- Email: [email protected]
New Drugs and Devices
New Drugs and Devices
A new topical antibiotic (Bactroban [mupirocinl ointment 2% - Beecham Laboratories) is primarily for the treatment ofimpetigo, a contagious bacterial skin infection that affects more than 1.4 million Americans a year, mostly children. The agent is administered directly to the infection site, and is indicated as a sole therapeutic agent to treat impetigo. Most other topical antibiotics are approved for use only as adjuncts to oral antibiotics. The bacteria that cause impetigo include Staphylococcus aureus and Streptococcus pyogenes; mupirocin has been found effective against both of these pathogens. It is free of such side effects as cramps, vomiting, and diarrhea associated with erythromycin, the standard oral .antibiotic treatment for impetigo. Mupirocinhas very few side effects; one of the more 'common is slight burning at the site ofapplication in 1.5% of the patients. Biochemical studies have shown that mupirocin, the antibiotic component of Bactroban, inhibits protein synthesis in susceptible bacteria. Mupirocin is a new chemical entity that specifically binds to and inhibits the action of a bacterial enzyme named isoleucyl transferRNA synthetase, which is essential for the cellular ·g rowth of the bacteria that cause impetigo. As a result of mupirocin's action on the ·enzyme, susceptible bacteria cannot grow and replicate. Bactroban shows no cross resistance with ,any of the following antibiotics: chloramphenicol, erythro-
O
7-0
mycin, fusidic acid, gentamicin, lin,comycin, ' methicillin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Its effectiveness has been demonstrated inclinical tests on more than 1,300 patients in the past 5 years. Bactroban is contraindicated in individuals with a history of sensitivity reactions to any of its components, which include polyethylene glycol 400 and polyethylene glycol 3350. The recommended dosage regimen is application of a small amount directly to the affected area three times a day for . 7-12 days. Bactroban ointment is colorless, odorless, and will not stain clothing. The new drug will be available by prescription in 15-g tubes, usually enough for a single course of therapy.
.0
A new confirmatory AIDS antibody test (Hivagen SmithKline Beckman) virtually eliminates false positives , and dramatically reduces inconclusive results seen with the currently used supplemental testing procedure. The test, which is based on recombinant DNA technology and highly purified antigens, is intended for use in confirming specimens that are positive in the initial AIDS screening test. In clinical trials of more than 2,500 individual samples, the test had no false positives. It reduced indetenninate results by 84% in antibody-positive 'patients (true positives) and reduced the number by 77% in antibody-negative samples (true negatives). In controlled clinical trials, the test dem0nstrated 100% accuracy among 225 healthy (true negative) volunteers and was positive.in 135 of 136 asymptomatic HIV-infected patients (true positives). Only one infected patient (0.7%) gave an indeterminate -result, contrasted with an estimated 12% indetenninate rate for the Western .blot in infected patients. In contrast to the manual technology and subjective interpretation of results of the Western blot test,
Hivagen is highly specific. The antigens used as reagents against which the AIDS antibodies react are highly purified products of recombinant DNA technology, eliminating the possibility that nonAIDS antibodies in the patient's own blood will 'be detected in the test. Hivagen uses an ELISA technology, an enzyme immunoassay performed on automated equipment, the same laboratory technology used in the successful AIDS screening test; thus the test is objective .and automated. ®
~~/oo ~ 0000000000000000
MOVING? Our members' records and publications labels are computer-generated for better service. When'You change your address and give address label, we can ,make sure all publications and letters are mailed to the proper address. Please fill in the informa. tion requested below, attach your latest label, clip out and enclose the form in an envelope, and mail without delay to: Membership/Subscription Records American Pharmaceutical Association 2215 Constitution Avenue, NW Washington, DC 20037
NEW ADDRESS Last Name
MI
First Name .Street Address
.(second address line - .use if needed) State
City
Zip
Telephone Number Date you rec'eived last issue of American
Pharmacy?
. ~~ 0 :0 0 0 0 0 0 0 0 0 0 0 0 0 0 .0
Please enclose latest mailing label.
