CURAM Powder for oral suspension / Film-coated tablet Ref.[50585] Active ingredients: Amoxicillin Clavulanic acid

Dosage

Premature

No dosage recommendations can be made for this category.

Children 3 to 9 months

1.25 mL of Curam oral suspension 125 + 31.25 mg/5 mL three times a day.

Children 9 months to 2 years

2.5 mL of Curam oral suspension 125 + 31.25 mg/5 mL three times a day.

Children 2 to 6 years

5 mL of Curam oral suspension 125 + 31.25 mg/5 mL three times a day. In severe infections, this may be increased to 10 mL of Curam oral suspension 125 + 31.25 mg/5 mL three times a day.

Children 7 to 12 years

5 mL of Curam oral suspension 250 + 62.5 mg/5 mL three times daily. In severe infections, this may be increased to 10 mL of Curam oral suspension 250 + 62.5 mg/5 mL three times a day.

Adults and children 40 kg and over

One Curam Duo 500/125 tablet twice daily for mild to moderate infections. For lower respiratory tract infections, complicated urinary tract infections or severe infections at other sites, one to two Curam Duo 500/125 tablets three times daily.

Dosage for surgical prophylaxis

Surgical prophylaxis with amoxicillin/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 1.2 g amoxicillin/clavulanic acid intravenous given at induction of anaesthesia. Longer operations require subsequent doses of 1.2 g amoxicillin/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. Clear clinical signs of infection at operation will require a normal course of IV or oral amoxicillin/clavulanic acid therapy postoperatively.

Method of 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 amoxicillin/clavulanic acid is optimised when taken at the start of a meal.

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.

Dosage adjustment in:

• renal impairment:

Dosing adjustments are based on the maximum recommended level of amoxicillin.

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 amoxicillin/clavulanic acid. An additional dose may need to be supplemented at the end of dialysis.

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 + 3.75 mg/kg given 12 hourly (maximum 500 + 125 mg twice daily). Severe impairment (creatinine clearance <10 mL/min) 15/3.75 mg/kg given as a single daily dose (maximum 500 + 125 mg). Dialysis decreases serum concentrations of amoxicillin/clavulanic acid. Prior to haemodialysis one additional dose of 15 + 3.75 mg/kg should be administered. In order to restore circulating drug levels, another dose of 15 + 3.75 mg/kg should be administered after haemodialysis.

• 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.

• 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).

Drug dependency, addiction and recreational abuse have not been reported as problems.

Signs and symptoms

Gastrointestinal symptoms and disturbance of fluid and electrolyte balances may be evident.

Complications from amoxicillin crystalluria may present in high doses, in some cases leading to renal failure (refer to Section 4.4 Special warnings and precautions for use). When present at high concentrations in urine at room temperature, amoxicillin may precipitate in bladder catheters. A regular check of patency should be maintained.

Management

Amoxicillin and clavulanic acid can be removed from the circulation by haemodialysis. Gastrointestinal symptoms may be treated symptomatically by attending to the water and electrolyte balance. Treat other symptoms symptomatically. A prospective study of 51 paediatric patients at a poison control centre suggested that overdosages less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

Unopened container:

Curam tablets: 36 months.

Curam powder for oral suspension: 36 months.

After container first opened:

Not applicable.

After dilution or reconstitution:

Curam tablets: not applicable.

Curam powder for oral suspension: 7 days when stored at 2 to 8°C (refrigerate, do not freeze).

Store below 25°C. Protect from moisture.

Curam tablet: Blisters of 15, 21 and 100 tablets.

Curam Duo 500/125 tablet: Blisters of 10, 15, 21, 50, 80 and 100 tablets.

Curam powder for oral suspension: Bottles of 60 and 100 mL with a 5 mL dosing syringe.

All presentations, strengths or pack sizes may not be currently marketed.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

Curam powder for oral suspension reconstitution instructions

Curam powder for oral suspension 125 mg/5 mL: add water 95 mL to make up 100 mL.

Curam powder for oral suspension 250 mg/5 mL: add water 90 mL to make up 100 mL. Close and shake well at once. Store the prepared suspension under refrigeration (2 to 8°C) and use within 7 days of preparation. Shake well before use.