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CEFUROXIME FOR is a brand name for Cefuroxime, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CEFUROXIME FOR INJECTION, USP (Cefuroxime for Injection) is indicated for: Treatment Cefuroxime for Injection, USP may be indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: • Lower Respiratory Tract Infections: Pneumonia caused…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Cefuroxime for Injection, USP (sterile cefuroxime sodium) may be administered intravenously after reconstitution. Dosage and route of administration should be determined by severity of infection, susceptibility of the causative organism(s), and condition of the patient.
The intravenous route is preferable for patients with severe or life-threatening infections. The usual duration of treatment is 5 to 14 days. For β-hemolytic streptococcal infections, therapy should be continued for at least 10 days.
25 g / day), administered intravenously. 5 g / day) is recommended. For treatment of bacterial meningitis, a dosage of 3 g intravenous every 8 hours (9 g / day) should be used. 5 g / day) is recommended. Surgical intervention should be performed when indicated as an adjunct to cefuroxime therapy.
A course of oral antibiotics should be administered when appropriate following the completion of parenteral administration of Cefuroxime for Injection, USP. Infants and Children (1 month to 12 years) The usual dosage range is 30 to 100 mg / kg / day in 3 or 4 equally divided doses.
A dose of 60 mg / kg / day is appropriate for most infections. In cases of bacterial meningitis*, a dosage of 200 to 240 mg / kg / day intravenous in 3 or 4 equally divided doses should be used. For bone and joint infections, a dosage of 70 to 150 mg / kg / day administered intravenously every 8 hours is recommended.
In clinical trials, a course of oral antibiotics was administered to children following the completion of parenteral administration of Cefuroxime for Injection, USP. Doses in excess of the maximum adult dose should not be used in infants and children.
Neonates (up to 1 month) In the first few weeks of life, the serum half-life of cefuroxime can be 3 to 5 times that in adults. Infections in neonates should be treated with dosages in the range of 30 to 100 mg / kg / day in 2 or 3 equally divided doses.
For bacterial meningitis,* a dosage of 100 mg / kg / day intravenous in 2 or 3 equally divided doses should be used. * Delayed sterilization of cerebral spinal fluid has been reported in a few children treated with cefuroxime for bacterial meningitis.
Hearing impairment has occasionally occurred as a complication of meningitis in children treated with cefuroxime.
3 Adverse Reaction Overview The following reactions have been observed during treatment with Cefuroxime for Injection, USP. Hypersensitivity Rash, and eosinophilia. Anaphylaxis, urticaria, pruritus and drug fever have also been observed with cephalosporin treatment.
Like other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (exanthematic necrolysis). Local reactions Thrombophlebitis, stiffness at the site of injection, and inflammatory reactions at the site of injection; some degree of pain, after intramuscular injections when using water as diluent, has been observed.
CEFUROXIME FOR INJECTION, USP (Cefuroxime for Injection) Page 12 of 33 Blood Increased erythrocyte sedimentation rate and decreased hemoglobin; eosinophilia, leukopenia and neutropenia; some patients developed a positive direct Coombs’ test.
Renal Increases in BUN and serum creatinine. Hepatic Transient increases in serum bilirubin, transaminases and alkaline phosphatase. Others Drowsiness, loose stools, faint feeling, sweating, palpitations and Candida intertrigo.
, Immune. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3– Dosage Forms, Strengths, Composition and Packaging Cefuroxime for Injection, USP (sterile cefuroxime sodium) is available as follows: • 15 mL vials containing cefuroxime sodium powder equivalent to 750 mg of cefuroxime in packages of 10 vials.
5 g of cefuroxime, in packages of 10 vials. 7 WARNINGS AND PRECAUTIONS Gastrointestinal Cefuroxime for Injection, USP should be administered with caution to individuals with a history of gastrointestinal disease, particularly colitis.
Pseudomembranous colitis has been reported to be associated with cefuroxime therapy (and other broad-spectrum antibiotics). Therefore, it is important to consider its diagnosis in patients administered Cefuroxime for Injection, USP who develop diarrhea.
Treatment with broad-spectrum antibiotics, including cefuroxime, changes the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of antibiotic- associated colitis.
Mild cases of colitis may respond to drug discontinuance alone. Moderate to severe cases should be managed with fluid, electrolyte, and protein supplementation as needed. When the colitis is not relieved by discontinuance of Cefuroxime for Injection, USP administration or when it is severe, consideration should be given to the administration of vancomycin or other suitable therapy.
Other possible causes of colitis should also be considered. 5 g / vial None CEFUROXIME FOR INJECTION, USP (Cefuroxime for Injection) Page 10 of 33 Immune Before therapy with Cefuroxime for Injection, USP is instituted, careful enquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefuroxime, cephalosporins, penicillins, or other drugs.
