Cefuroxime-0.9% Nacl

Drug overview for CEFUROXIME-0.9% NACL (cefuroxime sodium in 0.9 % sodium chloride/pf):

Generic name: CEFUROXIME SODIUM IN 0.9 % SODIUM CHLORIDE/PF
Drug class: Ophthalmic Antibacterials
Therapeutic class: Ophthalmic Agents

Cefuroxime is a semisynthetic, second generation cephalosporin antibiotic.

Cefuroxime axetil is used orally for the treatment of mild to moderate respiratory tract infections (i.e., acute maxillary sinusitis, acute exacerbations of chronic bronchitis, secondary infections of acute bronchitis, community-acquired pneumonia+) caused by susceptible bacteria; acute bacterial otitis media; pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci); mild to moderate uncomplicated skin and skin structure infections caused by Staphylococcus aureus (including beta-lactamase-producing strains) or S. pyogenes; and uncomplicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae. Cefuroxime axetil also is used orally for the treatment of Lyme disease and has been used for the treatment of uncomplicated gonorrhea.

The manufacturers of cefuroxime axetil oral suspension state that safety and efficacy of the suspension have been established only for the treatment of pharyngitis and tonsillitis, acute otitis media, and impetigo caused by susceptible bacteria. and for the treatment of Lyme disease. Cefuroxime sodium is used parenterally in the treatment of lower respiratory tract infections (including pneumonia), serious skin and skin structure infections, genitourinary tract infections, bone and joint infections, septicemia, and meningitis caused by susceptible organisms.

Cefuroxime sodium also has been used parenterally for perioperative prophylaxis. Because cefuroxime, like other second generation cephalosporins, generally is less active against susceptible gram-positive cocci than are first generation cephalosporins, most clinicians state that cefuroxime probably should not be used in the treatment of infections caused by gram-positive bacteria when a penicillin or a first generation cephalosporin could be used. In addition, because cefuroxime generally is less active in vitro against Enterobacteriaceae than third generation cephalosporins, some clinicians state that a third generation drug such as cefotaxime or ceftriaxone generally is preferred if a parenteral cephalosporin is indicated in the treatment of infections known or suspected to be caused by these gram-negative bacteria.

Prior to initiation of cefuroxime therapy, appropriate specimens should be obtained for identification of the causative organism and in vitro susceptibility tests. If cefuroxime is started pending results of susceptibility tests, it should be discontinued if the causative organism is found to be resistant to the drug. In the treatment of known or suspected sepsis or the treatment of other serious infections when the causative organism is unknown, concomitant therapy with an aminoglycoside may be indicated pending results of in vitro susceptibility tests.

DRUG IMAGES

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The following indications for CEFUROXIME-0.9% NACL (cefuroxime sodium in 0.9 % sodium chloride/pf) have been approved by the FDA:

Indications:
None.

Professional Synonyms:
None.

The following dosing information is available for CEFUROXIME-0.9% NACL (cefuroxime sodium in 0.9 % sodium chloride/pf):

Dosing
Administration
Dosing Information
Generic

Dosage of cefuroxime axetil is expressed in terms of cefuroxime. Cefuroxime axetil tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis. (See Pharmacokinetics: Absorption.)

Dosage of cefuroxime sodium also is expressed in terms of cefuroxime and is identical for IM or IV administration.

For the treatment of uncomplicated skin and skin-structure infections in adults and adolescents 13 years of age or older, the usual oral dosage of cefuroxime given as cefuroxime axetil tablets is 250 or 500 mg twice daily for 10 days. For the treatment of uncomplicated urinary tract infections (UTIs), the usual oral dosage of cefuroxime given as cefuroxime axetil tablets is 125 or 250 mg twice daily for 7-10 days.

The usual parenteral adult dosage of cefuroxime given as cefuroxime sodium is 750 mg to 1.5 g every 8 hours. Uncomplicated UTIs, skin and skin structure infections, and uncomplicated pneumonia in adults generally respond to a parenteral dosage of 750 mg every 8 hours.

