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GREENFIELD CEFACLOR MR 375MG

Active substance(s): CEFACLOR MONOHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Greenfield Cefaclor MR 375mg,
Ranbaxy Cefaclor MR 375mg,
Bacticlor MR 375mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each extended release tablet contains as the active ingredient, cefaclor
monohydrate equivalent to 375mg of cefaclor base.

3.

PHARMACEUTICAL FORM
Extended release tablets of cefaclor ‘Modified Release’ are blue. Greenfield
Cefaclor MR tablets are engraved “TA4220”. Ranbaxy Cefaclor MR and
Bacticlor MR tablets have no markings.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Cefaclor MR is indicated in the treatment of the following infections when
caused by susceptible strains of the designated organisms:
Acute bronchitis and acute exacerbation’s of chronic bronchitis caused by
Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase
producing strains), Haemophilus parainfluenzae, Moraxella catarrhalis
(including beta-lactamase producing strains) and Staphylococcus aureus.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A
streptococci).
Pneumonia caused by S. pneumoniae, H. influenzae (including beta-lactamase
producing strains) and M catarrhalis (including beta-lactamase producing
strains).
Uncomplicated lower urinary tract infections, including cystitis and
asymptomatic bacteriuria, caused by Escherichia coli, Klebsiella pneumoniae,
Proteus mirabilis and Staphylococcus saprophyticus.

Skin and skin structure infections caused by S. pyogenes (group A
streptococci), S. aureus (including beta-lactamase producing strains) and
Staphylococcus epidermidis (including beta-lactamase producing strains).
Bacteriological studies, to determine the causative organism and its
susceptibility to cefaclor, should be performed. Therapy may be started while
awaiting the results of these studies. Once these results become available,
antimicrobial therapy should be adjusted accordingly.
Note: Cefaclor MR is generally effective in the eradication of streptococci
from the oropharynx. However, data establishing the efficacy of this antibiotic
in the subsequent prevention of rheumatic fever are not available.

4.2

Posology and method of administration
Cefaclor MR is administered orally.
Adults and the elderly:
Pharyngitis, tonsillitis, skin and skin structure infections: 375mg twice daily.
Lower urinary tract infections: 375mg twice daily or 500mg once daily.
Bronchitis:

375mg twice daily or 500mg twice daily.

Pneumonia:

750mg twice daily.

In clinical trials, doses of 1.5g/day of Cefaclor MR have been administered
safely for 14 days. Doses of 4g/day of cefaclor have been administered safely,
to normal subjects, for 28 days.
Elderly subjects with normal renal function do not require dosage adjustment.
Children:
The safety and effectiveness of Cefaclor MR have not been established.
Cefaclor suspensions are available (see Distaclor SPC for dosages).
In the treatment of infections caused by S. pyogenes (group A streptococci), a
therapeutic dosage should be administered for at least 10 days.
Cefaclor MR is well absorbed from the gastro-intestinal tract. Since
absorption is enhanced by administration with food, Cefaclor MR should be
taken with meals.
The tablets should not be cut, crushed or chewed.
There is no evidence of metabolism in humans.

4.3.

Contra-Indications
Hypersensitivity to cefaclor and other cephalosporins.

4.4.

Special Warnings and Special Precautions for Use
Warnings
Before instituting therapy with cefaclor, every effort should be made to
determine whether the patient has had previous hypersensitivity reactions to
the cephalosporins, penicillins or other drugs. Cefaclor should be given
cautiously to penicillin-sensitive patients and to any patient who has
demonstrated some form of allergy, particularly to drugs.
If an allergic reaction to cefaclor occurs, the drug should be discontinued and
the patient treated with the appropriate agents.
Pseudomembranous colitis has been reported with virtually all broad-spectrum
antibiotics, including macrolides, semi-synthetic penicillins and
cephalosporins. It is important, therefore, to consider its diagnosis in patients
who develop diarrhoea in association with the use of antibiotics. Such colitis
may range in severity from mild to life-threatening. Mild cases usually
respond to drug discontinuance alone. In moderate to severe cases,
appropriate measures should be taken.
Precautions
Prolonged use of cefaclor may result in the overgrowth of non-susceptible
organisms. If superinfection occurs during therapy, appropriate measures
should be taken.
A false-positive reaction for glucose in the urine may occur with Benedict’s or
Fehling’s solutions or with copper sulphate test tablets.

