Clobetasol Prop 0.05% Cream 60gm

Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines).

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some individuals 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 at the site of application
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation

Other Possible Side Effects

As with all medications, some individuals may experience 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 unusual symptoms, contact your doctor for guidance:

Burning or stinging
Dry skin
* Redness

This is not an exhaustive list of potential 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe use.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.

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 other skincare products or medications, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin.

Do not use this medication for an extended period beyond the duration prescribed by your doctor. If ingested, this medication 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 your doctor about potential risks. This medication may not be suitable for children of all ages, so it is crucial to discuss its use with your doctor before administering it to a child.

When using this medication in children, exercise caution, as they may have a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary; consult your doctor about this potential effect.

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.

• Other corticosteroids (systemic or topical): Increased risk of HPA axis suppression.
• Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, leading to increased risk of systemic corticosteroid effects, especially with prolonged or extensive use.

• Skin thinning or atrophy
• Striae (stretch marks)
• Telangiectasias (spider veins)
• Burning or stinging sensation at application site
• Itching or irritation
• Folliculitis
• Acneiform eruptions
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Signs of secondary infection (e.g., redness, pus, warmth)
• Symptoms of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, easy bruising, hyperglycemia, hypertension) - rare but possible with extensive systemic absorption
• Symptoms of adrenal insufficiency upon withdrawal (e.g., fatigue, weakness, nausea, vomiting, hypotension) - rare

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. High potency topical corticosteroids should generally be avoided or used with extreme caution and for limited duration during pregnancy.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are excreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when clobetasol propionate is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.

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 children 12 years and older should be limited to the shortest duration possible and closely monitored.

Clinical studies of clobetasol propionate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin, increasing susceptibility to local side effects like atrophy.

• Clobetasol propionate is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
• The total amount applied per week should generally not exceed 50 grams to minimize the risk of systemic side effects.
• Avoid using clobetasol on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to side effects like skin thinning and stretch marks.
• Do not use under occlusive dressings (e.g., bandages, plastic wrap) unless explicitly instructed by a healthcare provider, as occlusion significantly increases systemic absorption.
• Patients should be advised to report any signs of local irritation, skin thinning, or systemic symptoms (e.g., unusual weight gain, fatigue) to their doctor.
• If long-term corticosteroid therapy is needed, a lower potency agent should be considered after the initial acute phase of treatment with clobetasol.

• Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
• Vitamin D analogs (e.g., calcipotriene) for psoriasis.
• Retinoids (e.g., tazarotene) for psoriasis.
• Systemic therapies (e.g., methotrexate, biologics) for severe, widespread dermatoses not responsive to topical treatment.

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.