Clobex Lotion

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.

In controlled clinical trials with CLOBEX® (clobetasol propionate) Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia.

The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with CLOBEX® (clobetasol propionate) Lotion, 0.05% at 1.0% or greater was:

Other local adverse events occurred at rates less than 1.0%. Similar rates of local adverse reactions were reported in the comparator (clobetasol propionate cream, 0.05%). Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender.

The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Read the entire FDA prescribing information for Clobex Lotion (Clobetasol Propionate Lotion)

Indication

Clobex Lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.

Patients should be instructed to use Clobex Lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Limitations of Use

Clobex Lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobex Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.

Lotion, 0.05% w/w. Each gram of Clobex Lotion, 0.05%, contains 0.5 mg of clobestasol propionate in a white liquid.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled, clinical trials with Clobex Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with Clobex Lotion, 0.05% at 1% or greater was:

Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender.

Systemic absorption of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been identified during post-approval use of Clobex Lotion, 0.05%.

• Endocrine disorders: Cushing’s syndrome, Adrenal suppression
• Eye: Eye pain, Vision blurred, Eye irritation.
• Skin: Rash, Pain of skin, Skin exfoliation, Skin chapped, Scaling, Induration/papulation, Lichenification.
• Other: Psoriasis (aggravation), plaque elevation, excoriation.

Topically applied Clobex Lotion, 0.05% can be absorbed in sufficient amount to produce systemic effects [see Warnings and Precautions (5.1)].

Mechanism of Action

Like other topical corticosteroids Clobex Lotion, 0.05% has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids in general is unclear. However, corticosteroids are thought to act by 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.

Pharmacodynamics

Vasoconstrictor Assay
Clobex Lotion, 0.05% is in the super-high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression
In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, Clobex Lotion, 0.05% demonstrated rates of suppression that were numerically higher than those of a clobetasol propionate 0.05% cream (Temovate E® Emollient, 0.05%), [see Warnings and Precautions (5.1) and Use in Specific Population (8.4)].

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and other disease processes in the skin may increase percutaneous absorption.

There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical corticosteroids are handled through metabolic pathways similar to systemically administered corticosteroids. 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.

See FDA-approved patient labeling (Patient Information)

Information for Patients

Inform the patient using toical corticosteroids to adhere to the following instructions:

• This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.
• This medication should not be used for any disorder other than that for which it was prescribed.
• Do not use other corticosteroid-containing products while using CLOBEX (clobetasol propionate) Lotion, 0.05%.
• The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.
• Patients should wash their hands after applying the medication.
• Patients should report any signs of local or systemic adverse reactions to the physician.
• Patients should inform their physicians that they are using CLOBEX (clobetasol propionate) Lotion, 0.05% if surgery is contemplated.
• This medication is for external use only. It should not be used on the face, underarms, or groin area, and avoid contact with the eyes and lips.
• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
• Patients should be informed to not use more than 50 g (50 mL or 1.75 fl. oz.) per week of Clobex Lotion, 0.05%.

Patient Information
CLOBEX® (KLO-bex)
(clobetasol propionate)
Lotion

Important: For use on skin only. Do not get Clobex Lotion near or in your eyes, mouth or vagina.

Read the Patient Information that comes with Clobex Lotion before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Clobex Lotion?
Clobex Lotion is a prescription corticosteroid medicine used to reduce the swelling (inflammation) and itching caused by certain skin conditions called corticosteroid-responsive dermatoses, including atopic dermatitis and psoriasis, in people 18 years of age and older. Clobex Lotion is for use on the skin only (topical).

• Clobex Lotion should only be used for the shortest amount of time needed to treat your skin condition.
• Clobex Lotion should not be used for more than 2 weeks in a row unless your doctor tells you to use it for a longer time.
• You should not apply more than 50 mL (1.75 fluid ounces) of Clobex Lotion to your skin in 1 week.

