Salicylic Acid

SALICYLIC ACID-
PruGen, Inc.

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Rx Only

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

DESCRIPTION

Salicylic Acid 6% (w/w) Cream contains salicylic acid, USP 6% in a cream base composed of ammonium lactate, cetearyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, dimethicone 350, disodium EDTA, glycerine, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water and trolamine.

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

Chemical Structure

This formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin.

CLINICAL PHARMACOLOGY

Salicylic acid has been shown to produce desquamation of the horny layer of 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/100 ml). 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 extracellular 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 a salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the actions of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.(See PRECAUTIONS)

Salicylic Acid Indications and Usage

For Dermatologic Use

Salicylic Acid 6% (w/w) 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: Salicylic Acid 6% (w/w) Cream is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

CONTRAINDICATIONS

Salicylic Acid 6% (w/w) Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Cream should not be used in children under 2 years of age.

WARNINGS

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in more therapeutic benefit. 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 the Salicylic Acid 6% (w/w) Cream should be discontinued. Fluids should be administered to promote 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 and 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. 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 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 Salicylic Acid 6% (w/w) 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 level.
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 T3 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 FeCl3 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.
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