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4.3 Contraindications
Elocon is contraindicated in facial rosacea, acne vulgaris, skin atrophy, perioral dermatitis,
perianal and genital pruritis, napkin eruptions, bacterial (e.g. impetigo, pyodermas), viral
(e.g. herpes simplex, herpes zoster and chickenpox, verrucae vulgares, condylomata acuminata,
molluscum contagiosum), parasitical and fungal (e.g. candida or dermatophyte) infections,
varicella, tuberculosis, syphilis or post-vaccine reactions. Elocon should not be used on wounds
or on skin which is ulcerated. Elocon should not be used in patients who are sensitive to
mometasone furoate or to other corticosteroids or to any of the ingredients in this medicine.
4.4 Special Warnings and Special Precautions for Use
If irritation or sensitisation develop with the use of Elocon, treatment should be withdrawn and
appropriate therapy instituted.
Should an infection develop, use of an appropriate antifungal or antibacterial agent should be
instituted. If a favourable response does not occur promptly, the corticosteroid should be
discontinued until the infection is adequately controlled.
Systemic absorption of topical corticosteriods can produce reversible hypothalamicpituitaryadrenal
(HPA) axis suppression with the potential for glucocorticosteroid insufficiency
after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and
glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids
while on treatment. Patients applying a topical steroid to a large surface area or areas under
occlusion should be evaluated periodically for evidence of HPA axis suppression.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their
larger skin surface to body mass ratios. As the safety and efficacy of Elocon in paediatric patients
below 2 years of age have not been established, its use in this age group is not recommended.
Local and systemic toxicity is common especially following long continued use on large areas of
damaged skin, in flexures and with polythene occlusion. If used in childhood, or on the face,
occlusion should not be used. If used on the face, courses should be limited to 5 days and
occlusion should not be used. Long term continuous therapy should be avoided in all patients
irrespective of age.
Topical steroids may be hazardous in psoriasis for a number of reasons including rebound
relapses following development of tolerance, risk of centralised pustular psoriasis and
development of local or systemic toxicity due to impaired barrier function of the skin. If used in
psoriasis careful patient supervision is important.
As with all potent topical glucocorticoids, avoid sudden discontinuation of treatment. When long
term topical treatment with potent glucocorticoids is stopped, a rebound phenomenon can develop
which takes the form of a dermatitis with intense redness, stinging and burning. This can be
prevented by slow reduction of the treatment, for instance continue treatment on an intermittent
basis before discontinuing treatment.
Glucocorticoids can change the appearance of some lesions and make it difficult to establish an
adequate diagnosis and can also delay the healing.
ELOCON Cream contains propylene glycol which may cause skin irritation. ELOCON Cream
contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Elocon topical preparations are not for ophthalmic use, including the eyelids, because of the very
rare risk of glaucoma simplex or subcapsular cataract.
4.6 Pregnancy and Lactation
During pregnancy and lactation treatment with Elocon should be performed only on the
physician’s order. Then however, the application on large body surface areas or over a prolonged period should be avoided. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There are no adequate and well-controlled studies with Elocon in pregnant women and therefore the risk of such effects to the human foetus is unknown. However as with all topically applied glucocorticoids, the possibility that foetal growth may be affected by glucocorticoid passage through the placental barrier should be considered. There may therefore be a very small risk of such effects in the human foetus. Like other topically applied glucocorticoids, Elocon should be used in pregnant women only if the potential benefit justifies the potential risk to the mother or the foetus.
There may therefore be a very small risk of such effects in the human foetus.
It is not known whether topical administration of corticosteroids could result in sufficient
systemic absorption to produce detectable quantities in breast milk. Elocon should be
administered to nursing mothers only after careful consideration of the benefit/risk relationship. If treatment with higher doses or long term application is indicated, breast-feeding should be discontinued.
4.8 Undesirable Effects
Local adverse reactions occasionally reported with Elocon include paresthesia, folliculitis,
burning, pruritis, tingling, stinging, application site reactions, allergic contact dermatitis,
hypopigmentation, hypertrichosis, secondary infection, furunculosis, striae, acneiform reactions
and signs of skin atrophy.
Table 1: MedDRA table added
4.9 Overdose
None stated.
Excessive, prolonged use of topical corticosteroids can suppress hypothalamicpituitary-
adrenal function resulting in secondary adrenal insufficiency which is usually reversible.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid.
The steroid content of each container is so low as to have little or no toxic effect in the unlikely event of accidental oral ingestion.
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