Temovate 0.05% 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
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong steroid cream 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 only, usually no more than two weeks, because it is very potent.
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.
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 is 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.
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.
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 is 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.
Lifestyle & Tips
- Apply a very thin layer to the affected skin areas only, as directed by your doctor.
- Wash your hands before and after applying the cream.
- Do not use more than the prescribed amount or for longer than directed (usually no more than 2 weeks).
- Do not use on the face, groin, or armpits unless specifically instructed by your doctor.
- Do not cover the treated area with bandages or other dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on broken or infected skin without consulting your doctor.
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 once or twice daily.
Dose Range:
1 - 2 mg
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.
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 treatment to the least amount compatible with an effective therapeutic regimen and for the shortest duration possible.
Adolescent:
Not recommended for children under 12 years of age. For adolescents 12 years and older, use with caution and for limited duration, similar to adult dosing but with close monitoring for systemic effects.
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 considerations 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
Mechanism of Action
Clobetasol propionate is a highly potent 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 possesses anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; varies with skin integrity, vehicle, and occlusion. Can be up to 5% or more with damaged skin or occlusion.
Tmax:
Not typically relevant for topical application; systemic absorption is minimal and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application; if absorbed systemically, distributes widely.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids).
CnssPenetration:
Limited (for systemically absorbed corticosteroids).
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of corticosteroids varies (e.g., 2-4 hours for cortisol).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal excretion of metabolites if absorbed systemically.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Localized effect persists for several hours after application.
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 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 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 site 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact 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 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 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 site 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact 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:
- Worsening of your skin condition or new skin problems (e.g., severe irritation, redness, pus, thinning of skin, stretch marks).
- Signs of infection (e.g., fever, chills, increased pain or swelling, pus from the skin).
- Signs of too much steroid in your body (e.g., unusual weight gain, swelling in your face, muscle weakness, feeling tired, changes in mood, slow wound healing).
- Blurred vision or other vision problems (if applied near eyes).
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.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
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.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.
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 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 assessments; 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.
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 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 assessments; 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.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, resulting in hypercortisolism (Cushing's syndrome) and suppression of the hypothalamic-pituitary-adrenal (HPA) axis, which can lead to adrenal insufficiency upon withdrawal.
- Symptoms may include: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar, mood changes, and growth retardation in children.
What to Do:
If you suspect an overdose or excessive use, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Management involves gradual withdrawal of the steroid under medical supervision to prevent adrenal insufficiency.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Extent of affected body surface area (BSA)
Rationale: To guide appropriate dosing and assess risk of systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching)
Frequency: Regularly, at follow-up visits (e.g., weekly for initial 2 weeks, then as needed).
Target: Improvement in dermatosis with minimal local side effects.
Action Threshold: Worsening of condition, severe local irritation, or signs of skin atrophy/infection warrant re-evaluation and potential discontinuation.
Signs and symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)
Frequency: Periodically, especially with prolonged use, extensive BSA application, or use under occlusion.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants immediate evaluation (e.g., ACTH stimulation test) and potential discontinuation or tapering.
Intraocular pressure (if applied near eyes)
Frequency: Periodically, if applied to eyelids or periorbital area.
Target: Normal intraocular pressure.
Action Threshold: Elevated pressure warrants ophthalmologic consultation.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
- Signs of adrenal insufficiency (e.g., fatigue, weakness, dizziness, nausea, vomiting)
Special Patient Groups
Pregnancy
Clobetasol propionate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high doses; human data limited.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth retardation, HPA axis suppression) if used extensively or for prolonged periods.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth retardation, HPA axis suppression) if used extensively or for prolonged periods.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when clobetasol propionate is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use; potential for systemic effects in infant if significant maternal absorption occurs or if applied to breast area.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults because of a larger skin surface area to body weight ratio. Use in children should be limited to the least amount compatible with an effective therapeutic regimen and for the shortest duration possible. Adrenal function monitoring may be necessary.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have thinner skin and be more susceptible to local adverse effects such as skin atrophy and purpura. Monitor for these effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids; use should be limited to short-term treatment (typically 2 weeks) to minimize risk of local and systemic side effects.
- Avoid use on the face, groin, or axillae, and for diaper dermatitis, due to increased risk of atrophy, striae, and systemic absorption in these sensitive areas.
- HPA axis suppression is a significant concern, especially with prolonged use, large surface area application, or occlusive dressings. Patients should be monitored for signs and symptoms.
- Rebound flares can occur upon abrupt discontinuation after prolonged use; gradual tapering may be considered for some patients.
- Educate patients thoroughly on proper application technique (thin layer, gentle rub) and the importance of not exceeding prescribed duration or amount.
Alternative Therapies
- Medium-potency topical corticosteroids (for less severe conditions or maintenance)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for sensitive areas or long-term use)
- Emollients and moisturizers (for barrier repair and symptom relief)
- Phototherapy (UVB, PUVA - for widespread or resistant psoriasis/eczema)
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine - for severe, refractory conditions)
Cost & Coverage
Average Cost:
$20 - $100+ per 30gm tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic clobetasol propionate)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment.