Stadgentri

Rx

Indications

• Treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria (sensitive to gentamicin) and fungi (sensitive to clotrimazole) or when the possibility of such infections is suspected.
• Particularly for the treatment of the oozing stages of the disease

Dosage

Adolescents and adults

• A thin film of cream should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night.
• Duration of therapy varies depending upon the results of clinical examination, microbiological testing and patient response to treatment.
  In the case of foot mycoses, a longer course of treatment (2 – 4 weeks) should be considered.

Children 2 – 12 years old

• A small amount should be applied on affected skin areas only and massage gently. Use no more than twice in a day with an interval at least 6 – 12 hours. Under the care of a physician only, the cream should be applied to face, neck, scalp, genital area, rectal area and intertrigo. Duration of treatment is limited to 5 – 7 days.

Usage

• Apply sparingly a thin film of cream to the affected skin areas. This cream should be applied regularly.

• Topical corticosteroids are contraindicated in skin infections (viral, bacterial [including tuberculosis] and fungal origin), reaction to vaccines, skin ulcers and acne. Cream should not be applied for face in the case of rosacea or perioral dermatitis.
• Hypersensitivity to any of active ingredients of the preparation, other aminoglycosides (polyvalent allergy to gentamicin) or imidazole derivatives (polyvalent allergy to clotrimazole).
• Stadgentri is not indicated for use with occlusive dressing.
• Stadgentri should not be applied on mucosae, skin around eyes and close to eyes.

• Local skin disorders are possible if extensive body surface areas are treated, if the occlusive technique is used or if treatment is prolonged such as atrophy (especially on the face), telangiectasia, striae, strip-like skin atrophy, skin haemorrhagy, purpura, steroid acne, rosacea-like or perioral dermatitis, hypertrichosis, skin discoloration (not known if the skin discoloration is reversible).
• Systemic effect (adrenal suppression) is probable if extensive body surface areas are treated.
• Due to decreased local resistance to infections, there is increased risk for secondary infection.
• Some patients have experienced the evident photosensitivity which, however, did not recur after repeated using gentamicin with the subsequent influence of UV-radiation.
• Suppression of endogenous corticosteroids synthesis, hypercorticalism with oedema.
• Diabetes mellitus (manifestation of latent form).
• During treatment with using cream on extensive skin areas or applications on the injured skin when administered concurrently with systemic aminoglycosides, the cumulative ototoxicity/nephrotoxicity can occur.
• Osteoporosis, growth retardation (children).
• Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
• In case of appearance the listed adverse reactions, and also the reactions which are not listed in this instruction for medical use of the drug, it is necessary to address to the doctor.

• If irritation or sensitization develops with the use of Stadgentri, treatment should be discontinued and appropriate treatment should be instituted.
  The systemic absorption of active ingredients for topical use may be increased if extensive body surface areas are
• treated with Stadgentri, especially for prolonged periods or on the injured skin.
  At such circumstances, any of the side effects that have been reported following systemic use may also occur with topical use. Suitable precautions should be taken in these circumstances, particularly with children.
• A cumulative toxic effect should be expected (ototoxicity, nephrotoxicity) due to increased transcutaneous absorption when aminoglycosides for systemic use are co-administered.
• The probability of polyvalent allergy to other aminoglycosides should be taken into account.
• Prolonged use of antibiotic-containing preparations could result in growth of insensitive microorganisms. In such case or if a superinfection is developed, the appropriative treatment should be started.
• Extensive use and the use of occlusive dressings of high-dose potent or very potent corticosteroid should be monitored closely by physician, especially taking into account the suppression of endogenous corticosteroids and possibility of metabolic effect.
• Use on an open wound and damaged skin should be avoided.
• Continuous use during 2 to 3 weeks should not be exceeded.
• If used very potent, potent and moderate corticosteroids on the face or genital areas, the special care should be taken, and courses should be limited to 1 week.
• On the areas around eyes only mild corticosteroids should be used (due to the risk of glaucoma).
• Corticosteroids might mask symptoms of allergic skin reaction to ingredients of the drug.
• Patient should be informed to use the drug for current skin disease only and do not share the drug with other people.
• 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.
• Stadgentri is not recommended for children under 2 years.
• Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large 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. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
• Stadgentri contains cetyl alcohol (emulcire 61 WL 2659) which may cause local skin reactions (e.g. contact dermatitis).
• Stadgentri contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed).
• Stadgentri contains propylene glycol which may cause skin irritation.
• Pregnant women should use Stadgentri only if clearly necessary. Stadgentri should not be applied to a large surface area, in large amounts or during long time.
• Breast-feeding is contraindicated when Stadgentri is to be applied on breasts.
• The drug has no effects on ability to drive and use machines.