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| BACTICLOR |
BACTICLOR Cefaclor
(Capsules and Oral Suspension)
(Capsules and Oral Suspension)
DESCRIPTION
Bacticlor capsules contain cefaclor USP equivalent to 500 mg of anhydrous cefaclor.
Bacticlor for oral suspension contains cefaclor USP equivalent to 125mg or 250mg of anhydrous cefaclor per
5mL reconstituted suspension.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Bacticlor (cefaclor) is a semi-synthetic broad spectrum cephalosporin antibiotic, has an in vitro activity against a broad range of gram-positive and gram-negative bacteria. The bactericidal action of cefaclor results from inhibition of bacterial cell-wall synthesis, Cefaclor is stable in the presence of some bacterial )3-lactamases; consequently. some 13-lactamase-producing organisms are susceptible to cefaclor.
Pharmacokinetics
Following oral administration, cefaclor is well absorbed from the gastrointestinal tract. The pharmacokinetics ot cefaclor are not altered when administered with meals. Peak plasma concentrations (Cmax) are obtained within
0.5 to 1 hour. Plasma protein binding is approximately 25%. Cefaclor is not metabolised in the liver and widely distributed in the body tissues within first 2 hours following its administration with substantial concentrations achieved in middle ear fluid, sinus drainage and bronchial secretions. About 38-54% of the drug is detected in the urine and by the end of eight hours of oral administration about 85% of the drug is excreted unchanged in the urine. The plasma half-life in healthy subjects is 0.6 to 0.9 hours, but in patients with reduced renal function the plasma half-life of cefaclor is slightly prolonged.
INDICATIONS
Bacticlor is indicated for the treatment of the following infections when caused by susceptible strains of the designated organisms in the following conditions:
1. Respiratory tract infections
i) Upper respiratory tract infections including otitis media, pharyngitis, tonsillitis and sinusitis due to Sfreptococcus pyogenes (group A J3-haemolyfic streptococci), Haemophilus Thfluenzae, or Strepfococcus prIaumoniae. ii) Lower respiratory tract infections:
a) Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae (non-)3- lactamase-producing strains only), Moraxella cafarrha (is (including ft-lactamase-producing strains) or Sfreptococcus pneumoniae. b) Secondary Bacterial Infection of Acute Bronchitis (SBIAB) due to Haemophilus influenzae (nOn-plactamase-producing strains only), Moraxella catarrhalis (including 3-lactamase-producing strains) or Strep fococcus pneumoniae. c) Pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae (non-)3-lactamase-producing strains - only), or Moraxella catarrhalis (including 3-lactamase-producing strains).
2. Urinary tract infections including cystitis, pyelonephritis and asymptomatic bacteriuria due to E. coil, Profeus mirabilis, Kiebsiella pneumoniae, or Sfaphylococcus saprophyficus. 3. SkIn and skin structure infections due to Staphylococcus aureus (methicillin-susceptible strains), Strep fococcus pyogenes, or Sfaphylococcus epidermidis (including 3-lactamase-producing strains).
DOSAGE AND ADMINISTRATION Dosage in the different Bacticlor forms/strengths:
1. Bacticlor capsules 500 mp, children over 12 years and adults:
The usual recommended dosage is 500 mg every 8 hours, doubled for severe infections; maximum 4 g daily. 2. Bacticlor oral suspension (125 mg and 250 mp/5mL after constitutloni:
The usual recommended dosage is 20 mg/kg in divided doses every 8 hours, doses doubled for severe infections. 1 month-I year: 62,5 mg
1-5 years: 125mg
over 5 years: 250 mg
Bacticlor should be administered for at least 10 days in the treatment of 3-haemolytic strepfococcal Infections,
Bacticlor capsules contain cefaclor USP equivalent to 500 mg of anhydrous cefaclor.
Bacticlor for oral suspension contains cefaclor USP equivalent to 125mg or 250mg of anhydrous cefaclor per
5mL reconstituted suspension.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Bacticlor (cefaclor) is a semi-synthetic broad spectrum cephalosporin antibiotic, has an in vitro activity against a broad range of gram-positive and gram-negative bacteria. The bactericidal action of cefaclor results from inhibition of bacterial cell-wall synthesis, Cefaclor is stable in the presence of some bacterial )3-lactamases; consequently. some 13-lactamase-producing organisms are susceptible to cefaclor.
Pharmacokinetics
Following oral administration, cefaclor is well absorbed from the gastrointestinal tract. The pharmacokinetics ot cefaclor are not altered when administered with meals. Peak plasma concentrations (Cmax) are obtained within
0.5 to 1 hour. Plasma protein binding is approximately 25%. Cefaclor is not metabolised in the liver and widely distributed in the body tissues within first 2 hours following its administration with substantial concentrations achieved in middle ear fluid, sinus drainage and bronchial secretions. About 38-54% of the drug is detected in the urine and by the end of eight hours of oral administration about 85% of the drug is excreted unchanged in the urine. The plasma half-life in healthy subjects is 0.6 to 0.9 hours, but in patients with reduced renal function the plasma half-life of cefaclor is slightly prolonged.
INDICATIONS
Bacticlor is indicated for the treatment of the following infections when caused by susceptible strains of the designated organisms in the following conditions:
1. Respiratory tract infections
i) Upper respiratory tract infections including otitis media, pharyngitis, tonsillitis and sinusitis due to Sfreptococcus pyogenes (group A J3-haemolyfic streptococci), Haemophilus Thfluenzae, or Strepfococcus prIaumoniae. ii) Lower respiratory tract infections:
a) Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB) due to Haemophilus influenzae (non-)3- lactamase-producing strains only), Moraxella cafarrha (is (including ft-lactamase-producing strains) or Sfreptococcus pneumoniae. b) Secondary Bacterial Infection of Acute Bronchitis (SBIAB) due to Haemophilus influenzae (nOn-plactamase-producing strains only), Moraxella catarrhalis (including 3-lactamase-producing strains) or Strep fococcus pneumoniae. c) Pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae (non-)3-lactamase-producing strains - only), or Moraxella catarrhalis (including 3-lactamase-producing strains).
2. Urinary tract infections including cystitis, pyelonephritis and asymptomatic bacteriuria due to E. coil, Profeus mirabilis, Kiebsiella pneumoniae, or Sfaphylococcus saprophyficus. 3. SkIn and skin structure infections due to Staphylococcus aureus (methicillin-susceptible strains), Strep fococcus pyogenes, or Sfaphylococcus epidermidis (including 3-lactamase-producing strains).
DOSAGE AND ADMINISTRATION Dosage in the different Bacticlor forms/strengths:
1. Bacticlor capsules 500 mp, children over 12 years and adults:
The usual recommended dosage is 500 mg every 8 hours, doubled for severe infections; maximum 4 g daily. 2. Bacticlor oral suspension (125 mg and 250 mp/5mL after constitutloni:
The usual recommended dosage is 20 mg/kg in divided doses every 8 hours, doses doubled for severe infections. 1 month-I year: 62,5 mg
1-5 years: 125mg
over 5 years: 250 mg
Bacticlor should be administered for at least 10 days in the treatment of 3-haemolytic strepfococcal Infections,
Renal Impairment
Cefaclor should be administered cautiously in the presence of markedly impaired renal function. Dosage recommendations in such condition are:
Cefaclor should be administered cautiously in the presence of markedly impaired renal function. Dosage recommendations in such condition are:
Creatinine clearance (mLlminlt73m2)
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24 hour dose
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> 40
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No modification
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40 to 10
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50 % of usual 24 hour dose
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<10
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25 % of usual 24 hour dose
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