using on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
- Do not use for longer than 2 weeks continuously, or exceed 50 grams per week, without consulting your doctor.
- Avoid contact with eyes.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 grams per week.
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to affected areas twice daily for up to 2 consecutive weeks. Limit total dosage to 50 g/week.
eczema:
Apply a thin layer to affected areas twice daily for up to 2 consecutive weeks. Limit total dosage to 50 g/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.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration (e.g., up to 2 weeks), similar to adult dosing, but monitor closely for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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.
Pharmacokinetics
Absorption:
Bioavailability:
Not well quantified for topical application; systemic absorption varies depending on the vehicle, integrity of the epidermal barrier, and use of occlusive dressings. Absorption is increased on inflamed or damaged skin.
Tmax:
Not applicable for topical systemic absorption; systemic levels are generally very low.
FoodEffect:
Not applicable
Distribution:
Vd:
Not well quantified for topical application; systemically absorbed corticosteroids are distributed rapidly to all body tissues.
ProteinBinding:
Approximately 90% for systemically absorbed corticosteroids.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well defined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not well defined for topical application.
ExcretionRoute:
Renal excretion of metabolites, with some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Clinical effects (reduction in inflammation, pruritus) may be observed within hours to days of initiation.
PeakEffect:
Peak therapeutic effect typically observed within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as the drug is applied; residual effects may last for a short period 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 unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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, swelling, or pus at the application site (signs of infection)
- Severe burning, itching, or irritation that was not present before
- Skin thinning, easy bruising, or stretch marks (striae) in the treated area
- Changes in skin color (lightening)
- Acne-like breakouts or hair growth in the treated area
- Signs of systemic absorption (rare but serious): unexplained weight gain, swelling in the face (moon face), fatigue, muscle weakness, high blood pressure, or high blood sugar.
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, 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 dosage 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 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, 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 dosage 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 ingested, this medication can be harmful; in such cases, immediately contact a doctor or a poison control center.
There is a potential risk of developing cataracts or glaucoma associated with this medication. Discuss this with your doctor to understand the implications. The suitability of this medication for children of all ages has not been established; therefore, consult your doctor before administering it to a child.
When using this medication in children, caution is advised due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks. Your doctor can provide guidance on this matter.
If you are breastfeeding, avoid applying this medication directly on the nipple or the surrounding area. It is crucial 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 ingested, this medication can be harmful; in such cases, immediately contact a doctor or a poison control center.
There is a potential risk of developing cataracts or glaucoma associated with this medication. Discuss this with your doctor to understand the implications. The suitability of this medication for children of all ages has not been established; therefore, consult your doctor before administering it to a child.
When using this medication in children, caution is advised due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks. Your doctor can provide guidance on this matter.
If you are breastfeeding, avoid applying this medication directly on the nipple or the surrounding area. It is crucial 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:
- Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (characterized by moon face, central obesity, thin skin, easy bruising, muscle weakness, high blood pressure, high blood sugar)
- Adrenal insufficiency upon abrupt withdrawal after prolonged high-dose use (fatigue, weakness, nausea, vomiting, low blood pressure)
What to Do:
If you suspect an overdose or systemic effects, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management is supportive and may involve gradual withdrawal of the corticosteroid.
Drug Interactions
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) treated
Rationale: To estimate potential for systemic absorption and guide total weekly dosage.
Timing: Prior to initiation and periodically during treatment
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 condition after 2 weeks may indicate need for re-evaluation or alternative therapy.
Local skin adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching)
Frequency: At each follow-up visit
Target: Absence or minimal reactions
Action Threshold: Presence of significant local adverse effects warrants discontinuation or reduction in frequency/potency.
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings
Target: Normal adrenal function
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw therapy if suppression is confirmed.
Symptom Monitoring
- Skin thinning or atrophy
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Burning or stinging sensation at application site
- Itching
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Signs of systemic absorption: weight gain, moon face, fatigue, muscle weakness (Cushing's syndrome symptoms)
Special Patient Groups
Pregnancy
Clobetasol propionate is classified as Pregnancy Category C. It 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 adverse effects with prolonged or high-dose use.
Third Trimester:
Risk of fetal growth restriction or other adverse effects with prolonged or high-dose use; potential for adrenal suppression in the neonate if used extensively near term.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution in nursing mothers. If used, avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use; potential for adverse effects if significant systemic absorption occurs in the mother or if applied directly to areas accessible to the infant.
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 because of a larger skin surface area to body weight ratio. Use in adolescents (12 years and older) should be limited to short durations and small areas, with close monitoring.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura) and potentially increased systemic absorption. Monitor closely for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
- The ointment formulation is generally more potent and occlusive than creams or gels, making it suitable for thick, scaly lesions.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy, telangiectasias, and perioral dermatitis in these sensitive areas.
- Patients should be educated on the proper application technique (thin layer, gentle rub) and the importance of not exceeding the recommended duration or amount to minimize systemic absorption and local side effects.
- Consider HPA axis suppression if used extensively, for prolonged periods, or under occlusion, especially in children.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., halobetasol propionate, betamethasone dipropionate augmented)
- Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinonide)
- Low-potency topical corticosteroids (e.g., hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term maintenance
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Emollients and moisturizers for barrier repair and symptom relief
Cost & Coverage
Average Cost:
$20 - $100 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic formulations; higher tiers for brand-name products.
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.