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Amoksiklav

Amoksiklav

amoxicillin + clavulanic acid

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid). Per 1 g Amoksiklav tab Amoxicillin 875 mg, clavulanic acid 125 mg
Indications/Uses
Bacterial infections induced by gm -ve & +ve amoxicillin resistant microorganisms whose resistance is caused by β-lactamases sensitive to the combination of amoxicillin & clavulanic acid. Infections of upper (including ENT) & lower resp tract, GUT, skin & soft tissue, bone & joint, dental. Cholecystitis. Mixed infections due to gm -ve & +ve microorganisms & anaerobes eg, chronic sinusitis & otitis, peritonsillar & mammary abscess, aspiration pneumonia, peritonitis cholangitis, post-op intra-abdominal complications, abdominal infections.
Dosage/Direction for Use
Max treatment duration: 14 days. Tab Adult & childn >12 yr, weighing >40 kg Severe infections 1,000 mg tab bid or every 12 hr. Renal insufficiency Max daily dose for clavulanic acid (in K salt form): 600 mg in adult, 10 mg/kg in childn. Max daily dose for amoxicillin: 6 g in adult, 45 mg/kg in childn.
Administration
May be taken with or without food: Best taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid or to any penicillins. History of severe immediate hypersensitivity reactions eg, anaphylaxis to another β-lactam agent eg, cephalosporin, carbapenem or monobactam; jaundice or hepatic impairment due to amoxicillin/clavulanic acid.
Special Precautions
Serious & occasionally fatal hypersensitivity reactions (including anaphylactoid & severe cutaneous adverse reactions). Discontinue treatment if allergic reaction occurs. Immediately discontinue if antibiotic-associated colitis occurs. Not to be used for penicillin-resistant Strep pneumoniae. Acute generalised exanthematous pustulosis (AGEP). Switching from amoxicillin/clavulanic acid to amoxicillin. Avoid use in suspected infectious mononucleosis. Overgrowth of non-susceptible organisms in prolonged use. History of hypersensitivity reactions to penicillins, cephalosporins or other β-lactam agents. Atopic individuals. Patients w/ serious underlying disease or taking concomitant medications known to have potential for hepatic effects; who present w/ diarrhoea during treatment subsequent to administration of any antibiotics. Male patients. Periodically assess renal, hepatic & haematopoietic function during prolonged therapy. Monitor prothrombin time when using concomitantly w/ anticoagulants; liver function at regular intervals. Maintain adequate fluid intake & urinary output. Regularly check patency in patients w/ bladder catheters. Increased allergic reactions w/ concomitant allopurinol use during treatment. May cause false +ve results w/ non-enzymatic methods; false +ve Coombs' test; +ve test results using Bio-Rad lab Platelia Aspergillus EIA test in patients who were subsequently found to be free of Aspergillus infection. Convulsions may occur in patients w/ renal impairment or in those receiving high doses. May influence ability to drive & use machines. Renal & hepatic impairment. Pregnancy & lactation. Not recommended in childn <12 yr & weighing <40 kg. Elderly.
Adverse Reactions
Diarrhoea. Mucocutaneous candidiasis; nausea, vomiting. SJS, TEN, AGEP, DRESS.
Drug Interactions
Increased INR w/ acenocoumarol or warfarin. Reduced excretion of MTX. Decreased renal tubular secretion of amoxicillin w/ probenecid. Concomitant use w/ mycophenolate mofetil.
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
Amoksiklav 1,000 mg tab
Packing/Price
10 × 8's;10's
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