Temovate .05% Emollient Cream 30gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It's a type of steroid, but it works on the skin surface. Use it exactly as prescribed, usually for a short time, to avoid side effects.
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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using coverings such as bandages, dressings, or makeup on the treated area unless advised 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 it 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.
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.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using coverings such as bandages, dressings, or makeup on the treated area unless advised 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 it 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.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Apply a very thin layer to the affected skin area only.
- Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption.
- Avoid applying to the face, groin, or armpits unless specifically instructed by a doctor.
- Do not use for longer than 2 consecutive weeks, or more than 50 grams per week, unless advised by your doctor.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on broken or infected skin without medical advice.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Temovate 0.05% Cream 15gm
- Temovate 0.05% Cream 45gm
- Temovate 0.05% Ointment 60gm
- Temovate 0.05% Gel 15gm
- Temovate 0.05% Gel 30gm
- Temovate .05% Emollient Cream 15gm
- Temovate .05% Emollient Cream 30gm
- Temovate 0.05% Solution 50ml
- Temovate .05% Emollient Cream 60gm
- Temovate 0.05% Gel 60gm
- Temovate 0.05% Ointment 30gm
- Temovate 0.05% Cream 60gm
- Temovate 0.05% Cream 30gm
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice daily. Treatment should be limited to 2 consecutive weeks, and the 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. Max 50g/week.
eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Max 50g/week.
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, limit to 5 days and small areas.
Adolescent:
Not recommended for children under 12 years of age. For adolescents 12 years and older, use with caution and limit duration and amount similar to adult recommendations, but with increased monitoring for systemic effects.
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
Mechanism of Action
Clobetasol propionate is a super-high potency topical 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. 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (typically low, but can increase significantly with inflamed skin, occlusion, or application to large surface areas)
Tmax:
Not typically measured for topical application; systemic absorption is minimal but can occur within hours of application.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not available (not clinically relevant for topical application)
ProteinBinding:
Not available (not clinically relevant for topical application)
CnssPenetration:
Limited (systemic absorption is minimal)
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed clobetasol is eliminated similarly to other corticosteroids.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily as metabolites), some biliary excretion.
Unchanged:
Minimal (primarily metabolized)
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (e.g., reduction in redness, itching)
PeakEffect:
Typically within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; treatment duration is limited to 2 weeks.
Safety & Warnings
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 signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic reaction symptoms, 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 at the application site
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 have 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
Allergic reaction symptoms, 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 at the application site
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 have 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.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site (may indicate allergic reaction or worsening condition)
- Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks)
- Development of new skin infections (e.g., pus, fever)
- Unusual hair growth
- Acne-like rash
- Signs of systemic absorption (e.g., swelling in ankles/feet, unusual weight gain, increased thirst/urination, vision problems, fatigue, muscle weakness) - seek immediate medical attention for these.
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 you have an 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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting 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 you have an 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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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 any 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, 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.
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 using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication may 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 to discuss the potential benefits and risks to you and your baby.
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 any 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, 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.
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 using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication may 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 to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, skin thinning, easy bruising, striae, hyperglycemia, glucosuria, hypertension, muscle weakness, and HPA axis suppression (adrenal insufficiency upon withdrawal).
- In children, growth retardation and delayed weight gain may occur.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. If HPA axis suppression is severe, systemic corticosteroid replacement therapy may be necessary. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- None known for topical application
Major Interactions
- None known for topical application
Moderate Interactions
- None known for topical application
Minor Interactions
- None known for topical application
Monitoring
Baseline Monitoring
Skin condition and extent of dermatosis
Rationale: To assess the severity of the condition and guide treatment duration.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment (e.g., weekly)
Target: Significant improvement in symptoms
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.
Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: Regularly during treatment
Target: Absence or minimal local side effects
Action Threshold: Discontinue if severe irritation or signs of skin atrophy develop.
Signs of HPA axis suppression (e.g., fatigue, weight loss, weakness, dizziness)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusion.
Target: Normal adrenal function
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or taper if suppression confirmed.
Symptom Monitoring
- Burning or stinging at application site
- Itching
- Dryness
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy (thinning, easy bruising)
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, growth retardation in children)
Special Patient Groups
Pregnancy
Category C. Use 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 teratogenicity, though data for topical corticosteroids are limited. Use with caution.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., low birth weight) if used extensively or for prolonged periods.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., low birth weight) if used extensively or for prolonged periods.
Lactation
Caution is advised. It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, but avoid applying to the breast area to prevent infant ingestion.
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.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. If used, limit treatment to 5 days and small areas, and monitor closely for signs of HPA axis suppression and growth retardation.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local side effects (e.g., atrophy, purpura) and potentially systemic absorption. Monitor for skin integrity and adverse effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; use it sparingly and for short durations (max 2 weeks) to minimize side effects.
- Avoid using on the face, groin, or axillae due to increased risk of skin atrophy and other local side effects.
- Patients should be educated on the proper application technique (thin film) and the importance of not exceeding the recommended duration or amount (50g/week).
- Monitor for signs of HPA axis suppression, especially in patients using large amounts, on large surface areas, or under occlusion.
- Rebound flares can occur if treatment is stopped abruptly after prolonged use; gradual tapering may be considered for some conditions, but generally, short-term use is preferred.
- Not for use in rosacea or perioral dermatitis, as it can worsen these conditions.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of 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.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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 information. 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 details about the medication taken, the amount, and the time it happened.