KEFCIN 375

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KEFCIN 375

COMPOSITION: Cefaclor monohydrate equivalent to 375 mg of cefaclor

                             Excipients q.s .............................................. 1 caplet

(Sodium starch glycolate, pregelatinized starch, sodium lauryl sulfate, aerosil, talc, magnesium stearate, ludipress, sepifilm LP770, indigo carmine, blue No 1 alum lake).

DOSAGE FORM: Film coated caplet.

PRESENTATION: Box of 2 blisters x 5 caplets.

PHARMACODYNAMICS: Kefcin contains the active ingredient cefaclor which is a second-generation semi-synthetic cephalosporin antibiotic with the bactericidal action resulting from inhibition of bacterial cell-wall synthesis.

Cefaclor has in vitro action against Gram-positive cocci similar to that of cephalotin, but is reported to be more active against Gram-negative bacteria especially against Haemophilus influenzae and Moraxella catarrhalis, even beta-lactamase producing strains of H. influenzae and M.catarrhalis. Cefaclor has been shown to be active against most strains of the following microorganisms in vitro: staphylococci including coagulase-positive, coagulase-negative, penicillinase-producing strains; Streptococcus pneumoniae; Streptococcus pyogenes (group A beta-hemolytic streptococci); Moraxella catarrhalis, Haemophilus influenzae (including beta-lactamases producing, ampicillin-resistant strains); Escherichia coli; Proteus mirabilis; Klebsiella spp.; Citrobacter diversus; Neisseria gonorrhoeae; Propionibacterium acnes and Bacteroides spp. (excluding Bacteroides fragilis); Peptococcus; Peptostreptococcus.

Cefaclor has no activity against Pseudomonas spp. or Acinetobacter spp., methicillin-resistant staphylococci and most strains of enterococci.

PHARMACOKINETICS:

Cefaclor is well absorbed after oral administration to fasting subjects. The presence of food may delay the absorption of cefaclor but total amount absorbed 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 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:

For the treatment of respiratory tract infections due to susceptible microorganisms; acute otitis media, acute sinusitis, pharyngitis, repeated recurrent tonsillitis; pneumonia, acute exacerbations of chronic bronchitis; uncomplicated lower urinary tract infections (cystitis); skin and skin structure infections caused by susceptible Staphylococcus aureus and Streptococcus pyogenes.

CONTRAINDICATIONS:

A known history of hypersensitivity to the cephalosporin antibiotics.

PRECAUTIONS:

The patients have had previous hypersensitivity reactions to cephalosporins, particularly cefaclor or to penicillins. Pseudomembranous colitis has been reported with prolonged administration of cefaclor. Cefaclor should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. In patients with severe renal impairment, renal function should be monitored when applying a long-term therapy or co-administering other medicaments that affect renal function (such as aminoglycosides, furosemides, ...). In transfusion cross-matching procedures or in Coombs' testing of newborns whose mothers have received cefaclor before parturition, it should be recognized that a positive result may be due to the drug. A false-positive reaction for glucose in the urine may occur.

PREGNANCY AND LACTATION:

There are no adequate studies in pregnant women; therefore, cefaclor should be used during pregnancy only if clearly needed.

Small amounts of cefaclor have been detected in mother's milk. The effect on nursing infants is not known, but be cautious if diarrhea, or skin rash appears when the baby is being fed by a nursing woman taking cefaclor.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

Cautions should be taken when driving and using machines.

INTERACTIONS:

Observation of prothrombin time has been required when cefaclor and warfarin were administered concomitantly, with adjustment of dosage if necessary. The serum elimination of cefaclor is inhibited by probenecid. Renal toxicity has been reported in patients concurrently receiving cefaclor and aminoglycoside antibiotics or furosemide diuretics.

ADVERSE EFFECTS:

Frequent: Morbilliform eruptions. Diarrhoea. Eosinophilia.

Less frequent: Positive Coombs' test. 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 (happening more frequently in children than in adults). Thrombocytopenia, hemolytic anemia. Pseudomembranous colitis. Elevated liver enzymes, hepatitis and obstructive jaundice. Recoverable interstitial nephritis, slight elevations in blood urea or serum creatinine Epilepsy, increased irritation, headache, nervousness, insomnia, confusion, dizziness, hallucinations, 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. It is possible to employ gastric lavage or more activated charcoal or only using activated charcoal.

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:

The usual dose is 1 caplet twice daily.

For pharyngitis, pneumonia, tonsillitis, skin and skin structure infections, lower urinary tract infections, the dosage is 1 caplet twice daily.

For more severe conditions, 2 caplets twice daily is recommended, up to a daily maximum of 4 g.

In severe renal impairment cases, the dosage needs to be adjusted as follows:

- If creatinine clearance 10 - 50 ml per minute, 50% the usual dose is advised.

- If creatinine clearance < 10 ml per minute, 25% the usual dose is advised.

The elderly: As for adults.

Children:

The dose is 20 - 40 mg/ kg body weight/ 24 hours, in 2 to 3 divided doses.

For otitis media in children, the dosage is 40 mg/kg body weight/ 24 hours in 2 to 3 divided doses, but not exceeding a total daily dose of 1 g. The safety and efficacy have not been established for use in infants aged less than one month. A daily maximum dose for children should not exceed 1.5 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: Manufacturer's.

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