Cefpodoxime 100mg film coated tablets smpc- taj pharmaceuticals

Cefpodoxime 100mg Film-Coated Tablets SMPC, Taj Phar maceuticals
Cefpodoxime Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Cefpodoxime Dosage & Rx Info | Cefpodoxime Uses, Side Effects -: Indications, Side Effects, Warnings, Cefpodoxime - Drug Information - Taj Phar ma, Cefpodoxime dose Taj pharmaceuticals Cefpodoxime interactions, Taj Pharmac eutical Cefpodoxime contraindications, Cefpodoxime price, Cefpodoxime Taj Pharma Cefpodoxime 100mg Film-Coated Tablets SMPC- Taj Phar ma . Stay connected to all updated on Cefpodoxime Taj Phar maceuticals Taj pharmaceuticals Hyderabad.
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CEFPODOXIME
FILM COATED
TABLETS
100MG
1.NAME OF THE MEDICINAL PRODUCT
Cefpodoxime 100mg Film-Coated Tablets.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
One film-coated tablet contains cefpodoxime
proxetil corresponding to 100 mg cefpodoxime.
Excipient with known effect Each 100 mg tablet
contains 24 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Round, white to yellowish tablets with a
diameter of approx. 9 mm.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cefpodoxime is indicated for the treatment of
the following infections when caused by
susceptible organisms (see section 5.1).
• Acute bacterial sinusitis
• Tonsillitis and pharyngitis
• Acute exacerbation of chronic bronchitis
• Bacterial pneumonia (See section 4.4)
Consideration should be given to official
guidance on the appropriate use of antibacterial
agents
4.2 Posology and method of administration
Posology
Adults and adolescents with normal renal
function:
Acute bacterial sinusitis: 200mg twice daily.
Tonsillitis and pharyngitis: 100mg twice daily
Acute, exacerbation of chronic bronchitis and
bacterial pneumonia: 200 mg twice daily
Elderly
It is not necessary to modify the dose in elderly
patients with normal renal function.
Paediatric population
Cefpodoxime Powder for oral Suspension may
be available to treat infants (over 28 days (4
weeks) old) and children. Please refer to the
separate Summary of Product Characteristics for
details.
Renal Impairment
The dose of cefpodoxime does not require
modification if creatinine clearance exceeds
40ml/min/1.73 m2
. Below this value,
pharmacokinetic studies indicate an increase in
plasma elimination half-life and in the maximum
plasma concentrations. Therefore, the dose
should be adjusted appropriately.
CREATININE
CLEARANCE
(ML/MIN/1.73
m2
)
39 – 10 Unit dose¹ administered as a single
dose every 24 hours (i.e. half the
usual adult dose).
<10 Unit dose¹ administered as a single
dose every 48 hours (i.e. half the
usual adult dose).
Haemodialysis
Patients
Unit dose¹ administered after each
dialysis session.
NOTE: ¹the unit dose is either 100mg or 200mg,
depending on the type of infection as stated
above.
Hepatic Impairment
The dose does not require modification in cases
of hepatic impairment
Duration
The duration of therapy depends on the patient,
the indication and the causative pathogen(s).
When treating infections caused by the bacterial
species Streptococcus pyogenes, a duration of
treatment of at least 10 days is indicated in order
to prevent late complications such as rheumatic
fever or a severe kidney disease,
glomerulonephritis.

Method of administration
For oral administration.
The tablets should be taken with food for
optimum absorption. The tablets should be
swallowed whole with sufficient liquid (e.g. 1
glass of water).
4.3 Contraindications
Hypersensitivity to the active substance, other
cephalosporins or to any of the excipients listed
in section 6.1.
Previous history of immediate and / or severe
hypersensitivity reactions (anaphylaxis) to
penicillin or other beta-lactam antibiotic.
4.4 Special Warnings and precautions for use
Anaphylactic reactions
As with all beta-lactam antibacterial agents,
serious and occasionally fatal hypersensitivity
reactions have been reported. In case of severe
hypersensitivity reactions, treatment with
cefpodoxime must be discontinued immediately
and adequate emergency measures must be
initiated.
Before beginning treatment, it should be
established whether the patient has a history of
severe hypersensitivity reactions to
cefpodoxime, to other cephalosporins or to any
other type of beta-lactam agent. Cefpodoxime
may be given with caution to patients with a
history of nonsevere hypersensitivity reactions
to beta-lactam agents (for contraindications
related to hypersensitivity, see section 4.3).
