Clatacef

Cefotaxime sodium.

Off-white to pale yellow sterile powder for injection.
Each g contains Sterile Cefotaxime Sodium equivalent to Cefotaxime 1 g.
Excipients/Inactive Ingredients: Non excipients.

Pharmacotherapeutic group: Beta-lactam antibiotics, cephalosporins. ATC Code: J01D A10.
Pharmacology: Pharmacodynamics: Mode of action: Cefotaxime is a third generation broad spectrum bactericidal cephalosporin antibiotic. The bactericidal properties are due to the inhibitory effect of cefotaxime on bacterial cell wall synthesis.
Mechanisms of resistance: Resistance to Cefotaxime may be due to production of extended-spectrum beta-lactamases that can efficiently hydrolyse the drug, to the induction and/or constitutive expression of AmpC enzymes, to impermeability or to efflux pump mechanisms. More than one of these possible mechanisms may co-exist in a single bacterium.
Pharmacokinetics: Absorption/Distribution: Following IM administration of a single 500 mg or 1 g dose of cefotaxime to healthy volunteers, mean peak serum concentrations of 11.7 and 20.5 mcg/mL, respectively, were attained within 30 minutes and declined with an elimination half-life of approximately 1 hour. There was a dose-dependent increase in serum levels after the IV administration of 500 mg, 1 g, and 2 g of cefotaxime (38.9, 101.7, and 214.4 mcg/mL, respectively) without alteration in the elimination half-life. There is no evidence of accumulation following repetitive IV infusion of 1 g doses every 6 hours for 14 days as there are no alterations of serum or renal clearance. About 60% of the administered dose was recovered from urine during the first 6 hours following the start of the infusion.
Metabolism/Excretion: Approximately 20% to 36% of an IV dose of 14C-cefotaxime is excreted by the kidney as unchanged cefotaxime and 15% to 25% as the desacetyl derivative, the major metabolite. The desacetyl metabolite has been shown to contribute to the bactericidal activity. Two other urinary metabolites (M2 and M3) account for about 20% to 25%. They lack bactericidal activity.
Infants: A single 50 mg/kg dose of cefotaxime was administered as an IV infusion over a 10- to 15-minute period to 29 newborn infants grouped according to birth weight and age. The mean half-life of cefotaxime in infants with lower birth weights (less than or equal to 1,500 g), regardless of age, was longer (4.6 hours) than the mean half-life (3.4 hours) in infants whose birth weight was greater than 1,500 g. Mean serum clearance was also smaller in the lower birth weight infants. Although the differences in mean half-life values are statistically significant for weight, they are not clinically important. Therefore, base dosage solely on age. It is not necessary to differentiate between premature and normal-gestational age infants. Additionally, no disulfiram-like reactions were reported in a study conducted in 22 healthy volunteers administered cefotaxime and ethanol.
Toxicology: Preclinical safety data: There are no pre-clinical data of relevance to the prescriber that are additional to those included in other sections.

