COMPOSITIONS :
Cefadroxil Monohydrate Dry syrup 125 mg/5 ml, each 5 ml (a measurement spoonful) syrup contains : Cefadroxil monohydrate equivalent to Cefadroxil 125 mg.
DESCRIPTIONS :
Cefadroxil Monohydrate containing Cefadroxil monohydrate (equivalent to Cefadroxil) is available in 500 mg capsule, 125 mg/5 ml and 250 mg/5 ml dry syrup.
INDICATIONS :
Respiratory tract infections caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Skin and soft tissue infections caused by staphylococci and/or streptococci.
Urinary tract infections caused by E. coli, P. mirabilis and Klebsiella species.
Other infections : Osteomyelitis and septic arthritis.
DOSAGE AND ADMINISTRATIONS :
Adults :
Respiratory tract infections :
For mild infections : 1 g per day in 2 divided doses (500 mg, 2 times a day).
Moderate to severe infections : 1 – 2 g daily in 2 divided doses (500 mg to 1 g every 12 hours).
Pharyngitis and tonsillitis due to group A beta-hemolytic streptococci : 1 g per day in single or divided doses (500 mg 2 times a day) for at least 10 days.
Skin and soft tissue infections : 1 g per day in single or divided doses (2 times a day).
Urinary tract infections : For uncomplicated lower urinary tract infections (i.e., cystitis) : 1 – 2 g per day in single or divided doses (2 times a day).
For all other urinary tract infections : 2 g per day in divided doses (2 times a day).
Children :
Above 6 years : 500 mg, 2 times daily.
1 – 6 years : 250 mg, 2 times daily.
Infants < 1 year : 25 mg/kgBW in 2 divided doses (every 12 hours).
In the treatment of beta-hemolytic streptococcal infections : A therapeutic dosage of Cefadroxil should be administered for at least 10 days.
For the treatment of beta-hemolytic streptococcal pharyngitis or tonsillitis in both adults and children : Cefadroxil may be administered in the usual dose either in divided (2 times a day) or single doses.
In patients with renal impairment : The dosage of Cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. In adults, the initial dose is 1000 mg of Cefadroxil and the maintenance dose (based on the creatinine clearance rate [ml/minute/1.73 m2]) is 500 mg at the time intervals listed below :
| Creatinine clearance
(ml/minute) |
Dosage interval
(hours) |
| 0 – 10 | 36 |
| 10 – 25 | 24 |
| 25 – 50 | 12 |
| > 50 | Normal Dosage |
Preparation of dry syrup suspension :
Add 50 ml aquadest into the bottle. Shake well until evenly suspended. Keep container tightly closed. Use this suspension within 7 days. Shake well before use.
CONTRAINDICATION :
Patients with known allergy to the Cephalosporin group of antibiotics.
WARNINGS AND PRECAUTIONS :
Before used, should be performed hypersensitivity test to Cephalosporins and Penicillins.
Cephalosporin derivate should be administered carefully to patients with a history of hypersensitivity to Penicillins.
Pseudomembranous colitis has been reported with the use of Cephalosporins (and other broad-spectrum antibiotics), therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.
Cefadroxil should be used with caution in the presence of impaired renal function.
Prolonged use of Cefadroxil may result in the overgrowth of non-susceptible organisms. If super infection occurs during therapy, administration should be stopped.
Cefadroxil should be prescribed with caution in individuals with history of gastrointestinal disease, particularly colitis.
Cefadroxil should be used during pregnancy only if clearly needed.
Caution should be exercised when Cefadroxil is administered to a nursing mother.
If hypersensitivity reactions appear, the administration should be stopped immediately and give Ephinephrine/antihistamine/corticosteroid to the patient.
DRUG INTERACTIONS :
Positive direct Coombs’ tests have been reported during treatment with Cefadroxil.
Concomitant use with potent diuretics, Aminoglycosides and Probenecid may reduce Cephalosporins bactericidal activity and increase the risk of nephrotoxicity.
Patients who are under the treatment of Cefadroxil, their urine will give a positive reaction of glicosuria when tested with Benedict or Fehling solution. This will not happen in enzyme-based test.
ADVERSE REACTIONS :
Gastrointestinal : Symptoms of pseudomembranous colitis can appear during antibiotic treatment, such as : Nausea, vomiting and diarrhea have been reported rarely.
Hypersensitivity : Allergies (in the form of rash, urticaria, angioedema and pruritus).
Other reactions : Have included genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia and minor elevation in serum transaminase. Rarely reported : Reversible neutropenia, leucopenia, thrombocytopenia, fever, agranulocytosis, arthralgia, erythema multiforme and Steven-Johnson syndrome.
PRESENTATIONS :
Cefadroxil Monohydrate Dry syrup 125 mg/5 ml Bottle @ 60 ml
Reg. No. : GKL0902341938A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
