AMOXICILLIN

Posology Treatment of infection. Adults dosage (including the elderly patients) Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections. High dose therapy: 3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract (max daily dose 6g).

Short course therapy:

Simple acuteurinary tract infection : two 3g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses.

Gonorrhoea:

Single 3g dose.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. 2): Glomerular filtration rate>30ml/min No adjustment necessary.

Glomerular filtration rate 10-30ml/min:

Amoxicillin. d Glomerular filtration rate<10ml/min: Amoxicillin. Max. 500mg/day Helicobacter eradication in peptic (duodenal and gastric) ulcer disease: Amoxicillin is recommended at a dose of twice daily in association with a proton pump inhibitor and antimicrobial agents as detailed below: Omeprazole 40 mg daily, Amoxicillin 1G BID, Clarithromycin 500mg BID x 7days or Omeprazole 40mg daily, Amoxicillin750mg-1G BID, Metronidazole 400mg TID x 7 days Children weighing < 40 kg For these patients it is more appropriate to use the paediatric presentation, Amoxicillin Oral Suspension.

2). *PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range. Children weighing more than 40 kg should be given the usual adult dosage.

Renal impairment in children under 40 kg:

Creatinine clearance ml/min Dose Interval between administration > 30 Usual dose No adjustment necessary 10 – 30 Usual dose 12 h (corresponding to 2/3 of the dose) < 10 Usual dose 24 h (corresponding to 1/3 of the dose) Amoxicillin Paediatric Suspension is recommended for children under six months of age.

Special dosage recommendation Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media:

In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations. 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.

Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.

Prophylaxis for endocarditis:

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 eradication of the organism.

Condition Adults’ dosage (including elderly) Children's Dosage ( < 40 kg) Notes Patient not having general anaesthetic. 3 g Amoxicillin orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.

Patient having general anaesthetic: if oral antibiotics considered to be appropriate. Initially 3 g Amoxicillin 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.

Dental procedures: prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. B. Patients with prosthetic heart valves should be referred to hospital - see below).

Patient having general anaesthetic: if oral antibiotics not appropriate. 1 g Amoxicillin IV or IM immediately before induction; with 500 mg orally, 6 hours later. 50 mg Amoxicillin/ kg body weight given as a single dose one hour preceding the surgical procedure Note 1.

If prophylaxis with Amoxicillin 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, Amoxicillin may be given as two injections of 500 mg dissolved in sterile 1% lidocaime solution (see Administration). 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 Initially: 1 g Amoxicillin 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 50 mg Amoxicillin/ kg body weight given as a single dose one hour preceding the surgical procedure See Note 2. Note 3. Amoxicillin and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on attacks of endocarditis.

hours later): 500 mg Amoxicillin orally. 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 Amoxicillin IV or IM with 120 mg gentamicin […]

There are no modern clinical studies available that can be used to determine the frequency of undesirable effects.

The following convention has been utilised for the classification of frequency:

Very common, ≥ 1/10; common, ≥ 1/100 and < 1/10; uncommon, ≥ 1/1000 and < 1/100; rare, ≥ 1/10000 and < 1/1000; very rare, < 1/10000. 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. System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to < 1/100 Rar e ≥ 1/10 000 to < 1/1 000 Very Rare < 1/10 000 Frequenc y not known (cannot be estimated from available data) Infections & Infestations Mucocutaneous candidiasis.

Blood and lymphatic system disorders:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin. 4 Special Warnings and Precautions for Use), 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:

Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses Gastrointestin al disorders: *Clinical Trial Data: Diarrhoea; indigestion ; nausea. *Clinical Trial Data: Vomiting.

Post-marketing Data:

Antibiotic associated colitis (including pseudomembraneo us 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:

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:Skin rash Clinical Trial Data:Urticari a and pruritus Post-marketing Data: 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 & urinary disorders: Interstitial nephritis.

Crystalluria (see Section

The capsule shell colours sunset yellow (E110) and carmoisine (E122) may cause allergic reactions. The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

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.

2). Use with caution in patients with acute and chronic lymphocytic leukaemia. Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored. Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving Amoxicillin and oral anticoagulants.

Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. 8).

Amoxicillin is a penicillin and should not be given to patients that have hypersensitivity to penicillin's or to any of the excipients. g. cephalosporin. Before initiating therapy with Amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillin's, cephalosporin's.

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