Elixime

Tab: Cefuroxime axetil. Powd for Inj: Cefuroxime sodium.

Tab: Each tablet contains Cefuroxime (as axetil) 500 mg.
Powd for inj: Each vial contains 750 mg (potency) of cefuroxime sodium.

Tab: Pharmacology: Pharmacokinetics: Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolysed in the intestinal mucosa and blood to Cefuroxime; absorption is enhanced in the presence of food. Peak plasma concentrations are reported about 2 to 3 hours after an oral dose. The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 27 micrograms per mL have been achieved 45 minutes after an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of Cefuroxime in the circulation is bound to plasma proteins. The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and in neonates.
Microbiology: Antimicrobial Action and Resistance: Cefuroxime is bactericidal and has similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. It is more resistant to hydrolysis by beta-lactamases than cefamandole, 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 when compared with the minimum inhibitory concentration or with a significant inoculum effect. Reduced affinity of penicillin-binding proteins for Cefuroxime has also been reported to be responsible for resistance in a beta-lactamase-negative strain of H. influenzae.

Tab: Cefuroxime is a second generation cephalosporin antibiotic used in the treatment of susceptible infections: These have included 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), and urinary tract infections. It is also used for surgical infection prophylaxis.
Powd for inj: Susceptible Organisms: S. aureus (including penicillin-resistant strains, except methicillin-resistant strains), S. epidermidis (except methicillin-resistant strains), H. influenzae (including ampicillin-resistant strains), H. parainfluenzae (including ampicillin-resistant strains), Klebsiella spp., S. pyogenes, Streptococcus group B, Pneumococci, E. coli, Str. Viridans, Clostridium spp. (except Clostridium difficile), Proteus mirabilis, P. rettgeri, Salmonella typhi, Salmonella typhimurium and other Salmonella spp., Shigella spp., Neisseria spp. (including β-lactamase-producing Gonococci), Bordetella pertussis, Branhamella catarrhalis, Proteus vulgaris, Proteus morganii, Enterobacter spp., Citrobacter spp., Serratia spp., Streptococcus faecalis and susceptible strains of Bacteroides fragilis.
Indications: Main indications: Acute/chronic bronchitis, bronchiectasis (in case of infection), bacterial pneumonia, pulmonary abscess, postoperative infection on chest sinusitis, tonsilitis, pharyngitis, wound infection, osteomyelitis, septic arthritis, gonorrhea, septicemia, meningitis.
Following postoperative prophylaxis of infections: abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal, and vascular operations.
Can be used in the following disease: Adnexitis, intrautereine infection, inflammation of the pelvic dead space, bartholinitis, parametritis.

Tab: Usual oral doses for adults are 125 mg twice daily for uncomplicated urinary-tract infections and 250 to 500 mg twice daily for respiratory tract infections. A dose for children more than 3 months of age is 125 mg twice daily or 10 mg per kg body weight twice daily to a maximum of 250 mg daily. Children over 2 years of age with otitis media may be given 250 mg twice daily or 15 mg per kg twice daily to a maximum of 500 mg daily. Or as prescribed by a Physician.
Powd for inj: Adults: Administer i.m. or i.v. 750 mg (potency) of cefuroxime sodium three times a day. In severe cases, administer i.m. up to 1.5 g (potency) three times a day.
The frequency of i.m. or i.v. injections can be increased to four times if necessary, giving total doses of 3 g to 6 g daily.
Infants and children: Administer i.m. or i.v. 30~100 mg (potency)/kg/day in three or four divided doses. Usually appropriate doses are recommended to 60 mg (potency)/kg/day.
Neonates: Administer i.m. or i.v. 30~100 mg (potency)/kg/day in three or four divided doses. Since in case of neonate during 1 week after their birth half-life of cefuroxime in serum may be prolonged 3-5 times to adults, it should be carefully administered.
Gonorrhea: Administer i.m. 1.5 g (potency) once or 1.5 g (potency) injection may be equally divided between two gluteal injection sites.
Patients with impaired renal function: It is not necessary to adjust the dose in patients with slight impaired renal function. However, in patient with marked impairment (creatinine clearance: 10-20 mL/min), the daily dose is recommended to 750 mg (potency) twice and with severe impairment (creatinine clearance ≤10 mL/min) 750 mg (potency) once daily is adequate. For patients on haemodialysis a further 750 mg (potency) dose should be given at the end of each dialysis. For patients on continuous arteriovenous haemodialysis or high-flux haemofiltration a suitable dosage is 750 mg (potency) twice a day. For low-flux haemofiltration follow the dosage recommended under impaired renal function.
Postoperative prophylaxis of infections: Abdominal, pelvic and orthopedic operations: The usual dose is 1.5 g i.v. with induction of anesthesia. It may be supplemented with two 750 mg (potency) i.m. doses eight and sixteen hours later.
Cardiac, pulmonary, esophageal, and vascular operations: The usual dose is 1.5 g (potency) cefuroxime powder may be mixed with each pack of methyl methacrylate cement polymer before adding the liquid monomer.
Meningitis: Adults: Administer q.v. 3 g (potency) three times a day.
Infants and children: Administer i.v. 200-240 mg (potency) in three or four divided doses a day. This dosage may be reduced to 100 mg (potency)/kg/day after three days or when clinical improvement occurs.
Neonates: The initial dosage should be 100 mg (potency)/kg/day i.v. A reduction to 50 mg (potency)/kg/day may be made when clinical improvement occurs.
Preparation of injectable solution: 250 mg (potency) is dissolved in 2 mL, and 750 mg (potency) in 6 mL, and 1.5 (potency) in 15 mL sterile water for injection and injected. In case of i.v. drip infusion, 1.5 (potency) is dissolved in 50 mL sterile water for injection and the infusion should last at least 30 minutes. It is desirable not to use sodium bicarbonate solution as diluent.

