Cefproz are indicated for the treatment of patients with mild to moderate infections caused by
susceptible strains of the designated microorganisms in the conditions listed below:
Upper Respiratory Tract:
Pharyngitis/Tonsillitis:
Caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections,
including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route.
Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the
nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent
prevention of rheumatic fever are not available at present.

Otitis Media:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ßlactamaseproducing
strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamaseproducing
strains).
NOTE: In the treatment of otitis media due to ß-lactamase producing organisms, cefprozil had
bacteriologic eradication rates somewhat lower than those observed with a product containing a
specific ß-lactamase inhibitor. In considering the use of cefprozil, lower overall eradication
rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing ß-lactamase
inhibitors.
Acute Sinusitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase
producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing
strains).
Lower Respiratory Tract:
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of
Chronic Bronchitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including ß-lactamase -
producing strains), and Moraxella (Branhamella) catarrhalis (including ß-lactamase-producing
strains).

Skin and Skin Structure:
Uncomplicated Skin and Skin-Structure Infections:
Caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus
pyogenes. Abscesses usually require surgical drainage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil
and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns
may contribute to the empiric selection of therapy.

Cefprozil are administered orally.
Population/Infection Dosage
(mg)
Duration
(days)
ADULTS (13 years and older)
UPPER RESPIRATORY TRACT
Pharyngitis/Tonsillitis
Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)
LOWER RESPIRATORY TRACT
Secondary Bacterial Infection of Acute Bronchitis and
Acute Bacterial Exacerbation of Chronic Bronchitis
SKIN AND SKIN STRUCTURE
Uncomplicated Skin and Skin Structure Infections
500 q24h 10a
250 q12h or
500 q12h
500 q12h
250 q12h or
500 q24h or
500 q12h
10a
10
10
10

CHILDREN (2 years-12 years)
UPPER RESPIRATORY TRACTb
Pharyngitis/Tonsillitis
SKIN AND SKIN STRUCTUREb
Uncomplicated Skin and Skin Structure Infections
7.5mg/kg q12h
20 mg/kg q24h
10a
10
INFANTS & CHILDREN (6 months-12 years)
UPPER RESPIRATORY TRACTb
Otitis Media
Acute Sinusitis
(For moderate to severe infections, the higher dose
should be used)
15 mg/kg q12h
7.5 mg/kg q12h
or 15 mg/kg q12h
10
10

aIn the treatment of infections due to Streptococcus pyogenes, cefprozil should be
administered for at least 10 days.
bNot to exceed recommended adult doses.
Renal Impairment:
Cefprozil may be administered to patients with impaired renal function. The following dosage
schedule should be used.
Creatinine Clearance (mL/min) Dosage
(mg)
Dosing Interval
30-120 standard standard
0-29* 50% of standard standard

*Cefprozil is in part removed by hemodialysis; therefore, cefprozil should be administered after
the completion of hemodialysis.
Hepatic Impairment:
No dosage adjustment is necessary for patients with impaired hepatic function.
Directions for preparation:
1. Remove cap from bottle by pressing down and unscrewing.
2. Remove the desiccant capsule which is placed on the top of the bottle and discard.
3. Add sufficient quantity of water up to the bottle mark.
4. Replace the cap and shake well after addition of water until a homogeneous suspension is
obtained, check the volume and if required add water up to the bottle mark and shake well.

