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CEFACLOR 250MG/5ML ORAL SUSPENSION

Active substance(s): CEFACLOR ANHYDROUS / CEFACLOR ANHYDROUS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Cefaclor 250mg/5ml Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml of the constituted suspension contains Cefaclor monohydrate 262.2mg equivalent
to anhydrous Cefaclor 250 mg.
Excipient(s) with known effect:
Each 5 ml of the constituted suspension contains 2136.15mg sucrose. The suspension also
contains allura red.
For the full list of excipients, see 6.1.

3.

PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granular powder forming a red suspension on constitution
with water having a strawberry flavour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Cefaclor is used in the treatment of the following mild or moderately-severe
infections caused by susceptible microorganisms.
Respiratory tract infections, including pneumonia, bronchitis, exacerbations of
chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of
sinusitis.
Otitis media
Skin and soft tissue infections
Urinary tract infections, including pyelonephritis and cystitis

Cefaclor has been found to be effective in both acute and chronic urinary tract
infections.
Cefaclor is generally effective in the eradication of streptococci from the
nasopharynx, however, data establishing efficacy in the subsequent prevention of
either rheumatic fever or bacterial endocarditis are not available. Penicillin is the
usual drug of choice for the treatment of streptococcal infections.
Cefaclor should not be used in the treatment of meningitis.
Consideration should be given to local guidance regarding the appropriate use of
antibacterial agents.
4.2

Posology and method of administration

Posology
Adults (including the elderly): The usual adult dosage is 250mg every eight hours. A
dosage of 250mg, administered 3 times daily for 10 days, is recommended for
sinusitis. For more severe infections or those caused by less susceptible organisms,
doses may be doubled to 500mg every eight hours. Doses of 4g per day have been
administered safely to normal subjects for 28 days but the total daily dosage should
not exceed this amount.

Paediatric population: The usual recommended daily dosage for mild to moderatelysevere infections in children is 20 mg/kg/day in divided doses every eight hours. For
bronchitis and pneumonia, the dosage is 20 mg/kg/day in divided doses administered
three times daily. For otitis media and pharyngitis, the total daily dosage may be
divided and administered every 12 hours. Safety and efficacy have not been
established for use in infants aged less than one month. Suggested doses for children
are:
Cefaclor for oral
Suspension
< 1 year (9 kg)
1-5 years (9-18 kg)
Over 5 years

125 mg/5 ml

250 mg/5 ml

2.5 ml tid
5.0 ml tid
5.0 ml tid

In more serious infections, otitis media and infections caused by less susceptible
organisms, 40 mg/kg/day in divided doses is recommended, up to a daily maximum of
1 g.
In the treatment of beta-haemolytic streptococcal infections, therapy should be
continued for at least 10 days.
Patients with impaired renal function: Cefaclor may be administered in the presence
of impaired renal function. Under such conditions dosage is unchanged. Cefaclor
should be administered with caution in the presence of markedly impaired renal

function. Since the half-life of cefaclor in anuric patients is 2.3 to 2.8 hours (compared
to 0.6 to 0.9 hours in normal subjects), dosage adjustments for patients with moderate
or severe renal impairment are not usually required. Clinical experience with cefaclor
under such conditions is limited; therefore, careful clinical observation and laboratory
studies should be made.
Patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 2530%. In patients undergoing regular haemodialysis, a loading dose of 250mg-1g
administered prior to dialysis and a therapeutic dose of 250-500mg every six to eight
hours maintained during interdialytic periods is recommended.
Method of administration
Cefaclor is administered orally. The spoon provided with the package dispenses a
volume of 5 mL.
4.3

Contraindications

Cefaclor is contra-indicated in patients with hypersensitivity to the cephalosporin
group of antibiotics or any of its excipients (as listed in section 6.1).
4.4

Special warnings and 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 cefaclor, cephalosporins,
penicillins or other drugs. Cefaclor should be given cautiously to penicillin-sensitive patients
because cross-hypersensitivity, including anaphylaxis, among beta-lactam antibiotics has been
clearly documented.
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. Use of peristalsis-inhibiting preparations are contra-indicated in
such situations.
The suspension contains sucrose “May be harmful to the teeth if the therapy exceeds 2 weeks
or more”.
Precautions:
Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of
gastro-intestinal disease, particularly colitis.
Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If
superinfection occurs during therapy, appropriate measures should be taken.

