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Clobetasol Prop 0.05% Oint 45gm

Manufacturer TARO 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
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist; Anti-inflammatory Agent
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Pregnancy Category
Category C
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FDA Approved
Aug 1980
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol is a very strong (high-potency) steroid medicine that you put on your skin. It helps reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It works by calming down your body's immune response in the skin.
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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 the 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 applying the medication and dry it thoroughly.
 Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
 Avoid using bandages, dressings, or makeup on the treated area unless advised to do so 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 length of time 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.
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Lifestyle & Tips

  • Apply a very thin layer only to the affected skin areas, as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor, as this can lead to serious side effects.
  • Do not cover the treated area with bandages or dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, infected, or irritated skin without consulting your doctor.
  • Keep out of reach of children.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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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 g per week.

Condition-Specific Dosing:

psoriasis: Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.
eczema: Apply a thin layer to the affected skin areas 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 (generally not recommended for infants due to increased systemic absorption risk)
Child: Not recommended for children under 12 years of age. For children 12 years and older, use with caution and for the shortest duration possible, not exceeding 2 weeks.
Adolescent: For adolescents 12 years and older, apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week. Monitor closely for HPA axis suppression.
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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 adjustment needed 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 due 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 highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus, where it modulates gene expression. This leads to the inhibition of prostaglandin and leukotriene synthesis by inducing phospholipase A2 inhibitory proteins (lipocortins), thereby reducing the release of arachidonic acid from membrane phospholipids. It also suppresses the migration of neutrophils and macrophages, reverses capillary permeability, and stabilizes lysosomal membranes.
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Pharmacokinetics

Absorption:

Bioavailability: Varies; systemic absorption is generally low but can increase significantly with prolonged use, large surface area application, occlusion, or compromised skin barrier. Percutaneous absorption ranges from 0.1% to 5% depending on vehicle, site, and skin integrity.
Tmax: Not precisely defined for topical application due to variable absorption; systemic levels are typically very low.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical application; if absorbed systemically, it is distributed throughout the body.
ProteinBinding: Approximately 90% (if absorbed systemically, primarily to albumin and transcortin).
CnssPenetration: Limited (if absorbed systemically, minimal penetration into CNS).

Elimination:

HalfLife: Systemic half-life is approximately 3-5 hours (if absorbed).
Clearance: Not precisely quantified for topical application; systemic clearance occurs via hepatic metabolism.
ExcretionRoute: Primarily renal excretion of inactive metabolites; some biliary excretion.
Unchanged: Very little unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Within 1-2 weeks of consistent application.
DurationOfAction: Effects persist as long as applied; residual effects may last for days after discontinuation.

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 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 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 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 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:

  • Worsening of skin condition or no improvement after 2 weeks.
  • Severe burning, itching, or irritation at the application site.
  • New skin problems like thinning skin, stretch marks, spider veins, acne, or increased hair growth.
  • Signs of skin infection (e.g., increased redness, swelling, pain, pus).
  • Signs of systemic absorption (rare but serious): unexplained weight gain, rounding of the face (moon face), fatigue, muscle weakness, easy bruising, slow wound healing, mood changes, or vision problems.
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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 existing health problems to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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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.

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 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 the duration prescribed by your doctor. If ingested, this medication can be harmful; in such cases, 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 potential risks. The suitability of this medication for children of all ages has not been established; consult your doctor before administering it 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, 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. If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor 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 absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar, and adrenal suppression.

What to Do:

If you suspect an overdose or prolonged excessive use, contact your doctor or poison control center immediately (Call 1-800-222-1222). Treatment involves gradual withdrawal of the drug under medical supervision to avoid adrenal insufficiency.

Drug Interactions

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Contraindicated Interactions

  • Not available (no absolute contraindications for drug-drug interactions with topical clobetasol due to minimal systemic absorption)
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Major Interactions

  • Not available (systemic interactions are rare with appropriate topical use)
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Moderate Interactions

  • Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol if significant absorption occurs, leading to potential for systemic corticosteroid effects. Use with caution.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity, extent, and type of dermatosis.

Timing: Prior to initiation of therapy

Area of body surface affected

Rationale: To guide appropriate dosing and assess risk of systemic absorption.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, scaling)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypertrichosis)

Frequency: Weekly or as clinically indicated

Target: Absence or minimal signs of adverse effects

Action Threshold: If present, reduce frequency, discontinue, or switch to lower potency corticosteroid.

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

Frequency: Periodically, especially with prolonged use, large surface area, or occlusion

Target: Absence of symptoms

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

Signs of infection (e.g., worsening redness, pain, pus)

Frequency: As clinically indicated

Target: Absence of infection

Action Threshold: If present, discontinue clobetasol and treat infection appropriately.

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Symptom Monitoring

  • Skin thinning or atrophy
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions (folliculitis)
  • Increased hair growth (hypertrichosis)
  • Burning, itching, irritation at application site
  • Changes in skin color (hypopigmentation)
  • Signs of infection (redness, swelling, pus, warmth)
  • Symptoms of systemic absorption (e.g., unexplained weight gain, moon face, fatigue, muscle weakness, easy bruising, slow wound healing, mood changes)

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. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is low with topical use, but prolonged use or application to large areas may increase risk.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects observed in animal studies with systemic corticosteroids. Risk with topical clobetasol is considered low due to minimal systemic absorption, but caution is advised.
Second Trimester: Similar considerations as first trimester. Use with caution.
Third Trimester: Similar considerations as first trimester. Use with caution. Potential for HPA axis suppression in the neonate if significant systemic absorption occurs in the mother.
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Lactation

It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Use with caution. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption, but monitor for any unusual symptoms. Avoid direct contact with infant's skin.
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Pediatric Use

Not recommended for children under 12 years of age. Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio and immature skin barrier. Use in adolescents (12 years and older) should be limited to the shortest duration possible and under close medical supervision.

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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., skin atrophy, purpura) and potentially systemic absorption. Monitor closely for skin integrity and adverse effects.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate 0.05% ointment is a super high-potency topical corticosteroid; it should be used with extreme caution and for short durations (typically no more than 2 consecutive weeks).
  • The total weekly dose should not exceed 50 grams to minimize the risk of systemic side effects, particularly HPA axis suppression.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy and other side effects.
  • Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically prescribed.
  • Patients should be educated on the proper application technique (thin layer, gentle rub) and the importance of not exceeding the prescribed duration or amount.
  • Consider tapering down to a lower potency corticosteroid or using a 'weekend' dosing regimen (e.g., 2 days on, 5 days off) for chronic conditions to reduce cumulative exposure and side effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, 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 dermatoses.
  • Phototherapy (UVB, PUVA).
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Cost & Coverage

Average Cost: $20 - $100+ per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.