Warnings
Before Therapy with Cefproz is instituted, careful inquiry should be made to determine whether
the patient has had pervious hypersensitivity reaction to Cefprozil, cephalosporins, penicillin or
other drug. If Cefproz will be given to Penicillin sensitive patient, caution should be exercised
because of cross sensitivity among Beta-lactam antibiotic has been clearly documented and
incidace of cross sensitivity reach up to 10%. If any allergic reaction arise should discontinue
Cefproz treatment. Acute hypersensitivity reaction may require treatment with epinephrine and
other emergency measure including oxygen ventilation, intravenous fluids, IV antihistaminics,
corticosteroids, pressor amines and airway management as clinically indicated.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including Cefprozil, and may range in severity from mild diarrhea to fatal
colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to
overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the
development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these
infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must
be considered in all patients who present with diarrhea following antibiotic use. Careful medical
history is necessary since CDAD has been reported to occur over two months after the
administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may
need to be discontinued. Appropriate fluid and electrolyte management, protein
supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted
as clinically indicated.
Precautions
General:
Prescribing cefprozil in the absence of proven or strongly suspected bacterial infection or a
prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the
development of drug resistant bacteria.
In patients with known or suspected renal impairment, careful clinical observation and
appropriate laboratory studies should be done prior to and during therapy. The total daily dose
of cefprozil should be reduced in these patients because high and/or prolonged plasma antibiotic
concentrations can occur in such individuals from usual doses. Cephalosporins, including
cefprozil, should be given with caution to patients receiving concurrent treatment with potent
diuretics since these agents are suspected of adversely affecting renal function.
Prolonged use of cefprozil may result in the overgrowth of nonsusceptible organisms. Careful
observation of the patient is essential. If superinfection occurs during therapy, appropriate
measures should be taken.
Cefprozil should be prescribed with caution in individuals with a history of gastrointestinal
disease particularly colitis.
Positive direct Coombs’ tests have been reported during treatment with cephalosporin
antibiotics.

Patients should be counseled that antibacterial drugs including cefprozil should only be used to
treat bacterial infections. They do not treat viral infections (e.g., the common cold). When
cefprozil are prescribed to treat a bacterial infection, patients should be told that although it is
common to feel better early in the course of therapy, the medication should be taken exactly as
directed. Skipping doses or not completing the full course of therapy may (1) decrease the
effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will
develop resistance and will not be treatable by cefprozil or other antibacterial drugs in the
future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is
discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery
and bloody stools (with or without stomach cramps and fever) even as late as two or more
months after having taken the last dose of the antibiotic. If this occurs, patients should contact
their physician as soon as possible.

Nephrotoxicity has been reported following concomitant administration of aminoglycoside
antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the
AUC for cefprozil.
The bioavailability of the capsule formulation of cefprozil was not affected when administered 5
minutes following an antacid.
Drug/Laboratory Test Interactions:
Cephalosporin antibiotics may produce a false positive reaction for glucose in the urine with
copper reduction tests (Benedict’s or Fehling’s solution or with Clinitest® tablets), but not with
enzyme-based tests for glycosuria (e.g., Clinistix®). A false negative reaction may occur in the
ferricyanide test for blood glucose. The presence of cefprozil in the blood does not interfere
with the assay of plasma or urine creatinine by the alkaline picrate method.

Teratogenic Effects- Pregnancy Category B:
Reproduction studies have been performed in rabbits, mice, and rats using oral doses of
cefprozil of 0.8, 8.5, and 18.5 times the maximum daily human dose (1000 mg) based upon
mg/m2, and have revealed no harm to the fetus. There are, however, no adequate and wellcontrolled
studies in pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery:
Cefprozil has not been studied for use during labor and delivery. Treatment should only be
given if clearly needed.
Nursing Mothers:
Small amounts of cefprozil (<0.3% of dose) have been detected in human milk following
administration of a single 1 gram dose to lactating women. The average levels over 24 hours
ranged from 0.25 to 3.3 mcg/mL. Caution should be exercised when cefprozil
are administered to a nursing woman, since the effect of cefprozil on nursing infants is
unknown.

Cefprozil are not known to affect your ability to drive and use machines. Make sure you know
how you react to your medicine before you drive, use machines, or engage in any other activity
that could be dangerous if you are not alert.

The adverse reactions to cefprozil are similar to those observed with other orally administered
cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately
2% of patients discontinued cefprozil therapy due to adverse events.
The most common adverse effects observed in patients treated with cefprozil are:
Gastrointestinal:
Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).

