Augmentin

Augmentin

amoxicillin + clavulanic acid

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 375 mg tab Amoxycillin 250 mg (as trihydrate) & clavulanic acid 125 mg (as clavulanate K). Per 625 mg tab Amoxycillin 500 mg (as trihydrate) & clavulanic acid 125 mg (as clavulanate K). Per 1 g tab Amoxycillin 875 mg (as trihydrate) & clavulanic acid 125 mg (as clavulanate K). Per 156 mg/5 mL syr Amoxycillin 125 mg (as trihydrate) & clavulanic acid 31.25 mg (as clavulanate K). Per 457 mg/5 mL susp Amoxycillin 400 mg (as trihydrate) & clavulanic acid 57 mg (as clavulanate K). Per 600 mg vial Amoxycillin 500 mg (as amoxycillin Na) & clavulanic acid 100 mg (as clavulanate K). Per 1.2 g vial Amoxycillin 1 g (as amoxycillin Na) & clavulanic acid 200 mg (as clavulanate K)
Indications/Uses
Treatment of acute bacterial sinusitis; acute otitis media; acute exacerbations of chronic bronchitis; CAP; cystitis; pyelonephritis; skin & soft tissue infections, in particular cellulitis, animal bites, severe dental abscess w/ spreading cellulitis; bone & joint infections, in particular osteomyelitis. IV Treatment of severe infections of the ear, nose & throat (eg, mastoiditis, peritonsillar infections, epiglottitis, & sinusitis when accompanied by severe systemic signs & symptoms), intra-abdominal infections, female genital infections. Prophylaxis against infection associated w/ major surgical procedures.
Dosage/Direction for Use
Tab Adult & childn ≥40 kg One 375-mg tab tds or one 625-mg tab tds or one 1-g tab bd-tds. Childn <40 kg 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day given in 2 divided doses. Up to 70 mg/10 mg/kg/day given as 2 divided doses may be considered for some infections. Renal impairment Adult & childn ≥40 kg CrCl 10-30 mL/min One 375-mg tab bd or 625-mg tab bd; CrCl <10 mL/min Not more than one 375-mg tab once daily or 625-mg tab once daily; haemodialysis 2 doses of 375-mg every 24 hr, plus 2 doses of 375-mg during dialysis, to be repeated at the end of dialysis. Or one 625-mg tab every 24 hr, plus one 625-mg tab during dialysis, to be repeated at the end of dialysis. Childn <40 kg CrCl 10-30 mL/min 15 mg/3.75 mg/kg bd (max one 625-mg tab bd); CrCl <10 mL/min 15 mg/3.75 mg/kg as a single daily dose (max one 625-mg tab); haemodialysis 15 mg/3.75 mg/kg/day once daily. 15 mg/3.75 mg/kg prior & after haemodialysis. Syr 156 mg/5 mL Adult & childn ≥40 kg One 500 mg/125 mg dose tds. Childn <40 kg 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in 3 divided doses. Susp 457 mg/5 mL Childn ≥40 kg Should be treated w/ the adult formulations of Augmentin. Childn <40 kg 25/3.6 mg/kg/day to 45/6.4 mg/kg/day given as 2 divided doses. For some infections (eg, otitis media, sinusitis & lower resp tract infections) Up to 70/10 mg/kg/day given as 2 divided doses may be considered. Vial Adult & childn ≥40 kg Treatment of infections 1000 mg/200 mg every 8 hr. Surgical prophylaxis, procedures <1 hr in duration 1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesth; procedures >1 hr in duration 1000 mg/200 mg to 2000 mg/200 mg given at induction of anaesth, up to 3 doses of 1000 mg/200 mg in 24 hr. Childn <40 kg, ≥3 mth 25 mg/5 mg per kg every 8 hr; <3 mth or weighing <4 kg 25 mg/5 mg per kg every 12 hr. Renal impairment Adult & childn ≥40 kg CrCl 10-30 mL/min Initially 1000 mg/200 mg then 500 mg/100 mg bd; CrCl <10 mL/min Initially 1000 mg/200 mg then 500 mg/100 mg every 24 hr; haemodialysis Initially 1000 mg/200 mg then 500 mg/100 mg every 24 hr plus 500 mg/100 mg at the end of dialysis. Childn <40 kg CrCl 10-30 mL/min 25 mg/5 mg per kg given every 12 hr; CrCl <10 mL/min 25 mg/5 mg per kg given every 24 hr; haemodialysis 25 mg/5 mg per kg given every 24 hr, plus a dose of 12.5 mg/2.5 mg per kg at the end of dialysis. Elderly No dose adjustment necessary. Hepatic impairment Dose w/ caution.
Administration
Should be taken with food: Take at the start of meals for better absorption & to reduce GI discomfort. 1 g tab: The score line is only to facilitate breaking and ease of swallowing, do not divide.
Contraindications
Hypersensitivity to amoxycillin, K clavulanate, or to any of the penicillins. History of a severe immediate hypersensitivity reaction to another β-lactam agent (eg, a cephalosporin, carbapenem or monobactam). History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Special Precautions
Discontinue therapy if allergic reaction occurs. Convulsions may occur in patients w/ impaired renal function or in those receiving high doses. Avoid administration if infectious mononucleosis is suspected. Concomitant use of allopurinol. Overgrowth of non-susceptible organisms in prolonged use. Discontinue treatment in case of feverish generalized erythema associated w/ pustula. Antibiotic-associated colitis. Perform periodic assessment of organ system functions during prolonged therapy. Prothrombin time prolongation. Patients w/ reduced urine output; renal impairment; hepatic impairment. Hepatic events predominantly in males & elderly & may be associated w/ prolonged treatment. False positive results may occur when testing for the presence of glucose in urine using non-enzymatic methods. False positive Coombs test. False positive test results when using the Bio-Rad Laboratories Platelia Aspergillus EIA test. Patients w/ phenylketonuria (for 156 mg/5 mL syr & 457 mg/5 mL susp presentation); rare glucose-galactose malabsorption (for 457 mg/5 mL susp). May influence ability to drive & use machines. Pregnancy & lactation. Vial: Take into consideration the Na & K content of patients on controlled Na/K diet.
Adverse Reactions
Diarrhea, nausea & vomiting (uncommon for IV powd for inj), mucocutaneous candidiasis. Uncommon: Dizziness, headache, indigestion, AST or ALT elevations, skin rash, pruritus, urticaria.
Drug Interactions
Increased INR w/ oral anticoagulants (eg, acenocoumarol or warfarin). Reduced excretion of methotrexate. Decreased renal tubular secretion w/ probenecid. Reduced pre-dose conc of the active metabolite of mycophenolate mofetil (mycophenolic acid).
MIMS Class
Penicillins
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.
Presentation/Packing
Form
Augmentin 1.2 g IV powd for inj
Packing/Price
10 × 1's
Form
Augmentin 600 mg IV powd for inj
Packing/Price
10 × 1's
Form
Augmentin 457 mg/5 mL susp
Packing/Price
35 mL x 1's
Form
Augmentin 156 mg/5 mL syr
Packing/Price
60 mL x 1's
Form
Augmentin 1 g tab
Packing/Price
14's
Form
Augmentin 375 mg tab
Packing/Price
20's
Form
Augmentin 625 mg tab
Packing/Price
14's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in