Capabiotic

Capabiotic

cefaclor

Manufacturer:

Yarindo Farmatama
Full Prescribing Info
Contents
Cefaclor.
Description
Each film coated caplet contains: Cefaclor monohydrate equivalent to Cefaclor 500 mg.
Action
Pharmacology: Capabiotic 500 contains Cefaclor which is a cephalosporin antibiotic. It has a bactericidal action against gram-positive and gram-negative pathogens as well as β-lactamase-producing enzyme strains. In vitro tests demonstrated that the bactericidal action of cefaclor result from inhibition of bacterial cell wall synthesis. Cefaclor is also active against Staphylococcus, Streptococcus pyogenes, Streptococcus pneumoniae, Moraxella, Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Klebsiella and Neisseria gonorrhoeae.
Indications/Uses
Treatment of the following infections: Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae and Streptococcus pyogenes from group A β-haemolytic streptococci.
Lower respiratory tract infections including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes from group A β-haemolytic streptococci.
Urinary tract infection including pyelonephritis caused by E. coli, Proteus mirabilis and Klebsiella sp.
Soft tissue infections due to Staphylococcus aureus and Streptococcus pyogenes from group A β-haemolytic streptococci.
Dosage/Direction for Use
Adults usual dose: 250 mg every 8 hrs. For severe infection, e.g. pneumonia or infections caused by less susceptible organism, dose can be doubled. For infections due to group A β-haemolytic streptococci, therapy should be given for at least 10 days.
Contraindications
Patients with known allergy to cephalosporin antibiotics.
Special Precautions
Caution should be exercised when giving cephalosporin antibiotic to patients who are sensitive to penicillin. There is clinical evidence of cross-sensitivity of penicillin and cephalosporin and patients may have anaphylactic reactions.
Therefore cephalosporin antibiotics including cefaclor must be administered cautiously to patients who have demonstrated some forms of allergy particularly to Capabiotic 500.
Pseudomembranous colitis has been reported in patients taking broad-spectrum antibiotic including penicillin and cephalosporin. Therefore, it is important to consider the administration of cephalosporin antibiotic to patients who develop diarrhoea in association with the use of antibiotics as it can lead to a serious problem.
In general, broad-spectrum antibiotics therapy can alter the normal flora in the colon. This can lead to an overgrowth of Clostridium difficile which produces toxin that can cause colitis.
In patients with mild or severe pseudomembranous colitis, sigmoidoscopy examination is advisable and electrolyte or protein supplementation is recommended.
Long-term therapy with cefaclor can cause an overgrowth of nonsusceptible organism. Positive Coomb's test has been reported during therapy with cephalosporin antibiotic.
In newborn babies whose mothers have received cephalosporin antibiotic before parturition, they may show positive Coomb's test.
Cefaclor must be administered cautiously to patients with severe renal impairment. If half-life in anuria is between 2.3-2.8 hrs, dose adjustment is not required in patients with mild or severe renal impairment. Clinical experience with cefaclor under such conditions is limited, therefore careful clinical observation and laboratory studies should be made.
The administration of cefaclor can give false-positive reaction for blood glucose in the urine. As with other broad-spectrum antibiotic, cefaclor must be prescribed with caution in patients with history of gastrointestinal disturbances particularly colitis.
Use in Pregnancy: Caution should be exercised when administered to pregnant women.
Use In Pregnancy & Lactation
Pregnancy: Caution should be exercised when administered to pregnant women.
Side Effects
Hypersensitivity reactions, e.g. pruritus and urticaria, have been reported in about 1.5% of patients receiving cefaclor.
Serum sickness-like reactions have been reported. Such reactions were marked by the appearance of erythema multiforme, rash and other skin manifestations followed by arthritis symptoms or arthralgia and increase in body temperature. It was seldom followed by lymphadenopathy, proteinuria and absence of circulating immune complex. Thus, the serum sickness-like reactions were due to hypersensitivity reactions and long-term treatment with cefaclor. These side effects are mostly common in children than in adults with the incidence of 1 in 200 (0.5%). Symptoms usually appear a few days after treatment with cefaclor. Patients may need to be hospitalized for 2-3 days.
Gastrointestinal disturbances occurred in 2-5% of patients and the incidence of diarrhoea is 1 in 70 patients.
Storage
Store below 30°C.
MIMS Class
ATC Classification
J01DC04 - cefaclor ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
FC caplet 500 mg x 3 x 10's.
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