Concise Prescribing Info
Contents
Per 625 mg FC tab Amoxicillin trihydrate 500 mg, K clavulanate 125 mg. Per 1,000 mg FC tab Amoxicillin trihydrate 875 mg, K clavulanate 125 mg. Per 156 mg/5 mL susp Amoxicillin trihydrate 125 mg, clavulanate K 31 mg. Per 312 mg/5 mL susp Amoxicillin trihydrate 250 mg, clavulanate K 62 mg
Indications/Uses
FC tab: Short-term treatment of bacterial infections of the: Upper resp tract (including ENT) eg, tonsillitis, sinusitis, otitis media; lower resp tract eg, acute exacerbations of chronic bronchitis, lobar & bronchopneumonia; GUT eg, cystitis, urethritis, pyelonephritis; skin & soft tissue eg, boils, abscess, cellulitis, wound infections; bone & joint eg, osteomyelitis; dental eg, dentoalveolar abscess; & other infections eg, specific abortion, puerperal sepsis, intra-abdominal sepsis. Susp: Upper & lower resp tract, GUT, skin & soft tissue infection & other infections eg, osteomyelitis, septicemia, peritonitis.
Dosage/Direction for Use
FC tab Adult & childn >12 yr or weighing ≥40 kg 1 tab bid or every 12 hr. Severe renal impairment (CrCl <10 mL/min) Adult Not more than 375 mg bid or every 12 hr or not more than 625 mg tab every 24 hr. Childn 18.75 mg/kg given as a single daily dose. Max: 625 mg bid. Moderate renal impairment (CrCl 10-30 mL/min) Adult 375 mg or 625 mg tab bid or every 12 hr. Do not administer 1 g tab. Childn 18.75 mg/kg bid. Max: 625 mg bid. Susp Childn 7-12 yr 2 tsp, 2-7 yr 1 tsp, 9 mth to 2 yr ½ tsp.
Administration
May be taken with or without food. May be taken w/ meals to minimize adverse GI effects.
Contraindications
Hypersensitivity to any penicillin & cephalosporins. FC tab: History of amoxicillin/clavulanate K-associated cholestatic jaundice/hepatic dysfunction.
Special Precautions
Pregnancy & lactation. FC tab: Hypersensitivity w/ penicillins, cephalosporins or other drugs. Infectious mononucleosis. Periodically evaluate renal, hepatic, & hematologic function during prolonged therapy. C. difficile-associated diarrhea & colitis may develop. Susp: Severely impaired liver or renal function. Newborn & infants.
Adverse Reactions
Diarrhea, nausea, vomiting. FC tab: Diaper rash, skin rash, urticaria; abdominal discomfort, loose stools; vaginitis, vag mycosis; moniliasis. Susp: Indigestion, transient hepatitis.
Drug Interactions
FC tab: Higher & prolonged serum conc w/ probenecid. Increased incidence of rash w/ allopurinol. Susp: OC & probenecid.
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.
Presentation/Packing
Form
Coklav FC tab 1000 mg
Packing/Price
1 × 10's
Form
Coklav FC tab 625 mg
Packing/Price
1 × 10's
Form
Coklav susp 156 mg/5 mL
Packing/Price
60 mL x 1's
Form
Coklav susp 312 mg/5 mL
Packing/Price
60 mL x 1's
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