Clobetasol 0.05% Foam 100gm

Manufacturer TARO Active Ingredient Clobetasol Foam(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 scalp psoriasis.It is used to treat plaque psoriasis.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Corticosteroid, Synthetic; Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Aug 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol foam is a very strong steroid medicine used on the skin to treat severe itching, redness, and swelling caused by certain skin conditions like psoriasis or eczema. It works by reducing inflammation in the skin. Use it exactly as prescribed by your doctor, usually twice a day for a short period, and do not use more than directed.
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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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.

Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're applying the medication to your hand, do not wash that hand after use.

Prepare the affected area by cleaning it before application, and make sure it's completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Guidelines

Do not apply the medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
If your medication requires shaking before use, be sure to do so.
To use the foam, turn the can upside down. Note that some foams may melt when placed in your hand; consult your pharmacist for guidance on using the foam correctly. Apply the foam to the affected area and gently rub it in.

Storage and Disposal

Store the medication at room temperature, avoiding refrigeration or freezing. Be aware of the medication's expiration date and discard it when necessary. Protect the medication from heat and open flames, and do not puncture or burn the container, even if it appears empty.

Missed Dose

If you miss a dose, apply it as soon as you remember. However, if it's 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 once or use extra doses.
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Lifestyle & Tips

  • Wash your hands before and after applying the foam.
  • Shake the can well before use.
  • Invert the can and dispense a small amount of foam onto a clean surface (not directly onto hands, as it will melt).
  • Gently massage the foam into the affected skin area until it disappears.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • 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 occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
  • Do not use for longer than 2 consecutive weeks unless directed by your doctor.
  • Do not exceed 50 grams of foam per week.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin areas twice daily.

Condition-Specific Dosing:

Psoriasis (moderate to severe): Apply to affected areas twice daily for up to 2 consecutive weeks. Therapy should be limited to 50g per week. Discontinue when control is achieved. Re-evaluate if no improvement after 2 weeks.
Atopic Dermatitis (moderate to severe): Apply to affected areas twice daily for up to 2 consecutive weeks. Therapy should be limited to 50g per week. Discontinue when control is achieved. Re-evaluate if no improvement after 2 weeks.
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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 in children 12 years and older, use with extreme caution and for the shortest duration possible.
Adolescent: For adolescents 12 years and older, apply to affected areas twice daily for up to 2 consecutive weeks. Therapy should be limited to 50g per week. Discontinue when control is achieved. Re-evaluate if no improvement after 2 weeks.
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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 adjustment needed 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

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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, translocate to the nucleus, and modulate gene expression. This leads to the synthesis of lipocortins (annexins), 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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Bioavailability is generally low but can increase significantly under these conditions.
Tmax: Not well-defined for topical application; systemic absorption is gradual.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not specifically quantified for topical application; systemically absorbed clobetasol is distributed throughout the body.
ProteinBinding: Approximately 97% (for systemically absorbed clobetasol).
CnssPenetration: Limited for topical application; however, systemic absorption can lead to CNS effects.

Elimination:

HalfLife: Approximately 3-5 hours (for systemically absorbed clobetasol).
Clearance: Not specifically quantified for topical application.
ExcretionRoute: Primarily renal excretion of metabolites; some biliary excretion.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Within days to 2 weeks of consistent application.
DurationOfAction: Effects persist as long as applied; local effects may last for several hours after application.

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 immediately or seek 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 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. Many people experience no side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning or stinging
Dry skin
* Redness

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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:

  • Worsening of your skin condition or no improvement after 2 weeks.
  • Signs of a skin infection (e.g., increased redness, swelling, pus, fever).
  • Severe burning, itching, or irritation at the application site.
  • Thinning of the skin, easy bruising, or stretch marks (striae) where the medicine is applied.
  • Changes in skin color (lightening or darkening).
  • Signs of systemic absorption (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, fatigue, muscle weakness, mood changes, vision problems).
  • If used in children, monitor for slowed growth or weight gain.
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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 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 health problems you have to ensure safe use of this medication.

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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Precautions & Cautions

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

To ensure safe use, please note the following precautions:

This medication is flammable, so avoid using it near open flames or while smoking.
Do not use this medication to treat diaper rash, acne, rosacea, or rashes around the mouth.
When applying this medication to a large skin area or near open wounds, exercise caution and consult your doctor.
Before using other skin products or medications, including soaps, consult your doctor to avoid potential interactions.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Use this medication only for the duration prescribed by your doctor.

