DERMOVATE CREAM 25MG

Clobetasol is a topical (skin-applied) corticosteroid medication used to treat skin conditions that have not responded well to other corticosteroids, including moderate to severe psoriasis and eczematous dermatitis. The scalp lotion and shampoo are used to treat psoriasis and seborrheic dermatitis occurring on the scalp. Clobetasol works by reducing swelling, redness, and itching.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Cream 0.05%
Each gram contains 0.5 mg of clobetasol 17-propionate. Nonmedicinal ingredients: cetyl alcohol, chlorocresol, citric acid, glyceryl monostearate, glyceryl stearate/PEG 100 stearate, propylene glycol, purified water, stearyl alcohol, sodium citrate, and white wax.
Ointment 0.05%
Each gram contains 0.5 mg of clobetasol 17-propionate. Nonmedicinal ingredients: propylene glycol, sorbitan sesquioleate, and white petrolatum.
Scalp Application 0.05%
Each gram contains 0.5 mg of clobetasol 17-propionate. Nonmedicinal ingredients: carbomer 934P, isopropyl alcohol, purified water, and sodium hydroxide for pH adjustment.

How should I use this medication?

Cream and ointment: Apply the medication sparingly to cover the affected area and gently rub it into the skin 2 or 3 times daily. The total dose applied should not be more than 50 g in a week. Use this medication with caution on lesions near the eye. Take care to prevent it from getting into the eye.

Lotion: Apply the lotion to the affected areas of skin 2 times daily and rub it in gently and completely. The total dose should not exceed 50 g (50 mL) in a week.

Scalp lotion: Apply the lotion 1 or 2 times daily to the affected areas of the scalp and rub in gently. The total dose should not exceed 50 mL in a week. Clobetasol scalp applications should not be used near an open flame.

Spray: Apply the solution 2 times daily to the affected areas of the skin and rub in gently. The total dose should not exceed 50 mL in a week, and used for no longer than 4 weeks.

Shampoo: A thin film of clobetasol shampoo should be applied directly to the affected area of the scalp once daily. The shampoo is applied to the lesions on dry scalp and rubbed in gently. Leave it on for 15 minutes before wetting the hair, lathering, and rinsing. The total dose applied should not be more than 50 mL in a week.

Wash your hands well before and after applying clobetasol.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

When clobetasol 17 – propionate is used over extensive areas for prolonged periods or under dressings that don’t breathe, it is possible that enough medication will absorb into the bloodstream to cause unwanted side effects. Therefore, you should use clobetasol 17 – propionate only for brief periods and stop using it as soon as the problem clears.

This medication should not be used under dressings that don’t breathe.

If you have not noticed improvement in your skin after a week, stop using the medication and contact your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, apply it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children. The spray is flammable and should be kept away from heat or flame.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Clobetasol 17 – propionate should not be used by or given to anyone who:

• is allergic to clobetasol propionate or any ingredients of the medication
• is allergic to other corticosteroids
• is under 12 months old
• has untreated infected bacterial, fungal, viral (herpes simplex, skin rash resulting from vaccination, chickenpox), or tuberculous skin lesions

Clobetasol 17 – propionate should not be used to treat:

• acne vulgaris
• dermatitis around the mouth
• itching around the anus and genitals
• rosacea
• affected areas around the eyes or eyelids

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• burning, dryness, irritation, itching, or redness of skin (usually mild and temporary)
• headache
• increased redness or scaling of skin sores (usually mild and temporary)
• itchiness
• skin colour changes
• skin infection
• skin rash (usually mild and temporary)
• softening and tearing of the skin
• thinning of skin with easy bruising
• tingling, prickling feeling of the skin
• wounds that are slow to heal

