Cefaclor monohydrate ....... equivalent to 500 mg of cefaclor
Hard capsule (Green - White).
Box of 2 blisters x 7 capsules.
Kefcin 500 Caps with the active ingredient Cefaclor is a semi-synthetic second-generation cephalosporin antibiotic with the bactericidal property resulting from inhibition of bacterial cell-wall synthesis. Cefaclor is active in vitro against gram-positive cocci and is similar to cephalotin but is stronger against gram-negative bacteria, particularly Haemophilus influenzae and Moraxella catarrhalis, including beta-lactamase-producing H. influenzae and M. catarrhalis. Cefaclor is active against the following organisms in vitro, isolated from the patient e.g., Staphylococcus including coagulase-positive, coagulase-negative, penicillinase-producing strains (However, a cross resistance between cefaclor and methicillin has been reported); Streptococcus pneumoniae; Streptococcus pyogenes (group A beta-hemolytic Streptococcus); Moraxella catarrhalis, Haemophilus influenzae (including beta-lactamase-producing, ampicillin-resistant strains); Escherichia coli; Proteus mirabilis; Klebsiella spp.; Citrobacter diversus; Neisseria gonorrhoeae; Propionibacterium acnes and Bacteroides spp. (except Bacteroides fragilis); Peptococcus; Peptostreptococcus.
Cefaclor has no activity against Pseudomonas species or Acinobacter 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. Food delays cefaclor absorption but total absorption of the drug is the same. The serum half-life in normal subjects is 30 to 60 minutes; in patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete absence of renal function, the half-life is 2.3 to 2.8 hours. About 25% of cefaclor is bound to plasma protein. Cefaclor appears to be widely distributed in the body; it crosses the placenta and is excreted in low concentrations in breast milk. Cefaclor is rapidly excreted by the kidneys. Probenecid delays the excretion of cefaclor. Some cefaclor is removed by haemodialysis.
Caution should be exercised in drivers and machinery operators because of possibility of headache and dizziness.
Cefaclor should be used with caution in patients with a known history of hypersensitivity to cephalosporins, particularly to cefaclor or penicillin. The prolonged use of cefaclor may cause pseudomembranous colitis. Caution should be exercised in patients with a history of gastrointestinal diseases, particularly colitis and in those with severe renal impairment. A positive result may be reported in transfusion cross-matching procedures or in Coombs' testing of newborns whose mothers have received cefaclor before parturition. A false-postive reaction for glucose in the urine may occur.
There are no adequate and well-controlled studies in pregnant women; therefore, cefaclor should be used during pregnancy only if clearly needed. Small amounts of cefaclor have been detected in breast milk. The effect on nursing infants is not known. Caution should be exercised if symptoms of diarrhea, skin rash occur in babies whose mothers are taking cefaclor.
In patients receiving cefaclor and warfarin concomitantly, prothrombin time should be monitored with adjustment of dosage if
necessary. The serum excretion of cefaclor is inhibited by probenecid. Concurrent use of cefaclor and aminoglycoside antibiotics or furosemide diuretics may enhance toxicity to the kidneys.
Frequent: Rash. Diarrhoea. Eosinophilia.
Less frequent: Positive Coombs' tests. Lymphocytosis, leukopenia. Nausea, vomiting. Pruritus, urticaria. Genital pruritus, vaginitis, candidiasis.
Rare: Anaphylactic reaction, fever, Stevens-Johnson syndrome, Lyell's syndrome, generalized exanthematous pustulosis. Serum sickness-like reaction (Such reaction has been reported more frequently in children than in adults). Thrombocytopenia, hemolytic anemia. Pseudomembranous colitis. Elevated liver enzymes, hepatitis and obstructive jaundice. Reversible interstitial nephritis, slight elevations in blood urea or serum creatinine. Epilepsy, agitation, headache, nervousness, insomnia, confusion, dizziness, hallucinations, somnolence. Arthralgia.
Inform your physician about any adverse effects occur during the treatment.
The toxic symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress, and diarrhea. The severity of the epigastric distress and the diarrhea is dose related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication.
In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. Unless 5 times the normal dose of cefaclor has been ingested, gastrointestinal decontamination will not be necessary. Protect the patient’s airway and support ventilation and perfusion. Absorption of the drug may be decreased by giving repeated activated charcoal. Gastric lavage and administration of activated charcoal or only use of activated charcoal are possible. The benefits of forced diuresis, peritoneal dialysis, or hemodialysis in treating cefaclor overdosage have not been established.
Store in dry places, not exceeding 30oC, protect from light.
24 months from the manufacturing date.
For the treatment of respiratory tract infections caused by susceptible micro-organisms; acute otitis media, acute sinusitis, pharyngitis, repeated recurrent tonsillitis; pneumonia, acute exacerbations of chronic bronchitis; uncomplicated, lower urinary tract infections (including cystitis); skin and soft tisue infections caused by Staphylococcus aureus and Streptococcus pyogenes.
A known history of hypersensitivity to the cephalosporin antibiotics.
The drug is administered orally in fasting conditions.
Adults: 500 mg (1 capsule) twice daily. In more severe infections: 500 mg (1 capsule) 3 times daily. Maximum dose of 4 g/day.
In severe renal impairment patients, the dosage needs to be adjusted:
Creatinine clearances of 10 - 50 ml/ min: 50% of the usual dosage.
Creatinine clearances less than 10 ml/ min: 25% of the usual dosage.
Patients undergoing haemodialysis: A loading dose of 250 mg - 1 g administered prior to dialysis and a therapeutic dose of 250 - 500 mg every 6 to 8 hours maintained during interdialytic periods is recommended.
The elderly: As for adults.
For the treatment of infections caused by beta-hemolytic Streptococci, a therapeutic dosage of cefaclor should be administered for at least 10 days.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
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