American Pharmacy, Vol. NS28; No . .6, June 1988/414
Sale
Sale Price Dissolution Technology Code T58 Lewis J. Leeson and J. Thuro Carstensen
Pediatric Dosage Handbook Code T12 Harry C. Shirkey This handbook provides accurate, well-documented information on drug therapy in infants and children. 336 pages, soft cover, 1980.
Members $ 6.00 Nonmembers $ 9~00
An in-depth report on all aspects of dissolution technology. 198 pages, hard cover, 1974.
Supportive Personnel Training Manuals .Pharmacist's Manual Code T23
Provides listing of sources that can be contacted for data on pharmacy and health care. 58 pages, soft cover, 1981.
Handbook of Nonprescription Drugs, 7th edition Code T11 Members $14.00 Nonmembers $25.00
Members $ Nonmembers $
Tableting Specifications Manual Code:T82 Members $1 Provides terminology, specificaNonmembers $2 tions, and inspection procedure standards required for drug manufacturers and pharmaceutical tool suppliers. 39 pages, soft cover, 1981.
Rational Geriatric Drug Therapy Code T53 A program designed to be delivered Members $ 8.40 as a workshop. Reference guides and Nonmembers $12.50 workbook. 146 pages, soft cover, 1979.
Controlled -Release Pharmaceuticals Code T67 John Urquhart
Animal Health Products: Design and Evaluation Code T65 Edited by Donald C. Monkhouse
Controlled-release drugs are evaluated in terms of performance , clinical limitations, dosage form design, and patient compliance. 160 pages, soft cover, 1981.
A compilation of the concepts Members $ 6.00 relating to the design and evalua- Nonmembers $ 9.00 tion of drug products for animals. 152 pages, soft cover, 1978.
Members $ Nonmembers $I
Communicating the Value of Comprehensive Pharmaceutical Services to the Consumer Code T40
The Bioavailability of Drug P roducts Code T13 Leslie Z. Benet A definitive reference for relating concepts of bioavailability to drug product performance. 120 pages, soft cover, 1978.
Members ~ Nonmembers ~
Index to Sources of Data and Statistics in Pharmacy and the Health Care Field Code T64 Virginia B. Hall and Sharon W Schwerzel
Members $ 5.00 Helpful for job description and analysis, candidate selection, and Nonmembers $ 7.50 training. 328 pages, soft cover, 1978.
This earlier edition of the Handbook is still a helpful resource on nonprescription medications. (8th edition was published in 1986.) 722 pages, h3:rd cover, 1982.
Pric~
Members $ 6.00 Nonmembers $ 9.00
I
L -_ _ _ _
I ~
_ _ _ _ _ . _ _ _. _ _
~
The Dichter Report - A classic 1973 Members $ study conducted to identify strategies Nonmembers $[ for marketing pharmaceutical services. 56 pages, soft cover, 1973. I '---_._------~
-.
~-------------------------------------------------------------------------------------'~I 72
American Pharmacy, Vol. NS28, No.6, June 1988/41il\ll .....
[ Sale Price lcroencapsulation
Code T56
collection of 12 research papers on .aking and using microcapsules ld microspheres. 48 pages, soft ver, 1981.
tibiotic Audit
Members Nonmembers
$4.50 $6.75
Sale Price Drug Absorption and Disposition: Statistical Considerations Code T59 Explanations of the statistics COffi- Members $ 6.00 piled on drug absorption and dispos- Nonmembers $ 9.00 ition, from both scientific and regulatory points of view. 152 pages, soft cover, 1980.
Code T45
bertJ. M ichocki, Thomas H. Wiser, dPeter P. Lamy
You and Your Career
tlines the principles of phanna- Members utical review and details methods Nonmembers performing an audit. 72 pages, ft cover, 1981.
$ 7.00 $10.50
Code T42
An overview of the job market and Members $ 4.00 typical earnings by region, along with Nonmembers $ 6.00 tips for landing the pharmacy job you want. 12 pages, soft cover, 1986.
