Salicate

Salicate™ is for external use only. It is not for ophthalmic, oral, anal, or intravaginal use. Contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided. Salicate™ should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients. Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. 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 should be monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, Salicate™ should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician. When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Applying the serum more than once per week will increase the risk of skin sensitivity.

The following interactions are from a published review 5 and include reports concerning oral and topical salicylate administration. The relationship of these interactions to the use of SALICYLIC ACID is not known. A. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding B. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level C. Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone, and phenylbutazone inhibited D. The following alterations of laboratory tests have been reported during salicylate therapy: 6 Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl in Gerhardt reaction; red color persists with boiling 17-OH corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on the dose Prothrombin Decreased levels; slightly increased prothrombin time

Pregnancy (Category C) Salicylic acid is teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent four times the Maximum daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicate™ should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nursing Mothers It is unknown whether topically applied salicylic acid is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised by physicians when administering Salicate™ to nursing mothers and nursing mothers should certainly not apply Salicate™ to the chest area or any other part of the body with which the nursing child's mouth is likely to come in contact. Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicate™, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available concerning the potential carcinogenic or reproductive effects of Salicate™. It has been shown to lack mutagenic potential in the Ames Salmonella test.