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Concise Prescribing Info
Contents
Co-amoxiclav (amoxicillin & clavulanic acid) Per tab Amoxicillin trihydrate 500 mg, K clavulanate 125 mg
Indications/Uses
Acute & chronic bronchitis, lobar & bronchial pneumonia, empyema, pulmonary abscess, tonsillitis, sinusitis, otitis media; cystitis, urethritis, pyelonephritis; septic abortion, puerperal sepsis, pelvic inflammatory disease, chancroid, gonorrhea; furunculus & abscess, cellulitis, wound infection; peritonitis; myelitis; sepsis, intra-abdominal sepsis; dental infections or infection after operation.
Dosage/Direction for Use
Adult & childn >12 yr or weighing ≥40 kg 375 mg every 8 hr. More severe & resp tract infections 625 mg every 8 hr. Dental infections 375 mg every 8 hr for 5 days.
Administration
May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.
Contraindications
Hypersensitivity or allergic reactions including shock to amoxicillin, clavulanic acid or β-lactams (penicillin, cephem) drugs. Patients w/ accompanying infection of virus diseases eg, infectious mononucleosis & lymphocytic leukemia; history of amoxicillin/clavulanate K- or penicillin-associated jaundice or hepatic dysfunction (possible recurrence). Pregnancy (1st trimester).
Special Precautions
Severe hepatic dysfunction; moderate or severe renal disorder. Family history or known susceptibility to allergic symptoms eg, bronchial asthma, rashes, urticaria; poor oral intake or general condition (vit K deficiency) on parenteral nutrition; GI diseases w/ vomiting or diarrhea, K & Na restricted diet. Avoid prolonged use (>14 days) & when infectious mononucleosis occurs. Hypersensitivity (anaphylactic) reactions & angioedema, (rare) anaphylactic shock, moderate to severe pseudomembranous colitis. Discontinue use if symptoms eg, urticaria, skin rash & serum diseases occur. Regularly monitor hematopoiesis, renal & hepatic function. False +ve reactions for Clinitest, Benedict's or Fehling's soln. Influence result in urobilinogen tests & +ve Coombs' test. Lactation. Childn, premature babies & infants <2 mth. Elderly.
Adverse Reactions
Diarrhea, pseudomembranous colitis, indigestion, stomatitis; severe colitis w/ bloody stool, moderate rise in AST, ALT, ALP, LDH & serum bilirubin; mucocutaneous candidiasis, increased vag itch, soreness or discharge; superficial tooth discoloration (young childn).
Drug Interactions
Increased & prolonged blood levels of amoxicillin w/ probenecid. May increase allergic skin reactions (rashes) w/ allopurinol. Concomitant use w/ disulfiram is not recommended. Bleeding & prothrombin time prolongation w/ anticoagulant therapy. May reduce efficacy of OCs. Increased blood conc w/ ASA, phenylbutazone, anti-inflammatory agents (high dose). Decreased plasma conc of sulfasalazine. Antagonism of oral chemotherapy antibiotics including tetracyclines, macrolides, sulfonamides, chloramphenicol develops. Decreased renal clearance of methotrexate. Changes in INR w/ anticoagulants. Increased absorption of cardiac glycoside including digoxin.
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
Lox tab
Packing/Price
100's
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