salicylic acid topical (Rx, OTC)

Frequency Not Defined

Stinging/burning of skin

Dizziness

Headache

Tinnitus

Mental confusion

Peeling

Scaling

Burning/irritaion on normal tissue at site of exposure

Hyperventilation

Contraindications

Hypersensitivity

Prolonged use or application to large areas (risk for salicylism)

Children < 2 years

Virasal

• Impaired circulaiton (diabetes)
• Warts with hair growth or on face
• Birthmarks
• Moles

Cautions

External topical use only

Avoid contact with eyes

Caution in infants, diabetics, or those with impaired circulation (diabetes)

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism

Avoid concomitant use of other drugs which may contribute to elevated serum salicylate levels when the potential for toxicity is present

In children <12 years and patients with renal or hepatic impairment, area to be treated should be limited and patient monitored closely for signs of salicylate toxicity, including nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances

In event of salicylic acid toxicity, discontinue use of SA 6%

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 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 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 product other than what is needed to cover 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

Pregnancy

Drug shown to be teratogenic in rats and monkeys; 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.

Use SA 6% during pregnancy only if potential benefit justifies potential risk to fetus

Lactation

Because of potential for serious adverse reactions in nursing infants from mother's use of SA 6%, a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother; if used by nursing mothers, should not be used on chest area to avoid accidental contamination of child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Dissolves the intracellular cement that causes the hyperkeratotic tissue to swell, macerate, soften, and desquamate

Product is keratolytic at 3-6% and destructive at concentrations >6%; concentrations of 6-60% are used to remove corns and warts in the treatment of psoriasis and other keratotic disorders

Pharmacokinetics

Absorption: None with normal percutaneous use

Peak plasma time: Within 5 hours with occlusion is used