Allergic reactions
Cefpodoxime should also be used with particular
caution in patients with a high likelihood of
allergic reactions of another type (e.g. hayfever
or bronchial asthma), as in these cases, the risk
of severe hypersensitivity reactions is increased.
Gastrointestinal disorders
In the case of severe gastrointestinal disorders
with vomiting and diarrhoea, the administration
of cefpodoxime is not appropriate, as sufficient
absorption from the gastrointestinal tract is not
achieved.
The use of cefpodoxime can lead to vomiting
and diarrhoea (see section 4.8). In this case, the
efficacy of this and/or other medicinal products
which have been taken (such as oral
contraceptives) may be impaired.
Cefpodoxime should always be used with
caution in patients with a history of
gastrointestinal disease, particularly colitis.
Conditions associated with Clostridium
difficile (e.g. pseudomembranous colitis)
Antibacterial agent-associated colitis and
pseudo-membranous colitis have been reported
with nearly all anti-bacterial agents, including
cefpodoxime, and may range in severity from
mild to life-threatening. Therefore, it is
important to consider this diagnosis in patients
who present with diarrhoea during or subsequent
to the administration of cefpodoxime (see
section 4.8). Discontinuation of therapy with
cefpodoxime and the administration of specific
treatment for Clostridium difficile should be
considered. Medicinal products that inhibit
peristalsis should not be given.
Blood disorders
As with all beta-lactam antibiotics, neutropenia
and more rarely agranulocytosis may develop
particularly during extended treatment. For cases
of treatment lasting longer than 10 days, the
blood count should be monitored and treatment
discontinued if neutropenia is found.
Cephalosporins may be absorbed onto the
surface of red cell membranes and react with
antibodies directed against the drug. This can
produce a positive Coomb's test and very rarely,
haemolytic anaemia. Cross-reactivity may occur
with penicillin for this reaction.
Bullous rashes
As with other cephalosporins, cases of bullous
rashes have been reported (erythema
multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis). The medicinal product
should be discontinued if symptoms of this type
occur.
Encephalopathy
Beta-lactam antibiotics, including cefpodoxime,
predispose patients to the risk of encephalopathy
(which may involve convulsions, confusion,
disturbances in consciousness, movement
disorders), particularly in overdose or if renal
function is impaired.

Renal impairment
In cases of severe renal insufficiency it may be
necessary to reduce the dose dependent on the
creatinine clearance. At a creatinine clearance of
less than 40 ml/min/1.73 m2 and in
haemodialysis patients, an increase in the dose
interval is necessary (see section 4.2).
Changes in renal function have been observed
with cephalosporin antibiotics, particularly when
given concurrently with potentially nephrotoxic
drugs such as aminoglycosides and/or potent
diuretics. In such cases, renal function should be
monitored.
Hepatic impairment
There may be increases in the values of AST,
ALT, alkaline phosphatase and bilirubin. These
laboratory abnormalities, which may be due to
the infection, can occasionally be more than
twice the upper limit of the stated range and may
cause hepatic damage. This is usually cholestatic
and is very often asymptomatic.
Superinfections
As with other antibiotics, the long term or
repeated use of cefpodoxime may lead to a
superinfection and result in the overgrowth of
non-susceptible organisms (Candida and
Clostridium difficile).
Interactions with laboratory tests:
During treatment with cephalosporins, non-
enzymatic methods to determine the level of
glucose in the urine may give false positive
results (see section 4.5). A false positive reaction
for glucose in the urine may occur with
Benedict's or Fehling's solution or with copper
sulphate test tablets, but not with tests based on
enzymatic glucose oxidase reactions.
Lactose
This medicinal product contains lactose. Patients
with rare hereditary problems of galactose
intolerance, total lactase deficiency or glucose-
galactose malabsorption should not take this
medicine.
Sodium
This medicinal product contains less than 1
mmol sodium (23 mg) per tablet, that is to say
essentially ‘sodium-free’.
4.5 Interaction with other medicinal products
and other forms of interaction
In the case of high dose treatment with
parenterally administered medicinal products
With the administration of cephalosporins and
concomitantly administered strong saluretics
(e.g. furosemide) or potentially nephrotoxic
preparations (e.g.aminoglycoside antibiotics), it
has not been possible to rule out an impairment
of renal function. Pharmacological data and
clinical experience show, however, that this is
unlikely with cefpodoxime, which is for oral
use, at the recommended dose.
