NERIDERM Cream / Ointment Ref.[8329] Active ingredients: Diflucortolone

Additional, specific therapy is required in bacterially infected skin diseases and/or in fungus infections.

If the skin dries out too much under protracted use of Neriderm cream, the patient should be switched to a form which contains more fat (Neriderm ointment).

Extensive application of topical corticosteroids to large areas of the body or for prolonged periods of time, in particular under occlusion, significantly increases the risk of side effects.

Long-term continuous therapy with topical corticosteroids should be avoided, with a usual maximum duration of 4 weeks irrespective of age.Adrenal suppression can occur, even without occlusion. If used on children up to the age of 4 years or on the face, courses should be limited to 5 days and occlusion should not be used.

Neriderm may be applied under an occlusive dressing. However, each dressing should not be left on for more than 24 hours. Although occlusive dressings may be used repeatedly, it should be noted that systemic corticoid absorption is likely to be increased with a consequent increased risk of adrenal suppression. If occlusive treatment is expected to be prolonged, it is advisable to change the dressing every 12 hours.

Neriderm should not be allowed to come into contact with the eyes.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development of tolerance, risk of generalised pustular psoriasis, and local and systemic toxicity due to impaired barrier function of the skin. Careful patient supervision is important in psoriasis.

Exacerbation of skin infections may occur. Infections or secondarily infected dermatoses require additional therapy with antibiotics or chemotherapeutic agents. This treatment can often be topical, but for heavy infections systemic antibacterial therapy may be necessary. If fungal infections are present, a topically active antimycotic should be applied.

If aggravation of skin irritation develops with the use of Neriderm, treatment should be withdrawn and appropriate therapy installed.

Allergic contact dermatitis due to topical corticosteroids and excipients can occur. In these cases eczema fails to improve or deteriorates with treatment. Corticosteroid hypersensitivity occurs most frequently among patients with stasis dermatitis and leg ulceration. Such an observation should be corroborated with appropriate diagnostic patch testing. The appropriate corticosteroid concentration and the choice of the vehicle is crucial in detecting corticosteroid hypersensitivity in patch tests.

Patients with an allergy to corticosteroids may cross-react to several corticosteroids to which they have not previously been exposed.

After topical application, allergies to cross-reacting systemically applied corticosteroids may occur.

As known from systemic corticoids, glaucoma may also develop by using local corticoids (e.g. after large dosed or extensive application over a prolonged period, occlusive dressing technique or application to the skin around the eyes).

None stated.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects on the human foetus and, as a general rule, topical preparations containing corticoids should not be applied during the first trimester of pregnancy. In particular, application to large areas of the body or for prolonged periods must be avoided. Side effects cannot be excluded in neonates whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while lactating (for example, reduced adrenocortical function, when applied during the last weeks of pregnancy).

Nursing mothers should not be treated on the breasts.

None stated.

Common local adverse reactions reported with Neriderm formulations in clinical studies include burning, pruritus, erythema, itching, vesiculation and irritations.

In common with all other topical corticoids, side-effects may occur when Neriderm is applied to large areas of the body (10% or more) and for long periods of time (more than four weeks), especially if the ointment or an occlusive dressing is being used. There may be local signs such as atrophy of the skin, telangiectasia, striae, acneform changes, perioral dermatitis and hypertrichosis, or systemic corticoid effects caused by absorption. Systemic absorption can produce the features of hypercorticism. Therefore, caution should be exercised when using occlusive dressings, as there is a possibility that natural steroid production may be suppressed.

As with other corticosteroids for topical application, the following side-effects may occur in rare cases: Folliculitis and skin discoloration.

In rare cases, allergic skin reactions to any of the ingredients of the formulation may occur.

None stated.