| CLINICAL PHARMACOLOGY
Medaclor (Cefaclor,) is a semisynthetic cephalosporin antibiotic for oral administration In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis.
Cefaclor has been shown to be active against most strains of the following microorganisms :
*Aerobes, Gram-positive *Staphylococci, including coagulase-positive, coagulase-negative,and penicillinase-producing strains *Streptococcus pneumoniae *Streptococcus pyogenes (group A (beta)-hemolytic streptococci)
*Aerobes, Gram-negative *Escherichia coli *Haemophilus influenzae, excluding (beta)-lactamase-negative
ampicillin-resistant strains *Klebsiella spp *Proteus mirabilis
*Anaerobes *Bacteroides spp. (excluding Bacteroides fragilis )*Peptococcus *Peptostreptococcus *Propionibacterium acnes
Note : methicillin resistant stapylococi and most strains of enterococcui (Enterococcus faecalis {formerly Streptococcus faeccalis } And Enterococcus faecium { formerly Streptococcus faecium}) are resistant to cefaclor and other cephalosporins cefaclor is not active against most strains of Enterobacter , Serratia spp., morganella morganii, proteus vulgaris, it has no activity against pseudomonas spp or acinetobacter spp.
INDICATIONS AND USAGE :
Medaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
*Otitis media caused by Streptococcus pneumoniae , Haemophilus influenzae , staphylococci, and Streptococcus pyogenes *Lower respiratory tract infections , including pneumonia, caused by Streptococcus pneumoniae , Haemophilus influenzae , and Streptococcus pyogenes
*Pharyngitis and Tonsillitis , caused by Streptococcus pyogenes
*Urinary tract infections , including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
*Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
CONTRAINDICATIONS
Medaclor is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
PRECAUTIONS
1-before therapy with cefaclor is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor , cephalosporins, penicillins, or other drugs. if this product is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among (beta)-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy.
2-Prolonged use of cefaclor may result in the overgrowth of nonsusceptible organisms.
3-Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibiotics
4- Medaclor should be administered with caution in the presence of markedly impaired renal function.
5-Antibiotics, including cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
DRUG INTERACTIONS
1-Patients receiving Cefaclor may show a false-positive reaction for glucose in the urine with tests that use Benedict’s and Fehling’s solutions and also with clinitest tablets.
2-There have been reports of increased anticoagulant effect when Medaclor and oral anticoagulants were administered concomitantly.
3- As with other (beta)-lactam antibiotics, the renal excretion of cefaclor is inhibited by probenecid
Pregnancy Category – B : no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers :Caution should be exercised when Medaclor is administered to a nursing woman. Safety and effectiveness of this product for use in infants less than 1 month of age have not been established.
ADVERSE REACTIONS
1-Hypersensitivity reactions have been reported in about 1.5% of patients and include morbilliform eruptions Pruritus, urticaria. 2-More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been reported rarely. Anaphylactoid events may be manifested by solitary symptoms, including angioedema, asthenia, edema (including face and limbs), dyspnea, syncope, hypotension, or vasodilatation. Anaphylaxis may be more common in patients with a history of penicillin allergy.
3-Gastrointestinal diarrhea ,nausea and vomiting have been reported rarely
4-CNS :Rarely, reversible hyperactivity, agitation, nervousness, insomnia, confusion, , dizziness , and somnolence have been reported.
5-Hepatic :Slight elevations of AST, ALT, or alkaline phosphatase values
6-Hematopoietic -As has also been reported with other (beta)-lactam antibiotics, transient lymphocytosis, leukopenia, and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis, and reversible neutropenia of possible clinical significance.
7-Renal –Slight elevations in BUN or serum creatinine or abnormal urinalysis .
OVERDOSAGE
Signs and Symptoms –The symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress, and diarrhea Treatment:Unless 5 times the normal dose of cefaclor has been ingested, gastrointestinal decontamination will not be necessary. 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
DOSAGE AND ADMINISTRATION
Medaclor is administered orally.
Adults –The usual adult dosage is 250 mg every 8 hours. For more severe infections (such as pneumonia) or those caused by less susceptible organisms, doses may be doubled. Pediatric patients –The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. B.I.D. Treatment Option –For the treatment of otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours.
Packing :
Medaclor CAPSULE 500 box of 12 capsule Medaclor CAPSULE 250 box of 12 capsule
Medaclor 250 for Oral Suspension bottle of 60 ml Medaclor 125 for Oral Suspension bottle of 60 ml
Storage condition :
Store below 25°c . |
