Elocon 1mg Cream, Ointment, Lotion

ELOCON is indicated for the relief of the inflammatory manifestations of psoriasis and corticosteroid-responsive dermatoses. ELOCON Lotion may be applied to scalp lesions.

A thin film of ELOCON Cream or Ointment should be applied to completely cover the affected area once daily.

ELOCON Cream and Ointment may be used with caution in paediatric patients 2 years of age or older. Safety and efficacy of ELOCON Cream and Ointment in paediatric patients for more than 3 weeks of use have not been established. Use in paediatric patients under 2 years of age is not recommended.

A few drops of ELOCON Lotion should be applied to the affected skin area and massaged gently and thoroughly into the skin once daily. Treatment should be discontinued when the dermatologic disorder is controlled. According to clinical response, duration of therapy may vary from a few days to a longer period of time. However, treatment should not be continued for more than 3 weeks without patient re-evaluation.

ELOCON is contraindicated in those patients with a history of sensitivity reactions to any of its components.

ELOCON is contraindicated in the treatment of herpes simplex, vaccinia, or varicella.

ELOCON is not for ophthalmic use. If irritation or sensitisation develops with the use of ELOCON, treatment should be discontinued, and appropriate therapy instituted.

Systemic absorption of ELOCON may occur, particularly under the following conditions:

• when large quantities are used
• when application is made to wide areas of the body, to damaged skin and
• when the occlusive dressing technique is applied.

Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported.

Evidence of HPA axis suppression may be evaluated by periodic determinations of ACTH stimulation, AM plasma cortisol and urinary free cortisol tests. Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

Visual disturbance may be reported with systemic and topical (including intranasal, inhaled, and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Long-term continuous treatment with ELOCON should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used.

If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted.

ELOCON should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced. ELOCON should be used with caution near the eyes. ELOCON should be used for short courses only. Safety for use longer than 3 weeks has not been established. Regular review should be made of the necessity for continuing therapy.

ELOCON should not be used in the nappy areas in infants for flexural eruptions and ideally it should not be applied to infants and young children (under 2 years) at all. Since safety and efficacy of ELOCON Cream and Ointment have not been established in paediatric patients below 2 years of age, its use in this age group is not recommended.

The treatment of psoriasis with ELOCON may provoke the pustular form of the disease. ELOCON should not be applied to any skin crease areas. Long-term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.

None stated.

Pregnancy

Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, ELOCON should not be used during pregnancy.

Breastfeeding

The use of ELOCON is not recommended for mothers who are breastfeeding.

None stated.

Adverse reactions that have been reported with the use of topical corticosteroids include: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria and blurred vision.

Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

See Special warnings and precautions for use (section 4.4) and Undesirable effects (section 4.8).

Symptoms: Excessive or prolonged use of ELOCON can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, but may also produce manifestations of hypercorticism, including Cushing syndrome.

Treatment: Treatment is symptomatic and supportive. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.