ADVANTAN Cream, Ointment Ref.[50852] Active ingredients: Methylprednisolone

Care must be taken when using ADVANTAN to avoid contact with the eyes, deep open wounds and mucosae.

Additional specific therapy is required in bacterially infected skin diseases and/or in fungal infections. Any spread of infection may require withdrawal of topical corticosteroid therapy.

If the skin dries out excessively under protracted use of ADVANTAN Cream, a switch should be made to ADVANTAN ointment, a formulation which has a higher fat content.

If signs of hypersensitivity develop, ADVANTAN should be discontinued and appropriate treatment instituted.

Any of the side effects that have been reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.

ADVANTAN is a potent steroid formulation, as with other corticosteroids of this type the possibility of hypothalmic-pituitary-adrenal (HPA) axis suppression resulting from percutaneous absorption of methylprednisolone must be considered when initiating or reviewing therapy. However, to date, no impairment of adrenocortical function has been observed when used on large areas (40–60% of the skin surface) or even occlusive treatment with ADVANTAN for up to 12 weeks in adults or 4 weeks in children.

Nevertheless, for the treatment of large areas duration of use should be kept as brief as possible.

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 systemic effects. Note that nappies can be occlusive. Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than adults because of a larger skin-surface-area to bodyweight ratio. Use of topical corticosteriods in children should be limited to the least amount required for therapeutic effect. Chronic corticosteroid therapy may interfere with the growth and development of children.

Local atrophy, telangiectasia and striae may occur after prolonged treatment or excessive application. Treatment should be discontinued if symptoms such as cutaneous atrophy occur. Prolonged use on flexures and in intertriginous areas is undesirable.

ADVANTAN Cream or Ointment should not be used around the eyes. The use of topical corticosteroids on the face can exacerbate rosacea and lead to peri-orofacial dermatitis. Patients should be warned against using ADVANTAN on the face except on medical advice and any use on the face should be restricted to short periods.

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

Two excipients contained in ADVANTAN Cream (cetostearyl alcohol and butyl hydroxytoluene) may cause local skin reactions (e.g. contact dermatitis). Butyl hydroxytoluene may also cause irritation in the eyes and mucous membranes.

None so far known.

Pregnancy

There is no adequate data from the use of ADVANTAN in pregnant women.

Animal experimental studies with methylprednisolone aceponate have shown embryonic and/or teratogenic effects (refer to the Preclinical safety data section). In general, the use of topical preparations containing corticoids should be avoided during the first trimester of pregnancy. In particular, treating large areas, prolonged use of occlusive dressing should be avoided during pregnancy.

Epidemiological studies suggest that there could possibly be an increased risk or oral clefts among newborns of women who were treated with glucocorticosteroids during the first trimester of pregnancy.

Reduced placental and birth weight have been recorded in animals and humans after long-term treatment with topical corticosteroids. Since the possibility of suppression of the adrenal cortex in the newborn baby after long-term treatment must be considered, the needs of the mother must be carefully weighed against the risk to the fetus when prescribing these drugs. Maternal pulmonary oedema has been reported, with tocolysis and fluid overload.

As a general rule, topical preparations containing corticoids should not be applied during the first trimester of pregnancy. The clinical indication for treatment with ADVANTAN must be carefully reviewed and the benefits weighed against the risks in pregnant and lactating women. In particular, treatment of large areas or prolonged use (greater than 4 weeks) must be avoided.

Breastfeeding

It is not known if methylprednisolone aceponate is secreted in human milk; systemically administered corticosteroids have been reported to appear in human milk. It is not known whether topical administration of ADVANTAN could result in sufficient systemic absorption of methylprednisolone aceponate to produce detectable quantities in human milk. Therefore caution should be exercised when ADVANTAN is administered to a woman who is breastfeeding.

Nursing mothers should not be treated on the breasts. Treating large areas, prolonged use or occlusive dressings should be avoided during lactation.

There is no effect.

In clinical studies, most frequently observed side-effects included burning and pruritus at the application site with ADVANTAN Cream and Ointment.

Frequencies of side-effects observed in clinical studies and given in the table below are defined according to the MedDRA frequency convention: 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). MedDRA version 12.0 was used for coding.

ADVANTAN Cream 0.1%

ADVANTAN Ointment 0.1%

As with other corticoids for topical application, the following local side effects may occur: skin atrophy, skin striae, application site folliculitis, hypertrichosis, telangiectasia, perioral dermatitis, skin discolouration, allergic skin reactions to any of the ingredients of the formulations. Systemic effects due to absorption may occur when topical preparations containing corticoids are applied.

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 professionals are asked to report any suspected adverse reactions to https://nzphvc.otago.ac.nz/reporting/

None known.