Clobetasol Propionate

Like other topical corticosteroids, clobetasol propionate foam has anti-inflammatory, antipruritic, and vasoconstrictive properties. The precise mechanism of the anti-inflammatory activity of topical steroids in the treatment of steroid-responsive dermatoses, in general, is uncertain. 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 vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Due to the fact that circulating levels are well below the level of detection, the use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary. They are metabolized, primarily in the liver, and are then excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

A well-controlled clinical study evaluated 188 subjects with moderate to severe scalp psoriasis. Subjects were treated twice daily for 2 weeks with one of four treatments: OLUX Foam, Vehicle foam, a commercially available clobetasol propionate solution (Temovate® Scalp Application), or Vehicle solution. The efficacy of OLUX (clobetasol propionate) Foam in treating scalp psoriasis at the end of the 2 weeks' treatment was superior to that of Vehicle (foam and solution), and was comparable to that of Temovate Scalp Application. See Table 1 below.

Table 1: Efficacy results from a controlled clinical trial in scalp psoriasis

Another well-controlled clinical study evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean Body Surface Area at baseline was 6.7% with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with OLUX (clobetasol propionate) Foam or Vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of OLUX (clobetasol propionate) Foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of Vehicle foam. See Table 2 below.

Table 2: Efficacy results from a controlled clinical trial in non-scalp psoriasis Plaque Thickness - Clear at Endpoint 41 (66) 3 (10)

Clobetasol is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Clobetasol topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Clobetasol topical may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Synthetic fluorinated corticosteroid.1 80 87 88 89 b c

Absorption

Bioavailability

Topically applied clobetasol propionate can be absorbed through normal intact skin.1 80 87 88 a b c

Percutaneous penetration of clobetasol propionate varies among individuals5 33 34 35 41 42 61 66 67 69 70 and can be altered by using different vehicles.1 7 18 22 30 31 41 43 67 69 71 73 80 87 88 89 b c

Percutaneous penetration can be increased by use of occlusive dressings and by presence of inflammation and/or other disease of the epidermal barrier (e.g., psoriasis, eczema).1 80 87 88 a b c

Distribution

Extent

Not known whether topical clobetasol is distributed into milk.1 80 87 88 89 b c

Elimination

Metabolism

Once absorbed through the skin, topically applied corticosteroids are metabolized primarily in the liver.80 88 b

Elimination Route

Topical corticosteroids and metabolites are excreted by the kidneys and, to a lesser extent, in bile.80 88 b

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.1 80 87 88 89 a b c (See Topical Administration under Dosage and Administration.)

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.1 80 87 88 89 a c

• Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.1 80 87 88 89 b

• Importance of patients informing clinician that they are receiving topical clobetasol propionate therapy, if surgery is contemplated.87 89 b c

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 80 87 88 89 b c

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 80 87 88 89 b c

• Importance of informing patients of other important precautionary information.1 80 87 88 89 b c (See Cautions.)

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical cream, foam, gel, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical cream, foam, gel, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical lotion, shampoo, or spray have not been established in children and use is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving clobetasol topical cream.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Nadroparin
• Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acne vulgaris (skin problem) or
• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Should not be used in patients with these conditions.

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Diaper dermatitis—Olux® foam should not be used in patients with this condition.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application or
• Liver failure—The chance of side effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Burning or stinging at the application site

• Burning sensation of the skin
• dry skin
• flushing or redness of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• skin irritation
• skin rash, encrusted, scaly and oozing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• hair loss
• redness and scaling around the mouth
• thinning of the hair
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• sore throat

• Body aches or pain
• changes in skin coloring
• congestion or cough
• dryness or soreness of the throat
• headache
• raised, dark red, wart-like spots on the skin, especially when used on the face
• skin discomfort
• stuffy or runny nose
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.