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Pronunciation:

(sef IKS eem)

U.S. Brand Names:

Suprax®

Generic Available:

Canadian Brand Names:

Suprax®

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; uncomplicated cervical/urethral gonorrhea due to N. gonorrhoeae

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to cefixime, any component of the formulation, or other 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%)

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, prolonged PT, pruritus, pseudomembranous colitis, rash, seizure, serum sickness-like reaction, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transaminases increased, urticaria, vaginitis, vomiting

Reactions reported with other cephalosporins include interstitial nephritis, aplastic anemia, hemolytic anemia, hemorrhage, pancytopenia, agranulocytosis, colitis, superinfection

Overdosage/Toxicology:

Symptoms of overdose include neuromuscular hypersensitivity and convulsions. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in the removal of drug from blood; otherwise, treatment is supportive or symptom-directed.

Drug Interactions:

Aminoglycosides: May be a possible additive to nephrotoxicity.

Carbamazepine: Cefixime may increase serum levels of carbamazepine; monitor.

Furosemide: May be a possible additive to nephrotoxicity.

Probenecid: May decrease cephalosporin elimination.

Warfarin: Cefixime may increase prothrombin time when administered with warfarin; monitor.

Ethanol/Nutrition/Herb Interactions:

Food: Delays cefixime absorption.

Stability:

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%

Bioavailability: Bioavailability of suspension is higher than that of the tablet.

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:

Oral:

Children 6 months: 8 mg/kg/day divided every 12-24 hours

Children >50 kg or >12 years 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%)

Administration:

May be administered with or without food; administer with food to decrease GI distress

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

Dietary Considerations:

May be taken with food.

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of glucose testing is preferable. May cause nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (yogurt, boiled milk, or buttermilk may help). Report changes in urinary pattern; unresolved diarrhea; opportunistic infection (eg, vaginal itching or drainage, sores in mouth, blood in stool or urine, unusual fever or chills); or respiratory difficulty; rash or other persistent adverse reactions. Breast-feeding precaution: Consult prescriber if breast-feeding.

Nursing Implications:

Modify dosage in patients with renal impairment

Additional Information:

Otitis media should be treated with the suspension since it results in higher peak blood levels than the tablet.

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

Dosage Forms:

Powder for oral suspension: 100 mg/5 mL (50 mL, 75 mL, 100 mL) [contains sodium benzoate; strawberry flavor]

Tablet [film coated]: 400 mg

International Brand Names:

Aerocef® (AT); Bonocef® (PT); Cef-3® (BD); Cefimix® (PT); Cefiton® (PT); Cefixdura® (DE); Cefixima Fabra® (AR); Cefixime Ilab® (AR); Cefixim® (HR); Cefixim ratiopharm® (DE); Cefixoral® (IT); Cefspan® (CL, ID, JP, TH); Cephoral® (CH, DE); Ceptik® (ID); Cetaxim® (AR); CFIX® (JP); Comsporin® (ID); Denvar® (CR, DO, ES, GT, HN, MX, PA, SV); Devoxim® (CO); Fixef® (ID); Fixime® (ZA); Fixim® (NL); Fixiphar® (ID); Fixx® (IN); Maxpro® (ID); Necopen® (ES); Neocef® (PT); Novacef® (AR); Oroken® (FR); Plenax® (BR); Prolifen® (AT); Sofix® (ID); Spancef® (ID); Sporetic® (ID); Starcef® (ID); Supran® (IL); Suprax® (CA, CZ, DE, EG, GB, HU, ID, IE, IT, JO, KW, LB, PL, SY, TR); Tocef® (ID); Tricef® (AT, CL, PT); Unixime® (IT); Uro Cephoral® (DE); Urotricef® (CL); Vixcef® (AR)

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.

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.

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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