Oral anticoagulants:
The concomitant administration of cefpodoxime
and warfarin may increase the anticoagulant
effect. There have been numerous reports of an
increase in the activity of oral anticoagulants in
patients who are taking antibacterial agents,
including the cephalosporins. The risk varies
according to the underlying infection and the
patient’s age and general condition. It is
therefore difficult to establish the
cephalosporins’ contribution to the increase in
the INR (International Normalised Ratio). It is
recommended that the INR should be monitored
frequently during and shortly after co-
administration of cefpodoxime with an oral anti-
coagulant agent Studies have shown that
bioavailability is decreased by approximately
30% when cefpodoxime is administered with
drugs which neutralise gastric pH or inhibit acid
secretions in patients with empty stomachs.
The studies carried out on this to date show the
following results:
Antacids:
Aluminium hydroxide -27%
Sodium bicarbonate -32%
H2 receptor blocker:
Ranitidine -29%
As a result, these preparations should be taken 2
to 3 hours after cefpodoxime administration.
Antibiotics with a bacteriostatic effect Where
possible, cefpodoxime should not be combined
with antibiotics with a bacteriostatic effect (such
as chloramphenicol, erythromycin, sulfonamide

or tetracycline), as the effect of cefpodoxime
may be decreased.
Probenecid reduces the excretion of
cephalosporins.
Cephalosporins potentially reduce the
contraceptive effect of oestrogens.
4.6 Fertility, Pregnancy and lactation
Pregnancy For cefpodoxime no clinical data on
exposed pregnancies are available. Animal
studies do not indicate direct or indirect harmful
effects with respect to pregnancy,
embryonal/foetal development, parturition or
postnatal development (see section 5.3). Due to
the lack of clinical experience, cefpodoxime
should only be used, in the first three months of
pregnancy in particular, after a careful
assessment of the risks and benefits. Breast-
feeding Cefpodoxime is excreted in human milk
in small quantities. Cefpodoxime should only be
used during breast-feeding after a careful
assessment of the risks and benefits. Breast-fed
infants can therefore experience changes to the
intestinal flora with diarrhoea and yeast
infections, so breast-feeding may need to be
stopped. The possibility of sensitisation must
also be taken into account.
4.7 Effects on ability to drive and use
machines
If adverse events, such as dizziness, a drop in
blood and encephalopathy (which may involve
convulsions, confusion, disturbances of
consciousness, movement disorders) occur,
patients must not use machines or drive.
4.8 Undesirable Effects
In this section the frequencies of undesirable
effects are defined as follows:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Very rare (<1/1000)
Not known (cannot be estimated from the
available data).
Adverse Drug Reactions by System Organ Class
and Frequency
Infections and infestations
Not known Superinfections
Blood and lymphatic system disorders
Uncommon Neutropenia
Rare Haematological disorders such
as reduced haemoglobin,
thrombocytosis (this change is
mostly reversible once the
treatment has ended),
eosinophilia, lymphocytosis,
leucopenia, leukocytosis,
thrombocytopenia
Very Rare Haemolytic anaemia
Not known Agranulocytosis
Immune system disorders
Uncommon Anaphylactic reactions,
bronchospasm
Very rare Angioedema
Not known Anaphylactic shock
Metabolism and nutrition disorders
Common Decreased appetite
Nervous system disorders
Very common Headaches
Common Dizziness
Uncommon Paraesthesias
Not known Encephalopathy.
Beta-lactam antibiotics,
including cefpodoxime,
predispose patients to the risk of
encephalopathy (which may
involve convulsions, confusion,
disturbances in consciousness,
movement disorders),
particularly in overdose or if
renal function is impaired.
Ear and labyrinth disorders
Common Tinnitus
Gastrointestinal disorders
Very common Abdominal pain, diarrhoea.
