Temovate 0.05% Gel 60gm
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 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong steroid medicine that you put on your skin to help reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It works by calming down your 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'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 application, unless your hand is the treated area, in which case you should not wash it after use.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
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, unless advised to do so 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'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 use extra doses.
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 application, unless your hand is the treated area, in which case you should not wash it after use.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
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, unless advised to do so 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'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 use extra doses.
Lifestyle & Tips
- Apply a very 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).
- Wash your hands before and after applying the medication.
- Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
- 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 getting the gel in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not use this medicine 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 area once or twice daily. Do not use for more than 2 consecutive weeks, and total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to the affected skin area twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Eczema:
Apply a thin layer to the affected skin area twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Pediatric Dosing
Neonatal:
Not established. Not recommended due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established. Not recommended due to increased risk of systemic absorption and HPA axis suppression.
Child:
Not recommended for children under 12 years of age. For children 12 years and older, use with extreme caution and for the shortest duration possible, typically not exceeding 5 days, due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
For adolescents 12 years and older, apply a thin layer to the affected skin area once or twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week. Use with caution and monitor for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Moderate:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Severe:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Dialysis:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Moderate:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant systemic absorption.
Severe:
No specific adjustment typically required for topical use unless extensive application or prolonged therapy leading to significant 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, 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) by inhibiting phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (typically low, but increased by occlusion, inflammation, or thin skin areas)
Tmax:
Not typically defined for topical application; systemic absorption is minimal but can occur.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not typically quantified for topical application; systemically absorbed clobetasol distributes widely.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids)
CnssPenetration:
Limited (for topical application, significant CNS penetration is not expected unless extensive systemic absorption occurs).
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of corticosteroids varies (e.g., 4-6 hours for cortisol).
Clearance:
Not typically quantified for topical application.
ExcretionRoute:
Renal (metabolites), Biliary (minor)
Unchanged:
<1% (for systemically absorbed corticosteroids)
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects)
PeakEffect:
Days to 1-2 weeks of consistent application
DurationOfAction:
Variable, depends on application frequency and skin condition; effects may persist for a few days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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, don't hesitate to reach out to 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 help right away:
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, don't hesitate to reach out to 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 burning, itching, redness, pus, skin thinning, stretch marks).
- Signs of infection (e.g., fever, chills, spreading redness, pus).
- Signs of too much steroid in your body (rare with proper use, but can include unusual tiredness, weight gain, swelling in ankles/feet, vision changes, mood changes).
- If you are using it on your scalp and experience hair loss or changes in hair texture.
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, 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 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, 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
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Contraindications and Precautions
Do not use this medication to treat diaper rash.
Avoid using this medication to treat acne, rosacea, or a rash around the mouth.
Exercise caution when applying this medication to a large area of skin or near open wounds. Consult your doctor before doing so.
Before using other medications or products on your skin, including soaps, consult your doctor.
Do not apply this medication to cuts, scrapes, or damaged skin.
Use this medication only for the duration prescribed by your doctor.
Safety Precautions
If this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Prolonged use of this medication may increase the risk of cataracts or glaucoma. Discuss this risk with your doctor.
Pediatric Use
This medication may not be suitable for children of all ages. 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 some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this risk with your doctor.
Breast-Feeding and Pregnancy
If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
* If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Contraindications and Precautions
Do not use this medication to treat diaper rash.
Avoid using this medication to treat acne, rosacea, or a rash around the mouth.
Exercise caution when applying this medication to a large area of skin or near open wounds. Consult your doctor before doing so.
Before using other medications or products on your skin, including soaps, consult your doctor.
Do not apply this medication to cuts, scrapes, or damaged skin.
Use this medication only for the duration prescribed by your doctor.
Safety Precautions
If this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center.
Prolonged use of this medication may increase the risk of cataracts or glaucoma. Discuss this risk with your doctor.
Pediatric Use
This medication may not be suitable for children of all ages. 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 some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this risk with your doctor.
Breast-Feeding and Pregnancy
If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
* If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication 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, acne, hirsutism, hypertension, hyperglycemia, hypokalemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- In children, HPA axis suppression, growth retardation, and delayed weight gain are more likely.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. HPA axis function may need to be monitored. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy
Area of application and total body surface area (BSA) involved
Rationale: To estimate potential for systemic absorption and guide appropriate dosing/duration.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during therapy, especially at follow-up visits (e.g., weekly or bi-weekly)
Target: Absence or minimal
Action Threshold: If severe or persistent, discontinue use and re-evaluate.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, extensive application, or in pediatric patients.
Target: Absence
Action Threshold: If suspected, perform HPA axis function tests (e.g., ACTH stimulation test) and consider gradual withdrawal or alternative therapy.
Signs of infection (e.g., worsening redness, pus, fever)
Frequency: Regularly during therapy
Target: Absence
Action Threshold: If present, discontinue clobetasol and initiate appropriate antimicrobial therapy.
Intraocular pressure (if applied near eyes)
Frequency: Periodically, especially with prolonged use near eyes.
Target: Normal range
Action Threshold: If elevated, consult ophthalmologist and discontinue use.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain at application site (signs of infection)
- Skin thinning, bruising, or shiny appearance (atrophy)
- Stretch marks (striae)
- Visible small blood vessels (telangiectasias)
- Excessive hair growth (hypertrichosis)
- Acne-like eruptions
- Fatigue, weakness, dizziness (signs of systemic absorption/HPA axis suppression)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Clobetasol is a potent corticosteroid and systemic absorption can occur. Animal studies have shown teratogenic effects.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects (e.g., cleft palate, skeletal abnormalities) observed in animal studies with high doses of potent corticosteroids. Avoid if possible.
Second Trimester:
Risk of fetal growth restriction or HPA axis suppression with prolonged or extensive use of potent topical corticosteroids.
Third Trimester:
Risk of fetal growth restriction or HPA axis suppression with prolonged or extensive use of potent topical corticosteroids. Neonates exposed in utero may be at risk for hypoadrenalism.
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. If used, avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use on small areas. Potential for systemic effects in infant if significant maternal systemic absorption occurs or if applied directly to breast and ingested by infant.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio and immature skin barrier. Use in children under 12 years is generally not recommended. If used in adolescents (12 years and older), limit duration and amount, and monitor closely for systemic effects.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could increase the risk of local side effects like atrophy or purpura. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; it should be used for short durations (typically 2 weeks maximum) to minimize systemic absorption and local side effects.
- Educate patients on the 'less is more' principle: a very thin layer is sufficient. Overuse can lead to significant side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy, telangiectasias, and striae.
- HPA axis suppression is a significant concern, especially with prolonged use, large surface areas, occlusive dressings, or in pediatric patients. Consider periodic monitoring if these risk factors are present.
- Patients should be advised not to stop treatment abruptly after prolonged use, especially if HPA axis suppression is suspected, to avoid adrenal insufficiency.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Retinoids (e.g., tazarotene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses not responsive to topical treatment.
Cost & Coverage
Average Cost:
$50 - $200 per 60gm tube (gel)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic clobetasol)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.