Hepatobiliary:
Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and
bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics,
cholestatic jaundice has been reported rarely.
Hypersensitivity:
Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children
than in adults. Signs and symptoms usually occur a few days after initiation of therapy and
subside within a few days after cessation of therapy.
CNS:
Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence
have been reported rarely (<1%). All were reversible.
Hematopoietic:
Decreased leukocyte count (0.2%), eosinophilia (2.3%).
Renal:
Elevated BUN (0.1%), serum creatinine (0.1%).
Other:
Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).
The following adverse events, regardless of established causal relationship to cefprozil, have
been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis
(including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like
reactions,Stevens-Johnson syndrome, and thrombocytopenia.
Cephalosporin Class Paragraph:
In addition to the adverse reactions listed above which have been observed in patients treated
with cefprozil, the following adverse reactions and altered laboratory tests have been reported
for cephalosporin-class antibiotics:

Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis,
toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH,
pancytopenia, neutropenia, agranulocytosis.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with
renal impairment, when the dosage was not reduced. If seizures associated with drug therapy
occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically
indicated.

Single 5000 mg/kg oral doses of cefprozil caused no mortality or signs of toxicity in adult,
weanling, or neonatal rats, or adult mice. A single oral dose of 3000 mg/kg caused diarrhea and
loss of appetite in cynomolgus monkeys, but no mortality.
Cefprozil is eliminated primarily by the kidneys. In case of severe overdosage, especially in
patients with compromised renal function, hemodialysis will aid in the removal of cefprozil
from the body.

Cefprozil is a semisynthetic, broad-spectrum cephalosporin antibiotic (which acts to inhibit cell
wall synthesis in suitable organisms); it is currently available in an oral dosage form (i.e., tablet
and suspension) for the treatment of respiratory-tract and skin or skin structure infections in
both adults and children. While this agent has provided acceptable clinical success rates for its
approved indications when the infecting pathogen is Streptococcus pneumoniae, the
pharmacodynamic profile of cefprozil against this important pathogen has not been fully
described. Therefore, the present study was undertaken to better define the in vivo activity of
cefprozil against S. pneumoniae using a neutropenic murine thigh infection model, those
isolates of S. pneumoniae were utilized in the neutropenic murine thigh infection model. Mice
were infected with 106 to 107 CFU per thigh, and therapy was initiated 2 h later. At 0 and 24 h
post infection, thighs were harvested to determine bacterial density. Survival was assessed

during 96 h of therapy. The magnitude of bacterial kill ranged from 0.5 to 4.4 log10 CFU per
thigh over 24 h, and the extent of microbial eradication was dependent on the MIC. Killing of
more than 2.6 log10 CFU per thigh was observed with MICs of ≤3 μg/ml, while either minimal
killing or growth was detected with MICs of ≥4 μg/ml. Mortality in untreated control animals
was 100%. Animals infected with strains for which the MICs were ≤2 μg/ml survived the
infection, whereas MICs exceeding 2 μg/ml resulted in substantial mortality. These studies
demonstrate the effectiveness of cefprozil against isolates of the pneumococcus for which the
MICs are ≤2 μg/ml using a drug exposure typically observed in children. These data support a
susceptibility breakpoint of ≤2 μg/ml for cefprozil.
Microbiology
Cefprozil has in vitro activity against a broad range of gram-positive and gram-negative
bacteria. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis.
Cefprozil has been shown to be active against most strains of the following microorganisms
both in vitro and in clinical infections

Aerobic gram-positive microorganisms: Aerobic gram-negative microorganisms:
Staphylococcus aureus (including β-
lactamase-producing strains)
NOTE: Cefprozil is inactive against
methicillin-resistant staphylococci.
Haemophilus influenzae (including β-lactamaseproducing
strains)
Moraxella (Branhamella) catarrhalis (includingβ-
lactamase-Streptococcus pneumoniae producing strains)
Streptococcus pyogenes

Cefprozil is an orally active cephalosporin which has demonstrated activity against a wide range
of organisms in vitro; it is relatively stable to hydrolysis by a number of beta-lactamases.

