Bostodroxil 500

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

The dosage depends on the susceptibility of the pathogens, the severity of the disease and on the clinical status of the patient (renal and hepatic function).

Children may benefit of increased posology up to 100 mg/kg/day.

Depending on the severity of the infection, adults may require increased posology. The dosage maximum is 4 g per day.

Chronic urinary tract infection may require a prolonged and intensive treatment with continued testing of susceptibility and clinical monitoring.

BOSTODROXIL 500 mg is not recommended for infants and children under 6 years. For younger children and children with a body weight < 40 kg, liquid oral forms  are available.

Renal impairment:

Adults 

The dosage should be adjusted according to creatinine clearance rates to prevent accumulation of cefadroxil. In patients with creatinine clearance of 50 ml/min or less, the following reduced dosage schedule is recommended as a guideline for adults:

Children (< 40 kg) 

Cefadroxil is not indicated in children suffering from renal insufficiency and children requiring haemodialysis.

Dosage for haemodialysis patients:

Haemodialysis eliminates 63% of 1000 mg of cefadroxil after 6 to 8 hours of haemodialysis. Elimination half-time of cefadroxil is about 3 hours during dialysis.

Patients with haemodialysis receive one additional dose of 500 mg - 1000 mg at the end of the haemodialysis.

Hepatic impairment:

No adjustment of posology is necessary.

Elderly:

As cefadroxil is excreted by renal route, the dosage should be adjusted, if necessary, as described under impaired renal function.

Administration

Bioavailability is not affected by food and cefadroxil may be taken with meals or on an empty stomach. In case of gastro-intestinal disturbances, it may be administered with food.

The capsules are taken unchewed with a liberal quantity of fluid.

Duration of therapy

Treatment should be applied for 2 to 3 further days after regression of the acute clinical symptoms or evidence of bacterial eradication has been obtained. In infections caused by Streptococcus pyogenes up to 10 days treatment may be considered

CONTRAINDICATIONS

Hypersensitivity to cefadroxil or any ingredient of drug.

History of severe reactions to penicillins or to any other beta-lactam drugs.

WARNINGS AND PRECAUTIONS

Cefadroxil does not penetrate the CSF and is not indicated for the treatment of meningitis 

Penicillin is the first drug of choice for the treatment of the Streptococcus pyogenes and for the prevention of rheumatic fever. Data for cefadroxil are not sufficiently substantial for prophylaxis therapy.

Special caution should be exercised in patients with a history of severe allergies or asthma.

In patients with a history of non-severe hypersensitivity to penicillins  or other non-cephalosporin beta–lactam drugs, cefadroxil should be used with special caution as cross allergies occur 

Renal impairment: Caution is necessary in patients with renal impairment; the dosage must be adjusted according to the grade of renal impairment 

History of gastro-intestinal disturbances: Cefadroxil should be used with caution in patients with a history of gastro-intestinal disturbances, particularly colitis.

The occurrence of diarrhoea may impair the resorption of other medicaments and therefore lead to an impairment of their efficacy.

Allergic reactions: Treatment must be discontinued at once if allergic reactions occur (urticaria, exanthema, pruritus, fall of blood pressure and increased heart rate, respiratory disturbances, collapse, etc.) and suitable countermeasures should be taken (sympathomimetics, corticosteroids and/or antihistamines).

Prolonged use: Particularly on prolonged use frequent checks on the blood count and regular hepatic and renal function tests are advisable. Superinfections with fungi (e.g. candida) can occur on prolonged treatment with cefadroxil.

In case of severe and persistent diarrhoea, an antibiotic-associated pseudomembranous colitis should be considered. In that case Cefadroxil must be discontinued immediately and a suitable therapy should be started (e.g. oral vancomycin, 250 mg q.i.d.). Antiperistaltics are contraindicated.

Severe life-threatening infections or those which require higher posology or repetitive administrations per day may benefit of parenteral cephalosporins.

The result of the Coombs' test can be transiently positive during or after treatment with cephalosporin. This also applies to Coombs' tests carried out in newborns whose mothers’ received treatment with cephalosporins before delivery.

Forced diuresis leads to a decrease of cefadroxil blood levels.

Urinary sugar should be determined enzymatically (e.g. with test strips) during treatment with cefadroxil since reduction tests can furnish falsely elevated values.

Precautions with excipients

This medicinal product contains FD&C Blue 1, Ponceau 4R: May cause allergic reactions.

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date

Box of 10 blisters x 10 hard capsules with the package insert