Diprogenta 0,64 mg and 1,7 mg Cream, Ointment

DIPROGENTA is indicated in the topical treatment of corticosteroid-responsive dermatoses with suspected, or complicated by, secondary infection caused by organisms sensitive to gentamicin.

DIPROGENTA Cream is recommended for wet, oozing infections, and DIPROGENTA Ointment for more dry, scaly conditions.

A thin film of DIPROGENTA should be massaged gently and thoroughly to cover the affected area completely twice daily, in the morning and at night. Some patients may achieve adequate maintenance therapy with less frequent application.

DIPROGENTA is contraindicated in the treatment of herpes simplex, vaccinia, varicella and tuberculosis of the skin.

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

DIPROGENTA is not for ophthalmic use. If irritation or sensitisation develops with the use of DIPROGENTA, treatment should be discontinued. Long-term continuous treatment with DIPROGENTA 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.

Systemic absorption of topically applied corticosteroids such as those contained in DIPROGENTA may occur, particularly under the following conditions:

• when large quantities are used,
• when application is made to wide areas of the body or 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.

Systemic absorption of topically applied gentamicin as contained in DIPROGENTA may be increased if extensive body surface areas are treated, especially over prolonged time periods or in the presence of dermal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is recommended under these conditions, particularly in infants and children.

DIPROGENTA should be used with particular caution in facial dermatoses, and only for short periods. A steroid rosacea-like facies may be produced.

DIPROGENTA should be used with caution near the eyes.

DIPROGENTA should be used for short courses only. Regular review should be made of the necessity for continuing therapy.

DIPROGENTA should not be used in the nappy areas in infants for flexural eruptions and ideally should not be used in infants and young children at all.

The treatment of psoriasis with DIPROGENTA may provoke the pustular form of the disease.

DIPROGENTA should not be applied to any skin crease areas.

Prolonged use of topical DIPROGENTA may result in overgrowth of non-susceptible organisms, particularly fungi. If this occurs or if irritation, sensitisation or super-infection develops, treatment with DIPROGENTA should be discontinued and appropriate therapy instituted.

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 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 advise is recommended in these cases or other treatment options should be considered.

None stated.

Pregnancy

Corticosteroids such as betamethasone 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, DIPROGENTA should not be used during pregnancy.

Breastfeeding

It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk. The use of DIPROGENTA is not recommended for mothers who are breastfeeding.

None stated.

Skin and subcutaneous tissue disorders: The following adverse reactions have been reported and the frequencies are unknown: burning, itching, irritation, transient irritation (erythema and pruritus), dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.

The following may occur more frequently with the use of occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Systemic absorption of aminoglycosides such as gentamicin in DIPROGENTA, may be associated with ototoxicity. Systemic adverse reactions, such as blurred vision, have also been reported with the use of topical corticosteroids.

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 topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency; manifestations of hypercorticism, including Cushing syndrome may occur.

Excessive prolonged use of topical gentamicin may lead to overgrowth of lesions by fungi or non-susceptible bacteria.

Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised. Appropriate antifungal or antibacterial therapy is indicated if overgrowth occurs.