Temovate 0.05% Cream 15gm

Manufacturer PHARMADERM Active Ingredient Clobetasol Cream, Gel, and Ointment(kloe BAY ta sol) Pronunciation kloe BAY ta sol
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
đŸˇī¸
Drug Class
Topical Corticosteroid
đŸ§Ŧ
Pharmacologic Class
Glucocorticoid
🤰
Pregnancy Category
Category C
✅
FDA Approved
Aug 1983
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Clobetasol is a very strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It's a type of steroid, but it's only for use on the skin.
📋

How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely.

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.
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 application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed 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 instructed to do so by your doctor.

Storing and Disposing of Your Medication

Store the medication at room temperature, away from refrigeration and freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Keep all medications in a safe and secure location, out of the reach of children and pets.

What to Do If You Miss 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 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 thin layer to the affected skin area(s) exactly as directed by your doctor, usually twice a day.
  • Do not use more than the prescribed amount or for longer than 2 weeks unless specifically instructed by your doctor.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Wash your hands before and after applying the cream.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
  • Keep out of reach of children.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply a thin layer to the affected skin areas twice daily.

Condition-Specific Dosing:

psoriasis: Apply a thin layer to affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
eczema: Apply a thin layer to affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established (use generally not recommended due to increased systemic absorption risk)
Child: Not established (use generally not recommended due to increased systemic absorption risk); if used, limit to shortest duration and smallest amount possible, and avoid occlusion.
Adolescent: Similar to adult dosing, but with caution regarding total amount and duration due to potential for HPA axis suppression.
âš•ī¸

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 considerations 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

đŸ”Ŧ

Mechanism of Action

Clobetasol propionate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1%) through intact skin; however, absorption can increase significantly with inflammation, skin barrier disruption, occlusion, or application to large surface areas.
Tmax: Not applicable for topical systemic absorption; local peak effect is within hours.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not precisely quantified for topical use; systemically absorbed clobetasol is distributed throughout the body.
ProteinBinding: Approximately 90% (for systemically absorbed portion).
CnssPenetration: Limited (for systemically absorbed portion).

Elimination:

HalfLife: Not precisely quantified for topical use; systemic half-life of corticosteroids varies.
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Primarily renal (for systemically absorbed portion), with some biliary excretion.
Unchanged: Minimal (for systemically absorbed portion).
âąī¸

Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within 12-24 hours of application.
DurationOfAction: Effects may persist for several hours after application.

Safety & Warnings

âš ī¸

Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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 at the site of application
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 contact your doctor or seek medical help if you notice any of the following:

Burning or stinging
Dry skin
* Redness

These are not all the possible side effects that may occur. 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, swelling, or irritation of the skin where the cream is applied.
  • Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks (striae).
  • Development of new skin infections (e.g., pus, fever).
  • Unusual hair growth.
  • Acne-like breakouts.
  • If you experience symptoms like unusual tiredness, weakness, nausea, vomiting, dizziness, or weight loss, especially after prolonged or extensive use, contact your doctor immediately as these could be signs of systemic absorption.
📋

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 change the dose 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.
âš ī¸

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. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth. When applying this medication to a large area of skin or near open wounds, exercise caution and consult with 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, it can be harmful. In such cases, immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.

This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can 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. It is crucial to discuss the potential benefits and risks of using this medication to both 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, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia (high blood sugar), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

What to Do:

Discontinue use and seek medical attention. Management is supportive. If HPA axis suppression is suspected, gradual withdrawal of the corticosteroid may be necessary. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for treatment.

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 after 2 weeks of continuous use.

Target: Improvement in dermatosis without significant local adverse effects.

Action Threshold: If no improvement after 2 weeks, or if adverse reactions develop, discontinue use and re-evaluate diagnosis/treatment.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Absence of symptoms.

Action Threshold: If symptoms occur, consider HPA axis evaluation (e.g., ACTH stimulation test) and gradual withdrawal of corticosteroid.

đŸ‘ī¸

Symptom Monitoring

  • Burning
  • Stinging
  • Itching
  • Skin atrophy (thinning)
  • Striae (stretch marks)
  • Telangiectasias (spider veins)
  • Folliculitis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Secondary infection
  • Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, growth retardation in children)

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester: Similar considerations as first trimester; minimal systemic absorption expected.
Third Trimester: Potential for HPA axis suppression in the newborn if used extensively or for prolonged periods near term.
🤱

Lactation

Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited topical use, but potential for systemic effects in infant if significant absorption occurs in mother and is excreted in milk. Monitor infant for adverse effects.
đŸ‘ļ

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. Use is generally not recommended for children under 12 years of age. If used, limit to the smallest effective amount for the shortest possible duration, and avoid occlusive dressings.

👴

Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy and purpura. Use with caution.

Clinical Information

💎

Clinical Pearls

  • Clobetasol propionate is a super-high potency topical corticosteroid; it should be used for short-term treatment (typically up to 2 weeks) of severe dermatoses that are unresponsive to less potent corticosteroids.
  • The total dosage should not exceed 50 g per week.
  • Avoid use on the face, groin, or axillae due to increased risk of local adverse effects (e.g., atrophy, telangiectasias, perioral dermatitis).
  • Patients should be advised to discontinue use once control is achieved and switch to a less potent corticosteroid or non-steroidal therapy if prolonged treatment is needed.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and do not use occlusive dressings unless specifically instructed by a physician.
  • Monitor for signs of HPA axis suppression, especially in children or with extensive/prolonged use.
🔄

Alternative Therapies

  • Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Topical retinoids (e.g., tazarotene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses.
💰

Cost & Coverage

Average Cost: $30 - $100+ per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
📚

General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take medication prescribed to someone else. Some medications may have additional patient information leaflets; consult your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.