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Co-trimoxazole may cause side effects. What other information should I know. Updated September 30, 2009If you are a consumer or patient please visit this version. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bactrim sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, Bactrim sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
BACTRIM is rapidly absorbed following oral administration. The metabolism of sulfamethoxazole occurs predominately by N4-acetylation, although the glucuronide conjugate has been identified. The principal metabolites of trimethoprim are the 1- and 3-oxides and the 3'- and 4'-hydroxy derivatives. The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.
Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Monitor patients for hematologic toxicity. Thrombocytopenia usually resolves within a week upon discontinuation of BACTRIM. Avoid use of BACTRIM in the treatment of streptococcal pharyngitis. Therefore, BACTRIM will not prevent sequelae such as rheumatic fever. Clostridium difficile associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including BACTRIM, and may range in severity from mild diarrhea to fatal colitis.
BACTRIM contains benzyl alcohol as a preservative. When prescribing BACTRIM in pediatric patients two months of age and olderconsider the combined daily metabolic load of benzyl alcohol from all sources including BACTRIM contains 10 mg of benzyl alcohol per mL and other drugs containing benzyl alcohol.
Treatment failure and excess mortality were observed when BACTRIM was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jirovecii pneumonia in a randomized placebo controlled trial. Avoid use of BACTRIM in patients with impaired renal or hepatic function, in those with possible folate deficiency e.
Hematologic changes indicative of folic acid deficiency may occur in elderly patients or in patients with preexisting folic acid deficiency or kidney failure. In glucose-6-phosphate dehydrogenase deficient individuals, hemolysis may occur. This reaction is frequently dose-related.
Local irritation and inflammation due to extravascular infiltration of the infusion have been observed with BACTRIM.
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This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection.
Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
You may report side effects to FDA at 1-800-FDA-1088 or at www.
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While there are no large, well-controlled studies on the use of sulfamethoxazole and trimethoprim in pregnant women, Brumfitt and Pursell,12 in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or sulfamethoxazole and trimethoprim.
In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral sulfamethoxazole and trimethoprim at the time of conception or shortly thereafter. Because sulfamethoxazole and trimethoprim may interfere with folic acid metabolism, BACTRIM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Acute: The amount of a single dose of BACTRIM that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim.
Not recommended for use in pediatric patients less than 2 months of age.
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Trimethoprim alters the disposition of procainamide and Nacetylprocainamide. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. Some epidemiologic studies suggest that exposure to BACTRIM during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot.
Fatalities associated with the administration of sulfonamides, have occurred due to severe reactions, including, Stevens-Johnson Syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sulfonamides, including sulfonamide-containing products such as BACTRIM, should be discontinued at the first appearance of skin rash or any sign of adverse reaction.
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Bactrim DS contains two different antibiotic medications: sulfamethoxazole and trimethoprim.
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It is used in kids most commonly to treat urinary tract infections UTIsotitis media ear infectionchronic bronchitis, acne and, less commonly, typhoid fever. Bactrim is the most well known of a class of drugs called sulfonamides. Others in this class include dapsone Aczonesulfadiazine and sulfasalazine Azulfidine.
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If you or your child start to have a skin rash, or if you think you are having a severe skin reaction, stop taking this medicine and call your doctor right away.
This medicine is a white, oblong, scored tablet imprinted with "93 089".