CEFUROXIME DRUG MONOGRAPH

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HARAMAYA UNIVERSITY HIWOT FANA COMPREHENSIVE
SPECIALIZED HOSPITAL
DRUG AND POISON INFORMATION SERVICE (DPIS)
PREPARED BY SALAHADIN MOHAMMED (B.PHARM)
MAY, 2022
HARAR, ETHIOPIA

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Cefuroxime (systemic) Drug Monograph
Introductory Information
Antibacterial; β-lactam antibiotic: second generation cephalosporin.
Action: Inhibits mucopeptide synthesis in bacterial cell wall.
Class: 8:12.06.08 Second Generation Cephalosporin
Chemistry:

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Brands*: Ceftin®, Zinacef®, Kefurox®
Preparations:
Cefuroxime
Tablets; oral: 125, 250 and 500 (as
axetil) (Rx)
Various, ceftin (Glaxowellcome)
Suspension; oral: 125, 250 and 500
(as axetil)/5 mL (when reconstituted)
(Rx)
Ceftin (Glaxowellcome)
Injection, powder for solution: 750 mg,
1.5 g and 7.5 g (as sodium)/vial (Rx)
Various, zinacef (Glaxowellcome)
Injection: 750 mg and 1.5 g (as
sodium) (Rx)
Zinacef (Glaxowellcome)
Excipients in commercially available drug preparations may have clinically
important effects in some individuals; consult specific product labeling for
details.

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Cefuroxime Axetil
Routes Dosage Forms Strengths Brand Names Manufacturer
Oral For suspension 125 mg (of
cefuroxime)
per 5 mL*
Ceftin® GlaxoSmithKline
Cefuroxime
Axetil for
suspension
250 mg (of
cefuroxime)
per 5 mL*
Ceftin® GlaxoSmithKline
Cefuroxime
Axetil for
suspension
Tablets, film-coated 125 mg (of
cefuroxime)*
Cefuroxime
Axetil Tablets
250 mg (of
cefuroxime)*
Ceftin® GlaxoSmithKline
Cefuroxime
Axetil Tablets
500 mg (of
cefuroxime)*
Ceftin® GlaxoSmithKline
Cefuroxime
Axetil Tablets
*available from one or more manufacturer, distributer, and/or repackager by
generic (nonproprietary) name

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Cefuroxime Sodium
Routes Dosage Forms Strengths Brand Names Manufacturer
Parenteral For injection 750 mg (of
cefuroxime)*
Cefuroxime
Sodium for
Injection
Zinacef* GlaxoSmithKline
1.5 g (of cefuroxime) Cefuroxime
Sodium for
Injection
Zinacef* GlaxoSmithKline
7.5 g (of cefuroxime)
pharmacy bulk package
Cefuroxime
Sodium for
Injection
Zinacef® GlaxoSmithKline
For injection,
for iv infusion
750 mg (of
cefuroxime)*
Cefuroxime for
Injection and
Dextrose
Injection
Zinacef® ADD-
Vantage®
GlaxoSmithKline
Zinacef®
Infusion Pack
GlaxoSmithKline
1.5 g (of cefuroxime) Cefuroxime for
Injection and
Dextrose
Injection
Zinacef® ADD-
Vantage
GlaxoSmithKline
Zinacef®
Infusion Pack
GlaxoSmithKline
*available from one or more manufacturer, distributer and/or repackager by
generic (nonproprietary) name

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Cefuroxime Sodium in Dextrose
Routes Dosage Forms Strengths Brand Names Manufacturer
Parenteral Injection (frozen),
for IV infusion
15 mg (of
cefuroxime)
per mL (750
mg) in 2.8%
Dextrose
Zinacef® in Iso-osmotic
Dextrose Injection
(Galaxy®[Better])
GlaxoSmithKline
Cefuroxime Sodium in Water
Routes Dosage Forms Strengths Brand Names Manufacturer
Parenteral Injection (frozen), for
IV infusion
30 mg (of
cefuroxime)
per mL (1.5 g)
Zinacef® in Iso-
osmotic in Sterile
Water Injection
(Galaxy®[Better])
GlaxoSmithKline
Comparative Pricing
This pricing information is subject to change at the sole direction of DS
Pharmacy. This pricing information was updated 03/2011. For the most
current and up-to-date pricing information, please visit www.drugstore.com.
Actual costs to patients will vary depending on the use of specific retail or mail-
order locations and health insurance copays.
Ceftin 250MG Tablets (GLAXO SMITH KLINE): 20/$213.98 or 60/$601.95.
Ceftin 500MG Tablets (GLAXO SMITH KLINE): 20/$359.97 or 60/$1049.98.
Cefuroxime Axetil 500 MG Tablets (RANBAXY PHARMACEUTICALS): 20/$96.99
or 60/$269.95.
† Use is not currently indicated in the labeling approved by the US Food and
Drug Administration.

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Generic Name: Cefuroxime Sodium
CAS Number: 56238-63-2
Chemical Name: [6R-[6α,7β(Z)]]-3-[[(2-Aminocarbonyl)oxy]methyl]-7-[2-
furanyl(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid monosodium salt
Generic Name: Cefuroxime Axetil
CAS Number: 64544-07-6
Chemical Name: [6R-[6α,7β(Z)]]-3-[[(2-Aminocarbonyl)oxy]methyl]-7-[2-
furanyl(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid
Molecular formula: C16H16N4O8S
Uses
Acute Otitis Media (AOM)
Treatment of AOM caused by streptococcus pneumonia, Haemophilus
influenzae (including β-lactamase-producing strains), Morexella Catarrhalis
(including β-lactamase-producing strains), or S. pyogenes.
Not a drug of choice; considered a preferred to amoxicillin or amoxicillin
clavulanate when these drugs are ineffective or cannot be used (e.g., in
patients with a history of non-type 1 hypersensitivity reactions to penicillin).
Bone and Joint Infections
Parenteral treatment of bone and joint infections caused by susceptible
Staphylococcus aureus (including penicillinase-producing strains).
Meningitis
Parenteral treatment of meningitis caused by susceptible S. pneumonia,
H.influenzae. (including ampicillin-resistant strains) Neisseria meningitidis, or
S. aureus (including penicillinase-producing strains).

