Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS/Zisuva 600/Zisuva 1200

Co-amoxiclav (amoxicillin & clavulanic acid). Per Zisuva 375 FC tab Amoxicillin 250 mg, clavulanic acid 125 mg. Per Zisuva 625 FC tab Amoxicillin 500 mg, clavulanic acid 125 mg. Per Zisuva 1G FC tab Amoxicillin 875 mg, clavulanic acid 125 mg. Per Zisuva DS powd for oral susp 5 mL Amoxicillin 125 mg, clavulanic acid 31.25 mg. Per Zisuva 600 powd for inj (vial) Amoxicillin 500 mg, clavulanic acid 100 mg. Per Zisuva 1200 powd for inj (vial) Amoxicillin 1,000 mg, clavulanic acid 200 mg

Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS Otitis media, sinusitis, infections caused by susceptible organisms involving the lower resp tract, skin & skin structure, & urinary tract w/ additional coverage of β-lactamase producing B. catarrhalis, H. influenzae, N. gonorrhoeae & S. aureus (not MRSA) in patients w/ amoxicillin resistance & those who cannot tolerate alternative treatments. Zisuva 600/Zisuva 1200 Severe infections of the ENT (eg, mastoiditis, peritonsillar infections, epiglottitis & sinusitis), acute exacerbations of chronic bronchitis, community-acquired pneumonia, cystitis, pyelonephritis, skin & soft tissue (particularly cellulitis, animal bites, severe dental abscess w/ spreading cellulitis), bone & joint (particularly osteomyelitis), intra-abdominal & female genital infections in adults & childn. Prophylaxis against infections associated w/ major surgical procedures in adults.

Zisuva 375 Adult & childn ≥40 kg 1 tab tds. Renal impairment: CrCl 10-30 mL/min 250 mg/125 mg bd, <10 mL/min 250 mg/125 mg once daily, haemodialysis 2 doses of 250 mg/125 mg every 24 hr + 2 doses of 250 mg/125 mg during dialysis, to be repeated at the end of dialysis. Zisuva 625/Zisuva 1G Adult & childn >12 yr Mild-moderate infection 625 mg tab bd. Severe infection 625 mg tab tds or 1 g tab bd. Renal impairment in adult: CrCl >30 mL/min (mild) 625 mg tab bd or 1 g tab bd; 1 g tab should only be used in patients w/ GFR >30 mL/min, CrCl 10-30 mL/min (moderate) 625 mg tab bd, CrCl <10 mL/min (severe) Not more than 625 mg tab every 24 hr. Zisuva DS Adult May be given in place of 500 mg/125 mg tab. Neonate & infant <12 wk 30 mg/kg daily. Zisuva 600/Zisuva 1200 May be administered either by slow IV inj over 3-4 min or by infusion over 30-40 min. Adult & childn ≥40 kg 1,000 mg/200 mg every 8-12 hr or 2,000 mg/200 mg every 12 hr. Severe infection May be increased to max 2,000 mg/200 mg every 8 hr. Surgical prophylaxis (duration of procedure >1 hr) 1,000 mg/200 mg-2,000 mg/200 mg given at induction of anaesth w/ up to 3 dose of 1,000 mg/100 mg in 24 hr, (duration of procedure <1 hr) 1,000 mg/200 mg-2,000 mg/200 mg given at induction of anaesth. Renal impairment in adult & childn >40 kg: CrCl 10-30 mL/min Initially 1,000 mg/200 mg & then 500 mg/100 mg bd, <10 mL/min Initially 1,000 mg/200 mg & then 500 mg/100 mg every 24 hr, haemodialysis Initially 1,000 mg/200 mg & then 500 mg/100 mg every 24 hr + 500 mg/100 mg at the end of dialysis. Childn <40 kg & ≥3 mth 50 mg/5 mg/kg every 8 hr, <4 kg or <3 mth 50 mg/5 mg/kg every 12 hr. Renal impairment in childn <40 kg: CrCl 10-30 mL/min 25 mg/5 mg/kg every 12 hr, <10 mL/min 25 mg/5 mg/kg every 24 hr, haemodialysis 25 mg/5 mg/kg every 24 hr + 12.5 mg/2.5 mg/kg at the end of dialysis.

May be taken with or without food. Best taken at start of meal to optimise absorption & to minimise gastrointestinal intolerance. Tab: Swallow whole, do not break.

Zisuva 600/Zisuva 1200 Hypersensitivity to amoxicillin, clavulanic acid or any of the penicillins. History of severe immediate hypersensitivity reaction to β-lactam agent eg, cephalosporin, carbapenem or monobactam; jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

History of β-lactam hypersensitivity, sensitivity to multiple allergens, or previous lgE-mediated reactions eg, anaphylaxis, angioedema, urticaria. Asthmatic patients. Risk of cross-allergy w/ cephalosporins; diarrhea, hepatic effects. Prolonged use may result to fungal/bacterial superinfections including C. difficile-associated diarrhea & pseudomembranous colitis. Rash development during therapy in patients w/ infectious mononucleosis. Hepatic & renal impairment. Avoid use during pregnancy. Lactation. Zisuva 375 Not recommended in childn <40 kg. Zisuva 625/Zisuva 1G Childn ≤12 yr. Zisuva 600/Zisuva 1200 Not suitable for IM administration. Convulsions may occur in patients w/ impaired renal function or those receiving high doses. Concomitant use w/ allopurinol.

Diarrhea/loose stools, nausea, vomiting. Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS Skin rashes & urticaria, vaginitis.

Potential for allergic or hypersensitivity reactions to amoxicillin may be enhanced by allopurinol. Penicillins may decrease excretion of methotrexate & serum conc of mycophenolate active metabolite. Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS Therapeutic effect of penicillins may be diminished (by fusidic acid & tetracycline derivatives) & excretion may be decreased (by uricosuric agents). May diminish the therapeutic effect of typhoid vaccine (only the live attenuated Ty21a strain). Zisuva 600/Zisuva 1200 Increased INR w/ acenocoumarol or warfarin. Decreased renal tubular secretion & may result in increased & prolonged blood levels of amoxicillin w/ probenecid.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

POM