4.5

Interaction with other medicinal products and other forms of interaction
There have been rare reports of increased prothrombin time, with or without
clinical bleeding, in patients receiving cefaclor and warfarin concomitantly. It
is recommended that in such patients, regular monitoring of prothrombin time
should be considered, with adjustment of dosage if necessary.
The extent of absorption of Cefaclor MR is diminished if magnesium
hydroxide or aluminium hydroxide containing antacids are taken within 1 hour
of administration. H2 blockers do not alter either the rate or extent of
absorption.

The renal excretion of cefaclor is inhibited by probenecid.
4.6.

Pregnancy and Lactation
Usage in pregnancy: Although animal studies have shown no evidence of
impaired fertility or harm to the foetus due to cefaclor, there are no adequate
and well-controlled studies in pregnant women. Cefaclor MR should be used
during pregnancy only if clearly needed.
Usage in nursing mothers: Small amounts of cefaclor have been detected in
breast milk following administration of single 500mg doses. Average levels
of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace
amounts were detected at one hour. As the effect on nursing infants is not
known, caution should be exercised when cefaclor is administered to a nursing
woman. No studies have been done with Cefaclor MR.
Usage during labour and delivery: Treatment should be given only if clearly
needed.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8.

Undesirable Effects
The majority of adverse reactions observed in clinical trials of Cefaclor MR
were mild and transient.
Drug-related adverse reactions requiring
discontinuation of therapy occurred in 1.7% of patients. The following
adverse reactions were reported in clinical trials. Incidence rates were less
than 1 in 100 (less than 1%), except as stated:
Gastro-intestinal: Diarrhoea (3.4%), nausea (2.5%), vomiting and dyspepsia.
Hypersensitivity: Rash, urticaria or pruritus occurred in approximately 1.7% of
patients. One serum sickness-like reaction (0.03%) was reported among the
3,272 patients treated with Cefaclor MR during the controlled clinical trials.
Serum sickness-like reactions (erythema multiforme minor, rashes or other
skin manifestations accompanied by arthritis/arthralgia, with or without fever)
have been reported with cefaclor. Lymphadenopathy and proteinuria are
infrequent, there are no circulating immune complexes and no evidence of
sequelae. Occasionally, solitary symptoms may occur, but do not represent a
serum sickness-like reaction. Serum sickness-like reactions are apparently due
to hypersensitivity and have usually occurred during or following a second (or
subsequent) course of therapy with cefaclor. 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 usually subside within
a few days of cessation of therapy. Antihistamines and corticosteroids appear
to enhance resolution of the syndrome. No serious sequelae have been
reported.
Haematological and lymphatic systems: Eosinophilia.
Genitourinary: Vaginal moniliasis (2.5%) and vaginitis (1.7%).
The following adverse effects have been reported, but causal relationship is
uncertain:
Central nervous system: Headache, dizziness and somnolence.
Hepatic: Transient elevations in AST, ALT and alkaline phosphatase.
Renal: Transient increase in BUN or creatinine.
Laboratory tests: Transient thrombocytopenia, leucopenia, lymphocytosis,
neutropenia and abnormal urinalysis.
In addition to the adverse reactions listed above that have been observed in
patients taking Cefaclor MR, the following have been reported in patients
treated with cefaclor:
Erythema multiforme, fever, anaphylaxis (may be more common in patients
with a history of penicillin allergy), Stevens-Johnson syndrome, positive direct
Coombs’ test and genital pruritus. Symptoms of pseudomembranous colitis
may appear either during or after antibiotic treatment. Anaphylactoid events
may present as solitary symptoms, including angioedema, asthenia, oedema
(including face and limbs), dyspnoea, paraesthesias, syncope, or
vasodilatation.
Rarely,hypersensitivity symptoms may persist for several months.
The following reactions have been reported rarely in patients treated with
cefaclor:
Toxic epidermal necrolysis, reversible interstitial nephritis, hepatic
dysfunction, including cholestasis, increased protbrombin time in patients
receiving cefaclor and warfarin concomitantly, reversible hyperactivity,
agitation, nervousness, insomnia, confusion, hallucinations, hypertonia,
aplastic anaemia, agranulocytosis and haemolytic anaemia.
The following adverse reactions have been reported in patients treated with
other beta-lactam antibiotics:
Colitis, renal dysfunction and toxic nephropathy.