Powd for inj: Patients with history of shock to cefuroxime sodium or cefuroxime axetil.

Tab: Gastrointestinal disturbances including diarrhea, nausea and vomiting, have occurred in some patients receiving Cefuroxime Axetil. There have been rare reports of erythema multiforme, Steven-Johnson syndrome, and toxic epidermal necrolysis. Cefuroxime is considered to be unsafe in patients with porphyria although there is conflicting experimental evidence of porphyrinogenecity.
Powd for inj: Should be given cautiously in the following patients: In principle this drug should not be administered to patients with history of hypersensitivity to this drug or cephem antibiotics, but if inevitable, cautious administration is required.
Patients with history of hypersensitivity to penicillins.
Patients oneself or whose parents, sisters, or brothers are prone to suffer from allergic symptoms such as bronchial asthma, exanthema, urticaria, etc.
Patients with severe renal disorder.
Patients with poor oral ingestion or parenteral nutrition patients, elderly patients, patients with poor general conditions (cautions monitoring is required since vitamin K deficiency may occur).
General Precautions: In order to prevent appearance of the resistant microorganisms susceptibility should be determined and treatment should be continued only for the minimum period of time required.
In order to predict adverse events such as shock, etc. patient history should be taken in detail and skin reaction test should be performed.
Emergency measures have to be available in preparation for occurrence of shock, and even after measures taken the patient should be observed cautiously in stable condition.
It is desirable to perform laboratory test (hepatic function, renal function, blood, etc.) at regular intervals during treatment.
This drug can be administered with combination of aminoglycosides antibiotics or metronidazole. However, these drugs must not be mixed in a syringe.
Interference in Laboratory Test: Caution should be taken as urine-glucose test using Benedict's-reagent, Fehling's reagent, Clinitest, except for Testape reaction, may give false positive results.
Caution should be taken as direct Coomb's test may give false positive results.
Precautions on Application: As vascular pain or venous thrombosis may rarely occur by large intravenous dose, caution should be taken on preparation of injectable solution, site of injection, method of administration, etc. and injection should be given as slowly as possible.
This drug should be used immediately after reconstitution. If the reservation of injectable solution is needed, the intravenous injectable solution should be used within 5 hours at room temperature or 48 hours at 4°C and the solution on intravenously drip infusion should be used within 12 hours at room temperature or 72 hours at 4°C.
Others: It has been reported that minor children have slight or severe auditory dysfunction with treatment of meningitis. After 18-36 hours with administration. Influenza positive strains may express in cultures of cerebral spinal fluid, but it is not known that clinical effects are associated with anything.
Use in Pregnancy: As safety in human pregnancy has not been established, this drug should not be administered to pregnant women or child bearing potential unless therapeutic benefit is considered to exceed the possible risk.
Use in Lactation: Since this drug is excreted in the breast-milk, caution is advised in nursing mothers.

Powd for inj: Use in Pregnancy: As safety in human pregnancy has not been established, this drug should not be administered to pregnant women or child bearing potential unless therapeutic benefit is considered to exceed the possible risk.
Use in Lactation: Since this drug is excreted in the breast-milk, caution is advised in nursing mothers.

Powd for inj: Shock: As shock may rarely occur, cautions monitoring is required, and in case that abnormality occurs, further administration should be discontinued and appropriate measures taken.
Skin: Since Stevens-Johnson syndrome (mucocutaneous ocular syndrome), erythema multiforme or Lyell syndrome (toxic epidermal necrolysis) may rarely occur, cautious monitoring is required. If the above symptoms occur, further administration should be discontinued.
Hypersensitivity: In case that pruritis, exanthema (erythema, wheals, etc.), pyrexia, urticaria, lymph node swelling, arthralgia or anaphylactic reaction occur, further administration should be discontinued and appropriate measures should be taken.
Renal: Since severe renal disorders such as acute renal insufficiency may rarely occur, cautious monitoring is required and if abnormality is acknowledged further administration should be discontinued and appropriate measures taken.
Hematological: Rarely reduction of hemoglobin concentration, anemia, granulocytopenia, leukopenia, thrombocytopenia, occasionally neutropenia, eosinophilia may occur. Also, when other cephem antibiotics are administered, it has been reported that haemolytic anemia occurred.
Hepatic: Occasionally elevation of GOT, GPT, and AL-P, rarely abnormality of hepatic function such as elevation of LDH and GTP may occur.
Gastrointestinal: Rarely severe enterocolitis with hemafecia such as pseudomembranous enterocolitis may occur, if abdominal pain and frequent diarrhea occur, appropriate measures such as immediate discontinuation should be taken. Also, occasionally nausea, diarrhea rarely vomiting, anorexia etc. may occur.
Respiratory: Since interstitial pneumonia, PIE syndrome, etc. accompanied with fever, cough, dyspnea, abnormal chest X-ray, etc. may rarely occur with other cephems, in case that such symptoms occur further administration should be discontinued and appropriate measures such as administration of corticosteroids, etc. should be taken.
Super infection: Rarely candida intertrigo may occur.
Vitamin deficiency: Rarely symptoms of vitamin K deficiency (hypoprothrombinemia, hemorrhage tendency, etc.) and vitamin B deficiency (glossitis, stomitis, anorexia, neuritis, etc.) may occur.
Others: Rarely paralysis may occur.

Powd for inj: Cautious treatment is required as renal insufficiency may be worsened with combination of diuretics such as furosemide and aminoglycoside antibiotics. In case of elderly patients or patients with a history of renal dysfunctions, renal function should be monitored.

Store at room temperature not exceeding 30°C.

Cephalosporins

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

Rx