Ceflon is a preparation of cefaclor, a second generation cephalosporin having greater stability against ß-lactamase inactivation and possesses a broader spectrum of activity.

• It is generally effective in the eradication of streptococci from the nasopharynx.
• Ceflon is active against the following organisms in vitro:

µ-and ß-haemolytic streptococci, staphylococci (including coagulase positive, coagulase-negative and penicillinase producing strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A ß-haemolytic streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (including ampicillin resistant strains), Neisseria gonorrhoeae.
 

Ceflon is indicated for the treatment of the following infections due to susceptible micro-organisms.

• Respiratory tract infections, including pneumonia, bronchitis,

exacerbation of chronic bronchitis, pharyngitis and tonsillitis.

• As part of the management of sinusitis.
• Otitis media, skin and soft tissue infections.
• Urinary tract infections (It has been found to be effective in

both acute and chronic urinary tract infections), including
pyelonephritis and cystitis.

Adult: The usual adult dosage is 250 mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4 g per day have been administered safely to normal subjects for 28 days, but the total daily dose should not exceed this amount.

Impaired renal function: It may be administered in the presence of impaired renal function. Under such conditions dose is usually unchanged.

Patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 25-30%. In patients undergoing regular haemodialysis, a loading dose of 250 mg - 1 g administered prior to dialysis and a therapeutic dose of 250-500 mg every six to eight hours maintained during interdialytic periods is recommended.

Elderly: As for adults.

Children: The usual recommended daily dosage for children over one month of age is 20 mg/kg/day in divided doses every eight hours, as indicted. For more serious infections and infections caused by less susceptible organisms, 40 mg/kg/day in divided doses are recommended, with a maximum dosage of 1 g/day. Safety and efficacy have not been established for use in infants aged less than one month. Another recommendation is as follows:
 

Note: In more serious infections, otitis media, sinusitis and infections caused by less susceptible organisms 40 mg/kg/day in divided doses is recommended, upto a daily maximum of 1 g. In the treatment of ß-haemolytic Streptococcal infections, therapy should be continued for at least 10 days. 

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.

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 women. 

Lactating mothers: Small amounts of cefaclor have been detected in breast milk following administration of single 500 mg doses. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to nursing women.

Gastro-intestinal: The most frequent side effect is diarrhoea. Nausea, vomiting and abdominal discomfort have also been reported. 

Hypersensitivity: Allergic reactions such as morbiliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness-like reactions have been reported and have usually occured during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than adults. There are reports of erythema multiforme major (Stevens-Johnson syndrome), toxic epidermal necrolysis, and anaphylaxis. Anaphylaxis may be more common in patients with history of penicillin allergy.

Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis, leucopenia and rarely haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia.

Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely.

Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.

Central Nervous System: Reversible hyperactivity, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.

Hypersensitivity to cephalosporins.
 

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 renal excretion of cefaclor is inhibited by probenecid.
 

Before instituting therapy with cefaclor, every effort should be made to determine whether the patients had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs.
 

Ceflon should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
 

Store in a cool (below 30°C), dry place away from light, Keep out of reach of children.
 

Ceflon 250 mg capsule  : Box containing 4 strips of 4 capsules. Each capsule contains cefaclor monohydrate BP equivalent to 250 mg cefaclor.
Ceflon 500 mg capsule  : Box containing 2 strips of 4 capsules. Each capsule contains cefaclor monohydrate BP equivalent to 500 mg cefaclor.
Ceflon suspension   : Bottle containing powder for the preparation of 100 ml suspension. After reconstitution each 5 ml contains cefaclor monohydrate BP equivalent to 125 mg cefaclor. 
Ceflon paediatric drops   : Bottle containing powder for the preparation of 15 ml drops. Each 1.25 ml contains cefaclor monohydrate BP equivalent 125 mg cefaclor. 
 


Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK