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ult complete product informatic i summary of Bactrim {trimethoprim and sulfamethoxazole) ■ succeeds Jactrim is useful for TT'vT^QTirli'nrp , Je following infec- lUlI Ig ^ l! 0 susceptible^ itS USGfulllGSS ill antimicrobial therapy ctio , there are limited r two years of age. stration in otitis itrains of indi ;ated organisms see indications section n summary of product nformation): in recurrent UTI... a continuing record of high clinical effectiveness against common uropathogens in acute otitis media in children... effective against both major otic pathogens...witn b.i.d. convenience in acute exacerbations of chronic bronchitis in adults... clears the sputum and lowers its volume.. .on b.i.d. dosage Before prescribing, please which follows: Indications and Usage: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella-Entero-bacter, Proteus mirabills, Proteus vulgaris, Proteus morganii. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Note: The Increasing frequency of resistant organisms limits the usefulness of all antibacterials, especially in these urinary tract infections. For acute otitis media in children due to susceptible strains of Haemophilus influenzae or Sfreptococcus pneumoniae when in physician s judgment it offers an advantage over other antimicrobials. Limited clinical information presently available on effectiveness of treatment of otitis media with Bactrim when infe Is due to ampicillin-resistant Haemophilus influenzae. To date data on the safety of repeated use of Bactrim in children unde Bactrim is not indicated for prophylactic or prolonged admin media at any age. For acute exacerbations of chronic bronchitis in adults due to susceptible strain: of Haemophilus influenzae or Streptococcus pneumoniae when in physician's judgment it offers an advantage over a single antimicrobial agent. For enteritis due to susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Also for the treatment of documented Pneumocystis carinii pneumonitis. To date, this drug has been tested only in patients 9 months to 16 years of age who were immunosuppressed by cancer therapy. Contraindications: Hyperser^sitivi!y to trimethoprim or sulfonamides; patients with, documented megaloblastic anemia due to folate deficiency; pregnancy at term; nursing mothers because sulfonamides are excreted in human milk and may cause kernicterus; infants less than 2 months of age. Warnings: BACTRIM SHOULD NOT BE USED TO TREAT STREPTOCOCCAL PHARYNGITIS. Clinical studies show that patients with group A /3-hemolytic streptococcal tonslllopharyngitis have higher incidence of bacteriologic failure whe treated with Bactrim than do those treated with penicillin. Deaths from hypersensitiv reactions, agranulocytosis, aplastic anemia and other blood dyscrasias have be associated with sulfonamides. Experience with trimethoprim Is much more limited but occasional interference with hematopoiesis has been reported as well as an increased incidence of thrombopenia with purpura in elderly patients on certain diuretics, primarily thiazides. Sore throat, fever, pallor, purpura or laundice may be early sign serious blood disorders. Frequent CBC's are recommended; therapy should be discontinued if a significantly reduced count of any formed blood element is noted. Precautions: General: Use cautiously in patients with impaired renal or hepatic function, possible folate deficiency, severe allergy or bronchial asthma. In patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis, frequently dose-related, may occur During therapy, maintain adequate fluid intake and perform frequent urinalyses, with careful microscopic examination, and renal function tests, particularly where there is impaired renal function. Bactrim may prolong prothrombin time in those receiving warfarin; reassess coagulation time when administering Bactnm to these patients- Pregnancy.