Olux-E (clobetasol propionate) Foam, an emulsion aerosol foam, contains the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C₂₅H₃₂ClFO₅, and a molecular weight of 466.97. The following is the chemical structure:

Clobetasol Propionate, USP

Clobetasol propionate is a white to cream-colored crystalline powder, practically insoluble in water.

Each gram of Olux-E Foam contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid USP, cetyl alcohol NF, cyclomethicone NF, isopropyl myristate NF, light mineral oil NF, polyoxyl 20 cetostearyl ether NF, potassium citrate monohydrate USP, propylene glycol USP, purified water USP, sorbitan monolaurate NF, white petrolatum USP, and phenoxyethanol NF as a preservative.

Olux-E Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.

Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week (see DOSAGE AND ADMINISTRATION).

Patients should be instructed to use Olux-E Foam for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).

Use in pediatric patients under 12 years of age is not recommended because of numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression seen in patients under 12 years of age (see PRECAUTIONS: Pediatric Use).

Apply a thin layer of Olux-E Foam to the affected area(s) twice daily, morning and evening. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (not more than a dollop the size of a golf ball) 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.

Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Unless directed by a physician, Olux-E Foam should not be used with occlusive dressings.

Olux-E (clobetasol propionate) Foam, 0.05%, is supplied in 100 gram (NDC 63032-101-00) aluminum cans.

Store at controlled room temperature 68-77°F (20-25°C).

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

Avoid contact with eyes or other mucous membranes.

Keep out of reach of children.

Manufactured for: Connetics Corporation
Palo Alto, CA 94304 USA
© 2006 Connetics Corporation
FDA rev date: 1/12/2007

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. 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.

No information provided.

The propellant in Olux-E Foam is flammable. Avoid fire, flame or smoking during and immediately following application.

General

Olux-E Foam has been shown to suppress the HPA axis.

Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

Conditions which increase systemic absorption include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids.

In a study evaluating the potential for HPA axis suppression, using the cosyntropin stimulation test, Olux-E Foam demonstrated adrenal suppression after two weeks of twice daily use in patients with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects twelve years of age and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this study HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30-min post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment.

Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use Olux-E Foam for the minimum amount of time necessary to achieve the desired results (see INDICATIONS AND USAGE).

If irritation develops, Olux-E Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Olux-E Foam should be discontinued until the infection has been adequately controlled.

Olux-E Foam should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face or the groin, axillae, or other intertriginous areas.

Laboratory Tests

The cosyntropin (ACTH_1-24) stimulation test may be helpful in evaluating patients for HPA axis suppression.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate was non-mutagenic in four different test systems: the Ames test, the mouse lymphoma test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test. In the in vivo mouse micronucleus test a positive finding was observed at 24 hours, but not at 48 hours, following oral administration at a dose of 2000 mg/kg.

Studies in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Olux-E Foam based on body surface area comparisons. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, clobetasol propionate was teratogenic at doses of 0.003 and 0.01 mg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of Olux-E Foam based on body surface area comparisons. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Olux-E Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Olux-E Foam is administered to a nursing woman.

Pediatric Use: Use in pediatric patients under 12 years of age is not recommended.

After two weeks of twice daily treatment with Olux-E Foam, 7 of 15 patients (47%) aged 6 to 11 years of age demonstrated HPA axis suppression. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment.

In 92 patients from 12 to 17 years of age, safety was similar to that observed in the adult population. Based on this data, no adjustment of dosage of Olux-E Foam in adolescent patients 12 to 17 years of age is warranted.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use: A limited number of patients at or above 65 years of age have been treated with Olux-E Foam (n = 58) in US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Olux-E Foam in geriatric patients is warranted.

Topically applied Olux-E Foam can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Olux-E Foam is contraindicated in patients who are hypersensitive to clobetasol propionate or to any ingredient in this preparation.

The contribution to efficacy by individual components of the vehicle has not been established.

Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties.

The mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that 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.

Pharmacokinetics

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Following twice daily application of Olux-E Foam for one week to 32 adult patients with mild to moderate plaque-type psoriasis, mean peak plasma concentrations (±SD) of 59 ± 36 pg/mL of clobetasol were observed at around 5 hours post-dose on day 8.

CLINICAL STUDIES

In a randomized study of subjects 12 years of age and older with moderate to severe atopic dermatitis, 251 subjects were treated with Olux-E Foam and 126 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 131 of 251 subjects (52%) treated with Olux-E Foam compared with 18 of 126 (14%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation.

In an additional randomized study of subjects 12 years of age and older with mild to moderate plaque-type psoriasis, 253 subjects were treated with Olux-E Foam and 123 subjects were treated with Vehicle Foam. Subjects were treated twice daily for two weeks. At the end of treatment, 41 of 253 subjects (16%) treated with Olux-E Foam compared with 5 of 123 (4%) treated with Vehicle Foam achieved treatment success. Treatment success was defined by an Investigator's Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Unless directed by the prescriber, it should not be used on the face, or in skin-fold areas, such as the underarms or groin. Avoid contact with the eyes or other mucous membranes. Wash hands after use.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged, wrapped, or otherwise covered so as to be occlusive unless directed by the physician.
4. Patients should report any signs of local or systemic adverse reactions to the physician.
5. Patients should inform their physicians that they are using Olux-E Foam if surgery is contemplated.
6. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
7. Patients should not use more than 50 grams per week of Olux-E Foam, or an amount greater than 21 capfuls per week (see DOSAGE AND ADMINISTRATION).

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CLOBETASOL/EMOLLIENT FOAM - TOPICAL

(kloh-BAY-tuh-sall/ee-MOL-yunt)

COMMON BRAND NAME(S): Olux-E

USES: This medication is used to treat a variety of skin conditions (e.g., psoriasis, eczema, dermatitis, allergies, rash). Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. It also can heal the rough, scaly patches on the skin seen with psoriasis. Clobetasol is a very strong (super-high-potency) corticosteroid. This medication also contains emollients. Emollients soften and moisturize the skin, leading to decreased itching and flaking. Emollients also help to protect the skin against irritation.

This medication is not recommended for use in children younger than 12 years.

HOW TO USE: Use this medication on the skin only. Do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Shake the can well before each use. Apply a small amount of medication to the affected area and gently rub in, usually 2 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because doing so may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water. If irritation occurs, contact your doctor immediately.

Use this medication only for the condition prescribed. Do not use it for longer than 2 weeks in a row or use more than 50 grams a week unless directed to do so by your doctor.

This medication contains an ingredient that could easily catch fire (flammable). After applying this medication, avoid smoking and being near open flames until the foam has dried.

Tell your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Burning, itching, irritation, or dryness may occur when this medication is first applied to the skin. Acne, unusual hair growth, or "hair bumps" (folliculitis) may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor promptly if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration.

Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clobetasol/emollients, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain skin conditions (rosacea, perioral dermatitis).

Do not use if there is an infection or sore present in the area to be treated.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. Children and those using this drug for an extended time over most of the skin may be at higher risk, especially if they also have serious medical problems such as severe infections, injuries, or surgeries. This precaution applies for up to 1 year after you stop using this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weight loss, unusual weakness, dizziness. Consult your doctor or pharmacist for more details, and tell all of your doctors that you use or have used this medication.

Caution is advised when using this drug in children because they may be more sensitive to the effects of too much steroid hormone. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may affect growth in children if used for prolonged periods. Monitor your child's height and rate of growth periodically.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids taken by mouth (e.g., prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial local poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.

If you use this drug for an extended time, apply it over large areas of the body, or bandage/wrap the treated areas, laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood test) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from heat and open flame. Do not puncture the can. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.