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Each vial contains 750mg (potency) of cefuroxime sodium.
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 sp., S. pyogenes, Streptcoccus group B, Pneumococci, E, coli, Str. Viridans, Clostridium sp. (except Clostridum difficile), Proteus mirabilis, P. rettgeri, Salmonel a typhi, Salmonella typhimurium and other Salmonella sp., Shigella sp., Neisseria sp. (including ß
– lactamase – producing Gonococci), Bordetel a pertussis, Branhamella catarrhalis, Proteus vulgaris, Proteus morgani , Enterobacter sp., Citrobacter sp., Streptococcus faecalis and susceptible strains of Bacteroides fragilis.
Acute/ chronic bronchitis, bronchiectasis (in case of infection), bacterial pneumonia, pulmonary abscess, postoperative infection on chest sinusitis, tonsil itis, pharyngitis, acute/ chronic neophropyelitis, cystitis, asymptomatic bacteruria, cellulites, erysipelas, peritonitis, wound infection, osteomyelitis, septic arthtitis, gonorrhea, septicemia, meningitis.
Following postoperative prophylaxis of infections: abdominal, pelvic, orthopeadic cardiac, pulmonary, esophageal and vascular operations.
Adnexitis, intrauterine infection, inflammation of pelvic dead space, bartholinitis, parametritis.
DOSAGE AND ADMINISTRATION
1) Adults : Administer i.m. or i.v 750mg (potency) of cefuroxime sodium three
times a day.
In severe cases, administer i.m. up to 4.5g (potency) three times a day.
The frequency of i.m. or i.v. injections can be increased to four times if necessarym giving total doses of 3g to 6g daily.
2) Infants and Children: Administer i.m. ir i.v. 30-100mg (potency) / kg/day in
three or four divided doses. Usual y appropriate doses are recommended to 60mg (potency) / kg/day.
3) Neonates: DMINISTER I>M> OR I>V> _MG (potency) / kg/day in two or
three 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.
4) Gonorrhea: Administer i.m. 1.5g (potency) once, or the 1.5g (potency)
injection may be equally divided between two gluteal injection sites.
5) Patients with Impaired Renal Function: It is not necessary to adjust the
dose in patients with slight impaired renal function. However, in patient with mark impairment (creatinine clearance : 10-20ml/min), the daily dose is recommended to 750mg (potency) twice and with severe impairment (creantinine clearance : ≤ 10ml/min) 750mg (potency) once daily is adequate. For patients on haemodialysis a further 750mg (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 750mg (potency) twice a day. For low-flux haemofiltration fol ow the dosage recommended under impaired renal function.
6) Postoperative Propylaxis of Infections
1. Abdominal, pelvic and arthopedic operations: The usual dose is .5g
i.v. with induction of anesthesia. It may be supplemented with two 750mg (potency) i.m. doses eight and sixteen hours later.
2. Cardiac, pulmonary, esophageal and vascular operations : the
usual dose is 1.5g (potency) i.v. with induction of anesthesia continuing with 750mg (potency) i.m. for a further 24 or 48 hours three times a day.
3. Total joint replacement: 1.5g (potency) cefuroxime powder may be
mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.
1. Adults: Administer i.v. 3g (potency) three times a day.
2. Infants and children
Administer i.v. 200-540mg (potency) in three or four divided doses a day. This dosage may be reduced to 100mg (potency) / kg/day after three days or when clinical improvement occurs.
3. Neonates: the initial dosage should be 100mg (potency) / kg/day
i.v. A reduction to 50mg (potency) /kg/day may be made when clinical improvement occurs.
250mg(potency) is dissolved in 1ml sterile water for injection and injected. For i.v. injection, 250mg (potency) is dissolved in 2ml, and 750mg(potency) in 6ml, and 1.5(potency) in 15ml sterile water for injection and injected. In case of i.v. drip infusion, 1.5(potency) is dissolved in 50ml sterile water for injection and the infusion should last at least 30 minutes. It is desirable not to use sodium bicarbonate solution as diluent.
a. Patients with history of shock to cefuroxime sodium or cefuroxime axetile.
2. Should be given cautiously in the fol owing patients.
a. 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.
b. Patients with history of hypersensitivity to penicillins.
c. Patients oneself or whose parents, sisters or brothers are prone to suffer from allergic symptoms such as bronchial asthma, exanthema, urticaria, etc.
d. Patients with severe renal disorder.
e. Patients with poor oral ingestion or parenteral nutrition patients, elderly patients, patients with poor general conditions (cautious monitoring is required since vitamin K deficiency may occur).
a. Shock : as shock may rarely occur, cautious monitoring is required, and in case that abnormality occurs, further administration should be discontinued and appropriate measures taken.
b. Skin: Since Stevens-Johnson syndrome (muco cutaneous ocular syndrome), erythema multiforme or Lyell syndrome (toxic epidermal necrolysis) may rarely occur, cautious monitoring is required, and in case that such symptoms occur, further administration should be discontinued.
c. Hypersensitivity: in case pruritus, exanthema (erythema, wheals, etc), pyrexia, urticaria, lymph node swelling, arthralgia or anaphylactic reaction occur, further administration should be discontinued and appropriate measures taken.
d. Renal: since several 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.
e. Hematologic: rarely reduction of heamoglobin concentration, anemia, granulocytopenia, leukopenia, thrombocytopenia, occasional y neutropenia, eosinophila may occur. Also, when other cephem antibiotics are administered, it has been reported that heamolytic anemia occurred.
f. Hepatic: Occasionally elevation of GOT, GPT AND AL – P, rarely abnormality of hepatic function such as elevation of LDH and γ – GTP may occur.
g. 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.
h. Respiratory: Since intersitial 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.
i. Superinfection: rarely candida intertrigo may occur.
j. Vitamin deficiency: rarely symptoms of vitamin K deficiency (jypoprothrombinemia, zhemorrhage tendency, etc.) and vitamin B deficiency (glossitis, stomititis, anorexia, neuritis, etc.) may occur.
k. Other: rarely paralysis may occur.
1. 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.
2. in order to predict adverse reactions such as shock, etc. patient history should be taken in detail and skin reaction test should be performed.
3. emergency measures have to be available in preparation for occurrence of shock, and even after measures taken the patients should be observed cautiously in stable condition.
4. it is desirable to perform laboratory test (hepatic function, renal function, blood, etc.) at regular intervals during treatment.
5. this drug can be administered with combination of aminoglycosides antibiotics or Metronidazole. However, these drugs must be not mixed in a syringe.
Cautious treatment is required as renal insufficiency may be worsened with combination of diuretics such as furosemide or aminoglycoside antibiotics. In case of elderly patients or patients with a history of renal dysfunctions, renal function should be monitored.
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.
Since this drug is excreted in the breastmilk, cautions are advised in nursing mothers.
1. 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.
2. 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.
It has been reported that the 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.
Store in a hermetic container at temperature not exceeding 25˚C.
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Manufactured by:SHIN POONG PHARM. CO., LTD.
434 – 4 Moknae – Dong, Ansan – si, Kyunggi – Do. Korea
Exclusively Distributed by: LARGEN MED., INC.
Unit 1604 Antel Global Bldg. J. Vargas St. Ortigas
Center, Pasig City
has met the requirements of the IAS Accreditation Criteria for Testing Laboratories (AC89), has demonstrated compliance with ISO/IEC Standard 17025:2005, General requirements for the competence of testing and calibration laboratories , and has been accredited, commencing August 9, 2013, for the test methods listed in the approved scope of accreditation. (see attached scope of accreditation for
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