Olux

Your pharmacist can provide more information about clobetasol topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using clobetasol topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medicine over a large area of skin.

Do not cover the treated skin area unless your doctor tells you to.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with clobetasol topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Call your doctor if your symptoms do not improve after 2 weeks of treatment, or if you have signs of a bacterial, fungal, or viral skin infection.

If you use this medicine long-term, you may need frequent medical tests at your doctor's office.

Store at room temperature away from moisture and heat. Keep from freezing.

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.

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Make sure your doctor knows that you are using clobetasol cream or gel. You may need to stop using this medicine several days before having surgery.

Do not use clobetasol together with other topical corticosteroid-containing medicines, such as betamethasone, hydrocortisone, triamcinolone, Cortaid®, or Lotrisone®. Using these medicines together may cause serious unwanted effects.

Do not use cosmetics or other skin care products on the treated areas.

• If you have an allergy to clobetasol or any other part of Olux (clobetasol foam).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have thinning of the skin where you are putting this medicine.

This is not a list of all drugs or health problems that interact with Olux.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Dry skin.
• Burning.
• Redness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

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

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically. 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 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 Foam based on body surface area comparisons. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

Nursing Mothers

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

Pediatric Use

Safety and effectiveness of Olux Foam in patients younger than 12 years of age have not been established; therefore, use in children younger than 12 years is not recommended.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when they are treated with topical drugs. They are, therefore, also at greater risk of adrenal insufficiency upon the use of topical corticosteroids.

Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.

Avoid use of Olux Foam in the treatment of diaper dermatitis.

Geriatric Use

Clinical studies of Olux Foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Inform patients of the following:

• Avoid use of Olux Foam on the face, underarms, or groin areas unless directed by the physician. • Do not occlude the treatment area with bandage or other covering, unless directed by the physician. • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • For proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin. • Limit treatment to 2 consecutive weeks. Use no more than 50 grams of Olux Foam per week, or more than 21 capfuls per week. • Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use. • Avoid use of Olux Foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing. • The product is flammable; avoid heat, flame, and smoking when applying this product. • Do not use other corticosteroid-containing products without first consulting with the physician.

Olux is a registered trademark of Stiefel Laboratories, Inc.

For additional information:
1-866-897-5002
or visit
www.Olux.com

Manufactured for
Prestium Pharma, Inc.
Newtown, PA 18940
By DPT Laboratories, Ltd.
San Antonio, TX 78215
©2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

OLX:XPI

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