Cormax 0.05% Cream 15gm

Manufacturer WATSON LABS Active Ingredient Clobetasol Cream, Gel, and Ointment(kloe BAY ta sol) Pronunciation kloe BAY ta sol
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
đŸˇī¸
Drug Class
Topical Corticosteroid
đŸ§Ŧ
Pharmacologic Class
Corticosteroid, Super-High Potency
🤰
Pregnancy Category
Category C
✅
FDA Approved
Aug 1983
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Cormax 0.05% Cream contains clobetasol, a very strong steroid medicine used on the skin to treat severe itching, redness, and swelling caused by certain skin conditions like eczema or psoriasis. It works by reducing inflammation. It should only be used for a short time and exactly as prescribed 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's 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 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 use 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'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 make up for a missed one.
💡

Lifestyle & Tips

  • Apply a very thin layer to the affected skin areas only.
  • Wash hands before and after applying the cream.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor.
  • Do not cover the treated area with bandages or other dressings unless instructed by your doctor, as this can increase absorption.
  • Avoid contact with eyes.
  • Do not use for longer than 2 weeks continuously, or more than 50 grams per week, without consulting your doctor.
  • Do not use on children under 12 years old without specific medical advice.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 g per week.

Condition-Specific Dosing:

Psoriasis: Apply twice daily for up to 2 weeks.
Eczema: Apply once or twice daily for up to 2 weeks.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years due to increased risk of systemic absorption and HPA axis suppression. If used, limit to shortest duration and smallest amount.
Adolescent: For adolescents 12 years and older, use with caution and limit to shortest duration and smallest amount, similar to adult dosing but with increased monitoring for systemic effects.
âš•ī¸

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

đŸ”Ŧ

Mechanism of Action

Clobetasol propionate is a super-high potency corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by inducing 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
📊

Pharmacokinetics

Absorption:

Bioavailability: Variable; systemic absorption can occur, especially with prolonged use, large surface areas, broken skin, or occlusive dressings. Percutaneous absorption ranges from 0.1% to 5% depending on formulation and site.
Tmax: Not well-defined for topical application; systemic levels peak hours after application if significant absorption occurs.
FoodEffect: Not applicable

Distribution:

Vd: Not well-defined for topical application; systemically absorbed clobetasol is distributed throughout the body.
ProteinBinding: Approximately 97% (for systemically absorbed corticosteroids)
CnssPenetration: Limited for topical application; systemic penetration is possible but not primary route.

Elimination:

HalfLife: Not well-defined for topical application; systemic half-life of corticosteroids is typically several hours.
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged: Minimal
âąī¸

Pharmacodynamics

OnsetOfAction: Clinical effects typically observed within days of initiation.
PeakEffect: Peak therapeutic effect usually seen within 1-2 weeks of consistent application.
DurationOfAction: Effects persist as long as applied; residual effects may last for days after discontinuation.

Safety & Warnings

âš ī¸

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 of application
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:

  • Worsening of your skin condition or new skin problems (e.g., thinning, bruising, stretch marks, acne, increased hair growth).
  • Signs of skin infection (e.g., pus, fever, spreading redness).
  • Signs of systemic absorption (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes).
  • Severe burning, itching, or irritation where the medicine is applied.
📋

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 infection present 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, as they may interact with this medication.

To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs and health conditions.
âš ī¸

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 medications or products on your skin, including soaps, discuss them with your doctor. 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, it can be harmful, so immediately contact a doctor or a poison control center. Prolonged 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 your doctor before administering it to a child. When using this medication in children, it is essential to exercise caution, as they may have a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, and they may require regular growth checks; discuss this with your doctor.

If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Signs of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, skin thinning, easy bruising)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.

Drug Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition and extent of dermatosis

Rationale: To establish baseline for efficacy assessment and identify areas of concern.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Weekly during treatment

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of condition after 1 week may require re-evaluation.

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)

Frequency: Weekly during treatment and at follow-up

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant local adverse effects warrants discontinuation or change in therapy.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings. Consider morning cortisol levels if HPA axis suppression is suspected.

Target: Normal physiological function

Action Threshold: Any signs of systemic effects require immediate discontinuation and medical evaluation.

đŸ‘ī¸

Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, itching, or burning at application site
  • Development of skin thinning, bruising, or striae
  • Signs of infection (pus, fever)
  • Unusual fatigue or weakness
  • Weight gain, moon face, or other signs of Cushing's syndrome

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should be used with caution and for the shortest possible duration.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids are limited and generally low risk.
Second Trimester: Risk of systemic absorption and potential fetal effects, though generally low with appropriate topical use.
Third Trimester: Risk of systemic absorption and potential fetal effects, including HPA axis suppression in the neonate, though generally low with appropriate topical use.
🤱

Lactation

Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use; monitor infant for adverse effects if used extensively.
đŸ‘ļ

Pediatric Use

Children are more susceptible to systemic absorption and adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. If used, limit to the smallest amount and shortest duration possible, and monitor closely for systemic effects.

👴

Geriatric Use

No specific dosage adjustments are required. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Use with caution and monitor skin integrity.

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 adverse effects.
  • 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.
  • Patients should be educated on the correct application technique (thin film) and the importance of not exceeding the recommended duration or total weekly dose (50g).
  • Monitor for signs of HPA axis suppression, especially in patients using large amounts, on large surface areas, or under occlusion.
  • Rebound flares of dermatosis can occur upon abrupt discontinuation after prolonged use; gradual tapering may be considered for some patients.
🔄

Alternative Therapies

  • Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas.
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory conditions.
💰

Cost & Coverage

Average Cost: Not available per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic formulations; Tier 3 or higher for brand names.
📚

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.