Diprogenta Special Precautions

If irritation or sensitization develops with the use of Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment, treatment should be discontinued and appropriate therapy instituted.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topically applied gentamicin 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.
Prolonged use of topical antibiotics occasionally allows overgrowth of non-susceptible organisms, including fungi. If this occurs or if irritation, sensitization or superinfection develops, treatment with gentamicin should be discontinued and appropriate therapy instituted.
Betamethasone/Gentamicin (DIPROGENTA) Cream or Ointment is not for ophthalmic use.
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.
Use in Children: 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, headache and bilateral papilledema.