Temovate 0.05% Cream 45gm

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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid, Super-High Potency Topical Corticosteroid
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Pregnancy Category
Category C
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FDA Approved
Sep 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol is a very strong (super-high potency) steroid medicine that you put on your skin. It helps reduce redness, swelling, and itching caused by skin conditions like psoriasis and eczema. 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, 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. In that case, do not wash your hand after application.
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 Usage Precautions

Do not apply the 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 the 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 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 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.
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Lifestyle & Tips

  • Apply a very thin layer only to the affected skin areas as directed by your doctor. Do not use more than prescribed.
  • Wash your hands before and after applying the cream, unless your hands are the area being treated.
  • 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, as these areas are more prone to side effects.
  • Do not use for longer than 2 consecutive weeks, or exceed 50 grams per week, unless directed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use on children under 12 years old unless specifically advised by a doctor, due to higher risk of side effects.

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. Total dosage should 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. Total dosage should not exceed 50 g per week.
eczema: Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Total dosage should 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 risk of systemic absorption and HPA axis suppression)
Child: Not established (use generally not recommended due to increased risk of systemic absorption and HPA axis suppression). If used, limit to shortest duration possible and smallest effective amount.
Adolescent: Similar to adult dosing, but with caution and close monitoring for HPA axis suppression, especially if large surface areas or prolonged use.
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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 super-high potency topical corticosteroid. It induces 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. It exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly depending on the integrity of the epidermal barrier, vehicle, and use of occlusive dressings. Systemic absorption can occur, especially with prolonged use, large surface areas, or compromised skin.
Tmax: Not precisely defined for topical application due to variable absorption; systemic effects can be observed within days of extensive use.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical use; systemically absorbed corticosteroids are widely distributed.
ProteinBinding: Approximately 90% bound to plasma proteins (for systemically absorbed corticosteroids).
CnssPenetration: Limited for topical application; systemic absorption can lead to CNS effects, but not a primary route of penetration.

Elimination:

HalfLife: Approximately 3-5 hours (for systemically absorbed corticosteroids).
Clearance: Primarily hepatic metabolism followed by renal excretion.
ExcretionRoute: Renal (metabolites) and biliary.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Within days to a week of consistent application.
DurationOfAction: Effects persist as long as applied; systemic effects can linger after discontinuation depending on extent of absorption.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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

Most people do not experience significant side effects, but some may occur. If you notice 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, itching, burning, or irritation at the application site.
  • Thinning of the skin, easy bruising, stretch marks (striae), or spider veins (telangiectasias) in the treated area.
  • Acne-like breakouts or hair growth in the treated area.
  • Signs of infection (pus, fever) in the treated area.
  • Signs of systemic absorption (rare but serious): unexplained weight gain, swelling in the face (moon face), fatigue, muscle weakness, mood changes, blurred vision, or slow healing of cuts/sores. Contact your doctor immediately if these occur.
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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, inform them about any existing health problems. This will help ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
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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 any 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 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 your doctor about this potential risk.

This medication may not be suitable for children of all ages, so it is crucial to consult 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; 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 to discuss the potential benefits and risks to both 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, striae, hypertension, hyperglycemia, muscle weakness, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
  • Acute overdose is unlikely due to topical administration, but chronic overdose can lead to significant systemic effects.

What to Do:

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

Drug Interactions

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Moderate Interactions

  • Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to increased systemic corticosteroid effects. Use with caution.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Skin condition (type, severity, extent of lesion)

Rationale: To establish baseline for efficacy assessment and identify areas of concern.

Timing: Prior to initiation of therapy.

Area of body to be treated

Rationale: To assess risk of systemic absorption (larger areas increase risk).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Weekly during treatment, then as needed.

Target: Improvement in symptoms.

Action Threshold: Lack of improvement after 2 weeks, or worsening symptoms, requires re-evaluation.

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

Frequency: Weekly during treatment, then as needed.

Target: Absence or minimal signs of adverse effects.

Action Threshold: Development of significant local adverse effects requires discontinuation or change in therapy.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.

Target: Absence of symptoms.

Action Threshold: Any signs or symptoms warrant immediate investigation (e.g., ACTH stimulation test, plasma cortisol levels).

Intraocular pressure (if applied near eyes)

Frequency: Periodically, especially with prolonged use.

Target: Normal range.

Action Threshold: Elevated IOP requires ophthalmologic consultation.

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Symptom Monitoring

  • Burning, itching, irritation, dryness at application site
  • Folliculitis, hypertrichosis, acneiform eruptions
  • Hypopigmentation, perioral dermatitis, allergic contact dermatitis
  • Maceration of the skin, secondary infection, skin atrophy, striae, miliaria
  • Signs of systemic absorption: weight gain, moon face, central obesity, muscle weakness, fatigue, easy bruising, delayed wound healing, mood changes, blurred vision (cataracts/glaucoma)

Special Patient Groups

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Pregnancy

Category C. Use 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 teratogenic effects, though data for topical corticosteroids are limited. Avoid if possible.
Second Trimester: Use with caution; systemic absorption can occur.
Third Trimester: Use with caution; systemic absorption can occur. Potential for HPA axis suppression in the neonate if used extensively.
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Lactation

L3 (Moderate risk). It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Potential for growth retardation or other adverse effects if significant systemic absorption occurs in the mother and drug is transferred to milk. Monitor infant for adverse effects.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use is generally not recommended for children under 12 years of age. If used, limit to the smallest effective amount for the shortest duration possible, and avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy and purpura. Monitor closely for both local and systemic adverse effects.

Clinical Information

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Clinical Pearls

  • Clobetasol is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 weeks consecutively).
  • Educate patients on the 'less is more' principle: a very thin layer is sufficient. Overuse increases the risk of local and systemic side effects.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to skin thinning and other adverse effects.
  • Warn patients about the risk of HPA axis suppression, especially with prolonged use, large surface areas, or occlusive dressings. Symptoms can be subtle.
  • Consider tapering off if used for longer periods to prevent rebound flares of the skin condition.
  • Not for use in rosacea or perioral dermatitis, as it can exacerbate these conditions.
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Alternative Therapies

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

Average Cost: $50 - $150 per 45g tube (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 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 information about what was taken, the amount, and the time it occurred.