Olux-E

Name: Olux-E

Warnings

Included as part of the PRECAUTIONS section.

What is the most important information i should know about clobetasol topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told 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.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Proper Use of clobetasol

This section provides information on the proper use of a number of products that contain clobetasol. It may not be specific to Olux-E. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use this medicine on the face, groin, or underarms, or have skin thinning unless directed to do so by your doctor.

To use the cream, foam, gel, lotion, ointment, or spray:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
  • With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
  • With the foam, do not dispense directly from the can into your hands, unless the hands are the affected area.
  • Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

To use the foam, scalp solution, or shampoo:

  • Wash your hands with soap and water before and after using this medicine.
  • Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
  • Do not cover the scalp (eg, shower cap, bathing cap) while it is being treated.
  • With the shampoo, do not wet your hair before using it. And if the shampoo gets on any part of your body other than your scalp, rinse the area well with water.
  • Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For redness, itching, and swelling of the skin:
    • For topical dosage forms (cream, gel, or ointment):
      • Adults—Apply to the affected area of the skin two times per day.
      • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
      • Children younger than 12 years of age—Use is not recommended.
    • For topical dosage form (lotion):
      • Adults—Apply to the affected area of the skin two times per day.
      • Children—Use is not recommended.
  • For plaque psoriasis:
    • For topical dosage form (cream):
      • Adults—Apply to the affected area of the skin two times per day.
      • Children younger than 16 years of age—Use is not recommended.
    • For topical dosage form (foam):
      • Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
      • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
      • Children younger than 12 years of age—Use is not recommended.
    • For topical dosage form (spray):
      • Adults—Spray to the affected area of the skin two times per day.
      • Children—Use is not recommended.
  • For scalp problems:
    • For topical dosage forms (foam or scalp solution):
      • Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
      • Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
      • Children younger than 12 years of age—Use is not recommended.
    • For topical dosage form (shampoo):
      • Adults—Apply to the affected area of the scalp once a day.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Store the Temovate® E cream at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Uses of Olux-E

  • It is used to treat skin irritation.
  • It is used to treat skin rashes.

How is this medicine (Olux-E) best taken?

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

  • Use as you have been told, even if your signs get better.
  • Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • 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.
  • Shake well before use.
  • 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 or extra doses.

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.

Dosage Forms and Strengths

Foam, 0.05%. Each gram of OLUX E Foam contains 0.5 mg of clobetasol propionate in a white to off-white petrolatum-based emulsion aerosol foam.

Contraindications

None.

Overdosage

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

Olux-E - Clinical Pharmacology

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.

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

Pharmacodynamics

In a trial evaluating the potential for HPA axis suppression using the cosyntropin stimulation test, Olux-E Foam demonstrated reversible adrenal suppression after 2 weeks of twice-daily use in subjects with atopic dermatitis of at least 30% body surface area (BSA). The proportion of subjects aged 12 years and older demonstrating HPA axis suppression was 16.2% (6 out of 37). In this trial HPA axis suppression was defined as serum cortisol level ≤18 mcg/dL 30 minutes post cosyntropin stimulation. The laboratory suppression was transient; in all subjects serum cortisol levels returned to normal when tested 4 weeks post treatment [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].

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 1 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.

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