| 4.3 Contraindications
Elocon Scalp Lotion is contraindicated in skin atrophy, 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
of the scalp. Elocon should not be used on wounds or on skin which is
ulcerated. Elocon Scalp Lotion 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 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be withdrawn and appropriate therapy instituted.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. If used in childhood, occlusion should not be
used and courses should be limited to 5 days. 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 Scalp Lotion contains propylene glycol which may cause skin
irritation.
Care must be taken to keep the preparation away from the eyes. 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 may therefore be a very small risk
of such effects in the human foetus.
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.
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
Table 1: Treatment-related adverse reactions reported with Elocon by body system and
frequency
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100);
rare (≥1/10,000, <1/1,000); very rare (<1/10 000,); not known (cannot be estimated from
available data)
Infections and infestations
Not known
Very rare
Nervous system disorders
Not known
Very rare
Skin and subcutaneous tissue disorders
Not known
Very rare
General disorders and administration
site conditions
Not known
Infection, furuncle
Folliculitis
Paraesthesia,
burning sensation
Dermatitis contact, skin
hypopigmentation, hypertrichosis,
skin striae, dermatitis acneiform,
skin atrophy
Pruritus
Application site pain, application site
reactions
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.
Local adverse reactions reported infrequently with topical dermatologic
corticosteroids include: skin dryness, irritation, dermatitis, perioral dermatitis,
maceration of the skin, and miliaria and telangiectasiae.
Paediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced hypothalamic-pituitary-adrenal axis suppression and
Cushing’s syndrome than mature patients because of a larger skin surface area
to body weight ratio. Chronic corticosteroids therapy may interfere with the
growth and development of children.
4.9 Overdose
Excessive prolonged use of topical corticosteroids can suppress hypothalamicpituitary-
adrenal function resulting in secondary adrenal insufficiency which is
usually reversible. In such cases appropriate symptomatic treatment is
indicated.
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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