In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center.

Additionally, be aware of the following potential risks:

Long-term use of this medication may increase the risk of cataracts or glaucoma; discuss this with your doctor.
This medication may not be suitable for children of all ages; consult your doctor before administering it to a child.
When using this medication in children, be cautious, as the risk of certain side effects may be higher.
In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; discuss this with your doctor.

If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.

Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding, as you will need to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic corticosteroid effects, including:
  • Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, striae)
  • Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)
  • Hyperglycemia (high blood sugar)
  • Hypertension (high blood pressure)
  • Fluid retention
  • Growth retardation in children

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. In case of suspected overdose or significant systemic effects, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222).

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of the dermatosis and identify any pre-existing skin infections or atrophy.

Timing: Prior to initiation of therapy.

Adrenal function (e.g., morning plasma cortisol, ACTH stimulation test)

Rationale: Consider for patients at high risk of HPA axis suppression (e.g., extensive use, prolonged use, occlusive dressings, pediatric patients).

Timing: Prior to initiation if high risk, or if symptoms of systemic absorption are suspected.

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Routine Monitoring

Skin condition assessment (e.g., redness, scaling, itching, signs of atrophy, infection)

Frequency: Weekly or bi-weekly during active treatment, then as needed.

Target: Improvement in dermatosis symptoms without signs of adverse local reactions.

Action Threshold: Worsening condition, signs of infection, significant skin atrophy, or lack of improvement after 2 weeks should prompt re-evaluation.

Signs and symptoms of systemic corticosteroid effects (e.g., weight gain, moon face, striae, hyperglycemia, hypertension)

Frequency: Periodically, especially with prolonged or extensive use.

Target: Absence of systemic effects.

Action Threshold: Presence of any systemic effects warrants immediate re-evaluation and potential discontinuation.

Growth monitoring (in pediatric patients)

Frequency: Regularly (e.g., every 3-6 months) if prolonged use is considered.

Target: Normal growth velocity for age.

Action Threshold: Growth retardation warrants immediate re-evaluation and potential discontinuation.

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Symptom Monitoring

  • Burning
  • Stinging
  • Itching
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of HPA axis suppression (fatigue, weakness, nausea, vomiting, hypotension)
  • Signs of Cushing's syndrome (central obesity, moon face, buffalo hump, striae, easy bruising)

Special Patient Groups

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Pregnancy

Clobetasol propionate is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects with systemically administered corticosteroids. Clobetasol foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though systemic absorption from topical use is generally low. Use with caution and only if clearly needed.
Second Trimester: Similar considerations as first trimester. Risk of fetal growth restriction with high-dose systemic corticosteroids.
Third Trimester: Similar considerations as first and second trimesters. Risk of HPA axis suppression in the neonate if used extensively near term.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are excreted into breast milk in quantities not likely to have a deleterious effect on the infant. However, caution should be exercised when clobetasol foam is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: L3 - Moderately safe. Low risk of adverse effects on the infant due to minimal systemic absorption, but caution is advised. Monitor infant for any signs of adverse effects.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use in children under 12 years of age is not recommended. If used in adolescents 12 years and older, use with extreme caution, for the shortest duration possible, and monitor for signs of systemic toxicity and growth retardation.

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Geriatric Use

Clinical studies of clobetasol propionate foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin, increasing susceptibility to local adverse effects like atrophy and purpura.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate foam is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
  • Limit total weekly application to 50 grams to minimize the risk of systemic absorption and HPA axis suppression.
  • The foam formulation is often preferred for hairy areas or large surface areas due to its ease of spread and rapid absorption.
  • Advise patients to apply the foam to a clean, dry surface (e.g., a saucer or cotton swab) and then transfer it to the skin, as it melts quickly on warm skin.
  • Educate patients on the signs of local adverse effects (skin thinning, striae, telangiectasias) and systemic effects (e.g., weight gain, fatigue) and to report them promptly.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy and other side effects in these sensitive areas.
  • Re-evaluate the patient if no improvement is seen after 2 weeks of treatment.
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Alternative Therapies

  • Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis, especially on sensitive areas.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Retinoids (e.g., tazarotene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory dermatoses.
  • Phototherapy (UVB, PUVA) for psoriasis and severe eczema.
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Cost & Coverage

Average Cost: Varies widely, typically $200 - $1000+ per 100gm foam
Generic Available: Yes
Insurance Coverage: Often Tier 2 or 3, may require prior authorization depending on insurance plan.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.