NEW ZEALAND DATA SHEET Curam - Medsafe …

1 NEW ZEALAND data SHEET . Curam Amoxycillin Trihydrate Ph, Eur, and Potassium Clavulanate Ph, Eur,, film- coated tablet, 250 + 125 mg, powder for oral suspension, 125 + mg/5 ml and 250 + mg/5 ml (as amoxycillin/clavulanic acid). Curam Duo 500/125. Amoxycillin Trihydrate Ph. Eur. and Potassium Clavulanate Ph. Eur., film- coated tablet, 500 + 125 mg (as amoxycillin/clavulanic acid). Presentations Curam tablets 250 + 125 mg Tablet, film-coated, oblong biconvex formed, off-white colour. Scored on both sides. Each tablet contains Amoxycillin Trihydrate Ph. Eur. equivalent to amoxycillin 250 mg and Potassium Clavulanate Ph.

2 Eur. equivalent to clavulanic acid 125 mg. Curam Duo 500/125 tablets Tablet, film-coated, oval biconvex formed, off-white colour. Scored on both sides. Each tablet contains Amoxycillin Trihydrate Ph. Eur. equivalent to amoxycillin 500 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg. Curam powder for oral suspension 125 + mg/5 ml Suspension, oral, powder for, white to yellowish colour. Reconstituted suspension contains in 5 ml, Amoxycillin Trihydrate Ph. Eur. equivalent to amoxycillin 125 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid mg. 250 + mg/5 ml Suspension, oral, powder for, white to yellowish colour.

3 Reconstituted suspension contains in 5 ml, Amoxycillin Trihydrate Ph. Eur. equivalent to amoxycillin 250 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid mg. Indications Short term treatment of common bacterial infections such as: Upper respiratory tract infections (including ENT): tonsillitis, sinusitis, otitis media Lower respiratory tract infections: acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia Genito-urinary tract infections: cystitis, urethritis, pyelonephritis, female genital infections Skin and soft tissue infections Bone and joint infections: osteomyelitis Other infections: septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis and post-surgical infections.

4 Prophylaxis against infection which may be associated with major surgical procedures such as gastro- intestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract surgery. Infections caused by amoxycillin susceptible organisms are amenable to amoxycillin/clavulanic acid treatment due to its amoxycillin content. Mixed infections caused by amoxycillin susceptible organisms in conjunction with amoxycillin/clavulanic acid susceptible beta-lactamase-producing organisms may therefore be treated by amoxycillin/clavulanic acid. Dosage and administration Dosage Premature No dosage recommendations can be made for this category.

5 Children 3 to 9 months ml of Curam oral suspension 125 + mg/5 ml three times a day. Children 9 months to 2 years ml of Curam oral suspension 125 + mg/5 ml three times a day. Children 2 to 6 years 5 ml of Curam oral suspension 125 + mg/5 ml three times a day. In severe infections this may be increased to 10 ml of Curam oral suspension 125 + mg/5 ml three times a day. Children 7 to 12 years 5 ml of Curam oral suspension 250 + mg/5 ml three times daily. In severe infections this may be increased to 10 ml of Curam oral suspension 250 + mg/5 ml three times a day. Adults and children 40 kg and over 1 Curam Duo 500/125 tablet twice daily for mild to moderate infections.

6 For lower respiratory tract infections, complicated urinary tract infections or severe infections at other sites, 1 to 2 Curam Duo 500/125 tablets three times daily. Dosage for surgical prophylaxis Surgical prophylaxis with amoxycillin/clavulanic acid should aim to protect the patient for the period of risk of infection. Accordingly, procedures in adults lasting for less than 1 hour are successfully covered by g amoxycillin/clavulanic acid intravenous given at induction of anaesthesia. Longer operations require subsequent doses of g amoxycillin/clavulanic acid IV (up to 4 doses in 24. hours), and this regime can be continued for several days if the procedure has significantly increased the risk of infection.

7 Clear clinical signs of infection at operation will require a normal course of IV or oral amoxycillin/clavulanic acid therapy post-operatively. Dosage in renal impairment Dosing adjustments are based on the maximum recommended level of amoxycillin. Adults Mild impairment (creatinine clearance >30 ml/min): no change in dosage. Moderate impairment (creatinine clearance 10 to 30 ml/min): 1 tablet 12 hourly. For severe impairment (creatinine clearance <10 ml/min): 1 tablet once daily. Dialysis decreases serum concentrations of amoxycillin/clavulanic acid. An additional dose may need to be supplemented at the end of dialysis.

8 Children Oral suspension (in the majority of cases, parenteral therapy, where available, may be preferred). Mild impairment (creatinine clearance >30 ml/min): no change in dosage. Moderate impairment (creatinine clearance 10 to 30 ml/min) 15 + mg/kg given 12 hourly (maximum 500 + 125 mg twice daily). Severe impairment (creatinine clearance <10 ml/min) 15 given as a single daily dose (maximum 500 + 125 mg). Dialysis decreases serum concentrations of amoxycillin/clavulanic acid. Prior to haemodialysis one additional dose of 15 + mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 + mg/kg should be administered after haemodialysis.

9 Dosage in hepatic impairment Dose with caution; monitor hepatic function at regular intervals for both adults and children. There are as yet insufficient data on which to base a dosage recommendation. Dosage in elderly No adjustment needed, dose as for adults. If there is evidence of renal impairment, dose should be adjusted as for renally impaired adults (see above). Administration Therapy can be started parenterally and continued with an oral preparation. Curam oral suspensions To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of amoxycillin/clavulanic acid is optimised when taken at the start of a meal.

10 Treatment should not be extended beyond 14 days without review. For administration of suspensions to children below 3 months, a syringe graduated to permit accurate and reproducible volumes to be dispensed, should be used. Contraindications Hypersensitivity to one of the constituents of the medicine. Hypersensitivity to other beta-lactams such as penicillins, cephalosporins, carbapenems or monobactams. Previous history of jaundice or hepatic dysfunction associated with amoxycillin/clavulanic acid. Warnings and precautions Before initiating therapy with amoxycillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.