Common Abdominal distension, nausea,
vomiting, flatulence

Uncommon Enterocolitis (bloody diarrhoea
can occur as a symptom)
Not known Pseudomembranous colitis,
haematochezia, clostridium
difficile colitis
Hepatobiliary disorders
Common Increases in liver enzymes
(aspartate aminotransferase
(AST), alanine transaminase
(ALT), alkaline phosphatase
(ALP))
Rare Increased blood bilirubin, acute
hepatitis
Very rare Hepatic damage
Not known Cholestatic hepatitis
Skin and subcutaneous tissue disorders
Common Rashes, urticaria, pruritis
Uncommon Mucocutaneous hypersensitivity
reactions
Very rare Erythema multiforme, Stevens-
Johnson syndrome, Lyell’s
syndrome (toxic epidermal
necrolysis)
Not known Purpura, bullous dermatitis
Renal and urinary disorders
Rare Slight increases in blood urea
and creatinine, acute renal
insufficiency
Not known Disturbances of renal function
General disorders and administration site
conditions
Uncommon: Weakness such as asthenia,
tiredness and malaise
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
benefit/risk balance of the medicinal product.
4.9 Overdose
There is no knowledge of significant overdoses
in humans.
Signs and symptoms
In rare cases, overdoses up to a daily dose of
1,000 mg of cefpodoxime have been reported.
The undesirable effects observed were the same
as those at the recommended dose. In patients
with renal insufficiency, encephalopathy may
occur. The encephalopathy is usually reversible
once cefpodoxime plasma levels have fallen.
Management
In the event of overdose with cefpodoxime,
supportive and symptomatic therapy is
indicated. Cefpodoxime can be broken down by
dialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other beta -lactam
antibacterials, third generation cephalosporins
Mechanism of action
Like other beta-lactam drugs, cefpodoxime
exerts antibacterial activity by binding to and
inhibiting the action of certain bacterial cell wall
synthetic enzymes, namely the penicillin binding
proteins. This results in the interruption of cell
wall (peptidoglycan) biosynthesis, which leads
to bacterial cell lysis and death.
Pharmacokinetic/pharmacodynamic relationship
For cephalosporins, the most important
pharmacokinetic-pharmacodynamic index
correlating with in vivo efficacy has been shown
to be the percentage of the dosing interval that
the unbound concentration remains above the
minimum inhibitory concentration (MIC) of
ceftazidime for individual target species (i.e.
%T>MIC).
Mechanisms of resistance
Bacterial resistance to cefpodoxime may be due
to one or more of the following mechanisms:
• Deactivation through beta-lactamases.
Cefpodoxime may be efficiently hydrolysed by
certain beta-lactamases of the extended-
spectrum beta-lactamases (ESBLs) which occur
for example, in strains of Escherichia coli or
Klebsiella pneumoniae and by the
chromosomally-encoded (AmpC) enzyme that
may be induced or stably derepressed in certain
aerobic gram-negative bacterial species, e.g.
Enterobacter cloacae. In the case of infections

by bacteria with inducible AmpC-beta-lactamase
and in-vitro sensitivity to cefpodoxime, there is
a risk that during treatment mutants with
constitutive (depressed) AmpC beta-lactamase
formation will be selected.
• Reduced affinity of penicillin-binding proteins
(PBPs) for cefpodoxime: the acquired resistance
in pneumococci and other streptococci is based
on modifications of existing PBPs as a result of
a mutation. For resistance in methicillin
(oxacillin) resistant staphylococci, however, the
formation of an additional PBP with decreased
affinity to cefpodoxime is responsible.
• Insufficient penetration of cefpodoxime
through external cell wall in Gram-negative
bacteria can lead to the PBPs not being
sufficiently inhibited.
• Cefpodoxime can be actively transported out
of the cell by way of drug efflux pumps
Break points:
European Committee on Antimicrobial
Susceptibility Testing (EUCAST) clinical
breakpoints for MIC testing are presented below.
EUCAST clinical MIC breakpoints for
cefpodoxime (2015-01-01, v.5.0)
Organism Susceptible
(S) (mg/l)
Resistant
(R) (mg/l)
Enterobacteriaceae
(uncomplicated UTI
only)
≤ 1 >1
Staphylococcus spp. Note1
Note1
Streptococcus groups
A, B, C and G
Note2
Note2
Streptococcus
pneumoniae
≤ 0.25 >0.5
Haemophilus
influenzae
≤ 0.25 Note3
>0.5
Moraxella catarrhalis IP IP
Neisseria gonorrhoeae
Non-species related
breakpoint
IE IE
1 Susceptibility of staphylococci to
cephalosporins is inferred from the cefoxitin
susceptibility except for ceftazidime, cefixime
and ceftibuten, which do not have breakpoints
and should not be used for staphylococcal
infections. Some methicillinresistant S. aureus
are susceptible to ceftaroline and ceftobiprole.