For a listing of current offerings available from APhA, call toll free (800) 237-2742 or write: Order Desk American Pharmaceutical Association , 2215 Constitution Avenue, NW Washington, DC 20037 Use the form on reverse side to order "Remajndered References"
73
A new topical antibiotic (Bactroban [mupirocinl ointment 2% - Beecham Laboratories) is primarily for the treatment ofimpetigo, a contagious bacterial skin infection that affects more than 1.4 million Americans a year, mostly children. The agent is administered directly to the infection site, and is indicated as a sole therapeutic agent to treat impetigo. Most other topical antibiotics are approved for use only as adjuncts to oral antibiotics. The bacteria that cause impetigo include Staphylococcus aureus and Streptococcus pyogenes; mupirocin has been found effective against both of these pathogens. It is free of such side effects as cramps, vomiting, and diarrhea associated with erythromycin, the standard oral .antibiotic treatment for impetigo. Mupirocinhas very few side effects; one of the more 'common is slight burning at the site ofapplication in 1.5% of the patients. Biochemical studies have shown that mupirocin, the antibiotic component of Bactroban, inhibits protein synthesis in susceptible bacteria. Mupirocin is a new chemical entity that specifically binds to and inhibits the action of a bacterial enzyme named isoleucyl transferRNA synthetase, which is essential for the cellular ·g rowth of the bacteria that cause impetigo. As a result of mupirocin's action on the ·enzyme, susceptible bacteria cannot grow and replicate. Bactroban shows no cross resistance with ,any of the following antibiotics: chloramphenicol, erythro-
O
7-0
mycin, fusidic acid, gentamicin, lin,comycin, ' methicillin, neomycin, novobiocin, penicillin, streptomycin, and tetracycline. Its effectiveness has been demonstrated inclinical tests on more than 1,300 patients in the past 5 years. Bactroban is contraindicated in individuals with a history of sensitivity reactions to any of its components, which include polyethylene glycol 400 and polyethylene glycol 3350. The recommended dosage regimen is application of a small amount directly to the affected area three times a day for . 7-12 days. Bactroban ointment is colorless, odorless, and will not stain clothing. The new drug will be available by prescription in 15-g tubes, usually enough for a single course of therapy.
.0
A new confirmatory AIDS antibody test (Hivagen SmithKline Beckman) virtually eliminates false positives , and dramatically reduces inconclusive results seen with the currently used supplemental testing procedure. The test, which is based on recombinant DNA technology and highly purified antigens, is intended for use in confirming specimens that are positive in the initial AIDS screening test. In clinical trials of more than 2,500 individual samples, the test had no false positives. It reduced indetenninate results by 84% in antibody-positive 'patients (true positives) and reduced the number by 77% in antibody-negative samples (true negatives). In controlled clinical trials, the test dem0nstrated 100% accuracy among 225 healthy (true negative) volunteers and was positive.in 135 of 136 asymptomatic HIV-infected patients (true positives). Only one infected patient (0.7%) gave an indeterminate -result, contrasted with an estimated 12% indetenninate rate for the Western .blot in infected patients. In contrast to the manual technology and subjective interpretation of results of the Western blot test,
Hivagen is highly specific. The antigens used as reagents against which the AIDS antibodies react are highly purified products of recombinant DNA technology, eliminating the possibility that nonAIDS antibodies in the patient's own blood will 'be detected in the test. Hivagen uses an ELISA technology, an enzyme immunoassay performed on automated equipment, the same laboratory technology used in the successful AIDS screening test; thus the test is objective .and automated. ®
~~/oo ~ 0000000000000000
MOVING? Our members' records and publications labels are computer-generated for better service. When'You change your address and give address label, we can ,make sure all publications and letters are mailed to the proper address. Please fill in the informa. tion requested below, attach your latest label, clip out and enclose the form in an envelope, and mail without delay to: Membership/Subscription Records American Pharmaceutical Association 2215 Constitution Avenue, NW Washington, DC 20037
NEW ADDRESS Last Name
MI
First Name .Street Address
.(second address line - .use if needed) State
City
Zip
Telephone Number Date you rec'eived last issue of American
Pharmacy?
. ~~ 0 :0 0 0 0 0 0 0 0 0 0 0 0 0 0 .0
Please enclose latest mailing label.
