KEFCIN 250

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COMPOSITION:
Cefaclor monohydrate ........................ equivalent to 250 mg of cefaclor
Excipients q.s ..................................................................... 1 capsule
(Sodium starch glycolate, aerosil, sodium lauryl sulfate, ludipress, talc).
DOSAGE FORM: Hard capsules.
PRESENTATION: Box of 3 blisters x 10 capsules.
PHARMACODYNAMICS: Kefcin with the active ingredient Cefaclor is a semi-synthetic second-generation cephalosporin antibiotic with the bactericidal action resulting from inhibition of cell-wall synthesis.
Cefaclor has in vitro effect against Gram-positive cocci similar to cephalothin, but is stronger against Gram-negative bacteria especially Haemophilus influenzae and Moraxella catarrhalis, including beta-lactamase-producing H.influenzae and M.catarrhalis. Cefaclor in vitro, is effective against most strains of the following organisms, isolated from patients: Staphylococci including coagulase-positive, coagulase-negative and penicillinase-producing strains; however, a cross-resistance appears between cefaclor and methicillin; Streptococcus pneumoniae; Streptococcus pyogenes (group A beta-hemolytic streptococci); 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); Peptococci; Peptostreptococci.
Cefaclor is ineffective against Pseudomonas spp. or Acinobacter spp., methicillin resistant Staphylococci and all strains of enterococci (eg Str.faecalis as well as most strains of Enterobacter spp., Serratia spp., Morganella morganii, Proteus vulgaris and Providencia rettgeri.
According to data stated in ASTS report in 1997, E. coli (about 22%) and Enterobacter (about19%) have a resistance to cefaclor (the figures were gotten from Cho Ray Hospital, Ho Chi Minh City from 11/1992 to 11/1996).
PHARMACOKINETICS: Cefaclor is well absorbed after oral administration to fasting subjects. Food delays cefaclor absorption but total absorption is unchanged. 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 plasma half-life of the intact molecule is 2.3 to 2.8 hours. About 25% of cefaclor are 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.
INDICATIONS: Treatment of respiratory tract infections caused by susceptible organisms. Acute otitis media, acute sinusitis, pharyngitis, repeated recurrent tonsillitis. Pneumonia, acute exacerbations of chronic bronchitis; uncomplicated, lower urinary tract infections (cystitis). Skin and soft tissue infections caused by Staphylococcus aureus and Streptococcus pyogenes.
CONTRAINDICATIONS:
A known history of hypersensitivity to the cephalosporin antibiotics.
PRECAUTIONS: A known history of hypersensitivity to cephalosporins, particularly to cefaclor or penicillins. The prolonged use of cefaclor may cause pseudomembranous colitis; caution should be exercised in patients with a history of gastrointestinal disease, particularly colitis; in patients with severe renal impairment. It should be recognized that a positive Coombs' test may be due to the drug in transfusion cross-matching procedures or in Coombs' testing of newborns whose mothers have received cefaclor before parturition. A false positive reaction of glucose for cefaclor in the urine may occur.
PREGNANCY AND LACTATION:
There are no adequate and well-controlled studies in pregnant women; therefore, this drug 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, but be cautious if diarrhea, rash appear in babies whose mothers have received cefaclor.
VEHICLE DRIVERS AND MACHINERY OPERATORS: The effect of cefaclor on the ability to drive vehicles and operate machinery is rarely reported.
INTERACTIONS: In patients receiving cefaclor and warfarin concomitantly, prothrombin time should be monitored, with adjustment of dosage if necessary. The renal excretion of cefaclor is inhibited by probenecid. Concurrent use of Cefaclor and aminoglycoside antibiotics or furosemide diuretics may enhance the toxicity to the kidney.
ADVERSE EFFECTS:
Frequent: morbilliform eruptions, diarrhoea, eosinophilia.
Less frequent: positive Coombs' tests; lymphocytosis, leukopenia; nausea, vomiting; itching, urticaria; genital itching, vaginitis, candidiasis.
Rare: anaphylactic reaction, fever; Stevens - Johnson syndrome, Lyell's syndrome, generalized exanthematous pustulosis; serum sickness-like reaction (occurring in children more frequent than adults); hemolytic anemia; pseudomembranous colitis; elevated liver enzymes, hepatitis and obstructive jaundice; recoverable interstitial nephritis, mildly elevated uraemia or serum creatinine; epilepsy, agitation, headache, nervousness, insomnia, confusion, dizziness, hallucination, somnolence; arthralgia. 
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: 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 are 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 drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying.
Forced diuresis, peritoneal dialysis, hemodialysis have not been established as beneficial for an overdose of cefaclor.
DOSAGE & ADMINISTRATION:
The drug is administered orally in fasting condition.
Adults: usual dose: 250 mg (1 capsule) x 3 times a day. For the treatment pharyngitis, pneumonia, tonsillitis, skin and soft tissue infections, lower urinary tract infections: 250 - 500 mg (1 - 2 capsules) x 2 times/ day or 250 mg (1 capsule) x 3 times/ day. For severe conditions: 500 mg (2 capsules) x 3 times/day. Maximum dose of 4 g/ day.
In severe renal impairment cases, the dosage needs to be adjusted as follows:
- If creatinine clearance 10 - 50 ml per minute, 50% the recommended dose is advised.
- If creatinine clearance < 10 ml per minute, 25% the recommended dose is advised.
In patients undergoing regular hemodialysis, a loading dose of 250 mg to 1 g prior to dialysis and a therapeutic dose of 250 to 500 mg every 6 to 8 hours maintained during interdialytic periods is recommended.
Dosage for the elderly is similar to that for the adult.
Children: 20 - 40 mg/ kg body weight/ day in 2 to 3 divided doses.
For treatment of otitis media in children: 40 mg/ kg body weight/ day in 2 to 3 divided doses, but not exceeding a total daily dose of 1 g.
In the treatment of beta-hemolytic streptococcal infections, 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.
Shelf-life: 36 months from the manufacturing date.
Storage conditions:
Store in dry places, not exceeding 30oC, protect from light.
Specifications: Vietnamese Pharmacopoeia IV.

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