Temovate 0.05% Ointment 30gm

Clobetasol propionate is a high-potency topical 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
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Irritation at the site of application
Thinning of the skin
Changes in vision, 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 unusual symptoms, contact your doctor for advice:

Burning or stinging sensation
Dry skin
* Redness

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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.

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 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, so immediately contact a doctor or a poison control center. Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.

The safety and efficacy of this medication in children of all ages have not been established. If your child is using this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication can affect growth in children and teenagers, so they may require 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, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby.

• Not available (due to minimal systemic absorption)

• Not available (due to minimal systemic absorption)

• Immunosuppressants (e.g., cyclosporine, tacrolimus): Potential for additive immunosuppression if significant systemic absorption occurs, though rare.
• Drugs metabolized by CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure of clobetasol if significant systemic absorption occurs, leading to potential for Cushing's syndrome or adrenal suppression.

• Not available

• Burning or stinging at application site
• Itching
• Irritation
• Dryness
• Folliculitis
• Acneiform eruptions
• Hypopigmentation
• Perioral dermatitis
• Allergic contact dermatitis
• Skin atrophy (thinning, bruising)
• Striae (stretch marks)
• Telangiectasias (spider veins)
• Signs of systemic absorption: weight gain (especially central), moon face, buffalo hump, easy bruising, muscle weakness, fatigue, mood changes (Cushing's syndrome symptoms)

Clobetasol propionate is Pregnancy Category C. It 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. Caution should be exercised when clobetasol propionate is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.

Children are more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount for the shortest duration possible, and monitor closely for signs of HPA axis suppression and Cushing's syndrome.

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy and purpura. Use with caution and monitor skin integrity.

• Clobetasol propionate 0.05% ointment is a super high-potency topical corticosteroid; use it judiciously and for short durations (typically max 2 weeks).
• Educate patients on the 'thin layer' application technique to minimize systemic absorption and local side effects.
• Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
• Occlusive dressings significantly increase absorption and should only be used if explicitly prescribed by a physician.
• Always consider the risk of HPA axis suppression, especially with prolonged use, large surface areas, or in pediatric patients.
• If long-term treatment is needed, consider stepping down to a lower potency corticosteroid or using a 'pulse' therapy (e.g., 2 days on, 5 days off).

• Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for eczema, not corticosteroids)
• Vitamin D analogs (e.g., calcipotriene - for psoriasis)
• Topical retinoids (e.g., tazarotene - for psoriasis)
• Systemic therapies (e.g., biologics, methotrexate, cyclosporine - for severe cases)

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 this 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.