Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2019 Publisher: Novartis New Zealand Limited, PO Box 99102, Newmarket, AUCKLAND 1149 Telephone: 0800 354 335
Ospamox is indicated in the treatment of infections due to susceptible organisms.
Ospamox may be useful in instituting therapy prior to bacteriology; however, bacteriological studies to determine the causative organisms and their sensitivity to amoxicillin should be performed.
Ospamox may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
For upper respiratory tract infections due to streptococci, pneumococci, non-penicillinase-producing staphylococci and H. influenzae) or Genito-Urinary Tract Infections (due to Escherichia coli, Proteus mirabilis and Streptococcus faecalis or Skin and Soft Tissue Infections due to streptococci, sensitive staphylococci and Escherichia coli:
Adults: 250 mg every 8 hours.
Children (under 20 kg): 25 mg/kg/day in equally divided doses every 8 hours.
In severe infections or those caused by less susceptible organisms, 500 mg every 8 hours for adults and 50 mg/kg/day in equally divided doses every 8 hours for children may be needed.
For lower respiratory tract infections (due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae:
Adults: 500 mg every 8 hours.
Children (under 20 kg): 50 mg/kg/day in equally divided doses every 8 hours.
The maximum recommended oral dosage 6 g daily in divided doses. An adult dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues who have not received a penicillin in the previous month. Patients with prosthetic heart valves should be referred to hospital (see below).
Adults – 3 g orally, 1 hour before procedure. A second dose may be given 6 hours later if considered necessary. Children under 10 – half the adult dose. Children under 5 – quarter adult dose.
Adults – initially 3 g orally 4 hours prior to anaesthesia followed by 3 g orally (or 1 g amoxicillin/ampicillin IM if the dose is not tolerated) 6 hours after the initial dose.
Children under 10 – half adult dose.
Children under 5 – quarter adult dose.
Adults – 1 g amoxicillin IM immediately before induction with 500 mg orally 6 hours later.
Children under 10 – half adult dose.
Note: If prophylaxis with amoxicillin is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternatively, antibiotics are recommended if more frequent prophylaxis is required, or the patient has received a course of treatment with a penicillin during the previous month.
Adults – Initially 1 g amoxicillin/ampicillin with 120 mg gentamicin IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure, followed by 500 mg Ospamox orally, 6 hours later.
Children under 10 – the dose of amoxicillin should be half the adult dose. The dose of gentamicin should be 2 mg/kg.
Note: Amoxicillin and gentamicin should not be mixed in the same syringe. Please consult the appropriate Data Sheet for parenteral amoxicillin and gentamicin.
Adults: 3 g, as single dose. Cases of gonorrhoea with a suspected lesion of syphilis should have dark field examinations before receiving amoxicillin and monthly serological tests for a minimum of four months.
For acute, uncomplicated lower urinary tract infections (due to Escherichia coli, Proteus mirabilis, Streptococcus faecalis, non-penicillinase producing staphylococci):
Adults: 3 g as a single dose.
NOTE: The children’s dose is intended for individuals whose weight will not cause dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.
It should be recognised that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.
It is recommended that there be at least 10 days treatment for any infection caused by haemolytic streptococci to prevent the occurrence of rheumatic fever or glomerulonephritis.
Dosage adjustment in:
In renal impairment, the excretion of amoxicillin will be delayed. Depending on the degree of impairment, it may be necessary to reduce the total daily dosage. No dosage adjustment is required in patients with a creatinine clearance >30 ml/min. The maximum recommended dose in patients with creatinine clearance between 10 and 30 ml/min is 500 mg twice daily. The maximum recommended dose in patients with a creatinine clearance <10 ml/min is 500 mg/day.
In patients receiving peritoneal dialysis, the maximum recommended dose in 500 mg/day. Amoxicillin may be removed from the circulation by haemodialysis.
Renal impairment in children under 40 kg:
In the majority of cases, parenteral therapy will be preferred.
Cases of overdosage with amoxicillin are usually asymptomatic. Gastrointestinal disturbances such as nausea, vomiting and diarrhoea and symptoms of fluid-electrolyte imbalance may be evident. In patients with severely impaired renal function, large overdoses can result in signs of renal toxicity and crystalluria is possible. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria.
There is no specific antidote for an overdose of amoxicillin. Treatment consists primarily of administration of activated charcoal (a gastric lavage is usually not necessary), or symptomatic and supportive measures. Particular attention should be directed to the water and electrolyte balance of the patient. Amoxicillin can be removed from the circulation by haemodialysis. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
24 months, store below 25°C.
Ospamox capsules:
Store at or below 25°C. Protect from moisture.
Ospamox powder for oral suspension:
Store at or below 25°C. Protect from moisture.
Ospamox Paediatric Drops:
Store at or below 25°C. Protect from light. Protect from moisture.
Ospamox powder for oral suspension:
125 mg/5 ml: Bottle of 100 ml.
250 mg/5 ml: Bottle of 100 ml.
500 mg/5 ml: Bottle of 100 ml.
Ospamox Paediatric Drops 100 mg/ml:
Bottle of 30 ml with graduated dosing syringe.
Not all pack sizes and/or strengths may be currently marketed.
125 mg/5 ml: Add 94 ml of water to make up 100 ml.
250 mg/5 ml: Add 92 ml of water to make up 100 ml.
Close and shake well at once. Shake well before use. Store the reconstituted suspension at 2°C–8°C (refrigerate) and use within 14 days of preparation.
100 mg/ml: Add 16 ml of water to make up 30 ml. Close and shake well at once. Shake well before use. Store the reconstituted suspension below 25°C and use within 14 days of preparation.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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