Salacyn

Stratus Pharamceuticals, Inc
Sonar Products, Inc

SALACYN™ 6% CREAM SALACYN™ 6% LOTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• SALACYN DESCRIPTION
• CLINICAL PHARMACOLOGY
• SALACYN INDICATIONS AND USAGE
  • FOR DERMATOLOGIC USE
  • FOR PODIATRIC USE
• SALACYN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • DRUG INTERACTIONS
  • PREGNANCY
  • NURSING MOTHERS
  • CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
• SALACYN ADVERSE REACTIONS
• OVERDOSAGE
• SALACYN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 400 g Bottle Label
• PRINCIPAL DISPLAY PANEL - 414 mL Bottle Label

FULL PRESCRIBING INFORMATION

(6% Salicylic Acid)

Rx only

FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

SALACYN DESCRIPTION

SALACYN™ 6% CREAM contains 6% Salicyclic Acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of Ammonium Lactate, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Cetearyl Alcohol, Cetyl Alcohol, Dimethicone 350, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Methylparaben, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Propylparaben, Purified Water and Trolamine.

SALACYN™ 6% LOTION contains 6% w/w Salicylic Acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of of Ammonium Lactate, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Cetyl Alcohol, Dimethicone 350, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Methylparben, Mineral Oil, PEG-100 Stearate, Propylparaben, Purified Water and Trolamine.

Salicylic Acid is the 2-hydroxy derivative of benzoic acid having the following structure:

CLINICAL PHARMACOLOGY

Salicylic Acid has been shown to produce desquamation of the horny layer of the skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of intercellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis. Taylor and Halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted excellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. (SEE PRECAUTIONS).

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%). The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate. (SEE PRECAUTIONS).

SALACYN INDICATIONS AND USAGE

FOR DERMATOLOGIC USE

SALACYN™ 6% 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

SALACYN™ 6% 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.

SALACYN CONTRAINDICATIONS

SALACYN™ 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. SALACYN™ 6% should not be used in children under 2 years of age.

WARNINGS

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impariment could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salucylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal of hepatic impairment to 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 SALACYN™ 6% should be discontinued. Fluids should be administered to promote urinary execration. 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 is needed to cover the affected area will not result in a more rapid therapeutic benefit.

Due to the potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

PRECAUTIONS

For external use only. Avoid contact with eyes and other mucous membranes.

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 SALACYN™ 6% is not known.

• Due to the competition of salicylate with other drugs for binding to the serum albumin the following drug interactions may occur:

  DRUG	DISCRIPTION OF INTERACTION
  Sulfonylureas	Hypoglycemia potentiated
  Methotrexate	Decreases tubular reabsorption; clinical toxicity from methotrexate can result.
  Oral Anticoagulants	Increased bleeding

• Drugs changing salicylate levels by altering renal tubular reabsorption:

  DRUG	DISCRIPTION OF INTERACTION
  Corticosteroids	Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.
  Acidifying agents	Increases plasma salicylate levels.
  Alkcanizing agents	Decreased plasma salicylate levels.

• Drugs with completed interactions with salicylates:

  DRUG	DISCRIPTION OF INTERACTION
  Heparin	Salicylate decreases platelet adhesiveness and inteferes 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:

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 does to monkeys may represent six times the maximal daily human does of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. SALACYN™ 6% 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 SALACYN™ 6%, a decision should be made whether to discontinue nursing or 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.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No data are available concerning potential carcinogenic or reproductive effects of SALACYN™ 6%. It has been shown to lack mutagenic potential in the Ames Salmonella test.

SALACYN ADVERSE REACTIONS

Excessive erythema and scaling conceivably could result from the use on open skin lesions.

OVERDOSAGE

SEE WARNINGS.

SALACYN DOSAGE AND ADMINISTRATION

The preferable method of use is to apply SALACYN™ 6% 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 at 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 SALACYN™ 6% will usually maintain the remission. In those areas where occulsion 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 SALACYN™ 6% will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

HOW SUPPLIED

SALACYN™ 6% CREAM is available in 400 gram bottles, NDC 58980-631-90.

SALACYN™ 6% LOTION is available in 14 fl oz (414ml) bottles, NDC 58980-630-14

Store at controlled room temperature 20° - 25°C (68° - 77°F). Do not freeze.

Distributed by
STRATUS
PHARMACEUTICALS INC

Manufactured by
Sonar Products Inc.
Carlstadt, NJ 07072
exclusively for
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6208

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

©2008 Stratus Pharmaceuticals Inc.
SA6-IN200812.

PRINCIPAL DISPLAY PANEL - 400 g Bottle Label

NDC 58980-631-90

Rx only

SALACYN
CREAM

(6% Salicylic Acid)

STRATUS
PHARMACEUTICALS INC

Net WT. 400 grams

PRINCIPAL DISPLAY PANEL - 414 mL Bottle Label

NDC 58980-630-14

Rx only

SALACYN
LOTION

(6% Salicylic Acid)

STRATUS
PHARMACEUTICALS INC

Net WT. 14.0 fl. oz. (414 mL)