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• acne or oily skin
• allergic skin reaction (e.g., red rash, dry scaly skin, swelling, tenderness, crusting, oozing)
• general feeling of being unwell
• lack of healing of skin condition
• painful, red, or itchy pus-containing blisters in hair follicles
• unusual increase in hair growth, especially on the face
• visible lines or small blood vessels under the skin
• symptoms of cataracts (e.g., clouding of the lens of the eye, blurred vision, dim vision, eye pain)
• symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• unusual loss of hair, especially on the scalp
• worsening psoriasis symptoms (e.g., red, scaly, thick patches of skin)

The following side effects may occur if this medication is used improperly or for a long time:

• blurring or loss of vision (occurs gradually if certain products have been used near the eye)
• filling or rounding out of the face
• increased blood pressure
• irregular heartbeat
• irregular menstrual periods
• irritability
• irritation of skin around mouth
• loss of appetite
• depression
• muscle cramps, pain, or weakness
• rapid weight gain or loss
• stomach bloating, burning, cramping, or pain
• swelling of feet or lower legs
• unusual bruising
• unusual decrease in sexual desire or ability (in men)
• unusual tiredness or weakness
• vomiting
• weakness of the arms, legs, or trunk (severe)
• worsening of infections

Stop using the medication and seek immediate medical attention if any of the following occur:

• symptoms of a serious allergic reaction (e.g., difficulty breathing, dizziness, itching, rash, swelling)
• symptoms of high levels of corticosteroids in the blood stream (e.g., fatigue, increased thirst and urination, irritability, muscle weakness)
• symptoms of decreased adrenal function (e.g., nausea, vomiting, dizziness, fever, chest pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Inform all of your doctors that you are using topical (skin-applied) corticosteroids.

Absorption: When clobetasol 17 – propionate is used over extensive areas for prolonged periods and under dressings that don’t breathe, it is possible that enough medication will absorb into the bloodstream to cause unwanted side effects. Therefore, it is advisable to use this medication for brief periods only and to stop using it as soon as the problem clears. Talk to your health care provider about how long you should use this medication.

Diabetes: When clobetasol 17-propionate is used over large areas of the body for prolonged periods or under dressings that don’t breathe, it is possible that enough medication will absorb into the bloodstream to affect blood sugar levels. If you have diabetes, your doctor should closely monitor your condition while you are using clobetasol 17-propionate, as it may affect blood sugar control (either increase or decrease blood sugar levels).

Eyes: Avoid using this medication on lesions close to the eye or on the eyelids. Getting the medication in the eye can increase the risk of increased eye pressure, glaucoma, cataracts, or infection. If you experience eye symptoms such as blurred vision or eye pain, contact your doctor as soon as possible.

Infection: Topical corticosteroids may increase the risk of developing a skin infection. Contact your doctor if you notice any increased redness, swelling, heat or pain around the area where the medication is applied as these are possible signs of infection.

Liver function: Decreased liver function or liver disease can cause corticosteroids to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Long-term use: Some people experience decreasing effectiveness of clobetasol when it has been used too long. Reports of worsening psoriasis or development of a new form of psoriasis have also been reported. This medication should not be used any longer than until the condition clears.

Medical treatment: Inform all health professionals involved in your care that you have been using a topical (skin-applied) corticosteroid.

Thinning of skin: Using topical corticosteroid medications for a long period of time can cause skin to thin or soften or cause stretch marks. Your doctor may recommend you stop using this medication once in a while or to apply to one area of the body at a time. Suddenly stopping corticosteroid medication may cause psoriasis to return.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are breast-feeding and are using clobetasol 17-propionate, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Children are more likely to experience absorption of this medication into the bloodstream, resulting in unwanted effects. The safety and effectiveness of using this medication have not been established for children. Its use by children is not recommended.

Seniors: People over the age of 65 may need to use a smaller amount of this medication or use it less often.

What other drugs could interact with this medication?

There may be an interaction between clobetasol 17 – propionate and any of the following:

• aldesleukin
• other topical medications that contain corticosteroids
• itraconazole
• ritonavir
• topical medications that have irritating effects to the skin

If you are using any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.