In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. WARNINGS:Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. By similar competitive mechanisms other drugs can influence the serum levels of salicylate. Salicylates compete with the binding of several drugs and can modify the action of these drugs. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.įifty to eighty percent of salicylate is protein bound to albumin. ³The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. The sites were occluded for 10 hours over the entire body surface below the neck. Peak serum levels occurred within 5 hours of the topical application under occlusion. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). ⁴showed that peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. ³In a study of the percutaneous absorption of salicylic acid from KERALYT GEL in four patients with extensive active psoriasis, Taylor and Halprin ¹, ²The mechanism of action has been attributed to a dissolution of intercellular cement substance. CLINICAL PHARMACOLOGY:Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis.
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