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New and Nonofficial Remedies
Council descriptions of new drug products only are published regularly in THIS JOURNAL as they are accepted. Rules upon which the Council bases its action appeared in (he July (7:320) 1946 issue, and may be secured in· pamphlet form upon request to the Secretary, Council on Pharmacy and Chemistry, American Medical Association, 535 N. Dearborn St., Chicago 10, Ill. HEXACHLOROPHENE.-Gamophen (Ethicon).-Hex-0-San (Cole).-C1 3H 6Cl60 2.-M. W. 406.92.-2,2 '-Methylenebis- (3,5,6- trichloro )phenol. -2,2'-Dihydroxy-3,5,6,3',5',6'-hexachlorodiphenylmethane.-The structural formula for hexachlorophene may be represented as follows: HO OH
I
I
Cl-o~-CH2-o /' ~-CI ~
61
-Cl
Cl --"'-~
tl
Actions and Uses.-Hexachlorophene is incorporated in soaps, d~tergents, oils and other vehicles for topical application to reduce the numbers and to inhibit the metabolism of microorganisms which occur naturally and pathogenically in the skin bac· terial flora. Residual amounts of hexachlorophene, which are adsorbed on the skin, maintain a reduction in numbers of bacteria. Optimum results are obtained only with exclusi11e application of the agent to the skin surface; substitution of other cleansing agents, including water, removes the adsorbed hexachlorophene with a resultant rapid increase in numbers and metabolism of microorganisms. The activity of hexachlorophene, like that of other antibacterial agents, is considerably reduced by blood serum and other organic matter. Hexachlorophene is effective against gram-positive bacteria; the gram-negative organisms are much more resistant to its action. No evidence is presently available concerning its efficacy against acid-fast bacteria, fungi, bacterial spores, virus or spirochetes. Products containing hexachlorophene are used for p:eoperative scrubbing, and preoperative and post-
228
operative preparation of patients' skin. When used continually hexachlorophene is also an effective prophylactic agent in decreasing the incidence and severity of pyogenic skin infections including carbuncles, furuncles, miliaria, ammoniacal dermatitis, impetigo and seborrheic dermatitis ("Cradle cap"). Neither hexachlorophene nor any other chemical agent should be relied on as a substitute for mechanical cleansing of the skin. Dosage.-For use ·as an antibacterial agent hexachlorophene may be incorporated in a number of vehicles, viz., soap, detergents, creams and oils. Concentrations of 2 to 3 per cent (anhydrous weight basis) are efficacious in reducing the number of microorganisms inherent in the skin bacterial flora. Concentrations in excess of 3 per cent have not yet been shown to be more effective. Physical Properties: Hexachlorophene is an odorless (or has a slight, phenolic odor), white to light tim, crystalline powder, which melts between 161° and 167° C. It is freely soluble in acetone, alcohol and ether; soluble in chloroform, and insolubl in water. [For more detailed information regarding action and uses and for tests and standards, see J. Am. Med. Assoc., 145: 563 {1951).1
Surgical Soap Hex-O-San: 3. 78-liter and 18.9liter cans and 56.7-liter, 113.5-liter and 208.1-liter drums. A soap containing 2 per cent hexachlorophene. Cole Laboratories, Inc., Long Island City, N.Y. Surgical Soap Gamophen: 127.5-Gm. cakes. A soap containing 2 per cent hexachlorophene. Ethicon Suture Laboratories, Inc., New Brunswick, N. J. Germa-M~dica Surgical Soap Hexachlorophene: 3.78-liter bottles. A soap containing 2.5 per cent hexachlorophene. U. S. Trademark 213,093. Huntington Laboratories, Inc., Huntington, Ind. SODIUM p-AMINOSALICYLATE.- Pasem Sodium-(Massengill).
Actions and Uses.-See monograph on p-Aminosalicylic Acid. Dosage.-3 Gm. five times\ daily for a total dose of 15 Gm. every 24 hours. The duration of treatment is the same as wi~h p-aminosalicylic acid. Physical Properties: Sodium p-aminosalicylate is a white to pale yellow, practically odorless, crystalline powder. It is freely soluble in water, sparingly soluble in alcohol and practically insoluble in ether. One gram dissolved in 50 ml. of water to give a clear solution which is colorless or nearly so. The solution has a pH between 7.0 and 7.5. [For more detailed information regarding action and uses and for tests and standards, see J. Am. Med. Assoc., 145: 905 (1951).]
