CEFOTAXIME SODIUM  (sef-oh-taks'eem)  Claforan Classifications: beta-lactam antibiotic; third-generation cephalosporin; Therapeutic: antibiotic; cephalosporin Pregnancy Category: B
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Availability
500 mg, 1 g, 2 g injection
Action
Broad-spectrum semi-synthetic third-generation cephalosporin antibiotic. Preferentially binds to one or more of the penicillin-binding
proteins (PBP) located on cell walls of susceptible organisms. This inhibits third and final stage of bacterial cell wall
synthesis, thus killing the bacteria.
Therapeutic Effect
Generally active against a wide variety of gram-negative bacteria including most of the Enterobacteriaceae. Also active against some organisms resistant to first- and second-generation cephalosporins, and currently available aminoglycoside
antibiotics and penicillins.
Uses
Serious infections of lower respiratory tract, skin and skin structures, bones and joints, CNS (including meningitis and
ventriculitis), gynecologic and GU tract infections, including uncomplicated gonococcal infections caused by penicillinase-producing
Neisseria gonorrhoeae (PPNG). Also used to treat bacteremia or septicemia, intra-abdominal infections, and for perioperative prophylaxis.
Unlabeled Uses
Treatment of disseminated gonococcal infections (gonococcal arthritis-dermatitis syndrome) and as drug of choice for gonococcal
ophthalmia caused by PPNG in adults, children, and neonates.
Contraindications
Hypersensitivity to cefotaxime, cephalosporins and other beta-lactam antibiotics.
Cautious Use
History of type I hypersensitivity reactions to penicillin; history of allergy to other beta-lactam; antibiotics; coagulopathy;
renal impairment; history of colitis or other GI disease; pregnancy (category B).
Route & Dosage
Moderate to Severe Infections Adult: IV/IM 12 g q812h, up to 2 g q4h (max: 12 g/d) Child: IV/IM ≤1wk, 50 mg/kg q12h; 14 wk, 50 g/kg/q8h; 1 mo12 y, 50200 mg/kg/d divided q48h (max: 12 g/24 h)
Disseminated Gonorrhea Adult: IV 1 g q8h
Surgical Prophylaxis Adult: IV/IM 1 g 3090 min before surgery
Renal Impairment Clcr <20 mL/min: give ? normal dose
Hemodialysis: Supplemental dose may be needed
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Administration
Intramuscular
- Add 3 mL sterile water for injection or bacteriostatic water for injection to vial containing 1 g drug, providing a solution
of approximately 300 mg cefotaxime/mL.
- Administer IM injection deeply into large muscle mass (e.g., upper outer quadrant of gluteus maximus). Aspirate to avoid
inadvertent injection into blood vessel. If IM dose is 2 g, divide dose and administer into 2 different sites.
Intravenous
- IV administration to infants and children: Verify correct IV concentration and rate of infusion with physician.
- Do not admix cefotaxime with sodium bicarbonate or any fluid with a pH >7.5.
- Risk of phlebitis may be reduced by use of a small needle in a large vein.
PREPARE: Direct: Add 10 mL diluent to vial with 1 or 2 g drug providing a solution containing 95 or 180 mg/mL, respectively. Intermittent: To 1 or 2 g drug add 50 or 100 mL D5W, NS, D5/NS, D5/.45% NaCl, RL, or other compatible diluent. Continuous: Dilute in 5001000 mL compatible IV solution.
ADMINISTER: Direct: Give over 35 min. Intermittent: Give over 2030 min, preferably via butterfly or scalp vein-type needles. Continuous: Infuse over 624 h.
INCOMPATIBILITIES Solution/additive: aminoglycosides, aminophylline. Y-site: Allopurinol, azithromycin, cisatracurium, filgrastim, fluconazole, gemcitabine, hetastarch, pentamidine, vancomycin.
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- Protect from excessive light. Reconstituted solutions may be stored in original containers for 24 h at room temperature;
for 10 days under refrigeration at 5° C (41° F) or less; or for at least 13 wk in frozen state.
Adverse Effects (≥1%)
Body as a Whole: Fever, nocturnal perspiration, inflammatory reaction at
IV site, phlebitis, thrombophlebitis; pain, induration, and tenderness
at IM site, superinfections.
GI: Nausea, vomiting,
diarrhea, abdominal pain,
colitis,
pseudomembranous colitis, anorexia.
Metabolic: Transient increases in
serum AST, ALT, LDH,
bilirubin,
alkaline phosphatase concentrations.
Skin: Rash, pruritus.
Diagnostic Test Interference
May cause falsely elevated serum or urine creatinine values (Jaffe reaction). False-positive reactions for urine glucose have not been reported using copper sulfate reduction methods (e.g., Benedict's, Clinitest); however, since it has occurred with other cephalosporins, it may be advisable to use glucose oxidase tests (Clinistix, TesTape, Diastix). Positive direct antiglobulin (Coombs') test results may interfere with hematologic studies and cross-matching procedures.
Interactions
Drug: Probenecid decreases
renal elimination;
alcohol produces
disulfiram reaction.
Pharmacokinetics
Peak: 30 min after IM; 5 min after
IV.
Distribution: CNS penetration except with inflamed meninges; also penetrates aqueous humor, ascitic and prostatic fluids; crosses placenta.
Metabolism: In liver to active metabolites.
Elimination: 5060% unchanged in urine in 24 h; small amount excreted in breast milk.
Half-Life: 1 h.
Nursing Implications
Assessment & Drug Effects
- Determine previous hypersensitivity reactions to cephalosporins and penicillins, and history of other allergies, particularly
to drugs, before therapy is initiated.
- Lab tests: Perform culture and sensitivity tests before initiation of therapy and periodically during therapy if indicated.
Therapy may be instituted pending test results. Serum creatinine, creatinine clearance, BUN should be evaluated at regular
intervals during therapy and for several months after drug has been discontinued. Perform periodic hematologic studies (including
PT and PTT) and evaluation of hepatic functions with high doses or prolonged therapy.
- Monitor I&O rates and patterns: Report change in I&O in patients with impaired renal function or with chronic UTI or who
are receiving high dosages or an aminoglycoside concomitantly.
- Superinfection due to overgrowth of nonsusceptible organisms may occur, particularly with prolonged therapy.
- Report onset of diarrhea promptly. Check for fever. If diarrhea is mild, discontinuation of cefotaxime may be sufficient.
- If diarrhea is severe, suspect antibiotic-associated pseudomembranous colitis, a life-threatening superinfection (may occur
in 49 d or as long as 6 wk after cephalosporin therapy is discontinued). Chronically ill or debilitated older adult
patients undergoing abdominal surgery or those in an intensive care unit are most vulnerable.
Patient & Family Education
- Report any early signs or symptoms of superinfection promptly. Superinfections caused by overgrowth of nonsusceptible organisms
may occur, particularly during prolonged use.
- Yogurt or buttermilk, 120 mL (4 oz) of either (if allowed), may serve as a prophylactic against intestinal superinfection
by helping to maintain normal intestinal flora.
- Report loose stools or diarrhea.