Following oral administration of cefprozil to fasting subjects, approximately 95% of the dose
was absorbed. The average plasma half-life in normal subjects was 1.3 hours, while the steadystate
volume of distribution was estimated to be 0.23 L/kg. The total body clearance and renal
clearance rates were approximately 3 mL/min/kg and 2.3 mL/min/kg, respectively. Average
peak plasma concentrations after administration of 250 mg, 500 mg, or 1 g doses of cefprozil to
fasting subjects were approximately 6.1, 10.5, and 18.3 μg/mL, respectively.
During the first 4-hour period after drug administration, the average urine concentrations
following 250 mg, 500 mg, and 1 g doses were approximately700 μg/mL, 1000 μg/mL, and
2900 μg/mL, respectively.
Administration of Cefprozil as tablet or suspension formulation with food did not affect the
extent of absorption (AUC) or the peak plasma concentration (Cmax) of cefprozil. However,
there was an increase of 0.25 to 0.75 hours in the time to maximum plasma concentration of
cefprozil (Tmax).
Plasma protein binding is approximately 36% and is independent of concentration in the range
of 2 μg/mL to 20 μg/mL.
There was no evidence of accumulation of cefprozil in the plasma in individuals with normal
renal function following multiple oral doses of up to 1000 mg every 8 hours for 10 days.
In patients with reduced renal function, the plasma half-life may be prolonged up to 5.2 hours
depending on the degree of the renal dysfunction. In patients with complete absence of renal
function, the plasma half-life of cefprozil has been shown to be as long as 5.9 hours. The halflife
is shortened during hemodialysis. Excretion pathways in patients with markedly impaired
renal function have not been determined. In patients with impaired hepatic function, the half-life
increases to approximately 2 hours. The magnitude of the changes does not warrant a dosage
adjustment for patients with impaired hepatic function.
Healthy geriatric volunteers (≥65 years old) who received a single 1-g dose of cefprozil had
35% to 60% higher AUC and 40% lower renal clearance values compared with healthy adult
volunteers 20 to 40 years of age. The average AUC in young and elderly female subjects was approximately 15% to 20% higher than in young and elderly male subjects. The magnitude of
these age- and gender-related changes in the pharmacokinetics of cefprozil is not sufficient to
necessitate dosage adjustments.
Adequate data on CSF levels of cefprozil are not available.
Comparable pharmacokinetic parameters of cefprozil are observed between pediatric patients (6
months to 12 years) and adults following oral administration of selected matched doses. The
maximum concentrations are achieved at 1 to 2 hours after dosing. The plasma elimination halflife
is approximately 1.5 hours. In general, the observed plasma concentrations of cefprozil in
pediatric patients at the 7.5, 15, and 30 mg/kg doses are similar to those observed within the
same time frame in normal adult subjects at the 250, 500, and 1000 mg doses, respectively.

No additional data of relevance.

Microcrystalline cellulose
Methyl cellulose
Croscarmellose sodium
Colloidal silicon dioxide
Sodium starch glycolate
Magnesium stearate
Instacoat flavour Yellow (Hydroxypropylmethylcellulose, Polyethylene glycol, Titanium
dioxide, Yellow iron oxide, Banana flavour),
Isopropyl alcohol and
Purified water
 

6.2 Incompatibilities
None known

Do not Store above 30°C prior reconstitution, Once reconstituted store in refrigerator between
2°C to 8°C and use within 14 days.
Keep out of reach of children.
Do not use after the expiry date stated on the label.
Do not use if there is any physical change on the product.

Cefproz Suspension 250mg/5ml: Dry powder is light pink powder with pleasant tutti fruity
odour; Powder for 50ml of Suspension is filled in Type III amber glass bottle with silica gel on
the top of the bottle, sealed with white childproof cap, placed inside a box along with plastic
dosing spoon and a leaflet.
Reconstituted suspension is pink coloured moderately viscous, homogeneous suspension free
from foreign particles with sweet, pleasant fruity taste.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.