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Amoclav Suspension

Amoclav Suspension

amoxicillin + clavulanic acid

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Co-amoxiclav: amoxicillin & clavulanic acid. Per 156.25 mg/5 mL powd for oral susp Amoxicillin 125 mg, clavulanic acid 31.25 mg. Per 228.5 mg/5 mL powd for susp Amoxicillin 200 mg, clavulanic acid 28.5 mg. Per 312.5 mg/5 mL powd for oral susp Amoxicillin 250 mg, clavulanic acid 62.5 mg. Per 457 mg/5 mL powd for susp Amoxicillin 400 mg, clavulanic acid 57 mg
Indications/Uses
156.25 mg/5 mL & 312.5 mg/5 mL powd for oral susp: Acute bacterial sinusitis, acute otitis media, acute exacerbations of chronic bronchitis, community acquired pneumonia, cystitis, pyelonephritis, cellulitis, animal bites, severe dental abscess w/ spreading cellulitis, osteomyelitis in adult & childn. 228.5 mg/5 mL & 457 mg/5 mL powd for susp: Treatment of infections due to β-lactamase producing strains eg, resp tract infections, GUT & abdominal infections, cellulitis, animal bites & severe dental infection w/ spreading cellulitis.
Dosage/Direction for Use
156.25 mg/5 mL & 312.5 mg/5 mL powd for oral susp Adult & childn ≥40 kg One 500 mg/125 mg tid. Adult & childn ≥40 kg w/ renal impairment, CrCl 10-30 mL/min 500 mg/125 mg bid, <10 mL/min 500 mg/125 mg once daily, hemodialysis 500 mg/125 mg every 24 hr + 500 mg/125 mg during dialysis, to be repeated at the end of dialysis. Childn <40 kg 20 mg/5 mg/kg/day-60 mg/15 mg/kg/day in 3 divided doses. Childn <40 kg w/ renal impairment, CrCl 10-30 mL/min 15 mg/3.75 mg/kg bid, max 500 mg/125 mg bid, <10 mL/min 15 mg/3.75 mg/kg/day as single daily dose, max 500 mg/125 mg, hemodialysis 15 mg/3.75 mg/kg/day once daily, 15 mg/3.75 mg/kg prior to hemodialysis & 15 mg/3.75/kg after hemodialysis. 228.5 mg/5 mL powd for susp Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 5-10 mL. Severe infections 10-20 mL. Childn 1-6 yr w/ body wt 10-18 kg Mild to moderate infections 2.5-5 mL. Severe infections 5-10 mL. Childn <1 yr w/ body wt <10 kg Mild, moderate, severe infections 2.5 mL. 457 mg/5 mL powd for susp Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 2.5-5 mL. Severe infections 5-10 mL. Childn 1-6 yr w/ body wt 10-18 kg Mild to moderate infections 2.5 mL. Severe infections 2.5-5 mL. To be given 12 hrly.
Administration
Oral susp: May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.|Powd for oral susp: Should be taken with food.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid or to any of the penicillins. History of severe immediate hypersensitivity reaction to another β-lactam agent. History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
Special Precautions
Previous hypersensitivity reactions to penicillins, cephalosporins or other β-lactam agents. Discontinue if allergic reaction occurs or in case of acute generalised exanthematous pustulosis. Not suitable for use when there is high risk that the presumptive pathogens have reduced susceptibility or resistance to β-lactam agents that is not mediated by β-lactamases susceptible to inhibition by clavulanic acid. Not to be used to treat penicillin-resistant S. pneumoniae. Convulsions may occur in patients w/ impaired renal function or in those receiving high doses. Avoid use if infectious mononucleosis is suspected. Can increase risk of allergic skin reactions when concomitantly used w/ allopurinol. May occasionally result to overgrowth of non-susceptible organisms in prolonged use. Reports of antibiotic-associated colitis. Periodically assess organ system functions, including renal, hepatic & hematopoietic function during prolonged therapy. Rare reports of prolonged prothrombin time. Maintain adequate fluid intake & urinary output during administration of high doses of amoxicillin, to reduce possibility of crystalluria. False +ve results w/ non-enzymatic methods of glucose determination. False +ve Coombs test. Reports of +ve results w/ Bio-Rad Lab Platelia Aspergillus EIA test in patients who were subsequently found to be free of Aspergillus infection. Caution in patients w/ evidence of hepatic impairment. Adjust dose according to the degree of renal impairment. Undesirable effects (eg, allergic reactions, dizziness, convulsions) may occur which may influence ability to drive & use machines. Avoid during pregnancy unless considered essential. Should only be used during breast-feeding after benefit/risk assessment.
Adverse Reactions
Mucocutaneous candidosis; diarrhoea, nausea, vomiting.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. Potential increase in MTX toxicity. Decreased renal tubular secretion of amoxicillin w/ probenecid. Reduction in pre-dose conc of mycophenolic acid. Increased incidence of skin rashes w/ allopurinol.
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
Amoclav Suspension 228.5 mg/5 mL powd for susp
Packing/Price
70 mL x 1's (P304.65/bottle)
Form
Amoclav Suspension 457 mg/5 mL powd for susp
Packing/Price
35 mL x 1's (P293.59/bottle);70 mL x 1's (P468.91/bottle)
/philippines/image/info/amoclav-suspension-457-mg-5-ml-powd-for-susp/400-mg-57-mg-5-ml-x-35-ml?id=344156c8-bcde-4969-beae-9faa00d263e9
/philippines/image/info/amoclav-suspension-457-mg-5-ml-powd-for-susp/400-mg-57-mg-5-ml-x-70-ml?id=58c72f64-04b4-4762-aaa2-9faa00d26415
Form
Amoclav Suspension 156.25 mg/5 mL powd for oral susp
Packing/Price
60 mL x 1's (P210/bottle)
Form
Amoclav Suspension 312.5 mg/5 mL powd for oral susp
Packing/Price
60 mL x 1's (P267.5/bottle)
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