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Medication Safety Issues
Sound-alike/look-alike issues:
CeFAZolin may be confused with cefprozil, cefTRIAXone, cephalexin, cephalothin
Kefzol® may be confused with Cefzil®
Pronunciation
(sef A zoe lin)
Index Terms
Generic Available
Yes
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of respiratory tract, skin, genital, urinary tract, biliary tract, bone and joint infections, and septicemia due to susceptible gram-positive cocci (except enterococcus); some gram-negative bacilli including E. coli, Proteus, and Klebsiella may be susceptible; surgical prophylaxis
Use: Dental
Alternative antibiotic for prevention of infective endocarditis when parenteral administration is needed. Individuals allergic to amoxicillin (penicillins) may receive cefazolin provided they have not had an immediate, local, or systemic IgE-mediated anaphylactic allergic reaction to penicillin. Alternate antibiotic for premedication in patients not allergic to penicillin who may be at potential increased risk of hematogenous total joint infection when parenteral administration is needed.
Use: Unlabeled/Investigational
Prophylaxis against infective endocarditis
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse effects were not observed in animal reproduction studies; therefore, cefazolin is classified as pregnancy category B. Cefazolin crosses the placenta. Adverse events have not been reported in the fetus following administration of cefazolin prior to caesarean section. Cefazolin is recommended for group B streptococcus prophylaxis in pregnant patients with a nonanaphylactic penicillin allergy.Due to pregnancy-induced physiologic changes, the pharmacokinetics of cefazolin are altered. The half-life is shorter and the AUC is smaller. The volume of distribution is unchanged.
Lactation
Enters breast milk (small amounts)/use caution (AAP rates “compatible”)
Breast-Feeding Considerations
Small amounts of cefazolin are excreted in breast milk. The manufacturer recommends that caution be exercised when administering cefazolin to nursing women. The American Academy of Pediatrics considers cefazolin to be "usually compatible with breast-feeding." Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to cefazolin sodium, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient patients, prolonged treatment, hepatic or renal disease.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe impairment.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.
Adverse Reactions
Frequency not defined.
Central nervous system: Fever, seizure
Dermatologic: Rash, pruritus, Stevens-Johnson syndrome
Gastrointestinal: Diarrhea, nausea, vomiting, abdominal cramps, anorexia, pseudomembranous colitis, oral candidiasis
Genitourinary: Vaginitis
Hepatic: Transaminases increased, hepatitis
Hematologic: Eosinophilia, neutropenia, leukopenia, thrombocytopenia, thrombocytosis
Local: Pain at injection site, phlebitis
Renal: BUN increased, serum creatinine increased, renal failure
Miscellaneous: Anaphylaxis
Reactions reported with other cephalosporins: Toxic epidermal necrolysis, abdominal pain, cholestasis, superinfection, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prothrombin time prolonged, pancytopenia
Drug Interactions
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Storage
Store intact vials at room temperature and protect from temperatures exceeding 40°C. Reconstituted solutions of cefazolin are light yellow to yellow. Protection from light is recommended for the powder and for the reconstituted solutions. Reconstituted solutions are stable for 24 hours at room temperature and for 10 days under refrigeration. Stability of parenteral admixture at room temperature (25°C) is 48 hours. Stability of parenteral admixture at refrigeration temperature (4°C) is 14 days.
DUPLEX™: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) prior to activation. Following activation, stable for 24 hours at room temperature and for 7 days under refrigeration.
Reconstitution
Dilute 500 mg vial with 2 mL SWFI and 1 g vial with 2.5 mL SWFI; reconstituted solution may be directly injected after further dilution with 5 mL SWFI or further diluted for I.V. administration in 50-100 mL compatible solution; 10 g vial may be diluted with 45 mL to yield 1 g/5 mL or 96 mL to yield 1 g/10 mL.
Compatibility
Stable in D5W, D5LR, D51/4NS, D51/2NS, D5NS, D10W,LR, NS; variable stability (consult detailed reference) in peritoneal dialysis solutions.
Y-site administration: Compatible: Acyclovir, allopurinol, amifostine, atracurium, aztreonam, calcium gluconate, cefpirome, cyclophosphamide, diltiazem, docetaxel, doxorubicin liposome, enalaprilat, esmolol, etoposide, famotidine, filgrastim, fluconazole, fludarabine, foscarnet, gatifloxacin, gemcitabine, granisetron, heparin, insulin (regular), labetalol, lidocaine, linezolid, magnesium sulfate, melphalan, meperidine, midazolam, morphine, multivitamins, ondansetron, pancuronium, perphenazine, propofol, ranitidine, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, vecuronium, vitamin B complex with C, warfarin. Incompatible: Amphotericin B cholesteryl sulfate complex, idarubicin, pentamidine, vinorelbine. Variable (consult detailed reference): Amiodarone, cisatracurium, hetastarch, hydromorphone, promethazine, vancomycin.
