Temovate 0.05% Gel 15gm

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.

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 immediately or seek emergency 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 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 all 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.

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 all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Important Usage Precautions:
- This medication is not intended to treat diaper rash.
- Do not use this medication to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large skin area or near open wounds, exercise caution and consult your doctor.

Before Using Other Skin Products:
- Consult your doctor before using any other drugs or products on your skin, including soaps.

Application Guidelines:
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not use this medication for a longer duration than prescribed by your doctor.

Safety Precautions:
- If this medication is swallowed, it may cause harm. In such cases, immediately contact a doctor or a poison control center.
- This medication may increase the risk of developing cataracts or glaucoma. Discuss this 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 this population.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.

Breast-Feeding Precautions:
- If you are breast-feeding, avoid applying this medication directly on the nipple or the surrounding area.

Pregnancy and Breast-Feeding Considerations:
- If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to both you and your baby.

• Worsening of skin condition
• Development of new skin lesions (e.g., pustules, boils, signs of infection)
• Excessive skin thinning or bruising
• Development of stretch marks (striae)
• Increased hair growth in treated areas
• Changes in skin color (hypopigmentation)
• Unusual fatigue or weakness
• Increased thirst or urination (signs of hyperglycemia)
• Weight gain, especially in the face or trunk (Cushingoid features)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should generally be avoided or used with extreme caution, for the shortest duration, and on the smallest possible area.

Clobetasol is excreted in breast milk following systemic administration. While systemic absorption from topical application is generally low, caution should be exercised. Use only if the potential benefit outweighs the potential risk to the infant. Avoid applying to the breast area to prevent direct infant exposure.

Not recommended for children under 12 years of age. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) than adult patients. If use is unavoidable, limit to the smallest effective amount for the shortest duration.

No specific dose adjustments are typically needed. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Monitor closely for skin integrity and adverse effects.

• Clobetasol propionate is one of the most potent topical corticosteroids available; use should be limited to short courses (typically 2 weeks) to minimize local and systemic side effects.
• Avoid use on the face, groin, or axillae, and for diaper dermatitis, due to increased risk of skin atrophy, striae, and systemic absorption in these sensitive areas.
• Patients should be advised against using occlusive dressings unless specifically instructed by a healthcare provider.
• Abrupt discontinuation after prolonged or extensive use can lead to a rebound flare of the underlying dermatosis.
• Monitor for signs of HPA axis suppression, especially in pediatric patients or those using large amounts over extensive body surface areas.

• Other high-potency topical corticosteroids (e.g., halobetasol propionate, betamethasone dipropionate augmented)
• Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinonide) for less severe conditions or maintenance
• Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term management
• Emollients and moisturizers for barrier repair and symptom relief
• Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory conditions

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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.