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Not a drug of choice for meningitis; treatment failures have been reported,
especially in meningitis caused by H. influenzae. In addition, bacteriologic
response to cefuroxime appears to be slower than that reported with
ceftraixone, which may increase the risk for hearing loss and neurologic
squelae. When a cephalosporin is indicated for the treatment of bacterial
meningitis, parenteral third generation cephalosporin (usually ceftriaxone or
cefotaxime) generally recommended.
Pharnygitis and Tonsillitis
Treatment of pharnygitis and tonsillitis caused by S. pyogenes (group A β-
hemolytic streptococci. Generally effective in eradicating S. pyogenes from
nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not
been estabilished.
CDC, AAP, IDSA AHA, and others recommend oral penicillin V or IM penicillin G
benzathine as treatments of choice; oral cephalosporins and oral macrolides
considered alternatives. Amoxicillin sometimes used instead of penicillin V,
especially for young children.
Respiratory Tract Infections
Treatment of acute maxillary sinusitis caused by susceptible S. pneumonia or
H. influenza (non-β-lactamase-producing strains only). Data insufficient to date
to estabilish for treatment of acute maxillary sinusitis known or suspected to
be caused by β-lactamase-producing strains of H. influenzae or M. catarrhalis.
Treatment of secondary bacterial infections of acute bronchitis caused by
susceptible S. pneumoniae,H. influenza (non-β-lactamase-producing strains
only), or H. parainfluenzae (non-β-lactamase-producing strains only).
Treatment of acute exacerbation of chronic bronchitis caused by susceptible S.
puemoniae,H. influenae (non-β-lactamase-producing strains only), or H.
parainfluenzae (non-β-lacatamase-producing strains only).
Parenteral treatment of lower respiratory tract infections (pneumonia) caused
by susceptible S. puemonia, S. auerus (including penicillinase-producing
strains), S. pyogenes (group A β-hemolytic streptococci), H. influenzae
(including ampicillin-resistant strains), Escherichola coli, Kleibsiella.

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Treatment of community-acquired pneumonia (CAP). Recommended by ATS
and IDSA as an alternative for treatment of CAP caused by penicillin-
susceptible S. pneumonia. Also recommended as an alternative in certain
combination regimens used for emperic treatment of CAP. Select regimen for
CAP based on most likely pathogens and local susceptibility patterns; after
pathogen is identified, modify to provide more specific therapy (pathogen
direct-therapy).
For empiric outpatient treatment of CAP when risk factors for drug-resistant S.
pneumonia are present (e.g., comorbidities such as chronic heart, lung, liver, or
renal disease, diabetes, alcoholism, malignancies, asplenia,
immunosuppression; use of anti-infectives with in the 3 months), ATS and IDSA
recommend monotherapy with a fluoroquinolone active against S. puemoniae
(moxifloxacin, gemifloxacin, levofloxacin) or, alternatively a combination
regimen that includes a β-lactam active against S. pueminiae (high-dose
amoxicillin or fixed combination amoxicillin and clavulanic acid or, alternatively,
ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide
(azithromycin, clarithromycin, erythromycin) or doxycycline. Cefuroxime and
cefpodoxime may be less active against S. puemoniae than amoxicillin or
ceftriaxone.
If parenteral treatment of septicemia is used as alternative to penicillin G or
amoxicillin for treatment of CAP caused by penicillin-susceptible S.
pnuemoniae, ATS and IDSA recommend ceftriaxone, cefotaxime or cefuroxime;
if an oral cephalosporin for treatment of these infections, ATS and IDSA
recommend cefpodoxime, cefprozil, cefuroxime, cefdinir, or cefditoren.
Septicemia
Parenteral treatment of septicemia caused by susceptible S. aureus (including
penicillin-producing strains), S. pneumoniae, E.coli, H.influenzae (including
ampicillin-resistant strains), Klebsiella.
In the treatment of known or suspected sepsis or the treatment of other
serious infections when the causative organism is unknown, concomitant
therapy with aminoglycoside may be indicated pending results of invitro
susceptibility tests.

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Skin and skin structure infections
Oral treatment of skin and skin structure infections caused by susceptible S.
aureus (including β-lactamase-producing strains) or S. pyogenes.
Parentral treatment of skin and skin structure infections caused by susceptible
S. aureus (including β-lactamase-producing strains), S. pyogenes, E. coli,
Klebsiella, or Enterobacter.
Urinary Tract Infections (UTIs)
Oral treatment of uncomplicated UTIs caused by susceptible E. coli or K.
pnuemoniae.
Parenteral treatment of UTIs caused by susceptible E. coli, or K. pnuemoniae.
Gonorrhea and Associated Infections
Oral or parenteral treatment of uncomplicated gonorrhea caused by N.
gonorrhoeae. May be effective in urethral, endocervical and rectal gonorrhea;
not recommended for pharyngeal infections. Not drug of choice for treatment
of treatment of uncomplicated gonoccal infections; oral cefuroxime may be an
alternative for uncomplicated urogenital and anorectal infections when IM
ceftriaxone or oral cefixime cannot be used.
Parentaral treatment of uncomplicated gonococcal infections caused by
susceptible N. gonorrhoeae. Not included in CDC current recommendations for
disseminated gonococcal infections.
Lyme Disease
Treatment of early Lyme Disease manifested as erythema migrans. IDSA, AAP,
and other clinicians recommend oral doxycycline, oral amoxicillin, or oral
cefuroxime axetil as first-line therapy for treatment early localized or early
disseminated Lyme Disease associated with erythema migrans, in the absence
of specific neurologic involvement or advanced atrioventicular (AV) heart block.
Treatment of early Lyme Disease in patients with cranial nerve palsy alone
without evidence of meningitis (i.e., those with normal CSF examination or
those for whom CSF examination deemed unnecessary because there are no