Compatibility in syringe: Compatible: Heparin, vitamin B complex. Incompatible: Ascorbic acid injection, cimetidine, lidocaine. Variable (consult detailed reference): Hydromorphone, vitamin B complex with C.
Compatibility when admixed: Compatible: Aztreonam, clindamycin, famotidine, fluconazole, linezolid, meperidine, metronidazole, metronidazole with sodium bicarbonate, verapamil. Incompatible: Amikacin, amobarbital, atracurium, bleomycin, calcium gluconate, clindamycin with gentamicin, colistimethate, kanamycin, pentobarbital, polymyxin B sulfate, ranitidine. Variable (consult detailed reference): Cimetidine.
Mechanism of Action
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacodynamics/Kinetics
Distribution: Widely into most body tissues and fluids including gallbladder, liver, kidneys, bone, sputum, bile, pleural, and synovial; CSF penetration is poor
Protein binding: 74% to 86%
Metabolism: Minimally hepatic
Half-life elimination: 90-150 minutes; prolonged with renal impairment
Time to peak, serum: I.M.: 0.5-2 hours
Excretion: Urine (80% to 100% as unchanged drug)
Dosage
Usual dosage range: I.M., I.V.:
Children >1 month: 25-100 mg/kg/day divided every 6-8 hours; maximum: 6 g/day
Adults: 250 mg to 1.5 g every 6-12 (usually 8) hours, depending on severity of infection; maximum dose: 12 g/day
Indication-specific dosing:
Infants and Children: I.M., I.V.:
Prophylaxis against infective endocarditis (unlabeled use): 50 mg/kg 30-60 minutes before procedure; maximum dose: 1 g. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Adults: I.M., I.V.:
Endocarditis due to MSSA (without prosthesis) (unlabeled use): I.V.: 2 g every 8 hours; Note: Recommended for penicillin-allergic (non-anaphylactoid) patients (Baddour et al, 2005)
Prophylaxis against infective endocarditis (unlabeled use): 1 g 30-60 minutes before procedure. Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Moderate-to-severe infections: 500 mg to 1 g every 6-8 hours
Mild infection with gram-positive cocci: 250-500 mg every 8 hours
Perioperative prophylaxis: 1-2 g within 60 minutes prior to surgery (may repeat in 2-5 hours intraoperatively); followed by 500 mg to 1 g every 6-8 hours for 24 hours postoperatively
Cardiothoracic surgery: 1 g within 60 minutes prior to incision, followed by 1 g at sternotomy and 1 g after cardiopulmonary bypass; may continue 1 g every 6 hours for 24-48 hours postoperatively (Eagle, 2004)
Total joint replacement: 1 g 1 hour prior to the procedure
Pneumococcal pneumonia: 500 mg every 12 hours
Severe infection: 1-1.5 g every 6 hours
UTI (uncomplicated): 1 g every 12 hours
Dosing adjustment in renal impairment:
Clcr 35-54 mL/minute: Administer full dose in intervals of ?8 hours
Clcr 11-34 mL/minute: Administer 1/2 usual dose every 12 hours
Clcr ?10 mL/minute: Administer 1/2 usual dose every 18-24 hours
Hemodialysis: Moderately dialyzable (20% to 50%); administer dose postdialysis or administer supplemental dose of 0.5-1 g after dialysis
Continuous ambulatory peritoneal dialysis (CAPD): Administer 0.5 g every 12 hours
Continuous renal replacement therapy (CRRT): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug levels in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 L/hour) and should not supersede clinical judgment:
CVVH: 1-2 g every 12 hours
CVVHD/CVVHDF: 2 g every 12 hours
Dental Usual Dosing
Infective endocarditis prophylaxis (unlabeled use): I.M., I.V.:
Infants and Children: 50 mg/kg 30-60 minutes before procedure; maximum dose: 1 g
Adults: 1 g 30-60 minutes before procedure.
Note: Intramuscular injections should be avoided in patients who are receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Prophylaxis in total joint replacement patient: I.M., I.V.: Adults: 1 g 1 hour prior to the procedure
Administration: I.M.
Inject deep I.M. into large muscle mass.
Administration: I.V.
Inject direct I.V. over 5 minutes. Infuse intermittent infusion over 30-60 minutes.
Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concurrent use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment. However, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside levels, CBC, and clinical response should be considered. Refer to Compatibility.
Administration: I.V. Detail
pH: 4.5-6.0
Monitoring Parameters
Renal function periodically when used in combination with other nephrotoxic drugs, hepatic function tests, CBC; monitor for signs of anaphylaxis during first dose
Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction.
