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Drug Details

AMOXIL Paediatric Suspension

• Drug Class Description
  Broad spectrum penicillins / antibiotics.
• Generic Name
  Amoxicillin [amoxycillin] - H pylori
• Presentation
  Amoxil Paediatric Suspension: citrus flavoured suspension. Presented as powder in bottles for preparing 20 ml.
• Description
  Amoxil Paediatric Suspension contains 125 mg amoxicillin per 1.25 ml dose The amoxicillin is present as the trihydrate.
• Indications
  Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections Otitis media Acute and chronic bronchitis Chronic bronchial sepsis Lobar and bronchopneumonia Cystitis, urethritis, pyelonephritis Bacteriuria in pregnancy Gynaecological infections including puerperal sepsis and septic abortion Gonorrhoea Peritonitis Intra-abdominal sepsis Septicaemia Bacterial endocarditis Typhoid and paratyphoid fever Skin and soft tissue infections Osteomyelitis Dental abscess (as an adjunct to surgical management) In children with urinary tract infection the need for investigation should be considered. Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis. Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents.”Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.
• Adult Dosage
  

  Treatment of Infection:

  Adult dosage (including elderly patients):

  Oral:

  Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

  High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

  Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

  Renal impairment:

  Glomerular filtration rate >30ml/min No adjustment necessary.

  Glomerular filtration rate 10-30ml/min: Amoxicillin. max. 500mg b.d

  Glomerular filtration rate <10ml/min: Amoxicillin. max. 500mg/day

  Children's dosage (up to 10 years of age):

  Oral:

  Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

  Renal impairment in children under 40 kg:

  Creatinine clearance >30mL/min: No adjustment necessary.

  Creatinine clearance 10-30mL/min: 15 mg/kg given b.i.d (maximum 500mg/twice daily).

  Creatinine clearance <10mL/min: 15 mg/kg given as a single daily dose (maximum 500mg).

  Amoxil Paediatric Suspension is recommended for children under six months of age.

  In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

  Prophylaxis of endocarditis:

  CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE	NOTES
  Dental procedures: prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	Under 10: half adult dose. Under 5: quarter adult dose.	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lidocaine solution (see Administration).
  	Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
  	Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
  Dental procedures: patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.		Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	Under 10: the doses of 'Amoxil' should be half the adult dose; the dose of gentamicin should be 2 mg/kg. Under 5: the doses of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
  Genitourinary Surgery or Instrumentation: prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia. In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.		Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.		See Notes 2, 3 and 4 above.
  Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	Under 10: half adult dose. Under 5: quarter adult dose.	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
  	Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	Under 10: the dose of 'Amoxil' should be half the adult dose; the gentamicin dose should be 2 mg/kg. Under 5: the dose of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Notes 2, 3, 4 and 5 above.

  In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

  Prophylaxis of endocarditis: see table on previous page.

  Administration:

  Oral.

  Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci in order to achieve eradictaion of the organism.

• Contra Indications
  

  Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

• Special Precautions
  

  Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.

  Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics.

  Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

  Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

  In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria.

  In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly.

• Interactions
  

  Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxil may result in increased and prolonged blood levels of amoxicillin.

  In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

  Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

  Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

  It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

• Adverse Drug Reactions
  

  The following convention has been utilised for the classification of undesirable effects:-

  Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

  The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.

  Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

  Infections and infestations

  Very Rare:

  Mucocutaneous candidiasis

  Blood and lymphatic system disorders

  Very rare:

  Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin

  Immune system disorders

  Very rare:

  As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis. If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders)

  Nervous system disorders

  Very rare:

  Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

  Gastrointestinal disorders

  Clinical Trial Data

  *Common :	Diarrhoea and nausea.
  *Uncommon :	Vomiting.

   

  Post-marketing Data

  Very rare:

  Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). Black hairy tongue Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

  Hepato-biliary disorders

  Very rare:

  Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT. The significance of a rise in AST and/or ALT is unclear.

  Skin and subcutaneous tissue disorders

  Clinical Trial Data

  *Common :	Skin rash
  *Uncommon :	Urticaria and pruritus

  Post-marketing Data

  Very rare :

  Skin reactions such as erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)(See also Immune system disorders)

  Renal and urinary tract disorders

  Very rare :	Interstitial nephritis.
  Very rare:	Crystalluria

  *The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.