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Cefixime
Pronunciation
U.S. Brand Names
Generic Available
Pharmacological Index
Use
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Dietary Considerations
Monitoring Parameters
Test Interactions
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(sef IKS eem)

U.S. Brand Names
Suprax®

Generic Available

No


Pharmacological Index

Antibiotic, Cephalosporin (Third Generation)


Use

Treatment of urinary tract infections, otitis media, respiratory infections due to susceptible organisms including S. pneumoniae and S. pyogenes, H. influenzae and many Enterobacteriaceae; documented poor compliance with other oral antimicrobials; outpatient therapy of serious soft tissue or skeletal infections due to susceptible organisms; single-dose oral treatment of uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae


Pregnancy Risk Factor

B


Contraindications

Hypersensitivity to cefixime or cephalosporins


Warnings/Precautions

Prolonged use may result in superinfection; modify dosage in patients with renal impairment; use with caution in patients with a history of penicillin allergy especially IgE-mediated reactions (eg, anaphylaxis, urticaria); may cause antibiotic-associated colitis or colitis secondary to C. difficile


Adverse Reactions

>10%: Gastrointestinal: Diarrhea (16%)

1% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence

<1%: Rash, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, serum sickness -like reaction, fever, vomiting, pseudomembranous colitis, transaminase elevations, increased BUN, increased creatinine, headache, dizziness, thrombocytopenia, leukopenia, eosinophilia, prolonged PT, vaginitis, candidiasis

Other reactions with cephalosporins include anaphylaxis, seizures, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, interstitial nephritis, cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, neutropenia, agranulocytosis, colitis, superinfection


Overdosage/Toxicology

After acute overdose, most agents cause only nausea, vomiting, and diarrhea, although neuromuscular hypersensitivity and seizures are possible, especially in patients with renal insufficiency; many beta-lactam antibiotics have the potential to cause neuromuscular hyperirritability or seizures

Hemodialysis may be helpful to aid in the removal of the drug from the blood but not usually indicated, otherwise most treatment is supportive or symptom directed following GI decontamination


Drug Interactions

Increased effect: Probenecid may decrease cephalosporin elimination

Increased toxicity: Furosemide, aminoglycosides may be a possible additive to nephrotoxicity


Stability

After reconstitution, suspension may be stored for 14 days at room temperature


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: Oral: 40% to 50%

Distribution: Widely distributed throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, and peritoneal fluids; also bile, sputum, and urine; also bone, myocardium, gallbladder, and skin and soft tissue

Protein binding: 65%

Half-life: Normal renal function: 3-4 hours; Renal failure: Up to 11.5 hours

Time to peak serum concentrations: Within 2-6 hours; peak serum concentrations are 15% to 50% higher for the oral suspension versus tablets; presence of food delays the time to reach peak concentrations

Elimination: 50% of absorbed dose excreted as active drug in urine and 10% in bile


Usual Dosage

Oral:

Adolescents and Adults: 400 mg/day divided every 12-24 hours

Uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae: 400 mg as a single dose

For S. pyogenes infections, treat for 10 days; use suspension for otitis media due to increased peak serum levels as compared to tablet form

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%)


Dietary Considerations

May be administered with food, however, there is delayed absorption


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


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


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Complete full course of medication, even if you feel better. Drink 2-3 L fluid/day. If diarrhea occurs, yogurt or buttermilk may help. May cause false-positive test with Clinitest®; use another form of testing. May interfere with oral contraceptives; additional contraceptive measures are necessary. Report severe, unresolved diarrhea; vaginal itching or drainage; sores in mouth; blood, pus, or mucus in stool or urine; easy bleeding or bruising; unusual fever or chills,; rash; or respiratory difficulty. Breast-feeding precautions: Consult prescriber if breast-feeding.


Nursing Implications

Modify dosage in patients with renal impairment


Dosage Forms

Powder for oral suspension (strawberry flavor): 100 mg/5 mL (50 mL, 100 mL)

Tablet, film coated: 200 mg, 400 mg


References

"1998 Guidelines for the Treatment of Sexually Transmitted Diseases. Centers for Disease Control and Prevention," MMWR Morb Mortal Wkly 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.

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):S96-101.

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.

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.


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