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Kefurox

Kefurox

cefuroxime

Manufacturer:

Samchundang Pharm

Distributor:

PHARMASIA
Full Prescribing Info
Contents
Cefuroxime sodium.
Description
White to yellowish powder.
Each vial contains: Cefuroxime (as sodium) equivalent to Cefuroxime 750 mg.
Action
Antibacterial.
Indications/Uses
Main indications: Acute chronic bronchitis, bronchiectasis (with infection), pulmonary abscesses, bacterial pneumonia, chest infection after operation, paranasal sinusitis, tonsilitis, acute chronic pyelonephritis, cystitis, pharyngitis, bacterial urine without symptoms, cellulitis, erysipelas peritonitis, infection of lanceolate, septic arthritis, myelitis sepsis, gonorrhea, meningitis, prevention from infection after the following operations: the abdominal region, the pelvis, orthopedic treatment, heart, lung, esophagus, the blood vessel operation.
This drug can be used in the following diseases: intrauterine infection, bartholinitis.
Dosage/Direction for Use
Adult: Administer 750 mg three times daily intravenously or intramuscularly. In severe cases, the dose maybe raised to 1.5 g three times daily intravenously. If necessary, frequency of administration may be raised to four times and the total daily dose is 3 to 6 g.
Children and Infant: Administer 30 to 100 mg/kg/day of Cefuroxime 3 to 4 times in divided dose by IM or IV. Usually, it is reasonable for 60 mg/kg/day.
Neonate: Administer 30 to 100 mg/kg/day 2 to 3 times in divided doses by IM or IV. During 1 week after birth, administer carefully, because serum half-life of Cefuroxime could be prolonged 3 to 5 times as many as that of adult.
Gonorrhea: Administer 1.5 g once intramuscularly or could equally administer 750 mg in both side of the breech.
Renal Failure Patient: In light renal failure case, it need not adjust dose of administration, but in mild failure case (10 to 20 mL/min in creatinine clearance.) It is enough to administer 750 mg twice a day. In severe renal failure case (below 10 mL/min in creatinine clearance), it would be reasonable to administer 750 mg/day. In hemodialysis cases, administer 750 mg more after hemodialysis. In the case of performed continuously artery and venous dialysis or high fast hematofiltration, it is reasonable to administer 750 mg twice a day and in the case of performed slow hematofiltration follow that of general renal failure.
Protection from operation after operation.
The abdominal, pelvis, orthopedic treatment: administer 1.5 g intravenously in usually inducing anesthesia and can add to 750 mg intramuscularly each time after 8 hours and 16 hours.
The heart, lung, esophagus, or blood vessel operation: administer 750 mg/day for 24 to 48 hours three times by IM, after administering 1.5 g by IV in usually including anesthesia.
Total joint replacement: Before adding liquid monomer, may use to mix Cefuroxime powder 1.5 g with each pack of methyl methacrylate cement polymer.
Meningitis: Adult: Administer 3 g three times a day by IV; Children and Infant: Administer 200 to 240 mg/kg/day 3 to 4 times in divided doses by IV. If clinical symptoms are improved or after 3 days of treatment, it could be reduced to 10 mg/kg in dose; Neonate: Initial dose is recommended 100 mg/kg/day by IV, if symptoms are improved, it could be reduced to 50 mg/kg/day in dose.
Direction for Reconstitution: In the intramuscular injection, administer it with suspension after putting the water for injection 2 mL per 250 mg.
In the intravenous injection, administer it after putting water for injection over 2 mL in 250 mg, over 6 mL in 750 mg, over 15 mL in 1.5 g.
In the infusion, administer it for 30 minutes after melting 1.5 g in water for injection 50 mL. But, for sodium bicarbonate injection solution, it is desirable not to use it as diluting agent.
Contraindications
Patients with history of shock to this drug or Cefuroxime axetil.
Special 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 reaction 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.
It is permitted to administer with aminoglycosides and metronidazole, but do not mix in the same syringe.
Adverse Reactions
Shock: as shock may rarely occur cautious monitoring is required, and if abnormality is acknowledged further administration should be discontinued and appropriate measures taken.
Skin: as Steven-Johnson's syndrome, erythema multiforme syndrome and Lyell syndrome (toxic epidermonecrosis) may rarely occur, cautious monitoring is required, and in case that such syndrome occur, further administration should be discontinued.
Hypersensitivity: in case that pruritus, exanthema (erythema, wheal, etc.) fever, urticaria, lymphadenopathy, arthralgia, anaphylactic reaction occur, further administration should be discontinued and appropriate measures taken.
Kidney: as severe renal disorder such as renal insufficiency may occur, cautious monitoring is required and if abnormality is acknowledged, further administration should be discontinued and appropriate measures taken.
Blood: rarely reduction of hemoglobin concentration, anemia, granulocytopenia, thrombocytopenia, occasionally neutropenia, eosinophilia may occur. Also, it is reported that hemolytic anemia may occur with other cephems.
Liver: occasionally hepatic function disorder such as elevation of ALT, AST, AL-P, rarely elevation of bilirubin, LDH, y-GPT, may occur.
GI system: rarely severe enterocolitis with hemafecia such as pseudomembranous enterocolitis may occur. If abdominal pain and frequent diarrhea occur, appropriate measures such as immediate discontinuation of Cefuroxime should be taken. Also, occasionally nausea, diarrhea or rarely abdominal vomiting, anorexia, etc. may occur.
Respiratory system: since interstitial pneumonia, PIE syndrome, etc. Accompanied with fever, cough, abnormal chest X-ray, in case that such symptoms occur, further dyspnea, adrenocortical steroid, etc. should be taken.
Superinfection: rarely candidal intertrigo may occur.
Vitamin deficiency: rarely symptoms of Vitamin K deficiency (hypoprothrombinemia, hemorrhage frequency, etc.) and vitamin B deficiency (glossitis, stomatitis, anorexia, neuritis, etc.) may occur.
Others: rarely numbness may occur.
Drug Interactions
Cautious treatment is required as renal insufficiency maybe worsened with combination of similar compounds (other aminoglycosides) and diuretics such as furosemide, etc. In case that aged people and patient with history of renal insufficiency, the monitoring of renal function should be required.
Storage
Store at temperatures not exceeding 25°C. Protect from light.
MIMS Class
Cephalosporins
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Kefurox powd for inj 750 mg
Packing/Price
(USP Type I colorless glass) 10 mL x 10 × 1's (P520/vial)
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