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The dose of ZISUVA 375 Tablets that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents; The severity and the site of the infection; The age, weight and renal function of the patient as shown as follows.
The use of alternative presentations of ZISUVA Tablets (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary. Treatment should not be extended beyond 14 days without review.
Adults and children ≥ 40 kg: One tablet taken three times a day.
Children < 40 kg: ZISUVA 375 Tablets are not recommended in children <40 kg.
Elderly: No dose adjustment is considered necessary.
Renal Impairment: Dose adjustments are based on the maximum recommended level of amoxicillin. No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30ml/min.
Adults and children ≥ 40 kg: CrCl 10-30 ml/min: 250 mg/125 mg twice daily.
CrCl < 10 ml/min: 250 mg/125 mg once daily.
Haemodialysis: Two doses of 250 mg/125 mg every 24 hours, plus two doses of 250mg/125mg during dialysis, to be repeated at the end of dialysis (as serum concentrations of both amoxicillin and clavulanic acid are decreased).
Children < 40 kg: In children < 40 kg with creatinine clearance less than 30 ml/min, the use of ZISUVA 375 Tablets presentations with an amoxicillin to clavulanic acid ratio of 2:1 is not recommended, as no dose adjustments are available. In such patients, ZISUVA formulations with an amoxicillin to clavulanic acid ratio of 4:1 are recommended.
Hepatic impairment: Dose with caution and monitor hepatic function at regular intervals.
ZISUVA 625 mg and 1 g: Usual dosages for the treatment of infection: Adults and children over 12 years: Mild - Moderate infections: One ZISUVA 625 mg tablet twice daily.
Severe infections: One ZISUVA 1g tablet twice daily or One ZISUVA 625 mg tablet 3 times a day.
Therapy can be started parenterally and continued with an oral preparation.
ZISUVA 625mg / 1g tablets are not recommended in children of 12 years and under.
Dosage in renal impairment: Adults: ZISUVA 1g tablet should only be used in patients with a glomerular filtration rate of >30 ml/min. (See Table 1.)
Click on icon to see table/diagram/imageDosage in hepatic impairment: Dose with caution; monitor hepatic function at regular intervals.
Method of Administration: Tablet to be consumed in whole, not to be broken.
To minimise potential gastrointestinal intolerance, administer at the start of a meal.
The absorption of ZISUVA is optimised when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
Zisuva DS: Neonates and Infants aged < 12 weeks (3 months): The recommended dose of Amoxicillin and Clavulanate Potassium for Oral Suspension 250mg/62.5mg per 5 ml is 30 mg/kg/day.
Adults: Adults who have difficulty swallowing may be given the Amoxicillin and Clavulanate Potassium for Oral Suspension 250mg/62.5mg per 5 ml or 125 mg/31.25 mg per 5 ml suspension in place of 500mg/125mg tablet.
Directions for Mixing Oral Suspension: Shake the bottle to ensure the powder is free flowing. Add freshly boiled and cooled water a little below the mark on the bottle and shake well to get a uniform suspension. Add further water up to the mark and mix well. The reconstituted suspension to be stored in a refrigerator and should be consumed within 7 days,
Method of Administration: For oral administration.
Zisuva 600/Zisuva 1200: Posology: The dose of ZISUVA that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents.
The severity and the site of the infection.
The age, weight and renal function of the patient as shown as follows.
The use of alternative presentations of Zisuva (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary. The duration of therapy should he determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review.
Recommended doses for treatment of infections as indicated in previous section: Adults and children ≥ 40 kg: 1000 mg/200 mg every 8-12 hours or; 2000 mg/200 mg every 12 hours.
For very severe infections the dose may be increased to a maximum of 2000 mg/200 mg every 8 hours. (See Table 2.)
Click on icon to see table/diagram/imageChildren < 40 kg Recommended doses: Children aged 3 months and over: 50 mg/5 mg per kg every 8 hours.
Children aged less than 3 months or weighing less than 4 kg: 50 mg/5 mg per kg every 12 hours.
Elderly: No dose adjustment is considered necessary.
Renal impairment: Dose adjustments are based on the maximum recommended level of amoxicillin.
No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
Adults and children > 40 kg: See Table 3.
Click on icon to see table/diagram/imageChildren < 40 kg: See Table 4.
Click on icon to see table/diagram/imageHepatic impairment: Dose with caution and monitor hepatic function at regular intervals.
Method of Administration: ZISUVA Injection is for intravenous use.
ZISUVA Injection may be administered either by slow intravenous injection over a period of 3 to 4 min directly into a vein or via a drip tube or by infusion over 30 to 40 min. ZISUVA Injection is not suitable for intramuscular administration.
Children aged less than 3 months should be administered ZISUVA Injection by infusion only.
Treatment with ZISUVA Injection may be initiated by the use of an intravenous preparation and completed with an appropriate oral presentation as considered appropriate for the individual patient.