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clinical signs of meningitis). Parenteral anti-infectives (IV ceftriaxone, IV
penicillin G sodium, IV cefotaxime) recommended for treatment of early Lyme
disease when there are no acute neurologic manifestations such as meningitis
or radiculopathy.
Treatment of Lyme carditis. IDSA and other state that patients with AV hear
block and/or myopericarditis associated with early Lyme Disease may be
treated with oral regimen (doxycycline, amoxicillin, or cefuroxime axetil) or a
parenteral regimen (IV ceftriaxone or, alternatively, IV cefotaxime or IV penicillin
G sodium). A parenteral regimen usually recommended for initial treatment of
hospitalized patients; an oral regimen can be used to complete therapy and for
the treatment of outpatients.
Treatment of borrelial lymphocytoma. Although experience is limited, IDSA
states that available data indicate that borrelial lymphocytoma may be treated
with an oral regimen (doxycyline, amoxicillin, or cefuroxime axetil).
Treatment of uncomplicated Lyme arthritis without clinical evidence of
neurologic disease). An oral regimen (doxycycline, amoxicillin, or cefuroxime
axetil) can be used, but a parenteral regimen (IV ceftriaxone or, alternatively, IV
cefotaxime or IV penicillin G sodium) should be used in those with Lyme
arthritis and concomitant neurologic disease. Patients with resistant or
recurrent joint swelling after a recommended oral regimen should receive
retreatment with oral regimen or a switch a parenteral regimen. Some
clinicians prefer retreatment with oral regimen for those with arthritis
substantively improve but did not completely resolve; these clinicians reserve
parenteral regimens for those patients whose arthritis failed to improve or
worsened. Allow several months for joint inflammation to resolve after initial
treatment before an additional course of anti-infectives is given.
Perioperative Prophylaxis
Perioperative prophylaxis in patients undergoing noncardiac thoracic or
orthopedic surgery. A preferred agent.
Has been used for perioperative prophyalxis in patients undergoing surgery, GI
surgery, or gynecologic or obstetric surgery (e.g., vaginal hysterectomy). Other
drugs usually preferred.

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Dosage and Administration
Administration
Administer cefuroxime axetil orally. Administer cefuroxime sodium by IV
injection or infusion or by deep IM injection.
IV route preferred in patients with septicemia or other severe or life threatening
infections or in patients with lowered resistance, particularly if shock is
present.
Cefuroxime ADD-Vintage® vials, Duplex® drug delivery system containing
cefuroxime and dextrose injection in separate chambers, and the commercially
available premixed cefuroxime injection (frozen) should be used only for IV
infusion.
Oral Administration
Oral suspension must be administered with food.
Tablets may be given orally without regard to meals, but administration with
food maximizes bioavailability.
Children 3 months to 12 years of age unable to swallow tablets should receive
the oral suspension. Although the tablets have been crashed and mixed with
food (e.g., applesauce, ice cream), the crashed tablets have a strong, a strong
persistent taste and the manufacturers state that the drug should be not
administered in this manner.
Oral – Tablets and suspension are not bioequivalent and not suitable on a
mg/mg basis.
Tablets: Tablets may be given without regard to meals.
Suspension: administer with food.

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Dosage for Cefuroxime Axetil Tablets
Population/Infection Dosage Duration (days)
Adults (≥13 years of age)
Pharngitis/Tonsillitis 250 mg twice daily 10
Acute bacterial maxillary
sinusitis
250 mg twice daily 10
Acute bacterial
exacerbations of
bacterial bronchitis
250 mg or 500 mg twice
daily
10
Secondary bacterial
infections of acute
bronchitis
250 mg or 500 mg twice
daily
5 to 10
Uncomplicated skin and
skin structure infections
250 mg or 500 mg twice
daily
10
Uncomplicated urinary
tract infections
250 mg twice daily 7 to 10
Uncomplicated
gonorrhea
1,000 mg once Single dose
Early Lyme disease 500 mg twice daily 20
Children who can swallow tablets wholeb
Acute otitis media 250 mg twice daily 10
Acute bacterial maxillary
sinusitis
250 mg twice daily 10
a Safety and efficacy of drug administered less than 10 days in patients with
acute exacerbations chronic bronchitis have not been established.
b Do not exceed adult recommended dosage.

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Dosage for Cefuroxime Axetil suspension
Population/Infection Dosage Daily Maximum Dose Duration (days)
Infants and children (3 months to 12 years of age)
Pharngitis/Tonsillitis 20 mg/kg/day divided
twice daily
500 mg 10
Acute otitis media 30 mg/kg/day divided
twice daily
1,000 mg 10
Acute bacterial
maxillary sinusitis
30 mg/kg/day divided
twice daily
1,000 mg 10
Impetigo 30 mg/kg/day divided
twice daily
1,000 mg 10
Renal failure: Because renal failure is renally eliminated, its half-life will be
prolonged in patients with renal failure.
Reconstitution
Reconstitute powder for oral suspension at the time of dispensing by adding
the amount of water specified on the bottle to provide a suspension a
containing 125 or 250 mg of cefuroxime per 5 ml of suspension.
Tap the bottle to thoroughly loosen the powder; add the water in a single
portion and shake vigorously. Shake suspension well just prior to each use and
replace the cap securely after each opening.
IV injection
Reconstitution
Reconstitute vials containing 750 mg or 1.5 of cefuroxime with 8 or 16 ml of
sterile water for injection, respectively, to provide solutions containing
approximately 90 mg/mL.
Rate of Administration
Inject appropriate dose of reconstituted solution directly into a vein over a
period of 3-5 minutes or slowly into the tubing of a freely flowing compatible IV
solution.

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Parenteral -
Dosage:
Adults – 750 mg to 1.5 g IM or IV every 8 hours, for 5 to 10 days.
Cefuroxime Dosage Guidelines
Type of infection Daily dosage
(g)
Frequency
Uncomplicated urinary tract infection, skin
and skin structure, disseminated
gonococcal, uncomplicated pneumonia
2.25 750 mg every 8
h
Severe or complicated 4.5 1.5 g every 8 h
Bone and joint 4.5 1.5 g every 8 h
Life-threatening or caused by less
susceptible organisms
6 1.5 g every 6 h
Bacterial meningitis 9 ≤ 3 g every 8 h
Uncomplicated gonococcal 1.5 g IMb Single dose
a administered at 2 different sites together with 1 g oral probenecid.
Preoperative prophylaxis: For clean-contaminated or potentially contaminated
surgical procedures, administer 1.5 g IV prior to surgery (approximately ½ to 1
hour before). Therefore, give 750 mg IV or IM every 8 hours when the
procedure is prolonged.
For preventive use during open heart surgery, give 1.5 g IV at the induction of
anesthesia and every 12 hours thereafter for a total of 6 g.
Renal function impairment: Reduce dosage.
Parenteral Cefuroxime dosage in renal function impairment (adults)
CrCl (mL/min) Dose and frequency
> 20 750 mg to 1.5 g every 8 h
10 to 20 750 mg every 12 h
< 10 750 mg every 24 h a
acefuroxime dialyzable, give patients on hemodialysis a further at the end of
dialysis.

