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Olux-E: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
0.05 %
Active ingredient:
ATC code:
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Olux-E

ABOUT THIS MEDICATION

What the medication is used for:

OLUX®-E Foam is used in the treatment of swelling, redness, and itching of moderate to severe atopic dermatitis ( a type of eczema) in patients 12 years of age or older. The treatment is not recommended for more than 2 weeks and more than 50 grams OLUX®-E per week.

What it does:

OLUX®-E Foam contains clobetasol propionate delivered in a foam formulation. Clobetasol propionate is a very strong topical steroid which reduces inflammation (swelling and redness) and itching.

When it should not be used:

Do not use OLUX®-E Foam if you:

  • are allergic to clobetasol propionate, other corticosteroids, any component of the container, or to any of the other ingredients of OLUX®-E Foam (see What the nonmedicinal ingredients are).
  • have bacterial, fungal, parasitic, viral skin infection (e.g. herpes simplex, chickenpox), or tuberculous or syphilis skin lesions or skin reaction following a recent vaccination.
  • have acne.
  • have rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)).
  • have rashes around the mouth.
  • have itchy skin which is not inflamed
  • have itchy skin around the anus or genitals (penis and vagina)
  • have infection of the scalp

Do not apply OLUX®-E Foam in, or near the eye.

What the medicinal ingredient is:

clobetasol propionate

What the nonmedicinal ingredients are:

The foam contains white petrolatum, light mineral oil, isopropyl myristate, cyclomethicone, anhydrous citric acid, cetyl alcohol, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative.

What dosage forms it comes in:

OLUX®-E (clobetasol propionate) Foam, 0.05% w/w. Each 1 g of OLUX®-E contains 0.5 mg of clobetasol propionate.

WARNINGS AND PRECAUTIONS

Topical corticosteroids when used over large areas, broken skin, for prolonged periods and under occlusive dressing, are more likely to be absorbed into the bloodstream and cause side effects. OLUX®-E should not be applied over large areas; apply only enough to cover the affected areas. OLUX®-E should not be used on broken skin, the face, the scalp or in skin-fold areas, such as the groin, scrotum and armpit. Do not use occlusive dressing such as a bandage or cover the treated areas tightly.

Inform your doctor if you have previously used corticosteroids.

Before using OLUX®-E, talk to your doctor or pharmacist if:

  • you have any bacterial or fungal infections
  • you have eczema around a leg ulcer. Use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
  • you have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).

  • you are pregnant or planning to become pregnant.

  • you are breastfeeding. If your doctor suggests using OLUX®-E Foam when breastfeeding, don’t use OLUX®-E on your breast area to ensure that the baby does not accidentally get OLUX®-E in their mouth.
  • you have any liver or kidney problems. You may need to use a smaller amount of OLUX®-E or use it less often.
  • you are 65 years or older. You may need to use a smaller amount of OLUX®-E or use it less often.

While using OLUX®-E, talk to your doctor or pharmacist if:

  • you develop any skin infection
  • you have an allergic reaction
  • you develop significant skin irritation
  • you experience skin thinning or softening
  • your condition worsens or you develop raised bumps with pus under the skin

Avoid OLUX®-E Foam from getting in the eye, or mucous membrane. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).

OLUX®-E is not recommended for use in children under

12 years of age.

Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. Children may need to use a smaller amount of OLUX®-E.

The propellant in OLUX®-E Foam is extremely flammable. Avoid fire, open flame, spark or smoking during and immediately following application.

INTERACTIONS WITH THIS MEDICATION

Some drugs that may affect how OLUX®-E works, or make it more likely that you will have side effects. Some of these medicines may include:

  • Ritonavir (for HIV).
  • Itraconazole (for fungal infections).

Tell your doctor or pharmacist about all your other medications, including medicines that you bought without prescription and natural health products.

PROPER USE OF THIS MEDICATION

Usual dose:

For topical use only and not for ophthalmic, oral or intravaginal use.

Apply a thin layer of OLUX®-E Foam to the affected area(s) twice daily, morning and evening.

Treatment should be limited to 2 weeks, and patients should not use greater than 50 grams per week.

Always talk to your doctor about how to stop using OLUX®-E Foam. If your condition worsens or no improvement is seen within 2 weeks, contact your doctor.

OLUX®-E Foam should not be applied on the face, scalp, over extensive areas or on skin-fold areas such as the groin, scrotum and armpit.

OLUX®-E Foam should not be used with occlusive dressings.