Clatacef-3 is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the following diseases: Lower respiratory tract infections: Including pneumonia, caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Streptococcus pyogenes (efficacy for this organism, in this organ system, has been studied in less than 10 infections [group A streptococci]) and other streptococci (excluding enterococci, [eg, Enterococcus faecalis]), Staphylococcus aureus (penicillinase and nonpenicillinase producing), Escherichia coli, Klebsiella species, Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Proteus mirabilis, Serratia marcescens (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Enterobacter species, and indole-positive Proteus and Pseudomonas species (including Pseudomonas aeruginosa).
Genitourinary infections: Caused by Enterococcus species, Staphylococcus epidermidis, S. aureus (penicillinase and nonpenicillinase producing; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Citrobacter species, Enterobacter species, E. coli, Klebsiella species, P. mirabilis, Proteus vulgaris (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Providencia stuartii, Morganella morganii (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Providencia rettgeri (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Serratia marcescens, and Pseudomonas species (including P. aeruginosa). Also, uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase-producing strains.
Gynecologic infections: Including pelvic inflammatory disease, endometritis, and pelvic cellulitis, caused by S. epidermidis, Streptococcus species, Enterococcus species, Enterobacter species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Klebsiella species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, P. mirabilis, Bacteroides species (including Bacteroides fragilis; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Clostridium species, and anaerobic cocci (including Peptostreptococcus and Peptococcus species) and Fusobacterium species (including Fusobacterium nucleatum; efficacy for this organism, in this organ system, has been studied in less than 10 infections). Cefotaxime, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is 1 of the suspected pathogens, add appropriate antichlamydial coverage.
Bacteremia/Septicemia: Caused by E. coli, Klebsiella species, and S. marcescens, S. aureus and Streptococcus species (including S. pneumoniae).
Skin and skin structure infections: Caused by S. aureus (penicillinase and nonpenicillinase producing), S. epidermidis, S. pyogenes (group A streptococci) and other Streptococci, Enterococcus species, Acinetobacter species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, Citrobacter species (including Citrobacter freundii; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Enterobacter species, Klebsiella species, P. mirabilis, P. vulgaris (efficacy for this organism, in this organ system, has been studied in less than 10 infections), M. morganii, P. rettgeri (efficacy for this organism, in this organ system, has been studied in less than 10 infections), Pseudomonas species, S. marcescens, Bacteroides species, and anaerobic cocci (including Peptostreptococcus; efficacy for this organism, in this organ system, has been studied in less than 10 infections) species and Peptococcus species.
Intra-abdominal infections: Including peritonitis caused by Streptococcus species (efficacy for this organism, in this organ system, has been studied in less than 10 infections), E. coli, Klebsiella species, Bacteroides species, and anaerobic cocci (including Peptostreptococcus; efficacy for this organism, in this organ system, has been studied in less than 10 infections) species and Peptococcus (efficacy for this organism, in this organ system, has been studied in less than 10 infections) species, P. mirabilis (efficacy for this organism, in this organ system, has been studied in less than 10 infections), and Clostridium species (efficacy for this organism, in this organ system, has been studied in less than 10 infections).
Bone or joint infections: Caused by S. aureus (penicillinase and nonpenicillinase producing strains), Streptococcus species (including S. pyogenes; efficacy for this organism, in this organ system, has been studied in less than 10 infections), Pseudomonas species (including P. aeruginosa; efficacy for this organism, in this organ system, has been studied in less than 10 infections), and P. mirabilis (efficacy for this organism, in this organ system, has been studied in less than 10 infections).
CNS infections: Caused by Neisseria meningitidis, H. influenzae, S. pneumoniae, K. pneumoniae (efficacy for this organism, in this organ system, has been studied in less than 10 infections), and E.coli (efficacy for this organism, in this organ system, has been studied in less than 10 infections). Although many strains of enterococci (eg, Streptococcus faecalis) and Pseudomonas species are resistant to cefotaxime in vitro, cefotaxime has been used successfully in treating patients with infections caused by susceptible organisms.
Obtained specimens for bacteriologic culture prior to therapy in order to isolate and identify causative organisms and to determine their susceptibilities to cefotaxime. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, adjust the antibiotic treatment accordingly.
Concomitant aminoglycoside therapy: In certain cases of confirmed or suspected gram-positive or gram-negative sepsis, or in patients with other serious infections in which the causative organism has not been identified, cefotaxime may be used concomitantly with an aminoglycoside. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition. Carefully monitor renal function, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. It is possible that nephrotoxicity may be potentiated if cefotaxime is used concomitantly with an aminoglycoside.
Perioperative prophylaxis: The administration of cefotaxime preoperatively reduces the incidence of certain infections in patients undergoing surgical procedures (eg, abdominal or vaginal hysterectomy, GI and GU tract surgery) that may be classified as contaminated or potentially contaminated. For patients undergoing GI surgery, preoperative bowel preparation by mechanical cleansing, as well as with a nonabsorbable antibiotic (eg, neomycin), is recommended.
Cesarean section: In patients undergoing cesarean section, intraoperative (after clamping the umbilical cord) and postoperative use of cefotaxime may also reduce the incidence of certain postoperative infections. The first dose of 1 g is administered intravenously (IV) as soon as the umbilical cord is clamped. The second and third doses should be given as 1 g IV or intramuscularly (IM) at 6 and 12 hours after the first dose. Effective use for elective surgery depends on the time of administration. To achieve effective tissue levels, give cefotaxime ½ or 1½ hours before surgery. If there are signs of infection, obtain specimens for culture for identification of the causative organism so that appropriate therapy may be instituted.
Drug resistance: To reduce the development of drug-resistant bacteria and maintain the efficacy of cefotaxime and other antibacterial drugs, only use cefotaxime to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, consider them in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Posology: General dosing considerations: If C. trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added because cefotaxime has no activity against this organism.
Dosage adjustment required for patients with renal function impairment.
Maximum dose: Adults and children weighing at least 50 kg: 12 g/day.
Adults: Infections: For a list of infections, refer to Indications/Uses.
Gonococcal urethritis/cervicitis: 0.5 g IM (single dose).
Gonorrhea: rectal (men) 1 g IM (single dose), rectal (women): 0.5 g IM (single dose).
Moderate to severe infections: 1 to 2 g IM or IV every 8 hours.
More severe infections: For infections commonly needing antibiotics in higher dosage (eg, septicemia), 2 g IV every 6 to 8 hours.
Life-threatening infections: 2 g IV every 4 hours up to 12 g/day.
Perioperative prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 g IM or IV administered 30 to 90 minutes prior to start of surgery.
For Cesarean section patients, the first dose of 1 g is administered IV as soon as the umbilical cord is clamped. The second and third doses should be given as 1 g IV or IM at 6 and 12 hours after the first dose.
Uncomplicated infections: 1 g IM or IV every 12 hours.
Children: Infections: For a list of infections, refer to Indications/Uses. (See Table 1.)

