Posology : מינונים

4.2       Posology and method of administration

Posology
The usual course of therapy is seven days (may range from five to ten days).
Table 1. Adults and children (≥40 kg)

Indication                                          Dosage
Acute tonsillitis and pharyngitis, acute            250 mg twice daily bacterial sinusitis
Acute otitis media                                  500 mg twice daily Acute exacerbations of chronic bronchitis           500 mg twice daily Cystitis                                            250 mg twice daily Pyelonephritis                                      250 mg twice daily Uncomplicated skin and soft tissue                  250 mg twice daily infections
Lyme disease                                        500 mg twice daily for 14 days (range of 10 to 21 days) 

Table 2. Children (<40 kg)
Indication                                          Dosage
Acute tonsillitis and pharyngitis, acute            10 mg/kg twice daily to a maximum of 125 mg twice daily bacterial sinusitis
Children aged two years or older with otitis        15 mg/kg twice daily to a maximum of 250 mg twice daily media or, where appropriate, with more severe infections
Cystitis                                            15 mg/kg twice daily to a maximum of 250 mg twice daily 
Pyelonephritis                                      15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days
Uncomplicated skin and soft tissue infections       15 mg/kg twice daily to a maximum of 250 mg twice daily 
Lyme disease                                        15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to
21 days)

There is no experience of using Zinnat in children under the age of 3 months.

Cefuroxime axetil tablets and cefuroxime axetil granules for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see section 5.2).

In infants (from the age of 3 months) and children with a body mass of less than 40 kg, it may be preferable to adjust dosage according to weight or age. The dose in infants and children 3 months to 18 years is 10 mg/kg twice daily for most infections, to a maximum of 250 mg daily. In otitis media 
or more severe infections the recommended dose is 15 mg/kg twice daily to a maximum of 500 mg daily.

The following two tables, divided by age group, serve as a guideline for simplified administration, e.g measuring spoon (5 ml) for the 125 mg/5mL or the 250 mg/5 ml multi- dose suspension if provided.

Table 3. 10 mg/kg dosage for most infections

Age                  Dose (mg)         Volume per dose (ml) twice daily
125 mg                 250 mg
3 to 6 months        40 to 60          2.5                    -
6 months to 2        60 to 120         2.5 to 5               - years
2 to 18 years        125               5                      2.5


Table 4. 15 mg/kg dosage for otitis media and more serious infections 
Age                  Dose (mg)         Volume per dose (ml) twice daily

125 mg                 250 mg
3 to 6 months        60 to 90          2.5                    -
6 months to 2        90 to 180         5 to 7.5               2.5 years
2 to 18 years        180 to 250        7.5 to 10              2.5 to 5

Renal impairment
The safety and efficacy of cefuroxime axetil in patients with renal failure have not been established. Cefuroxime is primarily excreted by the kidneys. In patients with markedly impaired renal function it is recommended that the dosage of cefuroxime should be reduced to compensate for its slower excretion. Cefuroxime is effectively removed by dialysis.

Table 5. Recommended doses for Zinnat in renal impairment

Creatinine clearance                   T 1/2 (hrs)       Recommended dosage ≥30 ml/min/1.73 m2                     1.4–2.4           no dose adjustment necessary standard dose of 125 mg to 500 mg given twice daily

10-29 ml/min/1.73 m2                   4.6               standard individual dose given every 24 hours 
<10 ml/min/1.73 m2                     16.8              standard individual dose given every 48 hours 
During haemodialysis                   2–4               a single additional standard individual dose should be given at the end of each dialysis


Hepatic impairment
There are no data available for patients with hepatic impairment. Since cefuroxime is primarily eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of cefuroxime.

Method of administration
Oral use
For optimal absorption cefuroxime axetil suspension should be taken with food.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Depending on the dosage, there are other presentations available.