How to use OLUX®-E Foam

Shake the can before use. Remove the cap. Before applying for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.
Turn the can upside down and depress the actuator. Dispense a small amount of OLUX®-E Foam (not more than a dollop the size of a golf ball) into the palm of your hand.
Gently massage foam into affected area(s) until it disappears. Use enough OLUX®-E Foam to cover the affected area(s) with a thin layer. Avoid contact with the eyes; if contact occurs, rinse thoroughly with water.
OLUX®-E Foam should not be used on the face, groin, underarms, and skinfolds. Wash hands after use. Avoid fire, flame, or smoking during and immediately following application.

A moisturizer should be used as maintenance therapy.

OLUX®-E Foam should be used for the minimum amount of time required to achieve the desired results, but always use OLUX®-E Foam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

Missed Dose:

If you forget to use OLUX®-E Foam, apply it as soon as you remember. If it is close to the time scheduled to apply your next dose, wait and apply your next scheduled dose and then continue as before. Do not apply extra OLUX-E® to make up for missed doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, OLUX®-E Foam can have side effects although not everybody gets them. Side effects will affect your skin and may affect other parts of your body if a sufficient quantity of medicine is absorbed through the skin and enters your blood stream.

If your skin condition gets worse or your skin becomes swollen during treatment, you may be allergic to the medicine, have an infection or need other treatment. Stop using OLUX®-E and tell your doctor as soon as possible.

Side effects with OLUX®-E Foam include:

Common:

  • reactions at the application site
  • skin thinning or softening

Uncommon:

  • itching, burning, irritation, dryness, pain, itchy rash (urticaria)
  • skin infections at the application sites, inflammation of the lining of the nose (rhinitis), inflammation of hair follicles

  • headache, general feeling of being unwell

    In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

  • wheezing
  • dark red blotches on the skin
  • stretch marks
  • skin colour changes
  • secondary infection, acne
  • allergic contact dermatitis
  • skin irritation, heat rash (miliaria)
  • tingling, pricking (paresthesia)
  • the appearance of blood vessels under the surface of your skin (Telangiectasia)

Side effects with the use of topical corticosteroid include:

  • burning, itching, skin irritation, dryness, redness, swelling, flaking skin, superficial ulcers and blisters
  • inflammation of hair follicles, abnormal hair growth, hair loss
  • stretch marks
  • secondary infection, acne
  • allergic contact dermatitis
  • heat rash (miliaria)
  • skin thinning, loss of skin color (hypopigmentation), skin wrinkling, worsening of skin condition
  • if you have psoriasis you may get raised bumps with pus under the skin (pustular psoriasis)
  • rash around the mouth

Serious side effects such as Cushing’s syndrome may be associated with absorption in the body of topical corticosteroids (for example, from long-term, improper or excessive use). Symptoms include: increased weight, moon face / rounding of the face and obesity. Also, look out for delayed weight gain and slow growth in children.

Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.

Patients should report any signs of local or systemic adverse reactions to their doctor.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Allergic reactions: rash, hives, swelling of the skin.✓
Cushing's syndrome: weight gain, moon face / rounding of the face and obesity.✓

This is not a complete list of side effects. For any unexpected effects while taking OLUX®-E Foam, contact your doctor or pharmacist.

HOW TO STORE IT

Store upright at controlled room temperature 20–25°C. Avoid storage in an inverted position.

DANGER

EXTREMELY FLAMMABLE. AVOID FIRE, OPEN FLAME, SPARK OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 49°C. Do not place in hot water or near radiators, stoves or other sources of heat.

Avoid contact with eyes or other mucous membranes.

Keep out of reach and sight of children

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345

  • Complete a Canada Vigilance Reporting Form and:

    • Fax toll-free fax to 1-866-678-6789, or

    • Mail to: Canada Vigilance Program

      Health Canada

      Postal Locator 0701E

      Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

https://www.maynepharma.com/contact-us/ or by contacting the sponsor,

Mayne Pharma Inc.

1240 Sugg Parkway

Greenville, NC

USA 27834

Imported/Distributed by: C.R.I., Dundas, Ontario L9H 7P3

Last revised: February 27, 2018

®OLUX is a registered trademark of Mayne Pharma Inc.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02344408

Revision date stated in the text: February 27, 2018

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Olux-E

Rx or OTC
Prescription (Rx)?
DIN 02344408
Schedule(s) PRESCRIPTION
Active ingredient(s) Clobetasol propionate 0.05 %
Dosage form(s) Aerosol (Foam)
Route(s) of administration Topical
Drug class (WHO ATC)
  1. D Dermatologicals
    1. D07 Corticosteroids, dermatological preparations
      1. D07A Corticosteroid dermatological preparations, plain
        1. D07AD Corticosteroids, very potent (group IV)
          1. D07AD01 Clobetasol
Company MAYNE PHARMA INC
Current status Cancelled Post Market
Current status date January 9, 2020

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.