Temovate .05% Emollient Cream 15gm

Clobetasol propionate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated by the induction of phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

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

Important Usage Precautions:
- This medication is not intended for treating 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 any other skin products or drugs, including soaps, discuss them with your doctor.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not exceed the prescribed treatment duration as advised by your doctor.

Safety Warnings:
- If this medication is ingested, it may cause harm. In case of ingestion, immediately contact a doctor or a poison control center.
- The use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor about this potential risk.

Special Considerations:
- This medication may not be suitable for children of all ages. Consult your doctor before administering it to a child.
- When used in children, this medication requires careful administration due to a potentially higher risk of certain side effects.
- In some cases, this medication 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 on the nipple or the surrounding area.

Pregnancy and Breastfeeding:
- If you are pregnant, plan to become pregnant, or are breastfeeding, 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
• Increased redness, burning, stinging, or itching at application site
• Skin thinning, easy bruising, stretch marks (striae)
• Development of acne-like eruptions
• Signs of secondary infection (pus, fever, spreading redness)
• Systemic symptoms such as fatigue, weakness, weight gain (especially in face/trunk), increased thirst/urination (signs of hyperglycemia), or blurred vision (cataracts/glaucoma)

Category C. Clobetasol propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with high doses of corticosteroids.

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 infant ingestion.

Not recommended for children under 12 years of age due to a higher ratio of skin surface area to body weight, which increases the risk of systemic absorption and HPA axis suppression. If use is unavoidable, it should be for the shortest duration and smallest amount possible, under strict medical supervision.

No specific dose adjustments are required. However, elderly patients may have thinner skin and be more prone to local side effects like skin atrophy and purpura. Monitor closely for these effects.

• Clobetasol propionate is a super-high potency topical corticosteroid; it should be used judiciously and for short durations (typically ≤ 2 weeks) to minimize local and systemic side effects.
• Educate patients thoroughly on proper application technique (thin layer, only to affected areas) and the importance of not exceeding the recommended duration or total weekly amount (50g).
• Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy, telangiectasias, and striae.
• Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically prescribed for recalcitrant lesions.
• Monitor for signs of HPA axis suppression, especially in patients using large amounts, over large surface areas, or for prolonged periods. Consider periodic plasma cortisol levels or ACTH stimulation tests if concerns arise.
• Be vigilant for signs of secondary infection, as corticosteroids can mask or worsen infections.

• Other topical corticosteroids of lower potency (e.g., triamcinolone, fluocinonide, betamethasone)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term maintenance in atopic dermatitis.
• Vitamin D analogs (e.g., calcipotriene) for psoriasis.
• Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory dermatoses.

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.