SALYCIM

INDICATIONS AND USAGE For Dermatologic Use: Salycim™ Cream is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salycim™ Cream is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salycim™ Cream thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for a least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salycim™ Cream will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS .) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salycim™ Cream will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

WARNINGS 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 monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salycim™ Cream should be discontinued. Fluids should be administered topromote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based. Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Excessive application of the product other than what is needed to cover the affected area will not result in a more rapid therapeutic benefit. Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by physician.

CONTRAINDICATIONS Salycim™ Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salycim™ Cream should not be used in children under 2 years of age.

DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salycim™ Cream is not known. I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: DRUG DESCRIPTION OF INTERACTION Sulfonylureas Hypoglycemia potentiated. Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result. Oral Anticoagulants Increased bleeding. II. 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. Acidifying Agents Increases plasma salicylate levels. Alkanizing Agents Decreased plasma salicylate levels. III. 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 probenemide, sulfinpyrazone and phenylbutazone inhibited. The following alterations of laboratory tests have been reported during salicylate therapy: LABORATORY TESTS EFFECT OF SALICYLATES Thyroid Function Decreased PBI; increased t 3 uptake. Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). 5-Hydroxyindole acetic acid False negative with fluorometric test. Acetone ketone bodies False positive FeCI 3 in Gerhardt reaction; red color persists with boiling. 17-OH corticosteroids False reduced values with >4.8g q.d. salicylate. Vanilmandelic acid False reduced values. Uric Acid May increase or decrease depending on dose. Prothrombin Decreased levels; slightly increased prothrombin time.

Pregnancy: Category C. Salicylic acid has been shown to be 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 six times the maximal 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. Salycim™ Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salycim™ Cream , 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. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.

ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your physician for medical advice about side effects.