- BETA-LACTAM ANTIBIOTICS
- ANTI-INFECTIVE DRUGS
- Pharmaceutical Form : Dry Powder for oral suspension
- Composition : Cefadroxil ( Monohydrate ) 500 mg / 5 ml Susp
- Active Substance : Cefadroxil
In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall
synthesis . Cefadroxil has been shown to be active against the Following organisms both in vitro and in clinical infections : Beta-hemolytic streptococci , Staphylococci, including penicillinase-producing strains ,
Streptococcus ( Diplococcus ) pneumoniae , Escherichia coli , Proteus mirabilis , Klebsiella species ,
Most strains of Enterococcus faecalis (formerly Streptococcus faecalis ) and Enterococcus faecium (
formerly Streptococcus faecium ) are resistant to CIFADROX
It is not active against most strains of Enterobacter species Morganella morganii
( formerly Proteus morganii ), and P. vulgaris . It has no activity against Pseudomonas species
INDICATIONS AND USAGE
CIFADROX is indicated for the treatment of patients with Infection caused by susceptible strains of the designated organisms in the following diseases :
* Urinary tract infections caused by E. coli,P.mirabilis , and Klebsiella species
* Skin and skin structure infections caused by staphylococcus and/or streptococci.
* Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci)
CIFADROX is contraindicated in patients with known allergy to the cephalosporin group of antibiotics .
before therapy with CIFADROX is instituted , careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefadroxil , cephalosporins ,penicillins , or other drugs . if this product is to be given to penicillin sensitive patients , caution should be exercised because cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefadroxil occurs ,discontinue the drug . serious acute hypersensitivity reactions may require treatment
with epinephrine and other emergency measures , including oxygen , intravenous fluids , intravenous
antihistamines , corticosteroids, pressor amines , and airway management , as clinically indicated .
CIFADROX should be used with caution in the presence of markedly impaired renal Fuction (
creatinine clearance rate of less than 50 mL/min/1.73 M ) In patients with known or suspected renal
impairment , careful clinical observation and Appropriate laboratory studies should be made prior to and
during therapy .
Prolonged use of CIFADROX may result in the overgrowth of nonsusceptible organisms. Careful
observation of the patient is essential . If superinfection occurs during therapy ,appropriate measures
should be taken .CIFADROX should be prescribed with caution in individuals with history of
gastrointestinal disease , particularly colitis .
DRUG INTERACTIONS :
Positive direct Coombs tests have been reported during treatment with the cephalosporin antibiotics .
In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are
performed on the minor side or in Coombs testing of newborns whose mothers have received
cephalosporin antibiotics before parturition , it should be recognized that a positive Coombs test may be due to the drug .
Pregnancy : 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 Cefadroxil monohydrate is administeredTo a
nursing mother .
Gastrointestinal onset of pseudomembranous colitis symptoms may occur during or after antibiotic
treatment , dyspepsia, nausea and vomiting have been reported rarely . Diarrhea has also occurred .
hypersensitivity allergies ( in the form of rash , urticaria , angioedema , and pruitis ) have been observed. These reactions usually subsided upon discontinuation of the drug. anaphylaxis has also been reported.
Other reactions have included hepatic dysfunction including cholestasis and elevations in serum
Transaminase, genital pruritus, genital moniliasis, vaginitis , moderate transient neutropenia,
fever.agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure , erythema multiforme ,
stevens-Johnson syndrome , serum sickness, and arthralgia have been rarely reported .
A study of children under six years of age suggested that ingestion of less than
250 mg/kg of Cephalosporins is not associated with significant outcomes . No action is required other
than general support and observation . For amounts greater than 250 mg/kg, induce gastric emptying .
DOSAGE AND ADMINISTRATION : CIFADROX is acid-stable and may be administered orally without regard to meals .administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy .
Adults : Urinary tract infections :
for uncomplicated lower urinary tract infections ( i.e.,cystitis ) the usual Dosage is 1 or 2 g per day in single dose or divided doses (b.i.d.).
For all other urinary tract infections the usual dosage is 2g per day in divided doses( b.i.d.).
Skin and Skin Structure infections : For skin and skin structure infections the usual dosage is 1 g per
day in single dose or divided doses ( b.i.d.).
Pharyngitis and Tonsillitis :
Treatment of group A beta-hemolytic streptococcal pharyngitis And tonsillitis 1 g per day in single
dose or divided doses ( b.i.d.) for 10 days .
Children : For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in Divided doses every 12 hours.
For pharynigitis , tonsillitis, and impetigo , the recommended daily dosage for children is 30
mg/kg/day in a single dose or in equally divided doses every 12 hours.
For other skin and skin structure infections , the recommended daily dosage is 30 mg/kg/day In equally
divided doses every 12 hours. In the treatment of beta- hemolytic streptococcal infections.A
therapeutic dosage of CIFADROX should be administered for at least 10 days. See chart for total daily
dosage for children .
In patients with renal impairment , the dosage of Cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested . In adults, the initial dose is 1000 mg of Cefadroxil and the maintenance dose ( based on the creatinine clearance rate [ mL/min/1.73 M2 ]) is 500 mg at the time intervals listed below .
Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients
having normal renal function .
STORAG CONDITIONS :
store dry powder below 25° c .Store in refrigerator after reconstitution And used within 14 days,
or in room temperature for one week .Keep out of reach of children .
Cifadrox 125 dry powder : Bottle of 60 ml.
Cifadrox 250 dry powder : Bottle of 60 ml.
Cifadrox 500 dry powder : Bottle of 60 ml