NERISONE Cream, Ointment Ref.[27952] Active ingredients: Diflucortolone

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: LEO Pharma Limited, Auckland, New Zealand, Toll Free No.: 0800 497 456

4.1. Therapeutic indications

All skin diseases which respond to topical corticoid therapy (eg): contact dermatitis, contact eczema, occupational eczema vulgar, nummular, degenerative and seborrhoeic eczema, dyshidrotic eczema, eczema in varicose syndrome (but not directly onto lower limb ulcers), anal eczema, eczema in children, neurodermatitis (endogenous eczema, atopic dermatitis), psoriasis, lichen ruber planus et verrucosus, lupus erythematosus discoides, first degree burns, sunburn, insect bites.

4.2. Posology and method of administration

At the beginning of treatment, the NERISONE preparation best suited to the skin condition is applied thinly two or perhaps three times per day. Once the clinical picture has improved, one application per day usually suffices.

NERISONE is available as a cream and a fatty ointment. Which form should be used in the individual case will depend on the appearance of the skin: NERISONE CREAM in weeping skin conditions and NERISONE FATTY OINTMENT in very dry skin conditions.

NERISONE CREAM has a high water and low fat content. In weeping skin diseases it allows secretions to drain away, thus providing for rapid subsidence and drying up of the skin. It is also suitable for application to moist, exposed and hairy areas of the body.

If the skin dries out too much under protracted use of NERISONE CREAM, the patient should be switched to a form which contains more fat (NERISONE FATTY OINTMENT).

NERISONE FATTY OINTMENT is for very dry conditions and chronic stages demand an anhydrous fatty base. The occlusive effect of the NERISONE FATTY OINTMENT base promotes the healing process.

Occlusive dressings

An occlusive dressing may be called for in unusually refractory cases. When it is, it should be managed as follows: After application of the appropriate NERISONE preparation, the area under treatment should be covered with a plastic foil which should then be fixed firmly on all edges to healthy skin by means of adhesive plaster. Plastic gloves can be used to occlude the hands. The dressing should be kept in place for as long as can be expected of the patient, but generally not for longer than 24 hours. If the occlusive treatment is expected to be prolonged, it is advisable to change the dressing every 12 hours.

If an infection develops under the dressing, occlusive treatment must be terminated.

Paediatric population

Babies and children up to the age of 4 years should not be treated with NERISONE for longer than 3 weeks, particularly on skin areas covered by nappies.

4.9. Overdose

On the basis of results from acute toxicity studies with both diflucortolone valerate and the NERISONE preparations no acute risk of intoxication is to be expected either after a single dermal application of an overdose (application over a large area under conditions favouring resorption) or even after inadvertent oral intake of a whole package.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

NERISONE Cream: 3 years.

NERISONE Fatty Ointment: 5 years.

NERISONE cream should be used within 3 months of opening.

6.4. Special precautions for storage

NERISONE Cream: Store below 25°C.

NERISONE Fatty Ointment: Store below 25°C.

Store all drugs properly and keep them out of reach of children.

6.5. Nature and contents of container

Tubes made of pure aluminium, interior wall coated with epoxy resin, and with a polyester-based external coating. Fold seal ring is made of polyamide-based heat-sealable material. The screw cap is made of high density polyethylene.

6.6. Special precautions for disposal and other handling

None.

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