2 The susceptibility of streptococcus groups A,
B, C and G is inferred from the penicillin
susceptibility.
3 Isolates with MIC values above the susceptible
breakpoint are very rare or not yet reported. The
identification and antimicrobial susceptibility
tests on any such isolate must be repeated and if
the result is confirmed the isolate sent to a
reference laboratory. Until there is evidence
regarding clinical response for confirmed
isolates with MIC values above the current
resistant breakpoint they should be reported
resistant IE: Insufficient evidence IP: In
Preparation
Susceptibility:
The prevalence of acquired resistance may vary
geographically and with time for selected
species and local information on resistance is
desirable, particularly when treating severe
infections. As necessary, expert advice should
be sought when the local prevalence of
resistance is such that the utility of the agent in
at least some types of infections is questionable.
Antibacterial spectrum
Commonly Susceptible species
Aerobic Gram positive organisms:
Staphylococcus aureus (Methicillin-susceptible)
Streptococcus pyogenes
Aerobic Gram negative organisms:
Haemophilus influenzae
Moraxella catarrhalis
Proteus mirabilis%
Species for which acquired resistance may be a
problem
Aerobic Gram positive organisms
Streptococcus pneumoniae
Aerobic Gram negative organisms
Citrobacter freundi$
Enterobacter cloacae$

Escherichia coli%
Klebsiella pneumoniae%
Serratia marcescens$
Inherently resistant organisms
Aerobic Gram positive organisms
Enterococcus spp.
Staphylococcus aureus (methicillin resistant)
Aerobic Gram negative organisms
Morganella morganii
Pseudomonas aeruginosa.
Others
Chlamydia spp.
Chlamydophila spp.
Legionella pneumophila
Mycoplasma spp.
$
natural intermediate susceptibility
%
ESBL producing species are always resistant
5.2 Pharmacokinetic properties
Cefpodoxime proxetil is a prodrug of
cefpodoxime.
Absorption
Following oral administration, cefpodoxime
proxetil is absorbed in the gastrointestinal tract
and rapidly hydrolysed to the active metabolite
cefpodoxime in the intestinal mucosa.
When cefpodoxime proxetil is administered
orally to fasting subjects as a tablet
corresponding to 100 mg of cefpodoxime,
51.1% is absorbed and absorption is increased
by food intake, therefore cefpodoxime proxetil
should be taken with a meal.
Following oral administration of 100 mg
cefpodoxime*, average maximum plasma levels
(Cmax) of 1.2 mg/L were achieved; after a
single administration of 200 mg of
cefpodoxime*, Cmax was 2.5 mg/L. In both
cases (100mg /200 mg), the Cmax was reached
after 2-3 hours (Tmax)
*administered as cefpodoxime proxetil
In the case of multiple administration of 100 and
200 mg of cefpodoxime* at intervals of 12 hours
for a period of 14.5 days, the pharmacokinetic
parameters did not show any change, therefore,
no accumulation occurred.
Elderly patients
In patients who are 70 years old or above, the
steady sate was reached following the repeated
administration of 200 mg of cefpodoxime* at
12-hour intervals for a period of 6 to 10 days. In
the steady state, Cmax is an average of 3.05
mg/L and Tmax is 2.7 hours.
Patients with liver cirrhosis
In cirrhosis patients with or without ascites, the
Cmax following the single administration of 200
mg of cefpodoxime* was an average of 1.67
mg/L, the plasma levels are equivalent to those
of a healthy subject 12 hours after
administration.
Patients with chronic renal insufficiency
In patients with chronic renal insufficiency, the
plasma levels increase as the severity of the
disease increases. At a creatinine clearance of
less than 40 mL/min/1.73m2
, (10-40 mL/min),
the average Cmax after a dose of 200 mg of
cefpodoxime* is twice as high as in healthy
subjects; the Tmax is approximately 4 hours.
Haemodialysis patients
In patients with a creatinine clearance of less
than 10 mL/min/1.73m2
, the average Cmax is
1.5 times higher than in healthy subjects; the
Tmax is approximately 6 hours. Cefpodoxime
can be broken down by dialysis and therefore
has to be administered outside of the dialysis
periods.
Distribution
The volume of distribution is 32.3L in young
test subjects (=0.43 L/kg).