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Infants and children (3 months of age and older) – 50 to 100 mg/kg/day in
equally divided doses every 6 to 8 hours. Use 100 mg/kg/day (not to exceed
the maximum adult dose) for more severe or severe infections.
Bone and joint infections: 150 mg/kg/day (not to exceed maximum adult dose)
in equally divided doses every 8 hours.
Bacterial meningitis: Initially, 200 to 240 mg/kg/day IV in divided doses every
6 to 8 hours.
In renal function impairment, modify dosage frequency per adult guidelines.
(Drug facts and comparison, 2009)
IV infusion
Other IV infusions flowing through a common administration tubing or site
should be discontinued while cefuroxime is being infused unless the solutions
are to be compatible and the flow rate is adequately controlled. If an
aminoglycoside is concomitantly with cefuroxime, the drugs should be
administered at separate sites.
Reconstitution and Dilution
For intermittent or continous IV infusion, 100 ML of sterile water for injection,
5% dextrose injection, 0.9% sodium chloride injection, or compatible IV solution
may added to an infusion pack labeled as containing 750 mg or 1.5 g of
cefuroxime to provide solutions containing 7.5 or 15 mg/5mL, respectively.
Reconstitute 7.5-g pharmacy bulk package according to manufacturer’s
directions and then further dilute in a compatible IV infusion solution.
Reconstitute ADD-Vantage® vials containing 750 mg or 1.5 g according to
manufacturer’s directions.
Reconstitute (activate) the commercially available Duplex® drug delivery
system containing 750 mg or 1.5 g of crystalline cefuroxime and 50 mL of
dextrose injection in separate chambers according to manufacturer’s
directions.

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Thaw the commercially available premixed cefuroxime injection (frozen) at
room temperature (250C) or in a refrigerator (50C); do not force thaw by
immersion in a water bath or by exposure to microwave radiation. A precipitate
may have formed in the frozen, but should dissolve little or no agitation after
reaching room temperature. Discard thawed injection if insoluble precipitate is
present or if container seals or outlet ports are not intact. Do not in serious
connections with other plastic containers since such use could result in air
embolism from residual air being drawn from the primary container before
administration of fluid from the secondary container is complete.
Rate of Administration
Intermittent IV infusions generally infused over 15-60 minutes.
IM Injection
Administer IM injections deeply into a large muscle mass such as the gluteus
or lateral aspect of the thigh. Use aspiration to ensure needle is not in a blood
vessel.
Reconstitutions
Prepare IM injections by reconstituting vial containing 750 mg of cefuroxime
with 3 mL of sterile water for injection to provide a suspension containing
approximately 220 mg/dL.
Shake IM suspension gently prior to administration.
Dosage
Available as cefuroxime axetil or cefuroxime sodium; dosage expressed in
terms of cefuroxime.
Tablets and oral suspension are not bioequivalent and are not substitutable on
a mg/mg basis.

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Pediatric Patients
General Pediatric Dosage
Mild to Moderate Infections
Oral: AAP recommended 20-30 mg/kg daily given in 2 divided doses in children
>4 weeks of age.
IV or IM: AAP recommended 75-100 mg/kg daily given in 3 divided doses in
children >4 weeks of age.
Manufacturer states 50-100 mg/kg daily given in 3 or 4 equally divided doses
has been effective for most infections in children ≥3months of age.
Severe Infections
Oral: Oral route appropriate for severe infections per AAP.
IV or IM: AAP recommends 100-150 mg/kg daily given in 3 divided doses in
children >4 weeks of age.
Manufacturer recommends 100 mg/kg daily given in 3 or 4 equally divided
doses for ≥3months of age.
Acute Otitis Media (AOM)
Children >3 Months to 12 Years of Age
Oral: Tablets (for children able to swallow tablets whole): 250 mg twice daily for
10 days.
Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses
for 10 days.
Bone and Joint Infections
Children 3 Months to 12 Years of Age
IV or IM: 150 mg/kg daily given in equally divided doses every 8 hours.

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Meningitis
Children 3 Months to 12 Years of Age
IV or IM: 200-240 mg/kg daily given in equally divided doses every 6-8 hours.
Pharnygitis and Tonsillitis
Children 3 Months to 12 Years of Age
Oral: Oral suspension: 20 mg/kg daily (maximum 500 mg daily) in 2 divided
doses for 10 days.
Adolescents’ ≥13 Years of Age
Oral: Tablets: 250 mg twice daily for 10 days.
Respiratory Tract Infections
Acute Sinusitis in Children 3 Months to 12 Years of Age
Oral: Tablets (for children able to swallow tablets whole): 250 mg twice daily for
10 days.
Oral suspension: 30 mg/kg daily (maximum 1 g daily) given in 2 divided doses
for 10 days.
Acute Sinusitis in Adolescents ≥13 Years of Age
Oral: Tablets: 250 mg twice daily for 10 days.
Secondary Bacterial infections of Acute Bronchitis in Adolescents ≥13 Years of
Age
Oral: Tablets: 250 or 500 mg twice daily for 5-10 days.
Acute Exacerbations of Chronic Bronchitis in Adolescents ≥13 Years of Age
Oral: Tablets: 250 or 500 mg twice daily for 10 days. Efficacy of regimens <10
days has not been established.

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Skin and Skin Structure Infections
Impetigo in Children 3 Months to 12 Years of Age
Oral: Oral suspension: 30 mg/kg (maximum 1 g daily) in 2 divided doses for 10
days.
Uncomplicated Infections in Adolescents ≥13 Years of Age
Oral: Tablets: 250 or 500 mg twice daily for 10 days.
Urinary Tract Infections (UTIs)
Uncomplicated Infections in Adolescents ≥13 Years of Age
Oral: Tablets: 250 mg twice daily for 7-10 days.
Gonorrhea and Associated Infections
Uncomplicated Urethral, Cervical, or Gonorrhea in Adolescents ≥13 Years of
Age
Oral: Tablets: 1 g single dose.
Lyme Disease
Early Localized or Early Disseminated Lyme Disease Manifested as Erythema
Migrans
Oral: Tablets: 500 mg twice daily for 20 days in adolescents’ ≥13 years of age.
AAP, IDSA, and others recommend 30 mg/kg (maximum 500 mg) administered
in divided doses for 14 days (range 14-21 days) in children without specific
neurologic involvement advanced AV heart block.
Early Neurologic Lyme disease
Oral: 30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14
days (14-21 days) recommended by IDSA for children for cranial nerve palsy
alone without clinical evidence of meningitis.