American Pharmacy, Vol. NS28; No . .6, June 1988/414
Sale
Sale Price Dissolution Technology Code T58 Lewis J. Leeson and J. Thuro Carstensen
Pediatric Dosage Handbook Code T12 Harry C. Shirkey This handbook provides accurate, well-documented information on drug therapy in infants and children. 336 pages, soft cover, 1980.
Members $ 6.00 Nonmembers $ 9~00
An in-depth report on all aspects of dissolution technology. 198 pages, hard cover, 1974.
Supportive Personnel Training Manuals .Pharmacist's Manual Code T23
Provides listing of sources that can be contacted for data on pharmacy and health care. 58 pages, soft cover, 1981.
Handbook of Nonprescription Drugs, 7th edition Code T11 Members $14.00 Nonmembers $25.00
Members $ Nonmembers $
Tableting Specifications Manual Code:T82 Members $1 Provides terminology, specificaNonmembers $2 tions, and inspection procedure standards required for drug manufacturers and pharmaceutical tool suppliers. 39 pages, soft cover, 1981.
Rational Geriatric Drug Therapy Code T53 A program designed to be delivered Members $ 8.40 as a workshop. Reference guides and Nonmembers $12.50 workbook. 146 pages, soft cover, 1979.
Controlled -Release Pharmaceuticals Code T67 John Urquhart
Animal Health Products: Design and Evaluation Code T65 Edited by Donald C. Monkhouse
Controlled-release drugs are evaluated in terms of performance , clinical limitations, dosage form design, and patient compliance. 160 pages, soft cover, 1981.
A compilation of the concepts Members $ 6.00 relating to the design and evalua- Nonmembers $ 9.00 tion of drug products for animals. 152 pages, soft cover, 1978.
Members $ Nonmembers $I
Communicating the Value of Comprehensive Pharmaceutical Services to the Consumer Code T40
The Bioavailability of Drug P roducts Code T13 Leslie Z. Benet A definitive reference for relating concepts of bioavailability to drug product performance. 120 pages, soft cover, 1978.
Members ~ Nonmembers ~
Index to Sources of Data and Statistics in Pharmacy and the Health Care Field Code T64 Virginia B. Hall and Sharon W Schwerzel
Members $ 5.00 Helpful for job description and analysis, candidate selection, and Nonmembers $ 7.50 training. 328 pages, soft cover, 1978.
This earlier edition of the Handbook is still a helpful resource on nonprescription medications. (8th edition was published in 1986.) 722 pages, h3:rd cover, 1982.
Pric~
Members $ 6.00 Nonmembers $ 9.00
I
L -_ _ _ _
I ~
_ _ _ _ _ . _ _ _. _ _
~
The Dichter Report - A classic 1973 Members $ study conducted to identify strategies Nonmembers $[ for marketing pharmaceutical services. 56 pages, soft cover, 1973. I '---_._------~
-.
~-------------------------------------------------------------------------------------'~I 72
American Pharmacy, Vol. NS28, No.6, June 1988/41il\ll .....
[ Sale Price lcroencapsulation
Code T56
collection of 12 research papers on .aking and using microcapsules ld microspheres. 48 pages, soft ver, 1981.
tibiotic Audit
Members Nonmembers
$4.50 $6.75
Sale Price Drug Absorption and Disposition: Statistical Considerations Code T59 Explanations of the statistics COffi- Members $ 6.00 piled on drug absorption and dispos- Nonmembers $ 9.00 ition, from both scientific and regulatory points of view. 152 pages, soft cover, 1980.
Code T45
bertJ. M ichocki, Thomas H. Wiser, dPeter P. Lamy
You and Your Career
tlines the principles of phanna- Members utical review and details methods Nonmembers performing an audit. 72 pages, ft cover, 1981.
$ 7.00 $10.50
Code T42
An overview of the job market and Members $ 4.00 typical earnings by region, along with Nonmembers $ 6.00 tips for landing the pharmacy job you want. 12 pages, soft cover, 1986.
For a listing of current offerings available from APhA, call toll free (800) 237-2742 or write: Order Desk American Pharmaceutical Association , 2215 Constitution Avenue, NW Washington, DC 20037 Use the form on reverse side to order "Remajndered References"
73