• Cefuroxime for Injection, USP (Cefuroxime for Injection) is contraindicated for patients who have shown Type I hypersensitivity to cefuroxime or to the cephalosporin group of antibiotics, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Prevention:
Clean contaminated or potentially contaminated surgical procedures. 5 g of Cefuroxime for Injection, USP administered intravenously just prior to surgery. This may be supplemented with 750 mg at 8 and 16 hours when surgery is prolonged.
In general, prophylactic administration is normally not required after the end of surgical procedures, however, intraoperative administrations should be considered if the surgical procedure is lengthy. CEFUROXIME FOR INJECTION, USP (Cefuroxime for Injection) Page 7 of 33 In many surgical procedures, continuing prophylactic administration of any antibiotic does not appear to be related with a decreased incidence of subsequent infection, but will increase the possibility of adverse reactions and the development of bacterial resistance.
5 g of Cefuroxime for Injection, USP administered intravenously at the induction of anesthesia and every 12 hours thereafter for 48 hours.
Dosage in Patients with Impaired Renal Function:
For patients with markedly impaired renal function, a reduced dosage of Cefuroxime for Injection, USP must be used. For adult patients with moderate infections, dosage adjustment may be made according to the guidelines listed in Table 1.
5 g 750 mg 750 mg q8h q12h q24h For adults with severe infections who require doses higher than those recommended in Table 1, serum levels of cefuroxime should be monitored and dosage adjusted accordingly. Studies in children with renal impairment are not sufficient to recommend specific dosages.
If it is necessary to administer Cefuroxime for Injection, USP to a child with such impairment, consideration should be given to modifying the frequency of drug administration consistent with the recommendations for adults with renal impairment as indicated in Table 1.
When only serum creatinine levels are known, the following formulas may be used to estimate creatinine clearance. The serum creatinine must represent a steady state of renal function. 85 x male value For patients on hemodialysis, a further 750 mg dose of Cefuroxime for Injection, USP should be administered at the end of each dialysis treatment.
3 Reconstitution For Intravenous Use Reconstitute with Sterile Water for Injection. 0 mL Total 90 mg / mL Shake well until dissolved. 9% w / v, or 5% w / v Dextrose Injection. 5 g of Cefuroxime for Injection, USP is dissolved in 49 mL of Sterile Water for […]
Cefuroxime for Injection, USP should be administered with caution to any patient who has shown some form of allergy, particularly to drugs. There is some clinical and laboratory evidence of partial cross-allergenicity of the cephalosporins and penicillins.
, epinephrine, antihistamines, corticosteroids) administered as required. Monitoring and Laboratory Tests Cefuroxime may interfere with Benedict's and Fehling's tests for glycosuria. It may cause false-negative reactions in the ferricyanide test, and therefore it is recommended that either the glucose oxidase or hexokinase methods be used to determine blood / plasma glucose levels in patients receiving cefuroxime.
Cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method. 2 Recommended Dose and Dosage Adjustment. Normal dosages in these individuals are likely to produce excessive serum concentrations of cefuroxime.
The concomitant administration of aminoglycosides and some cephalosporins has caused nephrotoxicity. Although transient elevations of BUN and serum creatinine have been seen in clinical studies, there is no evidence that cefuroxime when administered alone, is significantly nephrotoxic.
Studies suggest that the concurrent use of potent diuretics, such as furosemide and ethacrynic acid, may increase the risk of renal toxicity with cephalosporins. Sensitivity/Resistance Development of Drug Resistant Bacteria. Prescribing Cefuroxime for Injection, USP in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Prolonged treatment with cefuroxime may result in the overgrowth of nonsusceptible organisms, including species originally sensitive to the drug. Repeated evaluation of the patient's condition is required. If superinfection occurs during therapy, appropriate measures should be taken.
Should an organism become resistant during antibiotic therapy, another antibiotic should be substituted. Skin Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (FEN) have been reported in association with beta-lactam CEFUROXIME FOR INJECTION, USP (Cefuroxime for Injection) Page 11 of 33 treatment.
When SCAR is suspected, Cefuroxime for Injection, USP should be discontinued and appropriate therapy and/or measures should be taken. 1 Pregnant Women The safety of Cefuroxime for Injection, USP in pregnancy has not been established.
The use of cefuroxime in pregnant women requires that the potential benefit from the drug be weighed against the possible risk to the mother and fetus. Animal studies have shown cefuroxime to affect bone calcification in the fetus and to show maternal toxicity in the rabbit.
5 mg / L). The clinical significance of this is unknown; therefore, caution should be exercised when Cefuroxime for Injection, USP is administered to a nursing mother. 3 Pediatrics As with other therapeutic regimens used in the treatment of meningitis, hearing loss has been reported in a few pediatric patients treated with cefuroxime.
Persistence of positive CSF cultures of Haemophilus influenzae at 18 - 36 hours has been noted with cefuroxime. The safety of the use of Cefuroxime for Injection, USP in […]