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Lyme Carditis
Oral: 30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14
days (14-21 days) recommended by IDSA.
Borrelial Lymphocytoma
Oral: 30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 14
days (14-21 days) recommended by IDSA.
Lyme Arthritis
Oral: 30 mg/kg daily in 2 equally divided doses (up to 500 mg per dose) for 28
days recommended by IDSA for children with uncomplicated Lyme arthritis
without clinical evidence of neurologic disease.
Perioperative Prophylaxis
Cardiac, Cardiothoracic, or Noncardic Thoracic Surgery
IV: 50 mg/kg given at induction of anesthesia (within 0.5-1 hour prior to
incision). Some experts suggest additional doses of 50 mg/kg every 8 hours for
up 48-72 hours; others state that prophylaxis for ≤24 hours is appropriate.
Adults
General Adult Dosage
IV or IM
750-1.5 g every 8 hours for 5-10 days.
Life-threatening Infections or Those Caused by Less Susceptible Organisms
IV or IM: 1.5 g every 6 hours.
Bone and Joint Infections
IV or IM
1.5 g every 8 hours.

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Meningitis
IV or IM
Up to 3 g every 8 hours.
Pharynigitis and Tonsillitis
Oral: Tablets: 250 mg twice daily for 10 days.
Secondary Bacterial Infections of Acute Bronchitis
Oral: Tablets: 250 or 500 mg twice daily for 5-10 days.
Acute Exacerbation of Chronic Bronchitis
Oral: Tablets: 250 or 500 mg twice daily for 10 days. Efficacy has not been
established.
Pneumonia
Oral: 500 mg twice daily recommended by ATS and IDSA for empiric treatment
of community-acquired pneumonia (CAP). Must be used in conjunction with
other anti-infectives for empiric treatment of CAP. (see Respiratory Tract
Infections under uses)
IV or IM: 750 mg every 8 hours. For severe or complicated infections, 1.5 g
every 8 hours.
Skin and Skin Structure Infections
Uncomplicated Infections
Oral: Tablets: 250 mg twice daily for 7-10 days.
IV or IM: 750 mg every 8 hours.
Severe or Complicated Infections
IV or IM: 1.5 g every 8 hours.

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Urinary Tract Infections (UTIs)
Uncomplicated Infections
Oral: Tablets: 250 mg twice daily for 7-10 days.
IV or IM: 750 mg every 8 hours.
Severe or Complicated Infections
IV or IM: 1.5 g every 8 hours.
Gonorrhea and Associated Infections
Uncomplicated Urethral, Cervical, or Rectal Gonorrhea
Oral: Tablets: 1 g as a single dose.
IM: 1.5 g as a single dose; divide the dose, give at different sites. given in
conjunction 1 g of probenecid.
Disseminated Gonococcal Infections
IV or IM: 750 mg every 8 hours.
Lyme Disease
Early Localized or Localized Disseminated Lyme disease Manifested as
Erythema Migrans
Oral: Tablets: 500 mg twice daily for 20 days.
IDSA and others recommend 500 mg twice daily for 14 days (14-21 days) in
adults without specific neurologic involvement or advanced AV heart block.
Early Neurologic Lyme disease
Oral: 500 mg twice daily for 14 days (range 14-21 days) recommended by IDSA
for adults with cranial nerve palsy alone without clinical evidence of meningitis.

24. Page | 24
Lyme Carditis
Oral: 500 mg twice daily for 14 days (range 14-21 days) recommended by
IDSA.
Borrelial Lymphocytoma
Oral: 500 mg twice daily for 14 days (range 14-21 days) recommended by
IDSA.
Lyme Arthritis
Oral: 500 mg twice daily for 28 days recommended by IDSA for adults with
uncomplicated Lyme arthritis without clinical evidence of neurologic disease.
Perioperative Prophylaxis
Non Cardiac Thoracic or Orthopedic Surgery
IV: Single 1.5-g dose given within 60 minutes before the procedure.
If the procedure is prolonged >4 hours or major blood loss occurs, give
additional doses every 3-4 hours during the procedure. Postoperative doses
usually unnecessary and may increase risk of bacterial resistance.
Cardiac Surgery
IV: For open-heart surgery, manufacturers recommend 1.5 g given of at the
time of induction of anesthesia and 1.5 g every 12 hours thereafter for a total
dosage of 6g.
During prolonged procedures (>4 hours) or if major blood loss occurs, some
clinicians state that additional anti-infective doses should be given every 3-4
hours during the procedure. There is some evidence that single-dose anti-
infective prophylaxis may be as effective as 48-hour prophylaxis; there is no
evidence of benefit beyond 48 hours.
For cardiothoracic surgery and heart and/or lung transplantation, some experts
suggest additional 1.5-g doses every 12 hours for up to 48-72 hours; others
state that prophylaxis <24 hours is appropriate. There is no evidence to

25. Page | 25
support continuing prophylaxis until chest and mediastinal drainage tubes are
removed.
Other Surgery
IV or IM: Manufacturer recommends 1.5 g given IV just prior to surgery
(approximately 0.5-1 hour prior to initial incision) and, in lengthy operations,
750 mg IV or IM every 8 hours. Postoperative doses usually unnecessary and
may increase risk of bacterial resistance.
Special Populations
Renal Impairment
Dosage adjustments of parentral cefuroxime necessary in patients Clcr ≤20
mL/minute.
Adults with impaired renal function: 750 mg IM or IV every 12 hours in those
with Clcr 10-20 mL/minute or 750 mg or 750 mg IM or IV every 12 hours in
those Clcr <10 mL/minute.
Patients undergoing hemodialysis: Give a supplemental dose parentral
cefuroxime after each dialysis period.
Children with impaired renal function: Make adjustments to dosing frequency
for IM or IV cefuroxime similar to those recommended for adults with renal
impairment.
Safety and efficacy of oral cefuroxime in patients with renal impairment not
established.
Geriatric Patients
Cautious dosage selection because of age-related diseases in renal function.
(See Renal Impairment under Dosage and Administration).

26. Page | 26
Cautions
Contraindications
Known hypersensitivity to cefuroxime or other cephalosporins.
Warnings/Precautions
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Possible emergence and overgrowth of nonsusceptible organisms with
prolonged therapy.
Careful observation of the patient is essential. Institute appropriate therapy if
superinfection occurs.
Treatment with anti-infectives alters normal colon flora and may permit
overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis
(CDAD; also known as antibiotic-associated diarrhea and colitis or
pseudomonas colitis) has been reported with nearly all anti-infectives,
including cefuroxime, and may range in severity from mild diarrhea to fatal
colitis. Hyper toxin-producing strains of C. difficile are associated with
increased morbidity and mortality since they may be refractory to anti-
infectives and colectomy may be required.
Consider CDAD if diarrhea develops during or after therapy manage
accordingly. Careful medical history is necessary since CDAD has been
reported to occur as late as 2 months or longer after anti-infective is
discontinued.
Some mild cases may respond to discontinuance alone. Manage moderate to
severe cases with fluid, electrolyte, and protein supplementation, anti-infective
therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and
surgical evaluation when clinically indicated.

