Clobetasol Prop 0.05% Oint 30gm

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
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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?

Clobetasol propionate is a very strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It's a type of steroid, but it's only for use on 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's essential to use this medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Precautions

Do not apply this medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area 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 disposing of it.
Keep all medications in a safe place, 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.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a very thin layer of the ointment only to the affected skin areas, as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than directed (usually no more than 2 weeks continuously).
  • Do not cover the treated area with bandages or other dressings unless specifically told to by your doctor, as this can increase absorption.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, infected, or irritated skin unless directed by your doctor.
  • 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: Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
eczema: Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use generally not recommended due to increased systemic absorption risk)
Child: Not established (use generally not recommended due to increased systemic absorption risk; if used, limit to shortest duration and smallest amount)
Adolescent: Similar to adult dosing, but with caution and limited duration due to potential for systemic effects.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical use, minimal systemic absorption)
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations for topical use

Hepatic Impairment:

Mild: No adjustment needed (topical use, minimal systemic absorption)
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Clobetasol propionate is a highly potent topical 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: Varies (depends on skin integrity, vehicle, occlusion, application site, duration of use)
Tmax: Not precisely defined for topical application, systemic absorption is minimal but can occur.
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not available (systemic distribution is minimal)
ProteinBinding: Varies (systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily corticosteroid-binding globulin and albumin)
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Not precisely defined for topical application (systemically absorbed corticosteroids have varying half-lives)
Clearance: Not precisely defined for topical application
ExcretionRoute: Renal (primarily as metabolites), some biliary
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within days of initiation
PeakEffect: Within 1-2 weeks of continuous use
DurationOfAction: Effects persist as long as applied; resolution of symptoms after cessation varies.

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 immediate 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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely 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 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:

  • Severe burning, itching, or irritation of the treated skin
  • New or worsening skin rash
  • Signs of skin infection (e.g., pus, spreading redness, warmth)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Unusual hair growth on the treated area
  • Changes in skin color
  • Swelling in the ankles or feet
  • Unusual weight gain, especially in the face or upper back
  • 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 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.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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 with your doctor.

Before using other skincare 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 this medication is accidentally 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; therefore, consult with your doctor to discuss potential risks.

This medication may not be suitable for children of all ages, so it is crucial to consult with your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to discuss this risk.

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, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Symptoms of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia)
  • Adrenal insufficiency (e.g., fatigue, weakness, dizziness, nausea, vomiting) upon abrupt withdrawal after prolonged, extensive use

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (type, severity, extent of lesion)

Rationale: To establish baseline for efficacy assessment and guide treatment duration.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

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

Local adverse reactions (e.g., 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 or minimal reactions

Action Threshold: Presence of significant or worsening reactions may require discontinuation or change in therapy.

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

Frequency: Periodically, especially with prolonged or extensive use, or in pediatric patients

Target: Absence of signs/symptoms

Action Threshold: Presence of signs/symptoms warrants immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Increased thirst or urination (hyperglycemia)
  • Unusual weight gain or moon face (Cushing's syndrome)
  • Fatigue, weakness, dizziness (HPA axis suppression)
  • Severe skin irritation, burning, itching, or rash at application site
  • Signs of skin infection (pus, redness, warmth, pain)
  • Skin thinning, easy bruising, or stretch marks (striae)

Special Patient Groups

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Pregnancy

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 can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids are limited. Avoid large amounts or prolonged use.
Second Trimester: Risk of fetal growth restriction or other adverse effects with high doses or prolonged use.
Third Trimester: Risk of fetal growth restriction or other adverse effects with high doses or prolonged use. Neonatal adrenal suppression is a theoretical risk with extensive maternal use near term.
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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. If used, apply to limited areas and avoid application to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Potential for adverse effects if significant systemic absorption occurs in mother and drug passes into milk, or if infant ingests directly from skin.
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Pediatric Use

Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. Use should be limited to the least amount compatible with an effective therapeutic regimen and for the shortest possible duration. Not recommended for children under 12 years of age.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy.

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 consecutive weeks) to minimize the risk of local and systemic adverse effects.
  • Total dosage should not exceed 50 grams per week.
  • Avoid use on the face, groin, or axillae, or for diaper dermatitis, due to increased risk of adverse effects (e.g., skin atrophy, striae, telangiectasias).
  • Patients should be advised to report any signs of local irritation, infection, or systemic effects.
  • HPA axis suppression is a significant concern, especially with prolonged use, large surface areas, or occlusive dressings. Tapering may be necessary if used extensively.
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Alternative Therapies

  • Other topical corticosteroids (e.g., fluocinonide, betamethasone, triamcinolone, hydrocortisone - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, 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 conditions
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Cost & Coverage

Average Cost: $20 - $100+ per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication taken, the amount, and the time it happened.