- Teratogenic Effects; Pregnancy Category 0. Because trimethoprim and sulfamethoxazole may interfere with folic acid metabolism, use during pregnancy only if potential benefits justify the potential risk to the fetus. Adverse Reactions: All major reactions to sulfonamides and trimethoprim are included, even if not reported with Bactrim. Blood dyscras/as-Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombopenia, leuko-^ penia. hemolytic anemia, purpura, hypoprothrombinemla and methemoglobinemia Allergic reactions: Erythema Stevens-Johnson syndrome, generalized skin eruptions, epidermal . urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid penorbital edema, conjunctival and scleral injection, photosensitization, and allergic myocarditis. Gastrointestinal reactions: G\oss\\\s. stomatitis, ibdominal pains, hepatitis, diarrhea and pancreatitis. CMS reactions: itis. mental depression, convulsions, ataxia, hallucinations, lomnia. apathy, fatigue, muscle weakness and nervousness. ig fever, chills, toxic nephrosis with oliguria and anuria, lomenon. Due to certain chemical similarities to some .ity 3 of in shigellosis faster relief of diarrhea than with ampicillin^ multiforme necrolysis, reactions, arthralgic nausea, emesis. Headache, penphe tinnitus, vertigo. Miscellaneous reactions: Dri _ periarteritis nodosa and L E. phe nts rats, long- nd 30 ml/mln. ne clearance is goitrogens, diuretics (acetazolamide, thiazides) and oral hypoglycemic i sulfonamides have caused rare instances of goiter production, diuresis i hypoglycemia in patients; cross-sensitivity with these agents may exist, term therapy with sulfonamides has produced thyroid malignancies. Dosage: Not recommended for infants less than two months of age. URINARY TRACT INFECTIONS AND SHIGELLOSIS IN ADULTS AND CHILDREN. AND ACUTE OTITIS MEDIA IN CHILDREN: Adults: Usual adult dosage for urinary tract infections—1 DS tablet (double strength). 2 tablets (single strength) or 4 teasp. (20 ml) b.i.d. for 10-14 days. Use identical daily dosage for 5 days for shigellosis. Children: Recommended dosage for children with urinary tract Infections or acute otitis media—8 mg/kg tnmethoprim and 40 mg/kg sulfamethoxazole per 24 hours, in two divided doses for 10 days. Use Identical daily dosage for 5 days for shigellosis. For patients with renal impairment: Use recommended dosage regimen when creatinine clearance is above 30 ml/min. If creatinine clearance is between 15 £ use one-half the usual regimen. Bactrim is not recommended If creatir below 15 ml/min. ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS IN ADULTS: Usual adult dosage: 1 DS tablet (double strength). 2 tablets (single strength) or 4 teasp. (20 ml) b.i.d. for 14 days. PNEUMOCYSTIS CARINII PNEUMONITIS: Recommended dosage: 20 mg/kg trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours in equal doses every 6 hours for 14 days. See complete product information for suggested children's dosage table. Supplied: Double Strength (DS) tablets, each containing 160 mg trimethoprim and 800 mg sulfamethoxazole, bottles of 100; Tel-E-Dose® packages of 100; Prescription Paks of 20 and 28, Tablets, each containing 80 mg trimethoprim and 400 mg sulfamethoxazole—bottles of 100 and 500; Tel-E-Dose® packages of 100; Prescription Paks of 40. Pediatric Suspension, containing 40 mg trimethopnm and 200 mg sulfamethoxazole per teaspoonful (5 ml); cherry-flavored—bottles of 100 ml and 16 oz (1 pint). Suspension, containing 40 mg trimethoprim and 200 mg sulfamethoxazole per teaspoonful (5 ml); fruit-licorlce flavored—bottles of 16 oz (1 pint). /ROCHr>D° \—A> Nu . ROCHE LABORATORIES ROCHE > Division of Hoffmann-La Roche Inc. " utley. New Jersey 07110
Object Description
Rating | |
Fixed Title * | NCHH-17: North Carolina Medical Journal [1940-2001] |
Document Title | North Carolina Medical Journal [1940-2001] |
Subject Topical Other | Public Health -- Periodicals.; Physicians -- North Carolina -- Directory.; Societies, Medical -- North Carolina -- Periodicals. |
Description | Includes Transactions of the Society, -1960; 1961- , Transactions issued separately, bound in.; Includes Transactions of the auxiliary to the Medical Society of the State of North Carolina and Proceedings of the North Carolina Public Health Association. Official organ of the Medical Society of the State of North Carolina, 1940-May 1972; of the North Carolina Medical Society, June 1972-. Vols. for 1940-May 1972 published by the Medical Society of the State of North Carolina; June 1972- by the North Carolina Medical Society. |
