Corticosteroid cream for lips

  • This cream is for external use only. Avoid contact with the eyes, the mouth, or intravaginally.
  • Patients under the age of 17 years, in diaper dermatitis and under occlusion.
  • Systemic absorption of topical corticosteroids has produced reversible hypothalamic - pituitary - adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.
  • Conditions which augment systemic absorption include use over large surface areas, prolonged use and use under occlusive dressings.
  • Patients applying cream to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.
  • If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
  • Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.
  • The use of gentamicin may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs during gentamicin therapy, the drug should be discontinued and appropriate therapy instituted.
  • Cross allergenicity among aminoglycosides has been demonstrated.
  • The possibility of cumulative toxicity should be considered if gentamicin is applied topically to large skin lesions or large areas of denuded skin in combination with systemic aminoglycoside therapy.
  • Pregnancy: There are no adequate and well controlled studies of the teratogenic potential of topically applied corticosteroids in pregnant women. Therefore topical steroids should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. The drug should not be used on extensive areas, in large amounts or for prolonged periods in pregnant women.
  • Lactation: Since it is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • Effects on ability to drive and use machines: None stated.

     

In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of Mometasone Furoate Cream % was %. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of Mometasone Furoate Cream % have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of Mometasone Furoate Cream % was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possibly or probably related to treatment with Mometasone Furoate Cream % during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with Mometasone Furoate Cream % in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

Corticosteroid cream for lips

corticosteroid cream for lips

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