D & G Pharma


D & G Pharma
Full Prescribing Info
Tab: Cefuroxime axetil. Inj: Cefuroxime sodium.
Each film-coated tablet contains Cefuroxime (as axetil) 500 mg.
Each vial contains Cefuroxime (as sodium) 750 mg.
CEFUROXIME is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to that of cephamandole. It is more resistant to hydrolysis by beta-lactamases than cephamandole, and therefore may be more active against beta-lactamases-producing strains of, for example, Haemophilus influenzae and Neisseria gonorrhoeae. However, treatment failures have occurred in patients with H. influenzae meningitis given cefuroxime and might be associated with a relatively high minimum bactericidal concentration (MBC) when compared with the minimum inhibitory concentration (MIC) or with significant inoculum effect. Reduced affinity of penicillin-binding proteins for cefuroxime has also been reported responsible for resistance in a beta-lactamase-negative strain of H. influenzae.
CEFUROXIME is a second generation cephalosporin antibiotic used in the treatment of susceptible infections. These include bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis (although treatment failures have been reported in H. influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft-tissue infections), surgical infection (prophylaxis) and urinary-tract infections.
Dosage/Direction for Use
CEFUROXIME is administered by mouth as the acetoxyethyl ester, cefuroxime axetil in the form of tablets or suspension or by injection as the sodium salt. Cefuroxime sodium may be given by deep intramuscular injection by slow intravenous injection over 3 to 5 minutes or by intravenous infusion. Doses of Cefuroxime axetil and Cefuroxime sodium are expressed in terms of the equivalent amount of cefuroxime.
URINARY TRACT INFECTION: Usual oral doses are 125mg twice daily.
RESPIRATORY TRACT INFECTION: 250 to 500mg twice daily.
INFANTS AND CHILDREN: A suggested dose for children more than 3 months of age is 125mg twice daily or 10mg/kg body weight twice daily to a maximum of 250mg daily.
CHILDREN over 2 years of age with otitis media may be given 250mg twice daily or 15mg/kg twice daily to a maximum of 500mg daily.
RENAL IMPAIRMENT: The parenteral doses may need to be reduced. The usual adult dose of 750mg should only be given twice daily when the creatinine clearance is between 10 and 20mL per minute and once daily when it is below 10mL per minute.
MENINGITIS: Administered intravenously in doses of 3g every 8 hours.
GONORRHOEA: Single dose of 1.5g by intramuscular injection, divided between 2 injection sites, has been suggested. A single 1g oral dose of cefuroxime has been given for uncomplicated gonorrhea.
PROPHYLAXIS: The usual dose is 1.5g of cefuroxime intravenously prior to procedures. This may be supplemented by 750mg intravenously every 8 hours for up to 24 to 48 hours depending upon the procedure. For total joint replacement, 1.5g of cefuroxime powder may be mixed with the methyl methacrylate cement.
Patients with history of shock by this drug or cefuroxime axetil.
Special Precautions
Should be administered cautiously to the following patients: In principle, should not be administered to the patients with a history of hypersensitivity to this drug or cephalosporins. If necessary, should be given cautiously.
Patients with a history of hypersensitivity to penicillin.
Patients, themselves or whose parents or brothers are constitutionally predisposed to allergic symptoms such as bronchial asthma, rash, urticaria, etc.
Patients with severe renal disorder.
Patients who are in poor condition systemically, unable to take diet in parenteral, and the aged (as the deficiency symptoms of vitamin K occurs, monitor carefully).
General Precautions: For the prevention of manifestation of resistant bacteria, in principle, administer this drug ring minimum period after conforming the susceptibility.
Regular clinical monitoring (hepatic function, renal function, blood, etc.) during therapy is advised.
This drug may be used concurrently with aminoglycoside antibiotics or metronidazole.
Others: Mild to moderate hearing loss has been reported in a few pediatric patients receiving cefuroxime sodium for the treatment of meningitis. Persistence of positive CSF cultures at 18-36 hours has been observed with cefuroxime sodium injection; however, the clinical relevance of this finding is unknown.
Use in Pregnancy: As the safety during pregnancy has not yet been established, this drug should be used during pregnancy or suspected pregnancy only if the potential benefit justifies the potential risk.
Use in Lactation: It is reported that this drug is secreted in human milk. Thus, should be used with caution in lactating mothers.
Adverse Reactions
Shock: As rarely shock may occur, monitor carefully. In such a case, discontinue therapy.
Skin: As rarely Stevens-Johnson syndrome, erythema multiforme, Lyell's syndrome (toxic epidermal necrolysis) may occur, monitor carefully. In such case, discontinue the therapy.
Hypersensitivity: When the symptoms such as pruritus, rash (erythema, etc) fever, urticaria, swelling of lymph node, arthralgia, anaphylactic reaction, etc. may occur, discontinue the therapy.
Renal: Rarely, severe renal disorder such as acute renal insufficiency may occur. Thus, monitor carefully, and discontinue the therapy in such a case.
Blood: Rarely, decreased hemoglobin concentration, anemia, agranulocytosis, leukopenia, thrombocytopenia, occasionally, neutropenia and eosinophilia may occur. And it is reported that hemolytic anemia have occurred following administration of other cephems.
Hepatic: Occasionally, rise in GOT, GPT, AL-P levels, rarely, rise in bilirubin, LDH and GPT levels may occur.
Gastrointestinal: Rarely, symptoms of pseudomembranous colitis may appear, when abnormal pain and frequent diarrhea occur, discontinue the therapy immediately. Sometimes, nausea, diarrhea. Rarely, vomiting, anorexia, etc. may occur.
Respiratory: Rarely, fever, coughing, dyspnea, and interstitial penumonia accompanying eosinophilia, PIE syndrome, etc may occur. In such case, discontinue the therapy and administer corticosteroids.
Superinfection: Rarely, candidal intertrigo may occur.
Deficiency symptoms of vitamin: Rarely, deficiency symptoms of vitamin K (hypoprothrombinemia, tendency of bleeding, etc) and vitamin B (glossitis, stomatitis, anorexia, neuritis, etc) may occur.
Others: Rarely, sense of paralysis may occur.
Drug Interactions
Drug interaction: Used concurrently, furosemide-diuretics or aminoglycoside antibiotics may increase renal disorder.
Thus, in such a case, carefully monitor renal function, particularly, for the aged and the patients with a history of renal impairment.
Laboratory test interactions: A false-positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution, or Clinitest tablets but not with enzyme based tests, such as Tes-tape.
Positive direct antiglobulin (Coombs) tests may occur.
Caution For Usage
Precautions in application: Due to intravenous administration in large quantities, rarely, vascular pain and thrombophlebitis may occur. Thus, care should be taken about preparation of solution, injection site, injection method, etc. So, should be injected as slowly as possible.
It is preferable to use freshly constituted solutions of CEFUROXIME for injection. If this is not practicable, solutions for IV injection may be stored for up to 5 hours at room temperature and 48 hours in the refrigerator, and those for IV infusion may be stored for up to 5 hours at room temperature and 48 hours in the refrigerator.
Store at temperatures not exceeding 25°C. Protect from light.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Xefu FC tab 500 mg
Xefu powd for inj 750 mg
10 × 1's
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