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Salicylic acid

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Overview

What is Salex?

Salex Shampoo contains 6% w/w salicylic acid USP in a vehicle consisting of purified water, acrylates copolymer, sodium laureth sulfate, trolamine, quaternium 26 and propylene glycol, cocamidopropyl betaine, behentrimonium methosulfate and cetearyl alcohol, propylparaben, methylparaben, glycerin, disodium EDTA and chamomile tea fragrance.

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



What does Salex look like?



What are the available doses of Salex?

Sorry No records found.

What should I talk to my health care provider before I take Salex?

Sorry No records found

How should I use Salex?

For Dermatologic Use: Salex Shampoo 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: Salex Shampoo 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.

Wet hair and apply Salex Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salex Shampoo will usually maintain the remission.


What interacts with Salex?

Salex Shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex Shampoo should not be used in children under 2 years of age.



What are the warnings of Salex?

The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

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 a 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 Salex 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 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.


What are the precautions of Salex?

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 Salex is not known.



  • I.


DRUGDESCRIPTION OF INTERACTION
SulfonylureasHypoglycemia potentiated.
MethotrexateDecreases tubular reabsorption; clinical toxicity from methotrexate can result.
Oral AnticoagulantsIncreased bleeding.




  • II.


DRUGDESCRIPTION OF INTERACTION
CorticosteroidsDecreases plasma salicylate level; tapering doses of steroids may promote salicylism.
Acidifying AgentsIncreases plasma salicylate level.
Alkalinizing AgentsDecreased plasma salicylate levels.




  • III.


DRUGDESCRIPTION OF INTERACTION
HeparinSalicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients.
PyrazinamideInhibits pyrazinamide-induced hyperuricemia.
Uricosuric AgentsEffect of probenemide, sulfinpyrazone and phenylbutazone inhibited.




The following alterations of laboratory tests have been reported during salicylate therapy:

LABORATORY TESTSEFFECT OF SALICYLATES
Thyroid FunctionDecreased PBI; increased T uptake.
Urinary SugarFalse negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.).
False negative with fluorometric test.
Acetone, ketone bodiesFalse positive FeCl in Gerhardt reaction; red color persists with boiling.
17-OH corticosteroidsFalse reduced values with >4.8g q.d. salicylate.
Vanilmandelic acid False reduced values.
Uric acidMay increase or decrease depending on dose.
ProthrombinDecreased 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. Salex® Shampoo 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 Salex® Shampoo, 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 the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salex® Shampoo. Salicylic acid has been shown to lack mutagenic potential in the Ames test.


What are the side effects of Salex?

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


What should I look out for while using Salex?

Salex Shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex Shampoo should not be used in children under 2 years of age.

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 a 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 Salex 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 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.


What might happen if I take too much Salex?

See.


How should I store and handle Salex?

Store Temozolomide Capsules at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Salex Shampoo is available in 6 fl. oz. (177 mL) bottle (NDC 13548-012-06).


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Clinical Information

Chemical Structure

No Image found
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)

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)

Non-Clinical Toxicology
Salex Shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex Shampoo should not be used in children under 2 years of age.

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 a 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 Salex 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 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.

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 Salex is not known.

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

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

Tips

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Interactions

Interactions

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