27. Page | 27
Sensitivity Reactions
Hypersensitivity Reactions
Possible hypersensitivity reactions, including rash (maculopapular or
erythematous), pruiritus, fever, eosinophilia, urticaria, anaphylaxis, erythema
multiforme, Steven-Johnson syndrome, and toxic epidermal necrolysis.
If an allergic reaction occurs, discontinue and institute appropriate therapy as
indicated (e.g., epinephrine, corticosteroids, maintenance of adequate airway
and oxygen).
Cross-hypersensitivity
Partial cross-sensitivity among cephalosporins and β-lactam antibiotics,
including penicillins and cephamycins.
Prior to initiation of therapy, make careful inquiry concerning previous
hypersensitivity reactions to cephalosporins; penicillins or other drugs.
Cautious use in individuals hypersensitivity to penicillins. Avoid use in those
who have had an immediate-type (anaphylactic) hypersensitivity reaction and
administer with caution in those who have had a delayed-type (e.g., rash, fever,
eosinophilia) reaction.
General Precautions
History of GI Disease
Used with caution in patients with a history of GI disease; particularly colitis.
(See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under
Cautions.)
Prolonged PT
Prolonged PT reported with some cephalosporins.
Monitor PT in patients at risk, including those with renal or hepatic impairment,
poor nutritional state, receiving prolonged therapy, or stabilized on
anticoagulant therapy. Administer vitamin K when indicated.

28. Page | 28
Renal Effects
Periodically evaluate renal status during therapy, especially in seriously ill
patients receiving maximum dosage.
Caution if used concomitantly with nephrotoxic drugs (e.g., aminoglycosides,
potent diuretics). (See Interactions)
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness
of cefuroxime and other antibactrials, use only for treatment or prevention of
infections or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use of culture results and in
vitro susceptibility testing. In the absence of such data, consider local
epidemiology and susceptibility patterns when selecting anti-infectives for
empiric therapy.
Patients with Meningitis
Mild to moderate hearing loss reported in pediatric patients who received
cefuroxime for treatment of meningitis.
Persistence of positive CSF cultures 18-36 hours reported; clinical importance
unknown.
Phenylketonuria
ceftin® oral suspensions containing 125 or 250 mg of cefuroxime/5 mL
contain aspartame (Nutrasweet®), which is metabolized in the GI tract to
provide 11.8 or 25.2 mg phenyalanine/5 mL, respectively.
Sodium content
Cefuroxime sodium contains approximately 54.2 mg (2.4 mEq) of sodium per g
of cefuroxime.

29. Page | 29
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk. Use with caution.
Pediatric Use
Safety and efficacy of oral parentral cefuroxime not established in children <3
months of age. Other cephalosporins accumulate in neonates resulting serum
half-life.
Safety and efficacy of oral cefuroxime for treatment of acute bacterial maxillary
sinusitis in pediatric patients 3 months to 12 years of age have been
established based on safety and efficacy of the drug in adults. In addition, use
of oral cefuroxime in pediatric patients is supported by pharmacokinetic and
safety data in adult and pediatric patients, clinical and microbilogic data from
adequate and well controlled studies of the treatment of acute bacterial
maxillary sinusitis in adults and acute otitis media with effusion in pediatric
patients, and post marketing surveillance of adverse effects.
Tablets should not be crushed for pediatric administration since the drug has
pediatric a strong, persistent, bitter taste, vomiting was induced aversively in
some children who received crushed tablets. The oral suspension should be
used in children who cannot swallow tablets whole.
To avoid over dosage, the commercially available duplex® drug delivery system
containing 750 mg or 1.5 g of cefuroxime and 50 mL of dextrose injection in
separate chambers but should not be used in pediatric patients unless the
entire 750-mg or 1.5-g dose is required.
Geriatric Use
No overall differences in safety and efficacy in those >65 years of age
compared with younger adults, but the possibility increased sensitivity in some
geriatric individuals cannot be ruled out.

30. Page | 30
Substantially eliminated by kidneys; risk of toxicity may be greater in those with
impaired renal function. Select dosage with caution; renal function monitoring
may be useful because of age-related decreases in renal function. (See Renal
Impairment under Dosage and Administration.)
Renal Impairment
Possible decreased clearance and increased serum half-life.
Dosage adjustments of parentral cefuroxime necessary in patients with ClCr
≤20 mL/minute. (See Renal Impairment under Dosage and Administration.)
Safety and efficacy of oral cefuroxime in patients with renal impairment not
established.
Common Adverse Effects
GI effects (nausea, vomiting, diarrhea/loose stools), hypersensitivity reactions,
local reactions at IV injection sites.

31. Page | 31
Interactions
Specific Drugs and Laboratory Tests
Drug or Test Interaction Comments
Aminoglycosides
Nephrotoxicity reported
with concomitant use of
some cephalosporins
and aminoglycosides
Invitro evidence of
additive or synergistic
antibacterial activity
against some
enterobacteriaceae
Administer separately;
do not admix
Diuretics Possible increased risk
of nephrotoxicity if used
concomitantly with
potent diuretics
Use concomitantly with
caution
Estrogens or progestins May affect gut flora,
leading to decreased
oxygen reabsorption and
reduced efficacy of oral
contraceptives
containing estrogen and
progestin
Probenecid Decreased clearance
and increased serum
concentrations and half-
life of cefuroxime
Test for glucose Possible false-positive
reactions in urine
glucose tests using
Clinitest®, Benedicts
solution, or Fehling’s
solution
Use glucose tests based
on enzymatic glucose
oxidase reactions (e.g.,
Clinistix®, Test-Tape®)

32. Page | 32
Pharmacokinetics
Absorption
Bioavailability
Following oral administration of cefuroxime axetil, the drug is absorbed from
the GI tract as the 1-(acetyloxy)ethyl ester and rapidly hydrolyzed to cefuroxime.
Cefuroxime axetil has little, if any, microbiologic activity until hydrolyzed in vivo
to cefuroxime.
Oral suspension is not bioequivalent to tablets.
In adults receiving film-coated tablets, peak serum concentrations attained
within 2.7-3.6 hours.
Cefuroxime sodium not appreciably absorbed from the GI tract; must be
parentrally. Following IM administration in healthy adults, peak serum
concentrations attained within 15-60 minutes.
In women, serum cefuroxime concentrations are lower when IM injections are
given into the gluteus maximus rather than into the thigh.
Food
In adults, bioavailability following oral administration of film-coated tablets
averages about 37% when given in the fasting state and 52% when given with
or shortly after food.
Absorption increased when cefuroxime axetil given with milk or infant formula.
The extent (but not rate) of absorption substantially greater when administered
concomitantly with milk compared with applesauce or fasting.
Distribution
Extent
Following IV or IM administration, widely distributed into body tissues and fluids
including peritoneal fluid, joint fluid, bile, sputum, bone, and aqueous humor.