You should not use Clobex Lotion:

• on your face, underarms (armpits), or groin areas
• if you have thinning of the skin (atrophy) at the treatment site
• to treat rosacea or a rash around your mouth (perioral dermatitis)

Clobex Lotion should not be used in children under 18 years of age.

What should I tell my doctor before using Clobex Lotion?

Before you use Clobex Lotion, tell your doctor if you:

• have a skin infection. You may need medicine to treat the skin infection before you use Clobex Lotion.
• have any open sores or cuts on your skin
• plan to have surgery
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Clobex Lotion can harm your unborn baby.
• are breast-feeding or plan to breast-feed. It is not known if Clobex Lotion passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Clobex Lotion.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. You should not use other products that contain corticosteroids while you are using Clobex Lotion. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Clobex Lotion?

• Use Clobex Lotion exactly as your doctor tells you to use it.
• Your doctor should tell you how much Clobex Lotion to use and where to apply it.
• Clobex Lotion is for skin use only (topical).
• You should not use Clobex Lotion on your face, underarms or groin. Avoid getting Clobex Lotion in your eyes or on your lips.
• Apply Clobex Lotion 2 times each day.
• Apply only enough Clobex Lotion to cover your affected skin areas.

To apply Clobex Lotion:

• Turn the bottle of Clobex Lotion upside down.
• Apply Clobex Lotion onto your fingertips or directly on your affected skin area.
• Rub Clobex Lotion into your affected skin area gently and completely.
• Repeat these steps to apply Clobex Lotion to all affected skin areas as your doctor tells you.
• Wash your hands after applying Clobex Lotion.
• Do not bandage, cover or wrap your treated areas unless your doctor tells you to.
• Tell your doctor if your skin condition is not getting better after using Clobex Lotion for 2 weeks in a row. Do not use Clobex Lotion for more than 2 weeks unless your doctor tells you to.

What are the possible side effects of Clobex Lotion?
Clobex Lotion can pass through your skin. Too much Clobex Lotion passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

The most common side effects of Clobex Lotion include:

• burning, stinging, itching, redness, irritation and dry skin
• thinning of the skin
• widening of small blood vessels in the skin
• skin discomfort at the site of application

If you go to another doctor for illness, injury or surgery tell your doctor that you are using Clobex Lotion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Clobex Lotion. For more information, ask your doctor or pharmacist.

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

You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store Clobex Lotion?

• Store Clobex Lotion at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze Clobex Lotion.

Keep Clobex Lotion and all medicines out of reach of children.

General information about Clobex Lotion.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Clobex Lotion for a condition for which it was not prescribed. Do not give Clobex Lotion to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Clobex Lotion. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Clobex Lotion that is written for health professionals.

What are the ingredients in Clobex Lotion?
Active ingredient: clobetasol propionate
Inactive ingredients: hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water.

This Patient Information has been approved by the U.S. Food and Drug Administration.


Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA
GALDERMA is a registered trademark.

US Patent Nos: 6,106,848 and foreign patents pending.
P51405-0

Rx Only

NDC 0299-3848-04

Clobex®
(clobetasol propionate)

LOTION

0.05%

4 FL OZ
(118 mL)

GALDERMA

For external use only. Not for eye use.

Usual dosage: Apply twice daily, once in the morning and once at night. Use only enough to cover the affected areas. Do not apply Clobex® Lotion, 0.05% to the face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information.

Each gram contains: Active: clobetasol propionate 0.5 mg. Inactive: hypromellose, polyoxyethylene glycol 300 isostearate, carbomer 1342, mineral oil, propylene glycol, sodium hydroxide, and purified water.

Store at controlled room temperature 68° to 77°F (20° - 25°C). Protect from freezing. See lot no. and expiration date on bottom of bottle.

US Patent No. 6,106,848

Marketed by:
GALDERMA LABORTORIES, L.P.
Fort Worth, Texax 76177 USA

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA

GALDERMA is a registered trademark.

www.clobex.com

P51413-0 0613