Product Elements:
Rayasal salicylic acid 5.9% salicylic acid salicylic acid peg-100 stearate .alpha.-tocopherol acetate white petrolatum edetate calcium disodium propylene glycol water jojoba oil cetyl alcohol phenoxyethanol sodium hydroxide stearic acid stearyl alcohol xanthan gum white wax glyceryl stearate se
Drug Interactions:
The following interactions are from a published review 5 and include reports concerning oral and topical salicylate administration. the relationship of these interactions to the use of salicylic acid is not known. a. due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: drug description of interaction tolbutamide; sulfonylureas hypoglycemia potentiated methotrexate decreases tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding b. 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 ammonium sulfate increases plasma salicylate level c. drugs with complicated interactions with salicylates: drug description of interaction heparin salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-
Read more...treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone, and phenylbutazone inhibited d. the following alterations of laboratory tests have been reported during salicylate therapy: 6 laboratory tests effect of salicylates thyroid function decreased pbi; increased t uptake urinary sugar false negative with glucose oxidase; false positive with clinitest with high-dose salicylate therapy (2-5g qd) 5 hydroxyindole acetic acid false negative with fluorometric test acetone, ketone bodies false positive fecl in gerhardt reaction; red color persists with boiling 17-oh corticosteroids false reduced values with >4.8 g qd salicylate vanilmandelic acid false reduced values uric acid may increase or decrease depending on the dose prothrombin decreased levels; slightly increased prothrombin time
Indications and Usage:
For dermatologic use rayasal is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis. for podiatric use rayasal is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.
Warnings:
Rayasal is for external use only. it is not for ophthalmic, oral, anal, or intravaginal use. contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided. rayasal should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients. 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 should be monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. in the event of salicylic acid toxicity, rayasal should be discontinued. fluids sh
Read more...ould be administered to promote urinary excretion. treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. considering the potential risk of developing reye's syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
Warnings and Cautions:
Keep this and all other medications out of the reach of children.
Dosage and Administration:
Clean and dry affected area of skin, then apply rayasal topically over the affected skin twice daily, or as directed by healthcare provider. rub in until completely fade. the preferable method of use is to apply rayasal cream thoroughly to the affected area and occlude the area at night. 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 the clearing is apparent, the occasional use of rayasal cream will usually maintain the remission. in those areas where occlusion is difficult or impossible, the application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. unless hands are being treated, hands should be rinsed thoroughly after application.
Contraindications:
Rayasal should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.
Adverse Reactions:
Transient stinging, burning, itching or irritation is possible. peeling of the skin may increase as the salicylic acid works to loosen excess keratin. if excessive burning, stinging or peeling occurs, discontinue use and consult your physician.
Drug Interactions:
The following interactions are from a published review 5 and include reports concerning oral and topical salicylate administration. the relationship of these interactions to the use of salicylic acid is not known. a. due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: drug description of interaction tolbutamide; sulfonylureas hypoglycemia potentiated methotrexate decreases tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding b. 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 ammonium sulfate increases plasma salicylate level c. drugs with complicated interactions with salicylates: drug description of interaction heparin salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-
Read more...treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone, and phenylbutazone inhibited d. the following alterations of laboratory tests have been reported during salicylate therapy: 6 laboratory tests effect of salicylates thyroid function decreased pbi; increased t uptake urinary sugar false negative with glucose oxidase; false positive with clinitest with high-dose salicylate therapy (2-5g qd) 5 hydroxyindole acetic acid false negative with fluorometric test acetone, ketone bodies false positive fecl in gerhardt reaction; red color persists with boiling 17-oh corticosteroids false reduced values with >4.8 g qd salicylate vanilmandelic acid false reduced values uric acid may increase or decrease depending on the dose prothrombin decreased levels; slightly increased prothrombin time
Use in Pregnancy:
Pregnancy (category c) salicylic acid is 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 four times the maximum 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. rayasal should be used during pregnancy only if the potential benefit justifies the risk to the fetus. nursing mothers it is unknown whether topically applied salicylic acid is excreted in human milk. since many drugs are excreted in human milk, caution should be exercised by physicians when administering rayasal to nursing mothers and nursing mothers should certainly not apply rayasal to the chest area or any other part of the body with which the nursing child's mouth is likely to come in contact. because of the potential for serious adverse reactions in nursing infants from the m
Read more...other's use of rayasal, 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. carcinogenesis, mutagenesis, impairment of fertility no data are available concerning the potential carcinogenic or reproductive effects of rayasal. it has been shown to lack mutagenic potential in the ames salmonella test.
Description:
Rayasal is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. each gram of rayasal contains salicylic acid 5.9% as the active ingredient and the following inactive ingredients: cetyl alcohol, disodium edta, emulsifying wax, glyceryl stearate se, jojoba oil, peg-100 stearate, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, stearic acid, stearyl alcohol, tocopheryl acetate, white petrolatum, xanthan gum.
Clinical Pharmacology:
Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in the structure of the viable epidermis 1,2 . the mechanism of action has been attributed to the dissolution of intercellular cement substances 3 . in a study of the percutaneous absorption of salicylic acid 6% in four patients with extensive active psoriasis, taylor and halprin 4 showed that 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 higher serum levels (30 to 40 mg/100 ml). peak serum levels occurred within 5 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 tho
Read more...se with common extracellular space. (see precautions) . the primary 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 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 salicylate serum levels. (see precautions) .
How Supplied:
Rayasal salicylic acid 5.9% gel is supplied in a 95-gram airless pump bearing the ndc number 382098-009-95 store at a controlled room temperature of 15° - 30°c (59° - 86°f). [see usp âcontrolled room temperatureâ]
Package Label Principal Display Panel:
Ndc: 382098-009-95 rayasal salicylic acid 5.9% topical cream for topical dermatological use only, not for ophthalmic, oral, or intravaginal use. rx only net wt. 3.35 oz (95 g) manufactured for raya pharmaceuticals, llc kingsland, ga, 31548 1-800-467-1205 rev 1/22 inner label outer carton