Temovate 0.05% Ointment 60gm

Manufacturer PHARMADERM 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 is a very strong topical steroid medication used to treat severe skin conditions like eczema and psoriasis. It works by reducing redness, swelling, and itching. It should be used for short periods and exactly as prescribed to avoid 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's 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.
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 disposing of it.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose

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 take extra doses.
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Lifestyle & Tips

  • Apply a very thin layer to the affected skin area only.
  • Wash hands before and after application.
  • Do not cover the treated area with bandages or occlusive dressings unless specifically instructed by your doctor.
  • Avoid using on the face, groin, or armpits unless directed by a doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than 2 consecutive weeks, or exceed 50 grams per week, unless advised by your doctor.
  • Do not use on broken or infected skin without medical advice.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

psoriasis: Apply twice daily for up to 2 consecutive weeks. If no response, re-evaluate diagnosis. Total dosage should not exceed 50 g/week.
eczema: Apply twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g/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.
Adolescent: Not recommended for children under 12 years of age. For adolescents 12 years and older, use with extreme caution and for limited duration if absolutely necessary, similar to adult dosing but with closer monitoring.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.
Dialysis: No specific adjustment needed due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Clobetasol propionate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated by the induction of 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.
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Pharmacokinetics

Absorption:

Bioavailability: Not well-quantified for topical application; minimal systemic absorption occurs, but can increase with occlusive dressings, inflamed skin, or large surface areas.
Tmax: Not applicable for topical application; systemic absorption is variable and low.
FoodEffect: Not applicable

Distribution:

Vd: Not well-quantified for topical application; systemically absorbed corticosteroids are extensively bound to plasma proteins (primarily albumin and corticosteroid-binding globulin).
ProteinBinding: Approximately 90% (for systemically absorbed portion)
CnssPenetration: Limited

Elimination:

HalfLife: Not well-defined for topical application due to minimal systemic absorption; for systemically absorbed corticosteroids, half-life varies.
Clearance: Not well-quantified for topical application.
ExcretionRoute: Metabolites are primarily excreted in the urine and feces.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for local anti-inflammatory effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as applied; local effects may last for 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 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
+ 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 fainting
+ 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 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:

  • Severe burning, itching, or irritation at the application site.
  • New or worsening skin thinning, stretch marks, or spider veins.
  • Signs of skin infection (e.g., increased redness, swelling, pus, fever).
  • Unusual weight gain, swelling in the face (moon face), or increased body hair (signs of systemic absorption).
  • Increased thirst or urination (signs of high blood sugar).
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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.

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 in conjunction 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. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth. When applying this medication to a large area of skin or near open wounds, exercise caution and consult with your doctor.

Before using 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. 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 with your doctor.

This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. 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, inform your doctor. You and your doctor 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 suppression (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

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

Drug Interactions

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Moderate Interactions

  • Strong CYP3A4 inhibitors (e.g., ritonavir, itraconazole)

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity, area of involvement, and presence of infection or skin breakdown.

Timing: Prior to initiation of therapy

Adrenal function (e.g., plasma cortisol levels, 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 for high-risk patients

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)

Frequency: Regularly during treatment, especially after 2 weeks of continuous use.

Target: Absence of new or worsening reactions.

Action Threshold: If severe or persistent reactions occur, discontinue use and re-evaluate.

Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)

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

Target: Normal physiological parameters.

Action Threshold: If signs develop, discontinue use gradually and manage symptoms. Consider HPA axis testing.

Infection (secondary skin infections)

Frequency: Regularly during treatment.

Target: Absence of signs of infection.

Action Threshold: If infection develops, discontinue clobetasol and initiate appropriate antimicrobial therapy.

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Symptom Monitoring

  • Skin thinning
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Easy bruising
  • Increased hair growth (hypertrichosis)
  • Acne-like eruptions
  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Numbness of fingers
  • Signs of infection (redness, swelling, pus)
  • Weight gain
  • Moon face
  • Fatigue
  • Muscle weakness
  • Increased thirst or urination (signs of hyperglycemia)

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. Systemic absorption is minimal, but high-potency topical corticosteroids should be used with caution, for limited duration, and on small areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester: Risk of fetal growth restriction or other adverse effects with extensive or prolonged use of high-potency topical corticosteroids.
Third Trimester: Risk of fetal growth restriction or other adverse effects with extensive or prolonged use of high-potency topical corticosteroids.
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Lactation

Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use due to minimal systemic absorption, but potential for adverse effects if ingested by infant or if significant systemic absorption occurs in mother.
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Pediatric Use

Not recommended for children under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Risk of HPA axis suppression and Cushing's syndrome is higher.

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Geriatric Use

Use with caution. Elderly patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura) and potentially systemic effects due to age-related skin changes.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate 0.05% is a super high-potency topical corticosteroid; it should be used for short durations (typically no more than 2 consecutive weeks) to minimize the risk of local and systemic side effects.
  • The total dosage should not exceed 50 grams per week.
  • 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.
  • Occlusive dressings significantly increase systemic absorption and should generally be avoided unless prescribed.
  • Patients should be advised to report any signs of local irritation, skin thinning, or systemic effects (e.g., weight gain, fatigue).
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Alternative Therapies

  • Lower potency topical corticosteroids (e.g., triamcinolone, fluocinolone, hydrocortisone) for less severe conditions or maintenance.
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory conditions.
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Cost & Coverage

Average Cost: $20 - $150+ per 60gm tube of 0.05% ointment (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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 details. 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 information about the medication taken, the amount, and the time it happened.