Triderm Special Precautions

If irritation or sensitization develops with the use of Betamethasone/Clotrimazole/Gentamicin (TRIDERM) 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.
Cross-allergenicity among aminoglycosides has been demonstrated.
Systemic absorption of topical corticosteroids or gentamicin will be increased if extensive body surface areas are treated or if occlusive dressings are used, especially over prolonged time periods or in the presence of dermal disruption. Application of gentamicin to open wounds or damaged skin should be avoided. 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 may result in overgrowth of non-susceptible microorganisms. If this occurs or if irritation, sensitization or superinfection develops, treatment with Betamethasone/Clotrimazole/Gentamicin (TRIDERM) Ointment should be discontinued and appropriate therapy instituted.
Betamethasone/Clotrimazole/Gentamicin (TRIDERM) 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, headaches and bilateral papilledema.