Distaclor is indicated for the treatment of the following infections due to susceptible micro

organisms:

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

Distaclor 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.

CECLOR MR is administered orally.

Distaclor is administered orally.

Adults: The usual adult dosage is 250mg every eight hours. For more severe infections or those

caused by less susceptible organisms, doses may be doubled. 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.

Distaclor may be administered in the presence of impaired renal function. Under such conditions,

dosage is usually unchanged (see 'Special warnings and special precautions for use').

Patients undergoing haemodialysis: Haemodialysis shortens serum half life by 25 30%. 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.

The elderly: As for adults.

Children: The usual recommended daily dosage for children is 20mg/kg/day in divided doses,

every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in

divided doses, administered 3 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.

Distaclor Suspension

In more serious infections, otitis media, sinusitis and infections caused by less susceptible

organisms, 40mg/kg/day in divided doses is recommended, up to a daily maximum of 1g.

In the treatment of beta haemolytic streptococcal infections, therapy should be continued for at

least 10 days

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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption

or sucrose – isomaltase insufficiency should not take this medicine.

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.

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 CECLOR 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.

Usage in pregnancy: Animal studies have shown no evidence of impaired fertility or

teratogenicity. However, since there are no adequate or well controlled studies in pregnant

women, caution should be exercised when prescribing for the pregnant patient.

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.

CECLOR may cause drowsiness and dizziness in some people. Make sure you know how you

react to CECLOR before you drive a car, operate machinery or do anything else that may be

dangerous if you are affected.

Gastro intestinal: 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.

Hypersensitivity: Allergic reactions such as morbilliform 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 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.

Haematological: Eosinophilia, positive Coombs' tests and, rarely 

thrombocytopenia. Transient

lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis 

and reversible neutropenia of possible clinical significance. See 'Interactions with other

medicaments and other forms of interaction'.

Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations

in AST, ALT or alkaline phosphatase values.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or

serum creatinine or abnormal urinalysis.

Central nervous system: Reversible hyperactivity, agitation, nervousness, insomnia, confusion,

hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.

Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment: Unless 5 times the normal total daily dose has been ingested, gastro intestinal

decontamination will not be necessary.

General management may consist of supportive therapy.

ATC code: J01DC04

Cefaclor is active against the following organisms in vitro:

Alpha and beta haemolytic streptococci

Staphylococci; including coagulase positive, coagulase negative and penicillinase producing

strains

Streptococcus pneumoniae

Streptococcus pyogenes (group A beta haemolytic streptococci)

Branhamella catarrhalis

Escherichia coli

Proteus mirabilis

Klebsiella species

Haemophilus influenzae, including ampicillin resistant strains.

Cefaclor has no activity against Pseudomonas species or Acinetobacter species. Methicillin

resistant staphylococci and most strains of enterococci (eg, Str. faecalis) are resistant to cefaclor.

Cefaclor is not active against most strains of Enterobacter spp, Serratia spp, Morganella

morganii, Proteus vulgaris and Providencia rettgeri.

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 75% of that observed when the drug is administered to

fasting subjects and generally appears from . to one hour later. Following administration of

250mg, 500mg and 1g doses to fasting subjects, average peak serum levels of approximately 7,

13 and 23 mg/l, respectively, were obtained within 30–60 minutes. Approximately 60–85% 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

250mg, 500mg and 1g doses were approximately 600, 900 and 1,900 mg/l, respectively. The

serum half life in normal subjects is 0.6–0.9 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 half life of the intact molecule is 2.3–2.8 hours. Excretion pathways in

patients with markedly impaired renal function have not been determined. Haemodialysis

shortens the half life by 25 30%.

There are no preclinical data of relevance to the prescriber which are additional to that already

included in other sections of the SPC.

Ceclor 500mg/250mg Capsules

Magnesium Stearate

Dimethicone

Pregelatinized Starch

Gelatin Capsule

Ceclor 125mg/250mg Suspension

Erythrosine Aluminium Lake

Methylcellulose 15

Sodium Lauryl Sulphate

Dimethicone

Xanthan Gum

Starch Pregelatinized

Artificial Strawberry Flavor 52.312 AP 05.51

Sucrose

Not Applicable.

Ceclor 500mg/250mg Capsules

Store below 30°C.

Ceclor 125mg/250mg Suspension

Store below 30°C, keep the containers tightly closed and protect from light. After reconstitution,

the suspension should be stored in a refrigerator (2‑ 8°C) and be used within 14 days

Ceclor 500mg/250mg Capsules

15/pack

Transparent Thermoformed PVC/PE/PCTFE and hard tempered aluminium foil lid.

Ceclor 125mg/250mg Suspension

75ml/pack

Translucent High Density Polyethylene bottle with plastic screw cap.

No Special Disposal.