HIGHLIGHT
Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS

Zisuva 375/Zisuva 625/Zisuva 1G/Zisuva DS

amoxicillin + clavulanic acid

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House
Concise Prescribing Info
Contents
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
Indications/Uses
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.
Dosage/Direction for Use
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 infections 625 mg tab bd. Severe infections 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.
Administration
May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort.
Special Precautions
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.
Adverse Reactions
Diarrhea/loose stools, nausea, skin rashes & urticaria, vomiting, vaginitis.
Drug Interactions
Potential for allergic or hypersensitivity reactions to amoxicillin may be enhanced by allopurinol. Therapeutic effect of penicillins may be diminished (by fusidic acid & tetracycline derivatives) & excretion may be decreased (by uricosuric agents). Penicillins may decrease excretion of methotrexate & serum conc of mycophenolate active metabolite. May diminish the therapeutic effect of typhoid vaccine (only the live attenuated Ty21a strain).
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zisuva 1G FC tab
Packing/Price
1 × 10's
Form
Zisuva 375 FC tab
Packing/Price
1 × 10's
Form
Zisuva 625 FC tab
Packing/Price
2 × 7's
Form
Zisuva DS powd for oral susp
Packing/Price
60 mL x 1's
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