33. Page | 33
Therapeutic concentrations may be attained in CSF following IV administration
in patients with inflamed meninges.
Readily crosses the placenta and is distributed into milk.
Plasma Protein Binding
33-55%.
Elimination
Metabolism
Following oral administration, cefuroxime axetil rapidly hydrolyzed to
cefuroxime by nonspecific estrases in the intestinal mucosa and blood.
Cefuroxime not metabolized.
Elimination route
Eliminated unchanged principally unchanged.
Half-life
Adults: 1.2-1.6 hours following oral administration and 1-2 hours following IV or
IM administration.
Neonates and children: Half-life inversely proportional to age.
Special Populations
Patients with renal impairment: Serum half-life prolonged and generally ranges
from 1.9-16.1 hours depending on the degree of impairment. Serum half-life of
15-22 hours has been reported in anuric patients.
Stability
Storage
Oral
Tablets
15-300C in tight container.

34. Page | 34
For suspension
2-300C . Following reconstitution, store immediately at 2-80C. discard any
unused suspension after 10 days.
Parenteral
Powder for Injection or Infusion
15-300C; protect from light.
Powder for injection and solutions may darken; does not indicate loss of
potency.
IV solutions containing 90 mg of cefuroxime/mL prepared using sterile water
for injection are stable for 24 hours at room temperature or 48 hours at 50C.
Reconstituted solutions further dilated in 100 mL of compatible IV solution are
stable for 24 hours at room temperature or 7 days at 5OC.
IV suspensions containing 220 mg/mL prepared using sterile water for
injection are stable for 24 hours at room temperature or 48 hours at 5OC.
Powder for Injection, for IV Infusion
Reconstituted ADD-Vantage® vials prepared using 5% dextrose injection or 0.9
or 0.45% sodium chloride injection are stable for 24 hours at room
temperature or 7 days under refrigeration; joined ADD-Vantage® vials that
have not been activated may be used within a 14-day period.
Store commercially available Duplex® drug delivery system containing 750 mg
or 1.5 mg of cefuroxime and 50 mL of dextrose injection at 20-250C (may be
exposed to 15-300C). Following reconstitution (activation), use these infusions
within 24 hours if stored at room temperature or within 7 days if stored within
in a refrigerator; do not freeze.
Injection (frozen) for Infusion
-200C or lower. After thawing, stable for 24 hours at room temperature (250C)
or up to 28 days under refrigeration (50C).
Do not freeze after thawing.

35. Page | 35
Compatibility
For more information on systemic interactions resulting concomitant use, see
interactions.
Parenteral
Solution compatibility
Sodium bicarbonate not recommended as diluent.
Compatible
Dextrose 5 or 10% in water.
Dextrose 5% in sodium chloride 0.2, 0.45 or 0.9%
Invert sugar 10% in water
Ringer’s injection
Sodium chloride 0.9%
Sodium lactate (1/6) M
Drug Compatibility
Admixture Compatibility
Compatible
Clindamycin phosphate
Floxacillin sodium
Forosemide
Metronidazole
Midazolam HCl
Incompatible
Ciprofloxacin
Ranitidine HCl
Variable
Gentamicin sulfate

36. Page | 36
Y-Site Compatibility
Compatible
Acyclovir sodium
Allopurinol sodium
Amifosine
Amiodarone HCl
Atracurium byselate
Aztreonam
Bivaluridin
Cyclophosphamide
Dexamedetomidine HCl
Dilitiazem HCl
Docetaxel
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fludarabine phosphate
Foscarnate sodium
Gemcitabine HCl
Granisetron HCl
Hetastrach in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Linezolid
Melphaline HCl
Meperidine HCl
Milrinone lactate
Morphine sulfate
Ondanestron HCl
Pancuronium bromide
Perphenazine
Propofol
Remifentanil HCl
Sargramostim
Tacrolimus
Teniposide
Thiotepa
Vecuronium bromide
Incompatible
Azithromycin

37. Page | 37
Clarithromycin
Filgrastim
Fluconazole
Midazolam HCl
Vinorelbine tartrate
Variable
Cisatracurium besylate
Vancomycin HCl

38. Page | 38
Actions and Spectrum
 Based on spectrum of activity, classified as a second generation
cephalosporin. Generally no more active in vitro against susceptible gram-
positive cocci than first generation cephalosporins, but has an extended
spectrum of activity against gram-negative bacteria compared with first
generation drugs. ‘
 Usually bactericidal.
 Like other β-lactum antibiotics, antibacterial activity results from
inhibition of bacterial cell wall synthesis.
 Spectrum of activity includes many gram-positive aerobic bacteria, some
gram-negative aerobic bacteria, and some anaerobic bacteria; inactive against
Chlamydia, fungi, and viruses.
 Gram-positive aerobes: active in vitro and in clinical infections against
Staphylococcus aureus, S. epidermidis, Streptococcus pneumonia, S.
pyogenes (group A β-hemolytic streptococci), and other streptococci. Oxacillin-
resistant (methicillin-resistant) staphylococci, Listeria monocytogenes, and
most enterococci (e.g., Entercoccus faecalis) are resistant.
 Strains of staphylococci resistant to penicillinase-resistant penicillins
(oxacillin-resistant staphylococci) should be considered resistant to cefuroxime
and cefuroxime axetil, although results of in vitro susceptibility tests may
indicate that the organisms are susceptible to the drug. In addition, β-
lactamase-negative, ampicillin-resistant (BLNAR) strains of H. influenza should
be considered resistant to cefuroxime and cefuroxime axetil despite the fact
that the results of in vitro susceptibility tests may indicate that the organisms
are susceptible to the drug.
 Gram-negative aerobes: Active in vitro and in clinical infections against
Citrobacter, Escherichia coli, Haemophilus influenza (ampicillin-resistant
strains), H. parainfluenzae (including K. pneumoniae), Morexalla catarrhalis
(ampicillin-resistant strains), Morgnella morganii, Neisseria gonorrhea, N.
meningitides, Proteus mirabilis, Providential rettgeri, Salmonella, and Shigella.
Some strains of Citrobacter, E. coacae, and M. moraganii are resistant.
Acinetobacter calcoaceticus, Legionella, Campylobacter, Pseodomonas, P.
vulgaris, Serratia usually resistant.