Contributor | Medical Society of the State of North Carolina. Transactions.; Medical Society of the State of North Carolina.; North Carolina Medical Society.; North Carolina Medical Society. Transactions.; North Carolina Public Health Association. Proceedings. |
Publisher | [Winston-Salem] : North Carolina Medical Society [etc.], 1940- |
Repository | University of North Carolina at Chapel Hill. Health Sciences Library. |
Host | University of North Carolina at Chapel Hill |
Date | 1982 |
Identifier | NCHH-17-043 |
Form General | Periodicals |
Language | English |
Rights | This item is part of the North Carolina History of Health Digital Collection. Some materials in the Collection are protected by U.S. copyright law. This item is presented by the Health Sciences Library of the University of North Carolina at Chapel Hill for research and educational purposes. It may not be republished or distributed without permission of the Health Sciences Library. |
Digital Collection | North Carolina History of Health Digital Collection |
Sponsor | The North Carolina History of Health Digital Collection is an open access publishing initiative of the Health Sciences Library of the University of North Carolina at Chapel Hill. Financial support for the initiative was provided in part by a multi-year NC ECHO (Exploring Cultural Heritage Online) digitization grant, awarded by the State Library of North Carolina, and funded through the Library Services and Technology Act (LSTA). |
Volume Number | 43 |
Health Discipline | Medicine |
Digital Format | JPEG 2000 |
Print / Download PDF Version | http://archives.hsl.unc.edu/nchh/nchh-17/nchh-17-043.pdf |
Document Sort | all; nchh-17 |
Volume Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/identi/searchterm/NCHH-17-043 |
Title Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/documa/searchterm/NCHH-17 |
Catalog Record link | http://search.lib.unc.edu/search?R=UNCb1306322 |
Revision History | done |
Description
Fixed Title * | Page iii (advert) |
Document Title | North Carolina Medical Journal [1940-2001] |
Subject Topical Other | Public Health -- Periodicals.; Physicians -- North Carolina -- Directory.; Societies, Medical -- North Carolina -- Periodicals. |
Description | Includes Transactions of the Society, -1960; 1961- , Transactions issued separately, bound in.; Includes Transactions of the auxiliary to the Medical Society of the State of North Carolina and Proceedings of the North Carolina Public Health Association. Official organ of the Medical Society of the State of North Carolina, 1940-May 1972; of the North Carolina Medical Society, June 1972-. Vols. for 1940-May 1972 published by the Medical Society of the State of North Carolina; June 1972- by the North Carolina Medical Society. |
Contributor | Medical Society of the State of North Carolina. Transactions.; Medical Society of the State of North Carolina.; North Carolina Medical Society.; North Carolina Medical Society. Transactions.; North Carolina Public Health Association. Proceedings. |
Publisher | [Winston-Salem] : North Carolina Medical Society [etc.], 1940- |
Repository | University of North Carolina at Chapel Hill. Health Sciences Library. |
Host | University of North Carolina at Chapel Hill |
Date | 1982 |
Identifier | NCHH-17-043-0179 |
Form General | Periodicals |
Page Type | all; all images; advertisement |
Language | English |
Rights | This item is part of the North Carolina History of Health Digital Collection. Some materials in the Collection are protected by U.S. copyright law. This item is presented by the Health Sciences Library of the University of North Carolina at Chapel Hill for research and educational purposes. It may not be republished or distributed without permission of the Health Sciences Library. |
Filename | ncmed431982mediv1_0179.jp2 |
Digital Collection | North Carolina History of Health Digital Collection |
