Clobetasol Foam

Name: Clobetasol Foam

How is this medicine (Clobetasol Foam) best taken?

Use clobetasol foam 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.
  • 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.

What are some other side effects of Clobetasol Foam?

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:

  • Stinging.
  • Dry skin.
  • Burning.
  • 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take clobetasol foam or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to clobetasol foam. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and usage

Clobetasol propionate Foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.

Dosage and administration

Apply a thin layer of Clobetasol propionate Foam to the affected skin areas twice daily.

Clobetasol propionate Foam is a super-high-potency topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week or more than 21 capfuls per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Therapy should be discontinued when control is achieved.
Clobetasol propionate Foam should not be used with occlusive dressings unless directed by a physician.
Clobetasol propionate Foam is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Warnings and precautions

Effects on Endocrine System

Clobetasol propionate Foam can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

In a trial evaluating the effects of Clobetasol propionate Foam on the HPA axis, 13 subjects applied Clobetasol propionate Foam to at least 20% of involved body surface area for 14 days. HPA axis suppression was identified in 5 out of 13 subjects (38%) [see Clinical Pharmacology (12.2)].

If HPA axis suppression is documented, gradually withdraw the drug, reduce the 96 frequency of application, or substitute with a less potent corticosteroid.

Cushing’s syndrome and hyperglycemia may also occur due to the systemic effects of the topical corticosteroid. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.

Flammable Contents

Clobetasol propionate Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.

Adverse reactions

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 clinical practice.

In a controlled clinical trial involving 188 subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the subjects treated with Clobetasol propionate Foam. In 2 controlled clinical trials with Clobetasol propionate Foam in 360 subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the subjects treated with Clobetasol propionate Foam included application site burning (10%), application site dryness (<1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

Postmarketing Experience

Because adverse 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.

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: striae, itching, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

Patient counseling information

See FDA-approved patient labeling (Patient Information and Instructions for Use)

Inform patients of the following:

  • Avoid use of Clobetasol propionate Foam on the face, underarms, or groin areas unless directed by the physician.
  • Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
  • Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
  • Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
  • For proper dispensing of foam, hold the can upside down and depress the actuator. Dispensing directly onto hands is not recommended (unless the hands are the affected area), as the foam will begin to melt immediately upon contact with warm skin.
  • Limit treatment to 2 consecutive weeks. Use no more than 50 grams of Clobetasol propionate Foam per week, or more than 21 capfuls per week.
  • Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
  • Avoid use of Clobetasol propionate Foam in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
  • The product is flammable; avoid heat, flame, and smoking when applying this product.
  • Do not use other corticosteroid-containing products without first consulting with the physician.

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

Patient Information
Clobetasol propionate Foam

Important: Clobetasol propionate Foam is for use on the skin only. Do not get Clobetasol propionate Foam near or in your eyes, mouth, or vagina.

What is Clobetasol propionate Foam?

Clobetasol propionate Foam is a prescription corticosteroid medicine used on the skin (topical) or scalp to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

It is not known if Clobetasol propionate Foam is safe and effective in children under 12 years of age.

Before using Clobetasol propionate Foam, tell your healthcare provider about all of your conditions, including if you:

  • have had irritation or other skin reaction to a steroid medicine in the past.
  • have a skin infection. You may need medicine to treat the skin infection before using Clobetasol propionate Foam.
  • have diabetes.
  • have adrenal gland problems.
  • have liver problems.
  • plan to have surgery.
  • are pregnant or plan to become pregnant. It is not known if Clobetasol propionate Foam will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Clobetasol propionate Foam passes into your breast milk. Do not apply Clobetasol propionate Foam to your chest area if you are breastfeeding a baby. This will help to prevent the baby from accidentally getting Clobetasol propionate Foam into the baby’s mouth.

Tell your healthcare provider about all the medicine you take including prescription or over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth, or injection, or use other products on your skin or scalp that contain corticosteroids.

How should I use Clobetasol propionate Foam?

  • Use Clobetasol propionate Foam exactly as your healthcare provider tells you to use it.
  • This medicine is for use on the skin or scalp only. Do not get Clobetasol propionate Foam in your eyes, mouth, or vagina.
  • Apply Clobetasol propionate Foam 2 times each day, 1 time in the morning and 1 time in the evening, or as directed by your healthcare provider.
  • Clobetasol propionate Foam should not be used if you have skin thinning (atrophy) at the treatment area.
  • Avoid using Clobetasol propionate Foam on your face, underarms, or groin area.
  • Do not bandage or cover your treated area unless your healthcare provider tells you to.
  • Do not use Clobetasol propionate Foam for longer than 2 weeks in a row.
  • You should not use more than 50 grams or 21 capfuls of Clobetasol propionate Foam in 1 week.
  • Talk to your healthcare provider if your skin or scalp does not improve after 2 weeks of treatment with Clobetasol propionate Foam.
  • See your healthcare provider regularly to check your symptoms and side effects while using Clobetasol propionate Foam.

See the “Instructions for Use” at the end of the Patient Information for detailed information about the right way to apply Clobetasol propionate Foam.

What should I avoid while using Clobetasol propionate Foam?
Clobetasol propionate Foam is flammable. Avoid heat, flames, or smoking during and right after you apply it to your skin.

What are the possible side effects of Clobetasol propionate Foam?

Clobetasol propionate Foam may cause serious side effects, including:

  • Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your healthcare provider may do blood tests to check for adrenal insufficiency while you are using Clobetasol propionate Foam. Tell your healthcare provider if you have any of these persistent symptoms of adrenal insufficiency:
    • tiredness that worsens and does not go away, muscle weakness
    • loss of appetite
    • nausea or vomiting
    • dizziness or fainting
    • irritability and depression
    • weight loss
  • Cushing’s syndrome, when the body is exposed to too much of the hormone cortisol. Your healthcare provider may do tests to check for this. Symptoms can include: weight gain, especially around your upper back and midsection
    • tiredness and muscle weakness
    • roundness of your face (moon face)
    • slow healing of cuts, insect bites, and infections
    • depression, anxiety, and irritability
    • new or worsening high blood pressure
  • High blood sugar (hyperglycemia) or diabetes mellitus that has not been diagnosed can happen with treatment. Your healthcare provider may do tests to check you for this.
  • Skin problems, including reactions where Clobetasol propionate Foam is applied, skin infections, and allergic reactions (allergic contact dermatitis). Tell your healthcare provider if you get any new skin problems.
  • Effects on growth and weight in children.

The most common side effects of Clobetasol propionate Foam include burning and skin reactions at the treated site.

These are not all the possible side effects of Clobetasol propionate Foam.

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

How should I store Clobetasol propionate Foam?

  • Store at 20 - 25°C (68- 77°F) [see USP Controlled Room Temperature].
  • Contents are flammable. Keep the can away from fire and heat.
  • Do not pierce or burn the can of Clobetasol propionate Foam. Never throw the can into a fire, even if the can is empty.

Keep Clobetasol propionate Foam and all medicines out of the reach of children.

General information about the safe and effective use of Clobetasol propionate Foam.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about Clobetasol propionate Foam that is written for health professionals. Do not use Clobetasol propionate Foam for a condition for which it was not prescribed. Do not give Clobetasol propionate Foam to other people, even if they have the same condition that you have. It may harm them.

What are the ingredients in Clobetasol propionate Foam ?
Active ingredient: clobetasol propionate, USP, 0.05%
Inactive ingredients: cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant

Manufactured for:
Ingenus Pharmaceuticals, LLC
Orlando, FL 32839

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

Revised: 02/2017

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