39. Page | 39
 Anaerobes: Active in vitro against Bacteroides (except B. fragilis),
Clostridium (except C. difficile), Fusobacterium, Pepticus, and
Peptostreptococcus.
Advice to Patients
 Advice to patients that antibacterials (including cefuroxime) should only be
used to treat bacterial infections; they do not treat viral infections (e.g., the
common cold).
 Importance of completing full course of therapy, even if feeling better after
few days.
 Advise patients that skipping doses or not completing the full course of
therapy may decrease effectiveness and increase the likelihood that
bacteria will develop resistance and will not be treatable with cefuroxime or
other antibacterials in the future.
 Advise patients that diarrhea is a common problem caused by anti-
infectives and usually ends when the drug is discontinued. Importance of
contacting a clinician if watery and bloody stools (with or without stomach
cramps and fever) occur during or as late as 2 months or longer after the
last dose.
 Advise individuals with phenylketonuria and other individuals who must
restrict their intake of phenylalanine that ceftin® oral suspensions contain
aspartame (Nutrasweet®), which is metabolized in the GI tract to
phenylalanine.
 Importance of informing clinicians if an allergic reaction occurs.
 Importance of women informing clinicians if they are or plan to became
pregnant or plan to breast-feed.
 Importance of informing clinicians of existing or contemplated concomitant
therapy, including prescription and OTC drugs as well as any concomitant
illnesses.
 Importance of informing patients of other important precautionary
information.

40. Page | 40
Interactions
Aminoglycosides: Increased risk of nephrotoxicity with parenteral cefuroxime.
Probenicid: Inhibition of excretion of cefuroxime. INCOMPATIBILITIES:
Aminoglycosides: Do not add aminoglycosides to cefuroxime solutions because
inactivation of both drugs may result; administer at separate sites if concurrent
therapy is indicated.
Lab Test Interferences
May cause false-positive glucose test result with Benedict’s solution. Fehling’s
solution, or Clinitest tablets but not with enzyme-based tests (eg, Clinistix, Test-
tape); false-positive test results for proteinuria with acid and denaturalization-
precipitation tests; false-positive Coombs’ test results in certain patients (eg,
those with azotemia); false elevations in urinary 17-ketosteroid values; false-
negative reaction with ferricyanide test for blood glucose.
Adverse Reactions
GI: Nausea; vomiting; anorexia; abdominal pain or cramps; flatulence; colitis,
including pseudomonas colitis. GU: Pyuria; renal dysfunction; dysuria;
reversible interstitial nephritis; hematuria; toxic nephropathy. HEMA:
Eosinophilia; neutropenia; lymphocytosis; leukocytosis; thrombocytopenia;
decreased platelet function; anemia; aplastic anemia; hemorrhage. HEPA:
Hepatic dysfunction; abnormal liver function test results. OTHER:
Hypersensitivity, including Stevenson-Johnson syndrome, erythema multiforme,
toxic epidermal necrolysis; candidal overgrowth; serum sickness-like reactions
(eg, skin rashes, polyarthritis, arthralgia, fever); phlebitis, thrombophlebitis and
pain at the injection site.
Precautions
Pregnancy: Category B. Lactation: Excreted in breast milk. Children: Safety and
efficacy in children <3 mo not established. Hypersensitivity: Reactions range
from mild to life threatening. Administer drug with caution to penicillin-sensitive
patients due to possible cross-reactivity. Pseudomembraneous colitis: Should
be considered in whom diarrhea develops. Renal impairment: Use drug with
caution in patients with renal impairment. Dosage adjustment based on renal

41. Page | 41
function may be required. Superinfection: May result in bacteria or fungal
overgrowth of non-susceptible microorganisms.
PATIENT CARE CONSIDERATIONS
Administration/Storage
 Sodium salt is for parenteral administration. Axetil salt is for oral
administration.
 Administer oral form with food to enhance absorption.
 May crush and mix with food or beverages; however, crushed tablets
have strong, persistent bitter taste. Consider alternative therapy if children
cannot swallow whole tablets.
 Reconstituted solution should be light yellow to amber. Do not administer
if solution is cloudy or precipitate is present.
 When giving by IM route, shake IM suspension gently before
administration. Aspirate to prevent injection into blood vessel. Inject deeply
into large muscle (eg, upper quadrant of gleutus muscle or lateral thigh);
massage well. Rotate injection sites.
 When giving IV route, use direct intermittent infusion. Administer slowly
over 3-5 min. Change IV sites q 48-72 hr.
 For intermittent IV infusion with Y-type administration set, administer
over 30 min. and temporarily stop other solutions at Y-site.
 For continuous infusion, reconstituted solution may be further diluted
with D5W or 0.9% Sodium Chloride.
 Reconstituted solution is stable for 24 hr at room temperature. When
refrigerated, solution in vials is stable for 48 hr; IV solution is stable for 7 days
when refrigerated.
 Completely thaw frozen solution at room temperature before use; do not
refreeze.
 Do not add supplementary medication to premixed solution.
 Store sterile powder at room temperature and protect from light.
 Store tablets at room temperature.

42. Page | 42
Assessment/Interventions
 Obtain patient history, including drug history and any known drug
allergies. Note renal impairment and allergy to cephalosphorins or penicillins.
 Obtain specimens for culture and sensitivity before beginning therapy
and periodically during treatment.
 Monitor renal function carefully during treatment.
 Monitor for signs of infection, especially fever, and for positive response
to antibiotic therapy.
 Assess for signs and symptoms of anaphylaxis (shortness of breath,
wheezing, laryngeal spasm). Have resuscitation equipment available.
 Assess for signs for superinfection, such as vaginitis or stomatitis.
 Assess for diarrhea with blood or pus, which may be symptom of
pseudomembraneous colitis. Symptom may occur after antibiotic treatment.
 Monitor IV site for infiltration, infection and thrombophlebitis.

43. Page | 43
References
1. AHFS Drug Information Essentials, 2011.
2. A to Z drug facts, 2003.
3. Drug facts and comparisons, 2009.