Sponsor | The North Carolina History of Health Digital Collection is an open access publishing initiative of the Health Sciences Library of the University of North Carolina at Chapel Hill. Financial support for the initiative was provided in part by a multi-year NC ECHO (Exploring Cultural Heritage Online) digitization grant, awarded by the State Library of North Carolina, and funded through the Library Services and Technology Act (LSTA). |
Volume Number | 43 |
Issue Number | 2 |
Page Number | iii |
Health Discipline | Medicine |
Full Text | ult complete product informatic i summary of Bactrim {trimethoprim and sulfamethoxazole) ■ succeeds Jactrim is useful for TT'vT^QTirli'nrp , Je following infec- lUlI Ig ^ l! 0 susceptible^ itS USGfulllGSS ill antimicrobial therapy ctio , there are limited r two years of age. stration in otitis itrains of indi ;ated organisms see indications section n summary of product nformation): in recurrent UTI... a continuing record of high clinical effectiveness against common uropathogens in acute otitis media in children... effective against both major otic pathogens...witn b.i.d. convenience in acute exacerbations of chronic bronchitis in adults... clears the sputum and lowers its volume.. .on b.i.d. dosage Before prescribing, please which follows: Indications and Usage: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella-Entero-bacter, Proteus mirabills, Proteus vulgaris, Proteus morganii. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Note: The Increasing frequency of resistant organisms limits the usefulness of all antibacterials, especially in these urinary tract infections. For acute otitis media in children due to susceptible strains of Haemophilus influenzae or Sfreptococcus pneumoniae when in physician s judgment it offers an advantage over other antimicrobials. Limited clinical information presently available on effectiveness of treatment of otitis media with Bactrim when infe Is due to ampicillin-resistant Haemophilus influenzae. To date data on the safety of repeated use of Bactrim in children unde Bactrim is not indicated for prophylactic or prolonged admin media at any age. For acute exacerbations of chronic bronchitis in adults due to susceptible strain: of Haemophilus influenzae or Streptococcus pneumoniae when in physician's judgment it offers an advantage over a single antimicrobial agent. For enteritis due to susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Also for the treatment of documented Pneumocystis carinii pneumonitis. To date, this drug has been tested only in patients 9 months to 16 years of age who were immunosuppressed by cancer therapy. Contraindications: Hyperser^sitivi!y to trimethoprim or sulfonamides; patients with, documented megaloblastic anemia due to folate deficiency; pregnancy at term; nursing mothers because sulfonamides are excreted in human milk and may cause kernicterus; infants less than 2 months of age. Warnings: BACTRIM SHOULD NOT BE USED TO TREAT STREPTOCOCCAL PHARYNGITIS. Clinical studies show that patients with group A /3-hemolytic streptococcal tonslllopharyngitis have higher incidence of bacteriologic failure whe treated with Bactrim than do those treated with penicillin. Deaths from hypersensitiv reactions, agranulocytosis, aplastic anemia and other blood dyscrasias have be associated with sulfonamides. Experience with trimethoprim Is much more limited but occasional interference with hematopoiesis has been reported as well as an increased incidence of thrombopenia with purpura in elderly patients on certain diuretics, primarily thiazides. Sore throat, fever, pallor, purpura or laundice may be early sign serious blood disorders. Frequent CBC's are recommended; therapy should be discontinued if a significantly reduced count of any formed blood element is noted. Precautions: General: Use cautiously in patients with impaired renal or hepatic function, possible folate deficiency, severe allergy or bronchial asthma. In patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis, frequently dose-related, may occur During therapy, maintain adequate fluid intake and perform frequent urinalyses, with careful microscopic examination, and renal function tests, particularly where there is impaired renal function. Bactrim may prolong prothrombin time in those receiving warfarin; reassess coagulation time when administering Bactnm to these patients- Pregnancy.