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BENZOYL PEROXIDE
Overview
What is BPO 6 Foaming?
DESCRIPTION: BPO 3% and 6% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:
BPO 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cream vehicle containing: cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
What does BPO 6 Foaming look like?
What are the available doses of BPO 6 Foaming?
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What should I talk to my health care provider before I take BPO 6 Foaming?
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How should I use BPO 6 Foaming?
INDICATIONS: BPO 3% and 6% Foaming Cloths are indicated for the topical treatment of acne vulgaris.
DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry.
If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.
What interacts with BPO 6 Foaming?
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What are the warnings of BPO 6 Foaming?
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What are the precautions of BPO 6 Foaming?
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What are the side effects of BPO 6 Foaming?
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What should I look out for while using BPO 6 Foaming?
CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.
What might happen if I take too much BPO 6 Foaming?
OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
How should I store and handle BPO 6 Foaming?
TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.TOBI should be stored under refrigeration at 2ºC–8ºC/36ºF–46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days. TOBI should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2ºC–8ºC/36ºF–46ºF) or beyond 28 days when stored at room temperature (25ºC/77ºF).TOBI ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.Store at controlled room temperature, 15° - 25°C (59° - 77°F).All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 0610 Store at controlled room temperature, 15° - 25°C (59° - 77°F).All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 0610 Store at controlled room temperature, 15° - 25°C (59° - 77°F).All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 0610
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
Non-Clinical Toxicology
CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.
Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of VERIPRED 20 (20 mg prednisolone per 5 mL) be increased.
Increased activity of both cyclosporin and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect.
Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.
Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Concomitant use of aspirin (or other non-steroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., diuretics, amphotericin-B), patients should be observed closely for development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued.
Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Corticosteroids may suppress reactions to skin tests.
PRECAUTIONS: General - For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
ADVERSE REACTIONS:Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
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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