Positive direct Coombs' tests have been reported during treatment with the cephalosporin
antibiotics. In haematological studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side, or in Coombs' testing of newborns whose
mothers have received cephalosporin antibiotics before parturition, it should be recognised
that a positive Coombs' test may be due to the drug.
A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's
solutions or with Copper sulphate test tablets.
Cross-resistance may exist between penicillins and cephalosporins.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase – isomaltase insufficiency should not
take this medicine.
This medicinal product also contains allura red which is a colouring agent and can cause
allergic reactions.

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.
A combination with oral contraceptives may require dose adjustment.
The absorption of cefaclor may be reduced by antacids.
The renal excretion of Cefaclor is inhibited by probenecid.

4.6

Fertility, pregnancy and lactation

Pregnancy
Cefaclor should not be administered during pregnancy unless considered essential by
the physician. Animal studies have shown no evidence of impaired fertility or
teratogenicity. However, there are no adequate or well-controlled studies in pregnant
women.
Breastfeeding
Small amounts of cefaclor have been detected in breast milk following administration
of single 500 mg doses. Average levels of about 0.2 micrograms/ml or less were
detected up to five 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.
4.7

Effects on ability to drive and use machines

Not known
4.8

Undesirable effects

Blood and lymphatic system disorders: Eosinophilia, positive Coombs' tests and, rarely,
thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia,
aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance
have also been reported (see section 4.5).
Immune system disorders Allergic reactions such as morbiliform eruptions, pruritus and
urticaria have been observed. These reactions usually subside upon discontinuation of
therapy. Serum sickness-like reactions (erythema multiforme minor, rashes or other skin
manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported.
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.
There are rare reports of erythema multiforme major (Stevens-Johnson syndrome), toxic
epidermal necrolysis and anaphylaxis. Anaphylaxis may be more common in patients with a
history of penicillin allergy. Anaphylactoid events may be solitary symptoms, including
angioedema, asthenia, oedema (including face and limbs), dyspnea, paresthesia, syncope,
hypotension or vasodilation.
Rarely, hypersensitivity symptoms may persist for several months.
Nervous System disorders: Reversible hyperactivity, agitation, nervousness, insomnia,
confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Beta lactam antibiotics may trigger seizures.
Gastro-intestinal disorders: The most frequent side-effect has been diarrhoea. It is rarely
severe enough to warrant cessation of therapy. Colitis, including rare instances of
pseudomembranous colitis, has been reported. Nausea and vomiting have also occurred.
Hepato-biliary disorders: Transient hepatitis and cholestatic jaundice have been reported
rarely, slight elevations in AST, ALT or alkaline phosphatase values.
Renal and urinary disorders: Reversible interstitial nephritis has occurred rarely, also slight
elevations in blood urea or serum creatinine or abnormal urinalysis.
Toxic nephropathy has been observed with other beta-lactam antibiotics.

Reproductive system and breast disorders: Genital pruritus, vaginitis andvaginal moniliasis.
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.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be
anticipated.
Treatment: Unless five times the normal total daily dose has been ingested,
gastro-intestinal decontamination will be not necessary.
General management may consist of supportive therapy.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC-code: J01DC04
General properties
Cefaclor is a semi-synthetic, orally active, 2nd generation cephalosporin antibiotic.
Like other β-lactam antibiotics cefaclor owes its antibacterial activity to its ability to
bind to and inhibit the action of certain bacterial cell wall synthetic enzymes, namely
the penicillin binding proteins. The results of inhibition of one or more of essential
penicillin binding proteins is the interruption of cell wall (peptidoglycan) biosynthesis
which leads, through the activity of the cell’s autolytic enzymes, to lysis and death.
Breakpoints
The preliminary MIC breakpoints for sensitive, intermediately sensitive or resistant
organisms are as follows:
MIC (mg/mL)
<8
8-16
>32

Interpretation
Sensitive
Intermediately sensitive
Resistant

Sensitivity
Sensitive: this category includes bacterial species which are fully sensitive to cefaclor
i.e. they are inhibited by usually achievable concentrations of cefaclor in blood.

Intermediate sensitive: this category includes bacterial species which have natural
intermediate sensitivity to cefaclor as demonstrated by moderate in vitro activity.
This category implies possible clinical applicability in body sites where the drug is
physiologically concentrated or in situations where high doses of the drug can be
used.
Resistant: this category includes bacterial species which are naturally resistant to the
antibiotic or with acquired resistance precluding antibiotic treatment with this
medicinal product.
The following table gives the antibacterial spectrum of cefaclor. The prevalence of
resistance may vary geographically and with time for selected species and local
information on resistance is desirable, particularly when treating severe infections.
This information gives only an approximate guidance on probabilities whether
microorganisms will be susceptible to cefaclor or not.

