Surgery News - April 2008 - (Page 10)

UROLOGY Survival Based on Risk Score and Metastasectomy of Renal Cancer Median Survival 2-Year 5-Year Survival Survival 89% 72% 68% 48% 50% 0% 71% 36% 38% 0% 0% 0% SURGERY NEWS • A P R I L 2 0 0 8 Metastasectomy Helpful for Renal Cancer Recurrence B Y S H E R RY B O S C H E R T ELSEVIER GLOBAL MEDICAL NEWS Favorable risk/Metastasectomy (n = 21) Favorable risk/No metastasectomy (n = 20) Intermediate risk/Metastasectomy (n = 19) Intermediate risk/No metastasectomy (n = 50) Poor risk/Metastasectomy (n = 4) Poor risk/No metastasectomy (n = 15) 78 months 57 months 28 months 22 months 4 months 5 months Else vier Global Medical Ne ws Note: Based on data for 129 patients who underwent partial or radical nephrectomy for clinically localized disease and who later developed a local or systemic recurrence. Source: Dr. Kundu S A N F R A N C I S C O — Surgical resection of metastasis when renal cancer recurs after nephrectomy improves chances of survival regardless of the patient’s prognostic risk score, researchers reported at a symposium on genitourinary cancers. Dr. Shilajit D. Kundu and colleagues retro- BRIEF SUMMARY Please see package insert for full prescribing information. INDICATIONS AND USAGE: Before initiating treatment with AZACTAM, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to aztreonam. Treatment with AZACTAM may be started empirically before results of the susceptibility testing are available; subsequently, appropriate antibiotic therapy should be continued. AZACTAM is indicated for the treatment of the following infections caused by susceptible gramnegative microorganisms: Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca,* Citrobacter species * and Serratia marcescens.* Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species and Serratia marcescens.* Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis,* Serratia marcescens * and Enterobacter species. Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers and burns caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae and Citrobacter species.* Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae,* Pseudomonas aeruginosa, Citrobacter species* including C. freundii * and Serratia species* including S. marcescens.* Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae,* Enterobacter species* including E. cloacae * and Proteus mirabilis.* AZACTAM is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces. AZACTAM is effective against most of the commonly encountered gram-negative aerobic pathogens seen in general surgery. Concurrent Therapy: Concurrent initial therapy with other antimicrobial agents and AZACTAM is recommended before the causative organism(s) is known in seriously ill patients who are also at risk of having an infection due to gram-positive aerobic pathogens. If anaerobic organisms are also suspected as etiologic agents, therapy should be initiated using an anti-anaerobic agent concurrently with AZACTAM (see DOSAGE AND ADMINISTRATION). Certain antibiotics (e.g., cefoxitin, imipenem) may induce high levels of betalactamase in vitro in some gram-negative aerobes such as Enterobacter and Pseudomonas species, resulting in antagonism to many beta-lactam antibiotics including aztreonam. These in vitro findings suggest that such beta-lactamase inducing antibiotics not be used concurrently with aztreonam. Following identification and susceptibility testing of the causative organism(s), appropriate antibiotic therapy should be continued. CONTRAINDICATIONS: This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation. WARNINGS: Both animal and human data suggest that AZACTAM is rarely cross-reactive with other betalactam antibiotics and weakly immunogenic. Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure. (See CONTRAINDICATIONS.) Careful inquiry should be made to determine whether the patient has any history of hypersensitivity reactions to any allergens. While cross-reactivity of aztreonam with other beta-lactam antibiotics is rare, this drug should be administered with caution to any patient with a history of hypersensitivity to beta-lactams (e.g., penicillins, cephalosporins, and/or carbapenems). Treatment with aztreonam can result in hypersensitivity reactions in patients with or without prior exposure to aztreonam. If an allergic reaction to aztreonam occurs, discontinue the drug and institute supportive treatment as appropriate (e.g., maintenance of ventilation, pressor amines, antihistamines, corticosteroids). Serious hypersensitivity reactions may require epinephrine and other emergency measures. (See ADVERSE REACTIONS.) Pseudomembranous colitis has been reported with nearly all antibacterial agents, including aztreonam, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis.” After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug effective against C. difficile colitis. Rare cases of toxic epidermal necrolysis have been reported in association with aztreonam in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy and other concomitantly administered drugs associated with toxic epidermal necrolysis. PRECAUTIONS: General: In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy. If an aminoglycoside is used concurrently with aztreonam, especially if high dosages of the former are used or if therapy is prolonged, renal function should be monitored because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. The use of antibiotics may promote the overgrowth of nonsusceptible organisms, including grampositive organisms (Staphylococcus aureus and Streptococcus faecalis ) and fungi. Should superinfection occur during therapy, appropriate measures should be taken. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies in animals have not been performed. Genetic toxicology studies performed in vivo and in vitro with aztreonam in several standard laboratory models revealed no evidence of mutagenic potential at the chromosomal or gene level. Two-generation reproduction studies in rats at daily doses up to 20 times the maximum recommended human dose, prior to and during gestation and lactation, revealed no evidence of impaired fertility. There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dosage, but not in offspring of rats that received five times the maximum recommended human dose. Pregnancy: Pregnancy Category B: Aztreonam crosses the placenta and enters the fetal circulation. Studies in pregnant rats and rabbits, with daily doses up to 15 and 5 times, respectively, the maximum recommended human dose, revealed no evidence of embryo- or fetotoxicity or teratogenicity. No drug induced changes were seen in any of the maternal, fetal, or neonatal parameters that were monitored in rats receiving 15 times the maximum recommended human dose of aztreonam during late gestation and lactation. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, aztreonam should be used during pregnancy only if clearly needed. Nursing Mothers: Aztreonam is excreted in human milk in concentrations that are less than 1 percent of concentrations determined in simultaneously obtained maternal serum; consideration should be given to temporary discontinuation of nursing and use of formula feedings. Pediatric Use: The safety and effectiveness of intravenous AZACTAM (aztreonam for injection, USP) have been established in the age groups 9 months to 16 years. Use of AZACTAM in these age groups is supported by evidence from adequate and well-controlled studies of AZACTAM in adults with additional efficacy, safety, and pharmacokinetic data from non-comparative clinical studies in pediatric patients. Sufficient data are not available for pediatric patients under 9 months of age or for the following treatment indications/pathogens: septicemia and skin and skin-structure infections (where the skin infection is believed or known to be due to H. influenzae type b). In pediatric patients with cystic fibrosis, higher doses o

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Surgery News - April 2008

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