Temovate 0.05% Solution 50ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Glucocorticoid; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong medicine called a corticosteroid that is applied to the skin. It helps reduce redness, itching, and swelling caused by certain skin conditions like psoriasis and eczema. It works by calming down the body's immune response in the skin.
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 this 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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages, dressings, or makeup unless advised to do so by your doctor.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposal.
Protect the medication from heat and open flames.
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 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, 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 this 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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages, dressings, or makeup unless advised to do so by your doctor.
Storage and Disposal
Store this medication at room temperature, away from refrigeration and freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposal.
Protect the medication from heat and open flames.
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 use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the medication.
- Apply a thin layer only to the affected skin areas as directed by your doctor.
- Do not use more than the prescribed amount or for longer than recommended (usually no more than 2 weeks).
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for diaper rash.
- 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, once in the morning and once at night.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g (or 50 mL for solution) per week. Re-evaluate if no improvement after 2 weeks.
Eczema/Dermatitis:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g (or 50 mL for solution) per week. Re-evaluate if no improvement after 2 weeks.
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 shortest duration and smallest amount possible under strict medical supervision.
Adolescent:
For adolescents 12 years and older, use with caution and limit duration to 2 weeks, similar to adult dosing, but with careful monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds to glucocorticoid receptors in the cytoplasm of target cells, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines).
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1%) through intact skin; absorption increases with inflammation, occlusion, prolonged use, and application to large surface areas or thin skin (e.g., face, scrotum).
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical application; systemically absorbed drug distributes widely.
ProteinBinding:
Approximately 90% (for systemically absorbed drug).
CnssPenetration:
Limited for topical application; systemic absorption can lead to some CNS penetration.
Elimination:
HalfLife:
Approximately 3-5 hours (for systemically absorbed drug).
Clearance:
Not well-quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites; some biliary excretion.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within days of initiation for local anti-inflammatory effects.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects may last for 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:
- Increased redness, itching, or irritation at the application site (may indicate allergic reaction or worsening condition).
- Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks (striae).
- Changes in skin color (lightening or darkening).
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of skin infection (pus, warmth, spreading redness).
- If used extensively or for prolonged periods, watch for signs of systemic absorption like unusual weight gain, swelling in the face (moon face), fatigue, or muscle weakness (signs of Cushing's syndrome or adrenal suppression).
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 you have. 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 change the dosage 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 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 you have. 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 change the dosage 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.
To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- 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.
- Use this medication only for the duration prescribed by your doctor.
Important safety considerations:
- If this medication is ingested, it can cause harm; immediately contact a doctor or a poison control center if this occurs.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma; discuss this risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established; 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, this medication may affect growth in children and teenagers, necessitating regular growth assessments; consult your doctor about this potential risk.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting this medication, it is crucial to discuss the following with your doctor:
- If you are pregnant, planning to become pregnant, or are breastfeeding, you and your doctor need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- 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.
- Use this medication only for the duration prescribed by your doctor.
Important safety considerations:
- If this medication is ingested, it can cause harm; immediately contact a doctor or a poison control center if this occurs.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma; discuss this risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established; 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, this medication may affect growth in children and teenagers, necessitating regular growth assessments; consult your doctor about this potential risk.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting this medication, it is crucial to discuss the following with your doctor:
- If you are pregnant, planning to become pregnant, or are breastfeeding, you and your doctor need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects of corticosteroids, including: Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, striae, hypertension, hyperglycemia), adrenal suppression (fatigue, weakness, dizziness, nausea, vomiting, hypotension), growth retardation in children, cataracts, glaucoma.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. In case of acute overdose, call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity, extent, and type of dermatosis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis)
Frequency: Regularly during treatment, especially at follow-up visits (e.g., after 1-2 weeks).
Target: Improvement in dermatosis symptoms without significant local or systemic adverse effects.
Action Threshold: If no improvement after 2 weeks, or if adverse reactions develop, discontinue or re-evaluate treatment.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, large surface area application, or use under occlusion.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw therapy if suppression is confirmed.
Signs of infection (e.g., redness, pus, increased pain)
Frequency: Regularly during treatment.
Target: Absence of secondary bacterial or fungal infections.
Action Threshold: If infection develops, discontinue clobetasol and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin maceration
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Cushing's syndrome symptoms (e.g., moon face, central obesity, easy bruising)
- Hyperglycemia
- Glucosuria
- Blurred vision (cataracts/glaucoma)
Special Patient Groups
Pregnancy
Clobetasol propionate is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic absorption from topical use is minimal. Use with caution.
Second Trimester:
Minimal systemic absorption, but still use with caution and only if clearly needed.
Third Trimester:
Minimal systemic absorption, but still use with caution. Risk of HPA axis suppression in the neonate is theoretical but low with appropriate topical use.
Lactation
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:
Low risk due to minimal systemic absorption, but monitor infant for any unusual effects. Avoid direct contact with infant's skin.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier function. Risk of HPA axis suppression, Cushing's syndrome, and growth retardation is higher. If used, limit to the smallest amount and shortest duration possible under strict medical supervision.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to skin atrophy and purpura. Monitor for these local adverse effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% is a super-high potency topical corticosteroid. It should be used for short durations (typically up to 2 weeks) to minimize the risk of local and systemic side effects.
- Do not use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy, telangiectasias, and other side effects.
- Patients should be educated on the 'less is more' principle: a very thin layer is sufficient. Using more does not increase efficacy but significantly increases the risk of side effects.
- Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the underlying skin condition.
- Consider pulse dosing (e.g., 2 days on, 5 days off) for chronic conditions to reduce cumulative exposure and side effects, under medical guidance.
- Always assess the patient's skin condition and the area of application to determine the appropriate potency and duration of corticosteroid therapy.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term management
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions not responsive to topical agents
Cost & Coverage
Average Cost:
$50 - $150 per 50ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.