Temovate 0.05% Cream 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
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong topical steroid medicine used on the skin to reduce redness, swelling, and itching caused by certain skin conditions like psoriasis and eczema. It should only be used for short periods and exactly as prescribed by your doctor.
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 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's close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses.
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 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's close to the time for your next dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream to the affected skin area and rub it in gently. Do not use more than prescribed.
- Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption.
- Avoid using on the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
- Do not use for longer than 2 consecutive weeks without consulting your doctor.
- Do not exceed 50 grams (one 60gm tube is 60g) of cream per week.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.
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
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 per week.
eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do 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 potential for systemic absorption and HPA axis suppression.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration (e.g., up to 2 weeks) if clinically necessary, similar to adult dosing, but with close monitoring for systemic effects. Do not exceed 50 g per week.
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 high-potency synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing 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; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Generally low.
Tmax:
Not typically reported for topical application due to variable and low systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption. Systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to variable absorption. Systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Depends on application frequency and severity of condition; effects persist for a period after discontinuation.
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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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 symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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:
- Severe burning, itching, or irritation of the treated skin.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Thinning of the skin, stretch marks, or changes in skin color where the cream is applied.
- Unusual hair growth.
- Acne-like breakouts.
- Any signs of systemic side effects such as unexplained weight gain, swelling in the face, fatigue, or muscle weakness (these are rare but serious).
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 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, 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 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.
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 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 your doctor regularly.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks. Discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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 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 your doctor regularly.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks. Discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, striae, hypertension, hyperglycemia)
- Adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia) upon abrupt withdrawal after prolonged high-dose use.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Moderate Interactions
- Ritonavir
- Itraconazole
Monitoring
Baseline Monitoring
Skin condition and extent of affected area
Rationale: To establish baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Regularly during treatment (e.g., weekly)
Target: Improvement in symptoms without adverse effects.
Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation.
Signs of local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: Regularly during treatment and at follow-up.
Target: Absence of adverse reactions.
Action Threshold: Presence of adverse reactions warrants discontinuation or reduction in potency/frequency.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Consider if large areas, prolonged use, or occlusive dressings are used, especially in children.
Target: Normal cortisol levels.
Action Threshold: Symptoms or abnormal cortisol levels (e.g., morning plasma cortisol, ACTH stimulation test) warrant discontinuation and medical evaluation.
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
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, easy bruising, hyperglycemia)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should be used sparingly and for the shortest duration possible.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited and generally low risk with appropriate use.
Second Trimester:
Risk of fetal growth restriction or other systemic effects with extensive or prolonged use.
Third Trimester:
Risk of fetal growth restriction or other systemic effects with extensive or prolonged use. Potential for HPA axis suppression in the neonate if used extensively near term.
Lactation
Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use. Potential for systemic effects in infant if significant absorption occurs in mother and passes into milk, or if direct exposure to infant.
Pediatric Use
Not recommended for children under 12 years of age. Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. If used, limit to the smallest amount for the shortest duration, and monitor closely for signs of HPA axis suppression and Cushing's syndrome.
Geriatric Use
Use with caution. Elderly patients may have thinner skin, which could increase systemic absorption and susceptibility to local adverse effects (e.g., skin atrophy, purpura). Use the lowest effective dose for the shortest duration.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids available; it should be used with caution and for short durations (typically no more than 2 consecutive weeks).
- Total weekly dosage should not exceed 50 grams to minimize the risk of systemic absorption and HPA axis suppression.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to adverse effects like skin atrophy and telangiectasias.
- Patients should be educated on proper application technique, including applying a thin layer and not using occlusive dressings unless prescribed.
- Monitor for signs of local adverse effects (e.g., skin thinning, striae, folliculitis) and systemic effects (e.g., Cushing's syndrome, adrenal suppression), especially with prolonged or extensive use.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies depending on the condition and body area.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like eczema, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Topical retinoids (e.g., tazarotene) for psoriasis.
- Emollients and moisturizers for dry skin conditions.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions not responsive to topical treatment.
Cost & Coverage
Average Cost:
$30 - $100 per 60gm tube
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 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.