Olux-E

Clinical Trials Experience

In controlled clinical trials involving 821 subjects exposed to Olux-E (clobetasol propionate foam) Foam and Vehicle Foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with Olux-E (clobetasol propionate foam) Foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Clobetasol is a highly potent steroid. It reduces the actions of chemicals in the body that cause inflammation.

Clobetasol topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Clobetasol topical may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medicine to treat any condition that has not been checked by your doctor.

Avoid using clobetasol topical to treat skin on your face, underarms, or groin area without your doctor's advice.

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use clobetasol topical on broken or infected skin. Also avoid using this medicine in open wounds.

It is not likely that other drugs you take orally or inject will have an effect on topically applied clobetasol. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution are used for scalp problems, the foam is used for mild to moderate plaque psoriasis, the cream, lotion, and spray are used for moderate to severe plaque psoriasis, and the foam and shampoo are used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Olux-E or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Olux-E (clobetasol emollient foam). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Olux-E Foam is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of Olux-E Foam to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In controlled clinical trials involving 821 subjects exposed to Olux-E Foam and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with Olux-E Foam was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender.

The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate.

Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness.

Applies to clobetasol topical: compounding powder, topical cream, topical foam, topical gel, topical kit, topical lotion, topical ointment, topical shampoo, topical solution, topical spray

General

The most common side effect reported was skin discomfort.[Ref]

Endocrine

Postmarketing reports: Cushing's syndrome, adrenal suppression[Ref]

Dermatologic

Common (1% to 10%): Skin discomfort, acne/folliculitis, telangiectasia, skin atrophy, dry skin
Uncommon (0.1% to 1%): Local signs of irritation, pruritus, urticaria
Frequency not reported: Stria, purpura, contact dermatitis, pigmentation changes, pustular eruptions, hypertrichosis, irritant dermatitis
Postmarketing reports: Erythema, alopecia, pain of skin, skin exfoliation, chapped skin, scaling, induration/papulation,
lichenification, psoriasis (aggravation) plaque elevation, excoriation, rash, hair color changes, skin tightness[Ref]

Local

Frequency not reported: Itching[Ref]

Ocular

Common (1% to 10%): Eye stinging/burning
Postmarketing reports: Eye pain, blurred vision, eye irritation[Ref]

Other

Frequency not reported: Edema[Ref]

Gastrointestinal

Postmarketing reports: Nausea[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Dizziness[Ref]

Some side effects of Olux-E may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.