Serum protein binding of cefpodoxime, is 40%
principally to albumin. This binding is non-
saturable in type.
Concentrations of cefpodoxime in excess of the
minimum inhibitory levels (MIC) for common
pathogens can be achieved in lung parenchyma,
bronchial mucosa, pleural fluid, tonsils, kidneys,
interstitial fluid and prostate tissue.

Studies in healthy volunteers show median
concentrations of cefpodoxime in the total
ejaculate 6-12 hours following administration of
a single 200 mg dose to be above the MIC90 of
N. gonorrhoeae.
As the majority of cefpodoxime is eliminated in
the urine, the concentration is high
(concentrations in 0-4, 4-8, 8-12 hour fractions
after a single dose exceed MIC90 of common
urinary pathogens). Good diffusion of
cefpodoxime is also seen into renal tissue, with
concentrations above MIC90 of the common
urinary pathogens 3-12 hours after an
administration of a single 200 mg dose (1.6-3.1
µg/g). Concentrations of cefpodoxime in the
medullary and cortical tissues are similar.
Biotransformation
Following absorption, the main metabolite,
cefpodoxime, is produced by the hydrolysis of
cefpodoxime proxetil.
Cefpodoxime is barely metabolised, following
the absorption of cefpodoxime proxetil.
Elimination
The main route of excretion is renal, 80% is
excreted unchanged in the urine with an
elimination half-life of approximately 2.4 hours.
The total clearance of cefpodoxime is 9.98L/h;
the average renal clearance is 7 L/h.
Elderly patients
In patients over the age of 70, the elimination
half-life (T1/2) increases to an average of 3.6
hours. In patients with chronic renal
insufficiency and a creatinine clearance of less
than 40 mL/min/1.73m2
, T1/2 is over 6 hours (an
average of 7.7 hours in the case of a creatinine
clearance between 10 and 40 mL/min/1.73m2
).
5.3 Preclinical safety data
Acute toxicity
The median lethal dose in mice and rats was
above 8 g/kg and 4 g/kg bodyweight,
respectively. In Fisher rats doses of 1 g/kg body
weight and higher influenced stool consistency
and weight gain. Single doses of 800 mg/kg
body weight were non-toxic in dogs.
Repeat-dose toxicity
Chronic toxicity studies were carried out over 12
months in rats and 6 months in dogs. Maximum
daily doses (1000 mg/kg body weight orally in
rats and 400 mg/kg orally in dogs) were
considerably higher than recommended
therapeutic doses (3-8 mg/kg body weight). No
mortality was observed in rats receiving 250,
500 or 1000 mg/kg for 12 months. Only at 1000
mg/kg, effects on the GI-tract, softened stools
and dilatation of the caecum were observed.
Intestinal side effects, which were more
pronounced in Fisher rats, are due to the change
in intestinal flora caused by the pronounced
antibacterial effect of cefpodoxime. Daily
administration of 0, 25, 100, and 400 mg/kg
body weight to dogs did not reveal mortality.
Unchanged cefpodoxime was detected in faeces.
Reproduction toxicity
Embryotoxicity studies in rats and rabbits have
not revealed any signs of teratogenic potential.
Cefpodoxime had no adverse effects on fertility
and peri-/postnatal toxicity studies in rats.
Cefpodoxime or its metabolites cross the
placenta and are excreted in breast milk in rats.
No experience is available on the use of
cefpodoxime during pregnancy and lactation in
humans.
Mutagenicity
Extensive mutagenicity testing in different
testing models was negative.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Carboxymethylcellulose calcium,
Lactose monohydrate,
Crospovidone,
Hydroxypropyl-cellulose,
Magnesium stearate,
Sodium lauril sulfate.
Coating:
Hypromellose,
Talc,
Titanium dioxide (E171).
6.2 Incompatibilities
Not applicable.

6.3 Shelf life
Alu-Alu blister: 3 years
Alu-PVC/PVDC blister: 2 years
6.4 Special precautions for storage
Alu-PVC/PVDC blister: Do not store above
25°C. Store in the original package
Alu-Alu blister: Store in the original package.
6.5 Nature and contents of container
Nature: Alu-Alu or Alu-PVC/PVDC blister
packs Contents: 100 mg: 10, 12, 20, 30 tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other
handling
No special requirements
7. MANUFACTURER:
Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad
438225, Gujarat, INDIA

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