DIPROGENTA Cream / Ointment Ref.[50610] Active ingredients: Betamethasone Gentamicin

If irritation or sensitization develops with the use of Diprogenta Cream or Ointment, treatment should be discontinued and appropriate therapy instituted.

When applied topically, systemic absorption of the active substances may be increased if Diprogenta is used extensively, particularly during prolonged use or if applied to damaged skin. Use beneath occlusive dressings further increases systemic absorption. Under such conditions, undesirable effects, which are seen following systemic application of the active substances, may occur. In such cases, particular caution is recommended in paediatric use.

During concomitant systemic administration of aminoglycoside antibiotics, it should be remembered that, in cases of increased dermal absorption, a cumulative toxic effect (ototoxicity, nephrotoxicity) is possible.

In particular, a possible cross reaction with other aminoglycoside antibiotics should be taken into consideration. Diprogenta cream contains chlorocresol which may cause allergic reactions and cetostearyl alcohol which may cause localized skin reactions (e.g. contact dermatitis).

During long-term treatment with preparations containing antibiotics, non-susceptible microorganisms may develop, in particular mycosis. In such an event, or at the onset of a superinfection, appropriate treatment should be instituted.

High-dose, extensive or occlusive application of potent or highly-potent corticosteroids should only take place under regular, medical supervision; particularly in regard to the suppression of endogenous corticosteroid production and a possible metabolic effect. A period of 2-3 weeks' continuous treatment should preferably not be exceeded. Highly-potent, potent and medium-dose corticosteroids should be used with caution in the facial and genital region; treatment should not exceed one week in such cases. Generally speaking, only low-dose corticosteroids should be used around the eyes (glaucoma).

Corticosteroids may mask the symptoms of an allergic skin reaction to one of the product ingredients.

The patient should be instructed to use the product solely in the treatment of his/her current skin condition, and not to pass it on to others.

Visual disturbances may occur with systemic and topical (including intranasal, inhaled and intraocular) use of corticosteroids. If a patient appears 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 the visual disturbance; these include among others cataract, glaucoma or rare diseases for example such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in paediatric patients

Use of this product in paediatric patients younger than 2 years of age is not recommended. When compared with adults, paediatric patients may demonstrate greater susceptibility to hypothalamicpituitary-adrenal (HPA) axis suppression (induced by topical corticosteroids) and to exogenous corticosteroid effects, as absorption in children is greater due to the higher skin surface area to body weight ratio.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids.

Symptoms of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Symptoms of intracranial hypertension include bulging fontanelles, headache and bilateral papilledema.

Pregnancy

In animal studies, topical application of corticosteroids was shown to have a teratogenic effect. There are no data on its use in human pregnancies.

Aminoglycosides cross the placental barrier and may harm the foetus if administered to pregnant women. There have been reports of total, irreversible, bilateral, congenital deafness in infants whose mothers received aminoglycosides (including gentamicin) during pregnancy. Sufficient data on the use of topically applied gentamicin during pregnancy is lacking.

During pregnancy, Diprogenta should only be used in cases where it is absolutely necessary.

Lactation

It is not known whether topically applied corticosteroids pass into breast milk. However, systemically available corticosteroids are excreted in breast milk.

It is not known whether gentamicin passes into breast milk. If applied to the breasts, Diprogenta may not be used by nursing mothers.

The effect on the ability to drive and operate machinery has not been studied.

Initiation of treatment

Skin and subcutaneous tissue disorders

Rare: irritations, burning sensations, pruritus, skin dryness, hypersensitivity reactions to one of the ingredients used in the product and skin discoloration.

Extensive, occlusive and/or prolonged use

During extensive, occlusive and/or prolonged use, local skin changes may occur. During extensive use, systemic effects (adrenal suppression) may occur.

It should be remembered that patients are at greater risk of developing secondary infections as a result of diminished local resistance to infection.

Skin and subcutaneous tissue disorders

Localised skin changes such as atrophy (particularly facial), telangiectasia, striae, striae distensae, cutaneous bleeding, purpura, steroid acne, rosacea-like/ perioral dermatitis and hypertrichosis, skin discoloration. It is not known whether the skin discoloration is reversible.

Uncommon: contact sensitisation to gentamicin.

Rare: skin irritation (erythema, pruritus)

Possible photosensitisation was observed in some patients; however, it was impossible to reproduce this effect when gentamicin was reapplied, with subsequent exposure to UV radiation.

Endocrine disorders

Endogenous corticosteroid synthesis suppression; overactive adrenal glands with oedema.

Metabolism and nutrition disorders

Manifestation of latent diabetes mellitus.

Eye disorders

Blurred vision

Ear and labyrinth disorders

In cases of concomitant systemic administration of aminoglycoside antibiotics, cumulative ototoxicity/nephrotoxicity can is possible if Diprogenta is used extensively or on damaged skin.

Musculoskeletal and connective tissue disorders

Osteoporosis, growth retardation (in children).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: /https://sideeffects.health.gov.il