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Pronunciation |
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(sef
IKS
eem) |
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U.S. Brand
Names |
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Suprax® |
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Generic
Available |
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No |
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Pharmacological Index |
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Antibiotic, Cephalosporin (Third Generation) |
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Use |
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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 |
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Pregnancy Risk
Factor |
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B |
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Contraindications |
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Hypersensitivity to cefixime or cephalosporins |
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Warnings/Precautions |
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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 |
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Adverse
Reactions |
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>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
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Overdosage/Toxicology |
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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 |
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Drug
Interactions |
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Increased effect: Probenecid may decrease cephalosporin elimination
Increased toxicity: Furosemide, aminoglycosides may be a possible additive to
nephrotoxicity |
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Stability |
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After reconstitution, suspension may be stored for 14 days at room
temperature |
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Mechanism of
Action |
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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. |
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Pharmacodynamics/Kinetics |
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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 |
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Usual Dosage |
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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%) |
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Dietary
Considerations |
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May be administered with food, however, there is delayed
absorption |
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Monitoring
Parameters |
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With prolonged therapy, monitor renal and hepatic function periodically;
observe for signs and symptoms of anaphylaxis during first
dose |
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Test
Interactions |
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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 |
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Mental Health: Effects
on Mental Status |
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May cause nervousness; case reports of euphoria, delusion, illusions, and
depersonalization with cephalosporins |
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Mental Health:
Effects on Psychiatric
Treatment |
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May rarely cause neutropenia; use caution with clozapine and
carbamazepine |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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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. |
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Nursing
Implications |
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Modify dosage in patients with renal impairment |
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Dosage Forms |
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Powder for oral suspension (strawberry flavor): 100 mg/5 mL (50 mL, 100 mL)
Tablet, film coated: 200 mg, 400 mg |
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References |
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"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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