Click on icon to see table/diagram/image

Elderly: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, take care in dose selection; it may be useful to monitor renal function.
Renal function impairment: Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dose should be reduced when cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime be halved in patients with estimated creatinine clearances (CrCl) of less than 20 mL/min/1.73 m². Alternatively, the following dosage adjustments have been recommended.
CrCl 10 to 50 mL/min: Give doses every 12 to 24 hours.
CrCl less than 10 mL/min: Give doses every 24 hours.
Adults receiving continuous renal replacement therapy (CRRT): One reference suggests a dosage of 1 g every 12 hours. The following alternative recommendations assume ultrafiltration and dialysis flow rates of 1 to 2 L/h.
Continuous venovenous hemofiltration (CVVH): 1 to 2 g IV every 8 to 12 hours.
Continuous venovenous hemodialysis (CVVHD): 1 to 2 g IV every 8 hours.
Continuous venovenous hemodialfiltration (CVVHDF): 1 to 2 g IV every 6 to 8 hours.
Adults receiving intermittent hemodialysis (IHD): One dosing recommendation is to administer a 0.5 to 2 g supplement after dialysis. Alternatively, administer 1 to 2 g IV every 24 hours after dialysis on dialysis days. This dosing recommendation assumes the patient is receiving standard IHD 3 times per week and completes the full dialysis sessions.
Continuous ambulatory peritoneal dialysis: 0.5 to 1 g every 24 hours.
CrCl calculation: When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into CrCl. The serum creatinine should represent a steady state of renal function.
Men: Weight (kg) x 140 - age/72 x serum creatinine.
Women: 0.85 x previous value.
Duration of therapy: As with antibiotic therapy in general, administration of cefotaxime should be continued for a minimum of 48 to 72 hours after the patient defervescence or after evidence of bacterial eradication has been obtained. A minimum of 10 days of treatment is recommended for infections caused by group A beta-hemolytic streptococci to guard against the risk of rheumatic fever or glomerulonephritis.
Frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed. Persistent infections may require treatment of several weeks. Doses smaller than those previously indicated should not be used.
Preparation for administration: Powder for injection: Cefotaxime sterile powder for IM or IV administration should be reconstituted as follows: See Table 2.

Click on icon to see table/diagram/image

Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.
A solution of cefotaxime 1 g in 14 mL of sterile water for injection is isotonic.
Preparation for IM administration: Reconstitute vials with sterile water for injection or bacteriostatic water for injection as previously described.
Preparation for IV administration: Reconstitute vials with at least 10 mL of sterile water for injection. Reconstitute infusion bottles with 50 or 100 mL of 0.9% sodium chloride injection or 5% dextrose injection. Reconstituted solutions may be further diluted up to 1,000 mL for other diluents.
Preparation of cefotaxime in ADD-Vantage system: Cefotaxime sterile powder for injection 1 or 2 g may be reconstituted in 50 or 100 mL of 5% dextrose or 0.9% sodium chloride in the ADD-Vantage diluent container. Refer to the manufacturer's instructions for ADD-Vantage system.
Method of administration: Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient. Cefotaxime sterile powder for injection may be administered IM or IV after reconstitution.
IM administration: Cefotaxime should be injected well within the body of a relatively large muscle, such as the upper outer quadrant of the buttock (ie, gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 g may be given if the dose is divided and administered in different IM sites.
IV administration: The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
Intermittent IV: For intermittent IV administration, a solution containing 1 or 2 g in 10 mL of sterile water for injection can be injected over a period of 3 to 5 minutes. Cefotaxime should not be administered over a period of less than 3 minutes. With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to temporarily discontinue the administration of other solutions at the same site.
Continuous IV: For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed in this section.
Admixture compatibility: Compatibility: Reconstituted solutions may be further diluted up to 1,000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 25°C, and at least 3 days under refrigeration (at or below 2-8°C): 0.9% sodium chloride injection; 5% or 10% dextrose injection; Ringer's lactate solution; sodium lactate injection (M/6); 10% invert sugar injection, 8.5% Travasol amino acid injection without electrolytes.
Solutions of cefotaxime sterile powder for injection reconstituted in 0.9% sodium chloride injection or 5% dextrose injection in Viaflex plastic containers maintain satisfactory potency for 24 hours at or below 25°C, 3 days under refrigeration (at or below 2-8°C). Solutions of cefotaxime sterile powder for injection sterile reconstituted in 0.9% sodium chloride injection or 5% dextrose injection in the ADD-Vantage flexible containers maintain satisfactory potency for 24 hours at or below 25°C. Do not freeze.
Incompatibility: Solution of cefotaxime must not be admixed with aminoglycoside solutions. If cefotaxime and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.
Cefotaxime solutions exhibit maximum stability in the pH 5 to 7 range. Do not prepare solutions of cefotaxime with diluents having a pH greater than 7.5, such as sodium bicarbonate injection.

The acute toxicity of cefotaxime was evaluated in neonatal and adult mice and rats. Significant mortality was seen at parenteral dosages in excess of 6,000 mg/kg/day in all groups.
Symptoms: Common toxic signs in animals that died were a decrease in spontaneous activity, tonic and clonic convulsions, dyspnea, hypothermia, and cyanosis. Cefotaxime overdosage has occurred in patients. Most cases have shown no overt toxicity. The most frequent reactions were elevations of BUN and creatinine.
Treatment: Carefully observe patients who receive an acute overdosage and give supportive treatment.

Hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.

1. Do not use in hypersensitive patients.
2. It may cause allergic reaction and could be fatal. Penicillin-sensitive patients may be allergic to this drug.
3. If skin rash, irritation or edema occurs, it should be discontinued and consult the doctor.

Arrhythmia: During postmarketing surveillance, a potentially life-threatening arrhythmia was reported in each of 6 patients who received a rapid (less than 60 seconds) bolus injection of cefotaxime through a central venous catheter. Therefore, only administer cefotaxime as instructed.
Pseudomembranous colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefotaxime, and may range from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic-associated colitis. After the diagnosis of pseudomembranous colitis has been established, initiate appropriate therapeutic measures. Mild cases of colitis may respond to drug discontinuance alone. In moderate to severe cases, consider management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis. When the colitis is not relieved by drug discontinuance or when it is severe, oral vancomycin is the treatment of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Also consider other causes of colitis. Prescribe cefotaxime with caution in individuals with a history of GI disease, particularly colitis.
Hematologic effects: As with other beta-lactam antibiotics, granulocytopenia and, more rarely, agranulocytosis may develop during treatment with cefotaxime, particularly if given over long periods. For courses of treatment lasting greater than 10 days, monitor blood counts.
Extravasation: Cefotaxime, like other parenteral anti-infective drugs, may be locally irritating to tissues. In most cases, perivascular extravasation of cefotaxime responds to changing of the infusion site. In rare instances, extensive perivascular extravasation of cefotaxime may result in tissue damage and require surgical treatment. To minimize the potential for tissue inflammation, regularly monitor infusion sites and change when appropriate.
Drug-resistant bacteria: Prescribing cefotaxime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Hypersensitivity reactions: Before therapy with cefotaxime is instituted, carefully determine whether the patient has had previous hypersensitivity reactions to cefotaxime, cephalosporins, penicillins, or other drugs. Give this product with caution to patients with type I hypersensitivity reactions to penicillin. Administer antibiotics with caution to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to cefotaxime occurs, discontinue treatment with the drug. Serious hypersensitivity reactions may require epinephrine and other emergency measures.
Renal function impairment: Because high and prolonged serum antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, reduce the total daily dose when cefotaxime is administered to such patients.
Determine continued dosage by degree of renal impairment, severity of infection, and susceptibility of the causative organism. Although there is no clinical evidence supporting the necessity of changing the dosage of cefotaxime in patients with even profound renal dysfunction, it is suggested that, until further data are obtained, the dose of cefotaxime be halved in patients with estimated Ccrs of less than 20 mL/min/1.73 m2. When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into Ccr.
The serum creatinine should represent a steady state of renal function.
Ccr calculation: Men: Weight (kg) x 140 - age/72 x serum creatinine.
Women: 0.85 x previous value.
Superinfection: As with other antibiotics, prolonged use of cefotaxime may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, take appropriate measures.
Carcinogenesis: Lifetime studies in animals to evaluate carcinogenic potential have not been conducted.
Mutagenesis: Cefotaxime was not mutagenic in the mouse micronucleus test or in the Ames' test.
Fertility impairment: Cefotaxime did not impair fertility to rats when administered subcutaneously at dosages up to 250 mg/kg/day (0.2 times the maximum recommended human dosage based on mg/m²) or in mice when administered IV at dosages up to 2,000 mg/kg/day (0.7 times the recommended human dose based on mg/m²).
Effects on ability to drive and use machine: Cefotaxime has been associated with dizziness, which may affect the ability to drive or operate machinery.
Use in Children: The potential for toxic effects in pediatric patients from chemicals that may leach from the plastic in single-dose Galaxy containers (premixed cefotaxime injection) has not been determined.
Use in the Elderly: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, take care in dose selection; it may be useful to monitor renal function. Of the 1,409 subjects in clinical studies of cefotaxime, 632 (45%) were 65 years of age and older, while 258 (18%) were 75 years of age and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity in some older individuals cannot be ruled out.

Pregnancy: Pregnancy Category B.
Reproduction studies have been performed in pregnant mice given cefotaxime IV at dosages up to 1,200 mg/kg/day (0.4 times the recommended human dosage based on mg/m²) or in pregnant rats when administered IV at dosages up to 1,200 mg/kg/day (0.8 times the recommended human dosage based on mg/m²). No evidence of embryotoxicity or teratogenicity was seen in these studies.
There are no well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, use this drug during pregnancy only if clearly needed. Use of the drug in women of childbearing potential requires that the anticipated benefit be weighed against the possible risks. In perinatal and postnatal studies with rats, the pups in the group given 1,200 mg/kg of cefotaxime were significantly lighter in weight at birth and remained smaller than pups in the control group during the 21 days of breast-feeding.
Lactation: Cefotaxime is excreted in human milk in low concentrations. Exercise caution when cefotaxime is administered to a breast-feeding woman.

Cefotaxime is generally well tolerated. The most common adverse reactions have been local reactions following IM or IV injection. Other adverse reactions have been encountered infrequently.
Incidence greater than 1%: The most frequent adverse reactions include: GI: Occurrence, 1.4%: Colitis, diarrhea, nausea, and vomiting. Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment. Nausea and vomiting have been reported rarely.
Hematologic: Occurrence, 2.4%: Eosinophilia.
Hypersensitivity: Occurrence, 2.4%: Fever, pruritus, rash, and, less frequently, anaphylaxis and urticaria.
Local: Occurrence, 4.3%: Injection site inflammation with IV administration. Pain, induration, and tenderness after IM injection.
Less frequent (incidence less than 1%) adverse reactions include: Cardiovascular: Potentially life-threatening arrhythmias following rapid (less than 60 seconds) bolus administration via central venous catheter have been observed.
CNS: Headache.
Dermatologic: As with other cephalosporins, isolated cases of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.
GU: Moniliasis, vaginitis.
Hematologic: Agranulocytosis, eosinophilia, neutropenia, thrombocytopenia, and transient leukopenia have been reported. Some individuals have developed positive direct Coombs' tests during treatment with cefotaxime and other cephalosporin antibiotics. Rare cases of hemolytic anemia have been reported.
Hepatic: Transient elevations in AST, ALT, serum lactate dehydrogenase, and serum alkaline phosphatase levels have been reported.
Renal: As with some other cephalosporins, interstitial nephritis and transient elevations of serum' urea nitrogen (BUN) and creatinine have been occasionally observed with cefotaxime.
Cephalosporin-class adverse reactions: In addition to the adverse reactions previously listed that have been observed in patients treated with cefotaxime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics: allergic reactions; aplastic anemia; false-positive test for urinary glucose; hepatic dysfunction, including cholestasis; and hemorrhage. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, discontinue the drug. Anticonvulsant therapy can be given if clinically indicated.

Aminoglycosides: Increased nephrotoxicity has been reported following coadministration of cephalosporins and aminoglycoside antibiotics.
Drug/Lab test interactions: Cephalosporins, including cefotaxime, are known to occasionally induce a positive direct Coombs' test.

Incompatibilities: Aminoglycosides: Increased nephrotoxicity has been reported following coadministration of cephalosporins and aminoglycoside antibiotics.
Drug/Lab test interactions: Cephalosporins, including cefotaxime, are known to occasionally induce a positive direct Coombs' test.

Store below 30°C, protected from light. Do not freeze.
Shelf life: 2 years.

Cephalosporins

J01DD01 - cefotaxime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

S