Micro-organisms

Sensitive (anaerobes are generally
not sensitive)
Staphylococcus aureus
Streptoccocuspneumoniae
Streptococcus pyogenes
E. coli

H. influenza
Klebsiellapneumoniae
Moraxella catarrhalis
Proteus mirabilis
Resistant
Enterococcus faecalis
Methicillin resistant S. aureus
Providenciarettgeri
Pseudomonas aeruginosa
Serratiamarcescens

European range of
acquired
resistance*
(%)

9
4.5
0.9
1.5 (hospital
isolates)
1.4 (community
isolates)
3.7
8.2
1.7
14.4
-

* consideration should be given to local guidance regarding information on acquired
resistance
Other information
Mechanisms of bacterial resistance to Cefaclor:

Bacteria may be resistant to cefaclor due to production of those beta lactamases which
can hydrolyse cephalosporins due to alterations in penicillin binding proteins, due to
impermeability to the drug or due to drug efflux pumps. One or more of these
mechanisms may coexist in the same organism, leading to variable and unpredictable
cross-resistance to other beta-lactams and to antibacterial drugs of other classes.
5.2.

Pharmacokinetic Properties
Cefaclor is well absorbed after oral administration to fasting subjects. Total
absorption is the same whether the drug is given with or without food.
However, when it is taken with food, the peak concentration achieved is 50%
to 75% of that observed when the drug is administered to fasting subjects and
generally appears from 45 to 60 minutes later. Following administration of
250 mg, 500 mg and 1 g doses to fasting subjects, average peak serum levels
of approximately 7, 13 and 23 μg/l, respectively, were obtained within 30 to
60 minutes. Approximately 60% to 85% of the drug is excreted unchanged in
the urine within eight hours, the greater portion being excreted within the first
two hours. During the eight hour period, peak urine concentrations following
the 250 mg, 500 mg and 1 g doses were approximately 600, 900 and 1900 μg/l
respectively. The serum half-life in normal subjects is 0.6 to 0.9 hours. In
patients with reduced renal function, the serum half-life of cefaclor is slightly
prolonged. In those with complete absence of renal function, the plasma halflife of the intact molecules is 2.3 to 2.8 hours. Excretion pathways in patients
with markedly impaired renal function have not been determined.
Haemodialysis shortens the half-life by 25% to 30%.
The Cefaclor plasma concentrations for various doses are shown in the table
below:
Cefaclor plasma concentrations for doses of 250 mg, 500 mg and 1000
mg.

Time (h)
0.5
1.0
2.0
4.0
6.0

250 mg
4.38 ± 1.32
6.31 ±0.95
1.94 ± 0.47
0.20 ± 0.18
0

N=10
500 mg
8.22±2.66
15.22 ±2.39
6.99 ± 1.49
1.83 ± 0.90
0

1000 mg
8.82 ±2.85
25.44 ± 3.70
12.74 ± 4.50
1.94 ± 0.28
0

Protein binding of cefaclor is 25%.

5.3

Pre-clinical Safety Data
Cefaclor is well established for its pharmacological and toxicological
properties. There are no preclinical data of clinical concern.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Xanthan gum
Sodium benzoate
Sucrose
Colloidal anhydrous silica
Allura Red (FD & C Red No 40,E129)
Strawberry flavour
Sodium citrate
Citric acid (anhydrous)
Simethicone emulsion 30% w/w

6.2

Incompatibilities

Not applicable
6.3.

Shelf-Life
Shelf life as packaged for sale: two years
Shelf life following constitution: 14 days

6.4.

Special Precautions for Storage
Do not store above 25oC. Store in the original package protected from light
and moisture.
After constitution the suspension should be stored in a refrigerator (2-8ºC) and
used within 14 days.

6.5

Nature and contents of container

HDPE bottle with polypropylene child resistant closure containing 60 or 100 ml of
suspension when constituted.
Not all pack sizes may be marketed

6.6

Special precautions for disposal and other handling

Directions for mixing:
100 mL
Measure 70 mL of water using a measuring cup. Add this volume of water in two portions to
the dry mixture in the bottle. Shake well after each addition.
60 mL
Measure 42 mL of water using a measuring cup. Add this volume of water in two portions to
the dry mixture in the bottle. Shake well after each addition.
The spoon provided with the package dispenses a volume of 5 mL.

7

Marketing authorisation holder
Ranbaxy (UK) Limited
20 Balderton Street
London W1K 6TL
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
Cefaclor Oral Suspension 250mg/5mL 14894/0004

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/08/2006

10

DATE OF REVISION OF THE TEXT
30/09/2015

Expand Transcript

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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