Olux

What is Olux used for?

Olux is used to treat skin irritation. It is used to treat skin rashes. Olux is also used to treat scalp psoriasis. It is used to treat plaque psoriasis.

Description

OLUX (clobetasol propionate) Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical 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-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, a molecular weight of 466.97.

The following is the chemical structure:

Clobetasol propionate is a white or almost white crystalline powder, practically insoluble in water.

Each gram of OLUX Foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Before taking Olux, tell your doctor:

• If you are allergic to Olux; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have thinning of the skin where you are putting Olux.
• If there is an infection where Olux will be used.

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

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 Olux with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Olux?

• Tell all of your health care providers that you take Olux. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use to treat diaper rash.
• Do not use Olux to treat acne, rosacea, or a rash around the mouth.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not put on cuts, scrapes, or damaged skin.
• Do not use longer than you have been told by the doctor.
• This medicine may cause harm if swallowed. If Olux is swallowed, call a doctor or poison control center right away.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Some products are not approved for use in children. Talk with the doctor.
• If you are breast-feeding, do not put Olux right on the nipple or the area right around it.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Olux best taken?

Use Olux as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Olux by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Use as you have been told, even if your signs get better.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.
• Some of these drugs need to be shaken before use. Be sure you know if this product needs to be shaken before using it.
• Turn the can upside down to use. Some foams may start to melt if put into the hand. Check with your pharmacist about how to use the foam.
• Put foam on affected part and rub in gently.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Olux that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Irritation where Olux is used.
• Thinning of the skin.
• Change in eyesight, eye pain, or very bad eye irritation.

What are some other side effects of Olux?

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:

• Burning or stinging.
• Dry skin.
• 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Olux?

• Store at room temperature. Do not refrigerate or freeze.
• Be sure you know how long you can store Olux before you need to throw it away.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 0.05%