Several beta-lactam antibiotics have been implicated in triggering seizures,
particularly in patients with renal impairment when the dosage was not
reduced. If seizures associated with drug therapy should occur, the drug
should be discontinued. Anticonvulsant therapy can be given if clinically
indicated.

4.9.

Overdose
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be
anticipated.
General management consists of supportive therapy. Consider activated
charcoal instead of, or in addition to, gastric emptying.
Forced diuresis, peritoneal dialysis, haemodialysis or charcoal haemoperfusion
have not been established as beneficial.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Cefaclor MR has been shown to be active in vitro against most strains of the
following organisms, although clinical efficacy has not been established:
Gram-negative organisms:
Citrobacter diversus
Neisseria gonorrhoeae
Anaerobic organisms:
Propionibacterium acnes
Bacteroides species (excluding Bacteroidesfragilis)
Peptococci
Peptostreptococci
Note: Pseudomonas sp, Acinetobacter calcoaceticus, most strains of
enterococci, Enterobacter sp, indole-positive Proteus and Serratia sp are
resistant to cefaclor. Cefaclor is inactive against methicillin-resistant
staphylococci.
Using the NCCLS recommended methods for sensitivity testing, the criteria
for dilution methods are:
MIC < 8 micrograms/ml:
MIC = 16 micrograms/ml:
MIC > 32 micrograms/ml:

susceptible
moderately susceptible
resistant

and for the standard disc test, using a 30 microgram cefaclor disc (zone
diameters)
Zone > 18 mm:
Zone = 15-17 mm:
MIC < 14 mm:

susceptible
moderately susceptible
resistant

Cefaclor is a semi-synthetic cephalosporin antibiotic.
5.2.

Pharmacokinetic Properties
Following administration of 375mg, 500mg and 750mg tablets to fed subjects,
average peak serum concentrations of 4, 8 and 11 micrograms/ml respectively,
were obtained within 2.5 to 3 hours. No drug accumulation was noted when
this was given twice daily.
Plasma half-life in healthy subjects is independent of dosage form and
averages 1 hour. Elderly subjects with normal, mildly diminished renal
function, do not require dosage adjustment, since higher peak plasma
concentrations and AUC had no apparent clinical significance.
There is no evidence of metabolism in humans.

5.3.

Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Mannitol
Methylhydroxypropylcellulose
Hydroxypropylcellulose
Methacrylic acid copolymer
Stearic acid
Magnesium stearate
Titanium dioxide (E171)
Polyethylene glycol
Propylene glycol
Indigo carmine aluminium lake (E132)
Talc

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf Life
Two years.

6.4.

Special Precautions for Storage
Do not store above 25°C. Protect from light.

6.5.

Nature and Contents of Container
Blister packs consisting of clear PVC with aluminium foil backing containing
either 2 or 14 tablets.

6.6.

Instruction for Use/Handling
Take by mouth.

7.

MARKETING AUTHORISATION HOLDER
Flynn Pharma Limited
Alton House
4 Herbert Road
Dublin 2
Ireland

8.

MARKETING AUTHORISATION NUMBER(S)
PL 13621/0013

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/11/2005

10

DATE OF REVISION OF THE TEXT

03/11/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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