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.
Dietary Considerations
Some products may contain sodium.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. This medication is administered by injection or infusion. Report immediately any redness, swelling, burning, or pain at injection/infusion site; rash or hives; or respiratory difficulty, chest pain, or difficulty swallowing. Maintain adequate hydration unless instructed to restrict fluid intake. If you have diabetes, drug may cause false test results with Clinitest® urine glucose monitoring; use of another type of glucose monitoring is preferable. May cause diarrhea. Report rash; breathing or swallowing difficulty; persistent diarrhea, nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage, sores in mouth, blood in stool or urine, unusual fever or chills); or CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations); or other adverse reactions. Breast-feeding precautions: Consult prescriber if breast-feeding.
Geriatric Considerations
Adjust dose for renal function.
Anesthesia and Critical Care Concerns/Other Considerations
Evidence-Based Information:
Surgical Prophylaxis: Cefazolin should be avoided in patients with a history of serious beta-lactam allergy (eg, respiratory difficulty, angioedema, hives, hypotension). Examples of beta-lactam antibiotics include penicillin, ampicillin, piperacillin, and cephalosporins. In operations where prophylaxis is directed towards gram-positive cocci, vancomycin or clindamycin may be used depending on local susceptibility patterns (Bratzler, 2004).
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Infectious Diseases Comment
A well-documented reaction can occur between beta-lactam and aminoglycoside antibiotics in vitro, leading to complexation, opening of the beta-lactam ring, and presumably, loss of antibacterial activity for one or both agents. However, the conditions under which this reaction occurs are variable and influenced by (but not limited to) assay methodology, sampling time and storage, and drug selection and concentration. In general, many of the in vitro studies employed artificial conditions that tested high concentrations of the penicillin derivative (equating to serum levels most likely observed only in severe renal impairment) in combination with gentamicin or tobramycin. Incubation of the agents at conditions of 37°C for up to 48 hours has definitely demonstrated inactivation and loss of bactericidal activity. However, some of these studies permitted a considerable time lapse prior to assaying the medium, or stored the samples at higher temperatures (-20°C or greater), which may have allowed continued chemical degradation prior to assay. In general, amikacin was the most resistant to penicillin-mediated chemical degradation, and cephalosporins were much less likely than penicillins to inactivate the aminoglycosides.
The more robust studies have been those which evaluated in vivo effects via rapid and frequent blood sampling during concomitant dosing. In vivo, there are a number of studies documenting significant changes in the half-life of gentamicin in combination with primarily ticarcillin and carbenicillin, but usually only in the setting of end-stage renal disease. A number of literature reports suggest that despite documented changes in gentamicin kinetics, this is not likely to lead to clinically-significant differences in outcomes in patients with normal renal function. Furthermore, there are no published, prospective, outcomes-based studies that provide compelling evidence of changes in rates of clinical or microbiological response as a function of dosing separation.
Based on the weight of evidence to date, coadministration of (but not coadmixture of) a penicillin or cephalosporin antibiotic with an aminoglycoside should not pose a significant concern in patients with even mild renal impairment. However, specific circumstances exist in which this approach should be undertaken with caution. Concurrent administration of either gentamicin or tobramycin with piperacillin, carbenicillin, or ticarcillin (including combinations with beta-lactamase inhibitors), particularly in the face of moderate-to-severe renal failure, would warrant careful monitoring of aminoglycoside serum levels, CBCs, and clinical response to avoid potentially-reduced efficacy due to chemical inactivation.
Mental Health: Effects on Mental Status
May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins
Mental Health: Effects on Psychiatric Treatment
May rarely cause neutropenia; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions (eg, anticoagulants). Assess results of laboratory tests, therapeutic effectiveness, and adverse response (eg, hypersensitivity can occur several days after therapy is started) regularly during therapy. Advise patients with diabetes about use of Clinitest®. Teach patient proper use, possible side effects/appropriate interventions, and adverse symptoms to report (eg, hypersensitivity, opportunistic infection, renal dysfunction, anemia).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Infusion [iso-osmotic dextrose solution]: 1 g (50 mL)
Injection, powder for reconstitution: 500 mg, 1 g, 10 g, 20 g
References
Abramowicz M, “Antimicrobial Prophylaxis in Surgery,” Medical Letter on Drugs and Therapeutics, Handbook of Antimicrobial Therapy, 16th ed, New York, NY: Medical Letter, 2002.
“Advisory Statement. Antibiotic Prophylaxis for Dental Patients With Total Joint Replacements. American Dental Association; American Academy of Orthopedic Surgeons,” J Am Dent Assoc, 1997, 128(7):1004-8.
“ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists,” Am J Health Syst Pharm, 1999, 56(18):1839-88.
Baddour LM, Wilson WR, Bayer AS, et al, “Infective Endocarditis. Diagnosis, Antimicrobial Therapy, and Management of Complications. A Statement for Healthcare Professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease in the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association,” Circulation, 2005, 111(23):e394-434.
Bratzler DW and Houck PM (for the Surgical Infection Prevention Guidelines Writers Workgroup), “Antimicrobial Prophylaxis for Surgery: An Advisory Statement From the National Surgical Infection Prevention Project,” Clin Infect Dis, 2004, 38(12):1706-15.
Chow MS, Quintiliani, and Nightingale CH, “In Vivo Inactivation of Tobramycin by Ticarcillin. A Case Report,” JAMA, 1982, 247(5):658-9.
Dajani AS, Taubert KA, Wilson WW, et al, “Prevention of Bacterial Endocarditis. Recommendations by the American Heart Association,” JAMA, 1997, 277(22):1794-801.
Daly JS, Dodge RA, Glew RH, et al, “Effect of Time and Temperature on Inactivation of Aminoglycosides by Ampicillin at Neonatal Dosages,” J Perinatol, 1997, 17(1):42-5.
Donowitz GR and Mandell GL, “Beta-Lactam Antibiotics,” N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.
Dowell JA, Korth-Bradley J, Milisci M, et al, “Evaluating Possible Pharmacokinetic Interactions Between Tobramycin, Piperacillin, and a Combination of Piperacillin and Tazobactam in Patients With Various Degrees of Renal Impairment,” J Clin Pharmacol, 2001, 41:979-86.
Eagle KA, Guyton RA, Davidoff R, et al, “ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1999 Guidelines for Coronary Artery Bypass Graft Surgery),” Circulation, 2004, 110(14):e340-437.
Farchione LA, “Inactivation of Aminoglycosides by Penicillins,” J Antimicrob Chemother, 1982, 8(Suppl A):27-36.
Fuchs PC, Stickel S, Anderson PH, et al, “In Vitro Inactivation of Aminoglycosides by Sulbactam, Other Beta-Lactams, and Sulbactam-Beta-Lactam Combinations,” Antimicrob Agents Chemother, 1991, 35(1):182-4.
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Gustaferro CA and Steckelberg JM, “Cephalosporin Antimicrobial Agents and Related Compounds,” Mayo Clin Proc, 1991, 66(10):1064-73.
Halstenson CE, Wong MO, Herman CS, et al, “Effect of Concomitant Administration of Piperacillin on the Dispositions on Isepamicin and Gentamicin in Patients With End-Stage Renal Disease,” Antimicrob Agents Chemother, 1992, 36(9):1832-36.
Hitt CM, Patel KB, Nicolau DP, et al, “Influence of Piperacillin-Tazobactam on Pharmacokinetics of Gentamicin Given Once Daily,” Am J Health Syst Pharm, 1997, 54(23):2704-8.
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Lau A, Lee M, Flascha S, et al, “Effect of Piperacillin on Tobramycin Pharmacokinetics in Patients with Normal Renal Function,” Antimicrob Agents Chemother, 1983, 24(4):533-37.
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Peterson CD, Lake KD, Arom KV, et al, “Antibiotic Prophylaxis in Open-Heart Surgery Patients: Comparison of Cefamandole and Cefuroxime,” Drug Intell Clin Pharm, 1987, 21(9):728-32.
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Trotman RL, Williamson JC, Shoemaker DM, et al, “Antibiotic Dosing in Critically Ill Adult Patients Receiving Continuous Renal Replacement Therapy,” Clin Infect Dis, 2005, 41(8):1159-66.
Viollier AF, Standiford HC, Drusano GL, et al, “Comparative Pharmacokinetics and Serum Bactericidal Activity of Mezlocillin, Ticarcillin and Piperacillin, With and Without Gentamicin,” J Antimicrob Chemother, 1985, 15(5):597-606.
Walterspiel JN, Feldman S, Van R, et al, “Comparative Inactivation of Isepamicin, Amikacin, and Gentamicin by Nine Beta-Lactams and Two Beta-Lactamase Inhibitors, Cilastatin and Heparin,” Antimicrob Agents Chemother, 1991, 35(9):1875-8.
Wilson W, Taubert KA, Gewitz M, et al, “Prevention of Infective Endocarditis. Guidelines From the American Heart Association. A Guideline From the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group,” Circulation, 2007, 115. Available at http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.106.183095v1; last accessed July 26, 2007.
International Brand Names
Lexi-Comp.com
Last full review/revision December 2009
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