- Teratogenic Effects; Pregnancy Category 0. Because trimethoprim and sulfamethoxazole may interfere with folic acid metabolism, use during pregnancy only if potential benefits justify the potential risk to the fetus. Adverse Reactions: All major reactions to sulfonamides and trimethoprim are included, even if not reported with Bactrim. Blood dyscras/as-Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombopenia, leuko-^ penia. hemolytic anemia, purpura, hypoprothrombinemla and methemoglobinemia Allergic reactions: Erythema Stevens-Johnson syndrome, generalized skin eruptions, epidermal . urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid penorbital edema, conjunctival and scleral injection, photosensitization, and allergic myocarditis. Gastrointestinal reactions: G\oss\\\s. stomatitis, ibdominal pains, hepatitis, diarrhea and pancreatitis. CMS reactions: itis. mental depression, convulsions, ataxia, hallucinations, lomnia. apathy, fatigue, muscle weakness and nervousness. ig fever, chills, toxic nephrosis with oliguria and anuria, lomenon. Due to certain chemical similarities to some .ity 3 of in shigellosis faster relief of diarrhea than with ampicillin^ multiforme necrolysis, reactions, arthralgic nausea, emesis. Headache, penphe tinnitus, vertigo. Miscellaneous reactions: Dri _ periarteritis nodosa and L E. phe nts rats, long- nd 30 ml/mln. ne clearance is goitrogens, diuretics (acetazolamide, thiazides) and oral hypoglycemic i sulfonamides have caused rare instances of goiter production, diuresis i hypoglycemia in patients; cross-sensitivity with these agents may exist, term therapy with sulfonamides has produced thyroid malignancies. Dosage: Not recommended for infants less than two months of age. URINARY TRACT INFECTIONS AND SHIGELLOSIS IN ADULTS AND CHILDREN. AND ACUTE OTITIS MEDIA IN CHILDREN: Adults: Usual adult dosage for urinary tract infections—1 DS tablet (double strength). 2 tablets (single strength) or 4 teasp. (20 ml) b.i.d. for 10-14 days. Use identical daily dosage for 5 days for shigellosis. Children: Recommended dosage for children with urinary tract Infections or acute otitis media—8 mg/kg tnmethoprim and 40 mg/kg sulfamethoxazole per 24 hours, in two divided doses for 10 days. Use Identical daily dosage for 5 days for shigellosis. For patients with renal impairment: Use recommended dosage regimen when creatinine clearance is above 30 ml/min. If creatinine clearance is between 15 £ use one-half the usual regimen. Bactrim is not recommended If creatir below 15 ml/min. ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS IN ADULTS: Usual adult dosage: 1 DS tablet (double strength). 2 tablets (single strength) or 4 teasp. (20 ml) b.i.d. for 14 days. PNEUMOCYSTIS CARINII PNEUMONITIS: Recommended dosage: 20 mg/kg trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours in equal doses every 6 hours for 14 days. See complete product information for suggested children's dosage table. Supplied: Double Strength (DS) tablets, each containing 160 mg trimethoprim and 800 mg sulfamethoxazole, bottles of 100; Tel-E-Dose® packages of 100; Prescription Paks of 20 and 28, Tablets, each containing 80 mg trimethoprim and 400 mg sulfamethoxazole—bottles of 100 and 500; Tel-E-Dose® packages of 100; Prescription Paks of 40. Pediatric Suspension, containing 40 mg trimethopnm and 200 mg sulfamethoxazole per teaspoonful (5 ml); cherry-flavored—bottles of 100 ml and 16 oz (1 pint). Suspension, containing 40 mg trimethoprim and 200 mg sulfamethoxazole per teaspoonful (5 ml); fruit-licorlce flavored—bottles of 16 oz (1 pint). /ROCHr>D° \—A> Nu . ROCHE LABORATORIES ROCHE > Division of Hoffmann-La Roche Inc. " utley. New Jersey 07110 |
Digital Format | JPEG 2000 |
Print / Download PDF Version | http://archives.hsl.unc.edu/nchh/nchh-17/nchh-17-043.pdf |
Document Sort | all; nchh-17 |
Volume Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/identi/searchterm/NCHH-17-043 |
Title Link | http://dc.lib.unc.edu/cdm/search/collection/nchh/field/documa/searchterm/NCHH-17 |
Catalog Record link | http://search.lib.unc.edu/search?R=UNCb1306322 |
Revision History | done |
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