Dermovate-NN cream (discontinued in the UK - June 2007)

Dermovate-NN cream contains three active ingredients, clobetasol propionate, neomycin sulphate and nystatin. Clobetasol propionate is a type of medicine known as a corticosteroid (or steroid). Corticosteroids are hormones that are produced naturally by the adrenal glands, and have many important functions, including control of inflammatory responses. Clobetasol is a synthetic corticosteroid and is used to decrease inflammation in the skin. When applied to the skin it is absorbed into the skin cells. Here it works by preventing the release of certain chemicals from the cells. These chemicals are important in the immune system, and are released as a result of allergy or irritation. They cause blood vessels to widen, resulting in the affected area of skin becoming red, swollen, itchy and painful, such as is seen in dermatitis or eczema. By decreasing the release of these chemicals in the skin, clobetasol reduces inflammation and relieves itch. There is a range of potencies of corticosteroids applied to the skin. Clobetasol propionate is classed as a very potent corticosteroid. It is prescribed to treat severe inflammatory skin disorders such as eczema and psoriasis that have not responded to weaker corticosteroids. Neomycin sulphate is an antibiotic of the aminoglycoside type and is used to treat infections with bacteria. It works by entering bacterial cells and interfering with the production of proteins that the bacteria need to divide and multiply. It doesn’t directly kill the bacteria, but leaves them unable to increase in numbers. The existing bacteria eventually die or are destroyed by the immune system. Neomycin is included in this preparation to treat the bacteria that sometimes infect inflammatory skin diseases. Nystatin is an antifungal medicine that kills fungi and yeasts by interfering with their cell membranes. It works by binding to a substance called ergosterol, which is a component of fungal cell membranes. Binding to ergosterol disrupts the cell membrane and causes holes to appear. The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As nystatin causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi. The combination of clobetasol, neomycin and nystatin is used to treat severe inflammatory skin disorders, such as those listed below, which are either already infected, or your doctor thinks are likely to become infected, for example because you are using airtight dressings. Dressings can create a warm, moist environment where bacteria and fungi can grow easily.

What is it used for?

- Inflammatory skin disorders, for example eczema or psoriasis that are resistant to treatment with weaker steroid creams and are either already infected, or your doctor thinks are likely to become infected

Warning!

- This cream is for external use only.
- The cream should be applied thinly and evenly to the affected area(s) as directed by your doctor.
- Wash your hands thoroughly after applying this medicine, unless the hands are the area being treated.
- Avoid contact of this medicine with the eyes and the moist membranes lining the inside of certain parts of the body, eg mouth, nasal passages (mucous membranes). Rinse with cold water if accidental contact occurs.
- This medicine should not be used for longer than five days on the face or in children.
- If corticosteroids are used for long periods of time, or on large areas of skin, raw skin, skin folds, or under airtight dressings (including nappies) they are absorbed into the body more. This increases the risk of local side effects such as skin thinning, and those on other parts of the body, such as a decrease in the production of natural hormones by the adrenal glands. For this reason, continuous, long-term use of this medicine should be avoided wherever possible, particularly in children and on large areas of skin. If continuous steroid treatment is necessary, a less potent preparation should be used. You should only use airtight dressings over the affected area if instructed by your doctor.
- If your doctor has advised you to use dressings with this medicine, the skin should be cleansed before a fresh dressing is applied.
- If this medicine is to be used on the face or in children, you should not use airtight dressings (including nappies) to cover the area treated, as this may increase the absorption of the medicine into the body, increasing the risk of adverse effects.
- If you have been prescribed this medicine to treat psoriasis you should have regular check-ups with your doctor. This is because although corticosteroids may be useful for psoriasis in the short-term, they can sometimes make psoriasis worse, and may cause the condition to relapse into generalised pustular psoriasis after the treatment is stopped.
- Consult your doctor if any infection spreads, or if after seven days of treatment with this medicine there is little or no improvement in your symptoms, as you may need to stop using this medicine or take a course of antibiotics by mouth.
- Do not dilute this cream with moisturisers or any other preparation.

Use with caution in

- Children
- Decreased kidney function
- Elderly people
- Psoriasis

Not to be used in

- Children under two years of age
- Allergy to peanuts
- Allergy to soya
- Acne vulgaris
- Chronic inflammatory disorder of the facial skin (acne rosacea)
- Inflammatory rash around the mouth (perioral dermatitis)
- Widespread plaque psoriasis
- Bacterial, viral, fungal or yeast skin infection that is not secondary to another disease state (primary skin infections, eg impetigo, chicken pox, ringworm, candidiasis)
- Skin disorders infected with Pseudomonas or Proteus species of bacteria (your doctor will know from a skin swab)
- Itching around the back passage and genitals
- Otitis externa in people with a perforated eardrum

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- The safety of this medicine during pregnancy and breastfeeding is not established. It is not recommended for use during pregnancy or breastfeeding. Consult your doctor for further advice.

Label warnings

- This medication is to be spread thinly and sparingly on the skin.

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