Severe or complicated infections or bone and joint infections in adults generally require 1.5 g every 8 hours and life-threatening infections or infections caused by less susceptible organisms may require 1.5 g every 6 hours.

Dosage of parenteral cefuroxime for the treatment of bacterial meningitis in adults should not exceed 3 g every 8 hours.

Cefuroxime axetil film-coated tablets and oral suspension are not bioequivalent and are not substitutable on a mg/mg basis. (See Pharmacokinetics: Absorption.)

For the treatment of most susceptible infections (except bone and joint infections or meningitis) in children 3 months of age or older, the manufacturers recommend a cefuroxime dosage of 50-100 mg/kg daily given IM or IV in equally divided doses every 6-8 hours; the manufacturer states that 100 mg/kg should be given IM or IV for more severe infections. The IM or IV dosage of cefuroxime recommended by the manufacturers for the treatment of bone and joint infections in children 3 months of age or older is 150 mg/kg daily in 3 divided doses every 8 hours.

The American Academy of Pediatrics (AAP) recommends that neonates 7 days of age or younger receive IM or IV cefuroxime in a dosage of 50 mg/kg every 12 hours, regardless of weight. Neonates 8-28 days of age should receive a dosage of 50 mg/kg every 8-12 hours if they weigh 2 kg or less or 50 mg/kg every 8 hours if they weigh more than 2 kg.

For pediatric patients beyond the neonatal period, the AAP recommends an IM or IV cefuroxime dosage of 75-100 mg/kg daily given in 3 equally divided doses for the treatment of mild to moderate infections or 100-200 mg/kg daily in 3 or 4 equally divided doses for the treatment of severe infections. These clinicians recommend that children beyond the neonatal period receive oral cefuroxime in a dosage of 20-30 mg/kg daily in 2 equally divided doses for the treatment of mild to moderate infections. The AAP states that oral cefuroxime is inappropriate for the treatment of severe infections.

Modification of usual dosage of parenteral cefuroxime is unnecessary in patients with creatinine clearances greater than 20 mL/minute. However, in patients with creatinine clearances of 20 mL/minute or less, doses and/or frequency of administration of parenteral cefuroxime must be modified in response to the degree of renal impairment, severity of the infection, and susceptibility of the causative organism. The manufacturers and some clinicians recommend that adults with creatinine clearances of 10-20 mL/minute receive 750 mg IM or IV every 12 hours and that adults with creatinine clearances less than 10 mL/minute receive 750 mg IM or IV every 24 hours.

In children with impaired renal function, the manufacturers recommend that the frequency of administration of parenteral cefuroxime be modified based on the recommendations for adults with impaired renal function.

In patients undergoing hemodialysis, a supplemental dose of parenteral cefuroxime should be given after each dialysis period.

Safety and efficacy of oral cefuroxime axetil in patients with renal impairment have not been established.

No enhanced Administration information available for this drug.

No dosing information available.

No generic dosing information available.

The following contraindication information is available for CEFUROXIME-0.9% NACL (cefuroxime sodium in 0.9 % sodium chloride/pf):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hypoprothrombinemia

The following precautions are available for CEFUROXIME-0.9% NACL (cefuroxime sodium in 0.9 % sodium chloride/pf):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Reproduction studies in mice and rabbits using cefuroxime sodium in dosages up to 6 and 2 times the usual human dosage based on mg/m2, respectively, and reproduction studies in mice and rats using cefuroxime axetil in dosages up to 14 and 9 times, respectively, the usual human dosage based on mg/m2 have not revealed evidence of impaired fertility or harm to the fetus. There are no adequate and controlled studies to date using cefuroxime in pregnant women, and cefuroxime axetil and cefuroxime sodium should be used during pregnancy only when clearly needed. Cefuroxime axetil has not been studied for use during labor and delivery.

Because cefuroxime is distributed into milk, cefuroxime axetil and cefuroxime sodium should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.