Clobex 0.05% Lotion 59ml

Clobetasol propionate is a high-potency corticosteroid. It induces 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.

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 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 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 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 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 and its symptoms.
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.

To guarantee your safety, always consult your doctor before starting, stopping, or adjusting the dose of any medication, including this one.

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 skin 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 what your doctor has prescribed.

If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.

This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. 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, necessitating regular growth checks; consult your doctor about 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 to discuss the potential benefits and risks to you and your baby.

• Burning or stinging at application site
• Itching
• Skin atrophy (thinning, shiny skin)
• Striae (stretch marks)
• Telangiectasias (spider veins)
• Folliculitis
• Acneiform eruptions
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Secondary infection
• Symptoms of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, hypertension, hyperglycemia)
• Symptoms of adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss) upon withdrawal

Clobetasol is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It 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 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 appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Clobex Lotion is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.

Not recommended for children under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Chronic corticosteroid therapy may interfere with growth and development in children.

Clinical studies of Clobex Lotion 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, which could increase systemic absorption.

• Clobetasol propionate 0.05% is a super high-potency topical corticosteroid. Use it sparingly and for short durations (typically no more than 2 consecutive weeks) to minimize the risk of local and systemic side effects.
• The 59 mL bottle of Clobex Lotion contains 50 grams of clobetasol propionate. Patients should be instructed not to use more than one bottle per week.
• Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, striae, and telangiectasias in these sensitive areas.
• Educate patients on the signs of HPA axis suppression (e.g., fatigue, weakness) and local skin adverse effects (e.g., thinning, bruising).
• Consider alternative therapies or lower potency corticosteroids for maintenance therapy once acute flares are controlled.
• Risk of HPA axis suppression is higher in pediatric patients, those using occlusive dressings, or those applying to large body surface areas.

• Other topical corticosteroids (e.g., fluocinonide, triamcinolone, betamethasone, hydrocortisone) of varying potencies.
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use.
• Vitamin D analogs (e.g., calcipotriene) for psoriasis.
• Systemic therapies (e.g., biologics, oral retinoids, methotrexate, cyclosporine) for severe or extensive disease.

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.