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Pronunciation
(sef IKS eem)
Generic Available (U.S.)
No
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of urinary tract infections, otitis media, respiratory infections due to susceptible organisms including S. pneumoniae and S. pyogenes, H. influenzae, and many Enterobacteriaceae; uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies; therefore cefixime is classified as pregnancy category B. It is not known if cefixime crosses the human placenta; other cephalosporins cross the placenta and are considered safe in pregnancy. Congenital anomalies have not been associated with cefixime use during pregnancy (limited data). Cefixime is recommended for use in pregnant women for the treatment of gonococcal infections.
Lactation
Excretion in breast milk unknown
Breast-Feeding Considerations
It is not known if cefixime is excreted in breast milk. The manufacturer recommends that consideration be given to discontinuing nursing temporarily during treatment. Other cephalosporins are considered safe during breast-feeding. If present in breast milk, nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to cefixime, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• 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.
Adverse Reactions
>10%: Gastrointestinal: Diarrhea (16%)
2% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence, loose stools
<2%: Acute renal failure, anaphylactic/anaphylactoid reactions, angioedema, BUN increased, candidiasis, creatinine increased, dizziness, drug fever, eosinophilia, erythema multiforme, facial edema, fever, headache, hepatitis, hyperbilirubinemia, jaundice, leukopenia, neutropenia, pruritus, pseudomembranous colitis, PT prolonged, rash, seizure, serum sickness-like reaction, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis, vomiting
Reactions reported with other cephalosporins: Interstitial nephritis, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, agranulocytosis, colitis, superinfection
Metabolism/Transport Effects
None known.
Drug Interactions
Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation of antibacterial agents. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Delays cefixime absorption.
Storage
After reconstitution, suspension may be stored for 14 days at room temperature or under refrigeration.
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
Absorption: 40% to 50%
Distribution: Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal; bile, sputum, and urine; bone, myocardium, gallbladder, and skin and soft tissue
Protein binding: 65%
Half-life elimination: Normal renal function: 3-4 hours; Renal failure: Up to 11.5 hours
Time to peak, serum: 2-6 hours; delayed with food
Excretion: Urine (50% of absorbed dose as active drug); feces (10%)
Dosage
Usual dosage range:
Children ≥6 months: Oral: 8 mg/kg/day divided every 12-24 hours (maximum: 400 mg/day)
Children >50 kg or >12 years and Adults: Oral: 400 mg/day divided every 12-24 hours
Indication-specific dosing:
Children: Oral:
S. pyogenes
infections: Treat for 10 days
Typhoid fever(unlabeled use): 20 mg/kg/day for 10-14 days; maximum 400 mg/day
Uncomplicated gonococcal infection: Note: Due to increased antimicrobial resistance, the Public Health Agency of Canada recommends 800 mg as a single dose (unlabeled dose) for treatment of uncomplicated gonococcal infections in children ≥9 years of age.
Adults: Oral:
S. pyogenes
infections: Treat for 10 days
Typhoid fever (unlabeled use): 20-30 mg/kg/day in 2 divided doses for 7-14 days after I.V. therapy
Uncomplicated cervical/urethral gonorrhea due to
N. gonorrhoeae:
400 mg as a single dose
Note: Due to increased antimicrobial resistance, the Public Health Agency of Canada recommends 800 mg as a single dose (unlabeled dose) for treatment of uncomplicated gonococcal infections.
Dosing adjustment in renal impairment:
Clcr 21-60 mL/minute or with renal hemodialysis: Administer 75% of the standard dose
Clcr <20 mL/minute or with CAPD: Administer 50% of the standard dose
Moderately dialyzable (10%)
Administration: Oral
May be administered with or without food. Administer with food to decrease GI distress. Shake oral suspension well before use.
Monitoring Parameters
With prolonged therapy, monitor renal and hepatic function periodically. Observe for signs and symptoms 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; false-positive urine ketones using tests with nitroprusside
Dietary Considerations
May be taken with food to decrease GI distress.
Patient Education
Take at regular intervals around-the-clock, with or without food. Chilling oral suspension improves flavor (do not freeze); shake suspension thoroughly before using. Maintain adequate hydration, unless instructed to restrict fluid intake. May cause nausea, vomiting, or 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).
Geriatric Considerations
Adjust dose for renal impairment.
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
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. Monitor for anemia, hemorrhage, pancytopenia, agranulocytosis, and colitis during therapy. Teach patient to report hypersensitivity and opportunistic infection.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Powder for suspension, oral, as trihydrate:
Suprax®: 100 mg/5 mL (50 mL, 100 mL); 200 mg/5 mL (50 mL, 75 mL) [contains sodium benzoate; strawberry flavor]
Tablet, oral, as trihydrate:
Suprax®: 400 mg [scored]
Pricing: U.S. (www.drugstore.com)
Suspension (reconstituted) (Suprax)
100 mg/5 mL (100): $293.93
References
“1998 Guidelines for the Treatment of Sexually Transmitted Diseases. Centers for Disease Control and Prevention,” MMWR Recomm Rep, 1998, 47(RR-1):1-111.
Ashkenazi S, Amir J, Waisman Y, et al, “A Randomized, Double-Blind Study Comparing Cefixime and Trimethoprim-Sulfamethoxazole in the Treatment of Childhood Shigellosis,” J Pediatr, 1993, 123(5):817-21.
Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76.
Centers for Disease Control and Prevention (CDC), "Sexually Transmitted Diseases Treatment Guidelines, 2010," MMWR Recomm Rep, 2010, 59(RR-12):1-110.
Chow AW, Benninger MS, Brook I, et al, “IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults,” Clin Infect Dis, 2012, 54(8):e72-112.
Donowitz GR and Mandell GL, “Beta-Lactam Antibiotics,” N Engl J Med, 1988, 318(7):419-26 and 318(8):490-500.
Faulkner RD, Bohaycheck W, Lanc RA, et al, “Pharmacokinetic of Cefixime in Young and Elderly,” J Antimicrob Chemother, 1988, 21(6):787-94.
Johnson CE, Carlin SA, Super DM, et al, “Cefixime Compared With Amoxicillin for Treatment of Acute Otitis Media,” J Pediatr, 1991, 119(1):117-22.
Levine WC, Berg AO, Johnson RE, et al, “Development of Sexually Transmitted Diseases Treatment Guidelines, 1993. New Methods, Recommendations, and Research Priorities,” STD Treatment Guidelines Project Team and Consultants, Sex Transm Dis, 1994, 21(2 Suppl):96-101.
Markham A and Brogden RN, “Cefixime. A Review of Its Therapeutic Efficacy in Lower Respiratory Tract Infections,” Drugs, 1995, 49(6):1007-22.
Marshall WF and Blair JE, “The Cephalosporins,” Mayo Clin Proc, 1999, 74(2):187-95.
Public Health Agency of Canada, “Canadian Guidelines on Sexually Transmitted Infections." Available at http://www.phac-aspc.gc.ca/std-mts/sti-its/alert/2011/alert-gono-eng.php. Accessed January 4, 2012.
Schatz BS, Karavokiros KT, Taeubel MA, et al, “Comparison of Cefprozil, Cefpodoxime Proxetil, Loracarbef, Cefixime, and Ceftibuten,” Ann Pharmacother, 1996, 30(3):258-68.
Smith GH, “Oral Cephalosporins in Perspective,” DICP, 1990, 24(1):45-51.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
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