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Salex 6 % Topical Cream |
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- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
Salex 6 % Topical Cream uses
Rx only- FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Salex® Cream contains 6% Salex 6 % Topical Cream USP incorporated into a patented Multivesicular Emulsion (MVE) vehicle consisting of ammonium lactate, behentrimonium methosulfate, cetearyl alcohol, cetyl alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water and trolamine.Salex® Lotion contains 6% w/w Salex 6 % Topical Cream USP incorporated into a patented Multivesicular Emulsion (MVE) vehicle consisting of ammonium lactate, behentrimonium methosulfate, cetearyl alcohol, cetyl alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, propylparaben, purified water and trolamine.
Salex 6 % Topical Cream is the 2-hydroxy derivative of benzoic acid having the following structure:
This MVE formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin.1
Chemical Structure
CLINICAL PHARMACOLOGY
Salex 6 % Topical Cream 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 Salex 6 % Topical Cream in a 6% Salex 6 % Topical Cream 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 Salex 6 % Topical Cream 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 .The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free Salex 6 % Topical Cream (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 Salex 6 % Topical Cream. 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 .
INDICATIONS AND USAGE
For Dermatologic Use: Salex® 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® is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% Salex 6 % Topical Cream have been reported to be useful adjunctive therapy for verrucae plantares.
CONTRAINDICATIONS
Salex® should not be used in any patient known to be sensitive to Salex 6 % Topical Cream or any other listed ingredients. Salex® 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 impairment, could result in salicylism. 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 Salex 6 % Topical Cream. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid 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 Salex 6 % Topical Cream 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 Salex 6 % Topical Cream. 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 Salex® is not known.- 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. |
- 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. |
| Alkalizing Agents | Decreased plasma salicylate levels. |
- 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. |
| 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. |
Pregnancy (Category C)
Salex 6 % Topical Cream 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 Salex 6 % Topical Cream when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salex® 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®, 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®. Salex 6 % Topical Cream has been shown to lack mutagenic potential in the Ames Salmonella test.ADVERSE REACTIONS
Excessive erythema and scaling conceivably could result from use on open skin lesions.OVERDOSAGE
DOSAGE AND ADMINISTRATION
The preferable method of use is to apply Salex® 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 Salex® will usually maintain the remission. In those areas where occlusion is difficult or impossible, 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. Excessive repeated application of Salex® will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.HOW SUPPLIED
Salex® Cream is available in a 454 g (16 oz.) jar - NDC 13548-010-16Salex® Lotion is available in a 8 fl. oz. (237 mL) bottle - NDC 13548-011-08
Store at controlled room temperature
20° to 25°C (68° to 77°F). Do not freeze.
(1) Data on file.
Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
by:
Denison Pharmaceuticals, LLC
Lincoln, RI 02865 USA
PATENT NO. 6,709,663
REORDER NO.
Salex® Cream: 13548-010-17
Salex® Lotion: 13548-011-09
Salex is a registered trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
MVE is a trademark of DFB TECHNOLOGY, LTD.
Any other product/brand names are trademarks of their respective owners.
©Valeant Pharmaceuticals North America LLC
9497700
70011485
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References
- Dailymed."Salex (salicylic acid) cream salex (salicylic acid) lotion [coria laboratories]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- "Salicylic acid". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
- "Salicylic acid". http://www.drugbank.ca/drugs/DB0093... (accessed August 28, 2018).
Salex 6 % Topical Cream - Frequently asked Questions
Can Salex 6 % Topical Cream be stopped immediately or do I have to stop the consumption gradually to ween off?
In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.
It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.
Can Salex 6 % Topical Cream be taken or consumed while pregnant?
Please visit your doctor for a recommendation as such case requires special attention.
Can Salex 6 % Topical Cream be taken for nursing mothers or during breastfeeding?
Kindly explain your state and condition to your doctor and seek medical advice from an expert.
Reviews
Following the study conducted by gmedication.com on Salex 6 % Topical Cream, the result is highlighted below. However, it must be clearly stated that the survey and result is based solely on the perception and impression of visitors and users of the website as well as consumers of Salex 6 % Topical Cream. We, therefore, urge readers not to base their medical judgment strictly on the result of this study but on test/diagnosis duly conducted by a certified medical practitioners or physician.Patient reports
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The information was verified by Dr. Vishal Pawar, MD Pharmacology