Powder Sodium Para-Aminosalicylate: 454-Gm. bottles. American Pharmaceutical Company, New York, N.Y. Tablets Sodium Para-Aminosalicylate: 0.5 Gm. American Pharmaceutical Company, New York, N.Y . . Capsules Pasem Sodium: 0.5 Gm. S. E. Masse:hgill Company, Bristol, Tenn.
I
I
Cl-o~-CH2-o /' ~-CI ~
61
-Cl
Cl --"'-~
tl
Actions and Uses.-Hexachlorophene is incorporated in soaps, d~tergents, oils and other vehicles for topical application to reduce the numbers and to inhibit the metabolism of microorganisms which occur naturally and pathogenically in the skin bac· terial flora. Residual amounts of hexachlorophene, which are adsorbed on the skin, maintain a reduction in numbers of bacteria. Optimum results are obtained only with exclusi11e application of the agent to the skin surface; substitution of other cleansing agents, including water, removes the adsorbed hexachlorophene with a resultant rapid increase in numbers and metabolism of microorganisms. The activity of hexachlorophene, like that of other antibacterial agents, is considerably reduced by blood serum and other organic matter. Hexachlorophene is effective against gram-positive bacteria; the gram-negative organisms are much more resistant to its action. No evidence is presently available concerning its efficacy against acid-fast bacteria, fungi, bacterial spores, virus or spirochetes. Products containing hexachlorophene are used for p:eoperative scrubbing, and preoperative and post-
228
operative preparation of patients' skin. When used continually hexachlorophene is also an effective prophylactic agent in decreasing the incidence and severity of pyogenic skin infections including carbuncles, furuncles, miliaria, ammoniacal dermatitis, impetigo and seborrheic dermatitis ("Cradle cap"). Neither hexachlorophene nor any other chemical agent should be relied on as a substitute for mechanical cleansing of the skin. Dosage.-For use ·as an antibacterial agent hexachlorophene may be incorporated in a number of vehicles, viz., soap, detergents, creams and oils. Concentrations of 2 to 3 per cent (anhydrous weight basis) are efficacious in reducing the number of microorganisms inherent in the skin bacterial flora. Concentrations in excess of 3 per cent have not yet been shown to be more effective. Physical Properties: Hexachlorophene is an odorless (or has a slight, phenolic odor), white to light tim, crystalline powder, which melts between 161° and 167° C. It is freely soluble in acetone, alcohol and ether; soluble in chloroform, and insolubl in water. [For more detailed information regarding action and uses and for tests and standards, see J. Am. Med. Assoc., 145: 563 {1951).1
Surgical Soap Hex-O-San: 3. 78-liter and 18.9liter cans and 56.7-liter, 113.5-liter and 208.1-liter drums. A soap containing 2 per cent hexachlorophene. Cole Laboratories, Inc., Long Island City, N.Y. Surgical Soap Gamophen: 127.5-Gm. cakes. A soap containing 2 per cent hexachlorophene. Ethicon Suture Laboratories, Inc., New Brunswick, N. J. Germa-M~dica Surgical Soap Hexachlorophene: 3.78-liter bottles. A soap containing 2.5 per cent hexachlorophene. U. S. Trademark 213,093. Huntington Laboratories, Inc., Huntington, Ind. SODIUM p-AMINOSALICYLATE.- Pasem Sodium-(Massengill).
Actions and Uses.-See monograph on p-Aminosalicylic Acid. Dosage.-3 Gm. five times\ daily for a total dose of 15 Gm. every 24 hours. The duration of treatment is the same as wi~h p-aminosalicylic acid. Physical Properties: Sodium p-aminosalicylate is a white to pale yellow, practically odorless, crystalline powder. It is freely soluble in water, sparingly soluble in alcohol and practically insoluble in ether. One gram dissolved in 50 ml. of water to give a clear solution which is colorless or nearly so. The solution has a pH between 7.0 and 7.5. [For more detailed information regarding action and uses and for tests and standards, see J. Am. Med. Assoc., 145: 905 (1951).]
Powder Sodium Para-Aminosalicylate: 454-Gm. bottles. American Pharmaceutical Company, New York, N.Y. Tablets Sodium Para-Aminosalicylate: 0.5 Gm. American Pharmaceutical Company, New York, N.Y . . Capsules Pasem Sodium: 0.5 Gm. S. E. Masse:hgill Company, Bristol, Tenn.