Temovate 0.05% Gel 30gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
May 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Temovate Gel contains clobetasol, a very strong medicine (corticosteroid) that helps reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It's applied directly to the skin.
How to Use This Medicine
Using Your Medication Correctly
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely.
Applying the Medication
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after applying the medication.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid covering the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature. Do not refrigerate or freeze it.
Be aware of the expiration date or the length of time you can store the medication before it needs to be discarded.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a 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 application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely.
Applying the Medication
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after applying the medication.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid covering the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature. Do not refrigerate or freeze it.
Be aware of the expiration date or the length of time you can store the medication before it needs to be discarded.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a 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 application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas.
- Wash your hands thoroughly before and after applying the gel.
- Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor.
- Do not use on the face, groin, or armpits unless directed by your doctor, as these areas are more prone to side effects.
- Avoid using occlusive dressings (like bandages or plastic wrap) over the treated area unless specifically instructed by your doctor, as this can increase absorption.
- Keep out of reach of children.
- Avoid contact with eyes.
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 for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
Psoriasis:
Apply twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Eczema:
Apply twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
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 adrenal suppression.
Adolescent:
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 for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific adjustment needed for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, collectively called 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. Thus, clobetasol exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Generally low but clinically significant absorption is possible.
Tmax:
Not typically reported for topical application; peak systemic levels, if measurable, would vary greatly.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-quantified for topical application; if absorbed systemically, distributed throughout the body.
ProteinBinding:
Not well-quantified for topical application; systemic corticosteroids are highly protein-bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of absorbed drug is variable.
Clearance:
Not well-quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites; some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect:
Within days to weeks for maximal therapeutic effect.
DurationOfAction:
Effects persist as long as applied; localized duration of action.
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 symptoms, contact your doctor or seek medical help right away:
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 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, 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 help right away:
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 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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased burning, itching, or irritation at the application site.
- Skin thinning, easy bruising, or stretch marks appearing on the treated skin.
- Changes in skin color.
- Acne or hair growth in the treated area.
- Signs of skin infection (e.g., pus, worsening redness, fever).
- Unusual weight gain, swelling in the face, or feeling unusually tired (rare signs of too much medicine absorbed into the body).
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.
To guarantee your safety, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all 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.
To guarantee your safety, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all 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 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 ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk.
This medication may not be suitable for children of all ages. Before administering it to a child, consult your doctor to determine the appropriate course of treatment. When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential risk.
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. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for 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 ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk.
This medication may not be suitable for children of all ages. Before administering it to a child, consult your doctor to determine the appropriate course of treatment. When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential risk.
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. You and your doctor will need to discuss the potential 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, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Local symptoms may include severe skin atrophy, striae, and telangiectasias.
What to Do:
Discontinue the drug gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
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
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly or as clinically indicated
Target: Improvement in symptoms and skin appearance.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: At each follow-up visit
Target: Absence or minimal signs of adverse effects.
Action Threshold: If severe or persistent, discontinue use or reduce frequency/potency.
Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or in children.
Target: Absence of systemic signs/symptoms.
Action Threshold: If suspected, perform appropriate endocrine tests (e.g., ACTH stimulation test, plasma cortisol) and gradually withdraw the drug.
Symptom Monitoring
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching that worsens or does not improve
- Skin thinning, easy bruising, or shiny appearance (atrophy)
- Stretch marks (striae)
- Spider veins (telangiectasias)
- Acne-like eruptions
- Folliculitis
- Signs of infection (pus, fever, spreading redness)
- Unusual weight gain, moon face, buffalo hump (signs of Cushing's syndrome, rare)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Clobetasol propionate 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 for fetal effects (e.g., HPA axis suppression) if used extensively.
Third Trimester:
Risk of systemic absorption and potential for fetal effects (e.g., HPA axis suppression) if used extensively.
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 due to minimal systemic absorption, but potential for adverse effects if significant absorption occurs or if applied to areas where infant could ingest.
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 patients due to a larger skin surface area to body weight ratio. Use in adolescents (12 years and older) should be limited to short durations and small areas.
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 closely for skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids available; use should be limited to short durations (typically 2 weeks) to minimize local and systemic side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy and other side effects.
- Patients should be educated on the proper application technique (thin layer, gentle rubbing) and the importance of not exceeding the recommended duration or amount (e.g., 50g per week).
- Risk of tachyphylaxis (decreased response with prolonged use) can occur; intermittent therapy or drug holidays may be considered for chronic conditions.
- Monitor for signs of secondary infection, as corticosteroids can mask or worsen infections.
Alternative Therapies
- Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinolone acetonide)
- Low-potency topical corticosteroids (e.g., hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use.
- Emollients and moisturizers for barrier repair.
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions.
Cost & Coverage
Average Cost:
$50 - $200 per 30gm tube of generic clobetasol propionate 0.05% gel
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic formulations); Brand name may be Tier 3 or higher.
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 taken, the amount, and the time it happened.