PACKAGE LEAFLET

Egerian 0.1%+0.1% cream

Gentamicin sulfate
and Betamethasone valerate
COMPOSITION
100 g of cream contain:
Active substances: Gentamicin 0.1 g (as gentamicin sulfate)
Betamethasone 0.1 g (as betamethasone valerate)
Excipients: chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin,
liquid paraffin, monobasic sodium phosphate, phosphoric acid, purified water.
PHARMACEUTICAL FORM AND CONTENT
Cream. Tube of 30 grams.
PHARMACOTHERAPEUTIC CATEGORY
Corticosteroids, combinations with antibiotics.
MARKETING AUTHORISATION HOLDER
AGIPS Farmaceutici Srl – Via Amendola, 4 – 16035 Rapallo (GE)
MANUFACTURER AND FINAL CONTROLLER
IDI Farmaceutici S.r.l. – via dei Castelli Romani, 83/85 – 00040 Pomezia (Rome)
THERAPEUTIC INDICATIONS
Topical treatment of allergic or inflammatory dermatoses that are secondarily infected or in which there is a risk of infection. Among its indications are: eczema (atopic, infantile, nummular), anogenital and senile pruritus, contact dermatitis, seborrheic dermatitis, neurodermatitis, intertrigo, sunburn, exfoliative dermatitis, radiation dermatitis, stasis dermatitis, and psoriasis.
CONTRAINDICATIONS
Cutaneous tuberculosis, herpes simplex, as well as in the presence of viral diseases with cutaneous manifestations.
The product is also contraindicated in patients with hypersensitivity to the active substances (gentamicin sulfate; betamethasone valerate) or to any of the excipients.
PRECAUTIONS FOR USE
If irritation or sensitization related to the use of the product occurs, treatment must be discontinued and appropriate therapy initiated. Any of the adverse effects described for systemic corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in pediatric patients (see also “Special warnings”).
Systemic absorption of topical corticosteroids increases with treatment of large skin areas or with the use of occlusive dressings. In such cases, or when prolonged treatment is anticipated, appropriate precautions are required, particularly in pediatric patients.
The use of topical antibiotics may occasionally allow the proliferation of non-sensitive organisms, including fungi.
In such cases, or if irritation, sensitization, or superinfection develops, treatment with gentamicin must be discontinued and specific therapy initiated.
INTERACTIONS
None known.
SPECIAL WARNINGS
The medicine contains chlorocresol which may cause allergic reactions. The medicine also contains cetostearyl alcohol which may cause local skin reactions (e.g., contact dermatitis).
This product must not be used for ophthalmic purposes.
Use in pediatrics: Pediatric patients may be more sensitive than adults to hypothalamic-pituitary-adrenal (HPA) axis suppression and other effects of exogenous corticosteroids due to greater absorption resulting from the higher ratio of skin surface area to body weight. In children treated with topical corticosteroids, suppression of the HPA axis, Cushing's syndrome, growth retardation (both stature and weight), and intracranial hypertension have been reported.
Manifestations of adrenal suppression in children include low plasma cortisol levels and lack of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headache, and bilateral papilledema.
Use during pregnancy and lactation: The safety of topical corticosteroids in pregnant women has not been established; therefore, during pregnancy, use of drugs belonging to this class should be limited to cases where the expected benefit justifies the potential risk to the fetus. In pregnant patients, these drugs should not be used intensively, at high doses, or for prolonged periods. It is not known whether topical administration of corticosteroids may result in sufficient systemic absorption to produce measurable concentrations in breast milk. Therefore, it is necessary to decide whether to discontinue breastfeeding or to discontinue therapy, taking into account the importance of the drug for the mother.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply a small amount of cream to the affected area 2–3 times daily.
Psoriatic lesions that are resistant and deeply infected dermatoses may respond better to therapy with local corticosteroids and antibiotics when used with the occlusive bandage technique described below.
Occlusive bandage technique:

apply a thick layer of cream over the entire lesion surface under a light gauze and cover with transparent, waterproof, flexible plastic material extending beyond the treated area;
seal the edges to healthy skin with adhesive tape or other means;
leave the dressing in situ for 1–3 days and repeat the procedure 3–4 times as needed.
With this method, marked improvement is often observed within a few days.
Rarely, milia-like folliculitis eruptions may develop on the skin under the dressing, requiring removal of the plastic covering.
OVERDOSE
Symptoms: excessive or prolonged use of topical corticosteroids may suppress the hypothalamic-pituitary-adrenal function, causing secondary adrenal insufficiency and manifestations of hypercorticism including Cushing's syndrome. A single episode of gentamicin overdose is unlikely to produce any symptoms. Excessive and prolonged use of topical gentamicin may lead to the development of lesions caused by non-sensitive fungi and bacteria.
Treatment: appropriate symptomatic treatment is indicated. Symptoms of acute hypercorticism are generally reversible. If necessary, treat electrolyte imbalance. In cases of chronic toxicity, gradual withdrawal of the corticosteroid is recommended. In case of fungal or bacterial proliferation, appropriate antifungal or antibacterial therapy is indicated.
ADVERSE EFFECTS
The following adverse effects related to the use of topical corticosteroids have been reported: burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. When using occlusive dressings, adverse effects such as skin maceration, secondary infection, cutaneous atrophy, striae, and miliaria may occur more frequently.
Treatment with gentamicin may cause temporary irritation (erythema and itching), which usually does not require discontinuation of treatment.
Following the instructions provided in this leaflet reduces the risk of side effects.
Patients should inform their physician or pharmacist of any adverse effect experienced.
EXPIRY DATE AND STORAGE
Expiry date: see the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, unopened packaging stored under appropriate conditions.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN