Ceftaxil-S

Ceftaxil-S

cefotaxime + sulbactam

Manufacturer:

Cosmas

Distributor:

Endure Medical
Full Prescribing Info
Contents
Cefotaxime sodium, sulbactam sodium.
Description
Each vial contains Cefotaxime 1 g, Sulbactam 500 mg.
Action
Pharmacology: Cefotaxime is a third-generation cephalosporin. It has a bacterial action similar to cefamendole, but a broader spectrum of activity. It is highly stable to hydrolysis by most beta-lactamases and has greater activity than first- or second-generation cephalosporins against Gram-negative bacteria. Although cefotaxime is generally considered to have slightly less activity than first-generation cephalosporins against Gram-positive bacteria, many streptococci are very sensitive. Desaceylcefotaxime is an active metabolite of cefotaxime and there may be additive or synergistic effects against some species. Among Gram-negative bacteria, cefotaxime is active in vitro against many Enterobacteriacaea including Citrobacter and Enterobacter spp., Escherichia coli, Klebsiella spp., both indole-positive and indole-negative Proteus, Providencia, Salmonella, Serratia, and Yersinia spp. Other susceptible Gram-negative bacteria, including penicillin-resistant strains are Haemophilus influenza, Moraxella catarrhalis (Branhamella catarrhalis), Neisseria gonorrhoeae, and N. meningitidis. Brucella melitensis is also reported to be moderately sensitive. Some strains of Pseudomonas spp. are moderately susceptible to cefotaxime, but most are resistant. Desacetylcefotaxime is active against many of these Gram-negative bacteria, but not against Pseudomonas spp.
Among Gram-positive bacteria, cefotaxime is active against staphylococci and streptococci. Staphylococcus aureus, including penicillinase-producing strains but not methicillin-resistant Staph. Aureus, is sensitive. Staph. Epidermidis is also sensitive but penicillinase producing strains are resistant. Streptococcus agalactiae (group B streptococci), Str. pneumoniae, and Str. pyogenes (group A streptococci) are all very sensitive although truly penicillin-resistant pneumococci are apparently not sensitive. Enterococci and Listeria monocytogenes are resistant. Cefotaxime is active against some anaerobic bacteria. Bacteroides fragilis may be moderately sensitive, but many strains are resistant; synergy has been demonstrated with desacetlycefotaxime in vitro. Clostridium perfringens is sensitive, but most C. difficile are resistant. Other organisms sensitive to cefotaxime include the spirochaete Borrelia burgdorferi and Haemophilus ducreyi.
The activity of cefotaxime may be enhanced by Aminogycosides.
Pharmacokinetics: Cefotaxime is given by injection as the sodium salt. It is rapidly absorbed after intramuscular injection and mean peak plasma concentrations of about 12 and 20 micrograms/m have been reported 30 minutes after doses of 0.5 and 1 g of cefotaxime, respectively. Immediately after intravenous injection of 0.5, 1, or 2 g of cefotaxime, mean peak plasma concentrations of 38, 102, and 215 micrograms/mL, respectively, has been achieved with concentrations ranging from about 1 to 3 micrograms/mL after 4 hours. The plasma half-life of cefotaxime is about 1 hour and that of the active metabolite desacetylcefotaxime about 1.5 hours; half lives are increased in neonates and in patients with severe renal impairment, especially those of the metabolite and a reduction in dosage may be necessary. The effects of liver disease on clearance of cefotaxime and its metabolite have been variable, but in general dosage adjustment has not been considered necessary. About 40% of cefotaxime is reported to be bound to plasma proteins.
Indications/Uses
Cefotaxime-Sulbactam is used in the treatment of infections caused by susceptible organisms including meningitis, lower respiratory tract infections, and intra-abdominal infections and also used for surgical infection prophylaxis.
Dosage/Direction for Use
Adult: Mild to moderate: 1 g/0.5 g to 2 g/1 g of cefotaxime/sulbactam every 8-12 hours.
Moderate to severe: 1 g/0.5 g to 2 g/1 g of cefotaxime/sulbactam every 6-8 hours.
Children: 100 mg/50 mg to 150 mg/75 mg of cefotaxime per kg per day in three divided doses.
Or as prescribed by the physician.
Overdosage
In case of over dosage, particularly in renal insufficiency, there is a risk of reversible encephalopathy. Serum levels of cefotaxime & sulbactam may be reduced by peritoneal dialysis or haemodialysis.
Contraindications
Cefotaxime-sulbactam is contraindicated in patients with history of allergy to cephalosporins, penicillins, beta lactam class of antibiotics and other components of the drug.
Special Precautions
Hypersensitivity reactions range from mild to life-threatening. Administer drug with caution to penicillin-sensitive patients because of possible cross-reactivity.
Use in patients with renal insufficiency: Use with caution in patients with renal insufficiency. Reduce dose when creatinine clearance is less than 20 mL/min.
Gastrointestinal: Use with caution in patients with history of colitis.
Local Reactions: Local irritation may occur on the infusion sites. Regularly monitor infusion sites and change location when it is needed.
Use in the Elderly: Because elderly are more likely to have decreased renal function, care should be taken in dose selection and consider monitoring in renal function.
Use in Pregnancy & Lactation: Cefotaxime-Sulbactam is included in Pregnancy Category B. Both drugs are excreted in breast milk; caution should be exercised in nursing mothers.
Adverse Reactions
Cefotaxime-sulbactam may cause local reactions including pain at the injection site and phlebitis, skin rash, diarrhea, nausea, vomiting and colitis. Gastrointestinal colitis, diarrhea, nausea, vomiting occurs at least 1% of the population as well as hypersensitivity rash, pruritus, fever, eosinophilia, urticaria, anaphylaxis. Pseudomembranous colitis symptoms can occur during or after treatment. Local injection-site inflammation occurs with IV administration and pain, indurations and tenderness are observed after IM administration.
Drug Interactions
Aminoglycoside: Increases risk of nephrotoxicity with concomitant use of aminoglycoside.
Incompatibility: Addition of aminoglycosides to cefotaxime may cause inactivation of both drugs. Administer at separate sites if concurrent therapy is indicated.
Laboratory Test: False-positive direct Coombs' test results in certain patients (eg. those with azotemia).
Storage
Store at temperatures not exceeding 30⁰C.
MIMS Class
ATC Classification
J01DD51 - cefotaxime and beta-lactamase inhibitor ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 1's, 10's.
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