Cormax 0.05% Cream 45gm

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.
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Drug Class
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Aug 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cormax 0.05% Cream contains clobetasol, a very strong steroid medicine applied to the skin. It helps reduce redness, swelling, and itching caused by certain skin conditions like eczema and psoriasis. It's important to use it exactly as prescribed because using too much or for too long can cause side effects.
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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 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 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 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 make up for a missed dose.
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Lifestyle & Tips

  • Apply a very thin layer only to the affected skin area, as directed by your doctor.
  • Wash your hands before and after applying the cream.
  • 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 on the face, groin, or armpits unless specifically told to by your doctor, as these areas are more sensitive to side effects.
  • Do not use for longer than 2 weeks continuously, unless advised by your doctor.
  • Do not exceed 50 grams of cream per week.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin area twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.

Condition-Specific Dosing:

Psoriasis: Apply a thin layer to the affected skin area twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.
Eczema: Apply a thin layer to the affected skin area twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.
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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 shortest duration and smallest amount possible.
Adolescent: Not recommended for children under 12 years of age. For adolescents 12 years and older, use with caution and limit to shortest duration and smallest amount possible, similar to adult dosing but with increased monitoring for systemic effects.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption.
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due0 to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption.

Pharmacology

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; minimal systemic absorption occurs through intact skin, but can increase significantly with inflammation, occlusion, prolonged use, or application to large surface areas. Not precisely quantified for topical use.
Tmax: Not typically reported for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical use; if absorbed systemically, distributes widely.
ProteinBinding: If absorbed systemically, extensively bound to plasma proteins.
CnssPenetration: Limited, unless significant systemic absorption occurs.

Elimination:

HalfLife: Not precisely quantified for topical use; systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Primarily renal excretion of metabolites, with some biliary excretion, if absorbed systemically.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as treatment continues; varies based on condition and individual response.

Safety & Warnings

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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 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 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, stinging, or irritation that wasn't present before
  • Thinning of the skin, easy bruising, or stretch marks appearing where the cream is applied
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of systemic side effects, though rare with proper use: unexplained weight gain, swelling in the face (moon face), fatigue, muscle weakness, increased thirst or urination.
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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 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.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Contraindications and Precautions

Do not use this medication to treat diaper rash.
Avoid using this medication to treat acne, rosacea, or a rash around the mouth.
Exercise caution when applying this medication to a large area of skin or near open wounds. Consult your doctor before doing so.
Before using other medications or products on your skin, including soaps, consult your doctor.
Do not apply 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.

Safety Precautions

If this medication is 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. Discuss this potential risk with your doctor.

Pediatric Use

This medication may not be suitable for children of all ages. Consult your doctor before administering this medication to a child.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential risk with your doctor.

Breast-Feeding and Pregnancy

If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area.
* If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Signs of Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising, muscle weakness)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • None known for topical application due to minimal systemic absorption.
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Major Interactions

  • None known for topical application due to minimal systemic absorption.
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Moderate Interactions

  • None known for topical application due to minimal systemic absorption.
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Minor Interactions

  • None known for topical application due to minimal systemic absorption.

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of lesion)

Rationale: To establish baseline for efficacy monitoring and identify contraindications (e.g., skin infections).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, lesion size)

Frequency: Weekly or as clinically indicated during treatment period.

Target: Improvement in symptoms and lesion appearance.

Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.

Local adverse reactions (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 or minimal adverse effects.

Action Threshold: Presence of significant or worsening local adverse effects requires discontinuation or reduction in frequency/potency.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)

Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.

Target: Absence of signs/symptoms.

Action Threshold: If suspected, perform ACTH stimulation test or morning cortisol levels. Discontinue or taper if confirmed.

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Symptom Monitoring

  • Burning or stinging sensation at application site
  • Itching or irritation
  • Skin thinning or atrophy
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Changes in skin color (hypopigmentation)
  • Acne-like eruptions (folliculitis)
  • Excessive hair growth (hypertrichosis)
  • Signs of secondary skin infection (redness, swelling, pus)
  • Signs of systemic absorption (e.g., unexplained weight gain, moon face, fatigue, muscle weakness, delayed wound healing, increased thirst/urination)

Special Patient Groups

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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, for the shortest duration, and on the smallest possible area.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical steroids are limited and generally reassuring for low-potency agents. High-potency agents should be used with caution.
Second Trimester: Risk of fetal growth restriction or other systemic effects if significant maternal absorption occurs. Use with caution.
Third Trimester: Risk of fetal growth restriction or other systemic effects if significant maternal absorption occurs. Use with caution.
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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 proper use (minimal systemic absorption), but potential for adverse effects if significant amounts are ingested by the infant or if applied to large areas of the mother's skin.
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Pediatric Use

Not recommended for children under 12 years of age due to a higher risk of systemic absorption and HPA axis suppression, especially with prolonged use or large surface area application. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. If used, limit to shortest duration and smallest amount possible, with close monitoring.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Clobetasol propionate is a super high-potency topical corticosteroid; it should be used for short-term treatment (typically up to 2 weeks) of severe dermatoses.
  • Avoid continuous long-term use to minimize the risk of local side effects (skin atrophy, striae) and systemic effects (HPA axis suppression).
  • Do not use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to side effects.
  • Patients should be instructed on the proper application technique: apply a very thin layer and rub in gently.
  • If no improvement is seen after 2 weeks, the diagnosis should be re-evaluated.
  • Consider tapering off the medication if used for longer periods to prevent rebound flares.
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Alternative Therapies

  • Other topical corticosteroids of lower potency (e.g., triamcinolone, fluocinonide, betamethasone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas like the face.
  • Systemic therapies (e.g., methotrexate, biologics) for severe, widespread, or recalcitrant conditions.
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Cost & Coverage

Average Cost: $20 - $100+ per 45g tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations) on most commercial and Medicare Part D plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 information about the medication taken, the amount, and the time it happened.