- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Treatment of Infection:Amoxicillin 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 In children with urinary tract infection the need for investigation should be considered. Prophylaxis of endocarditis: Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
Adult dosage (including elderly patients):
Treatment of infection:Moderate infections: 500 mg via intramuscular injection every 8 hours (or more frequently if necessary). This dose may be given by slow intravenous injection if more convenient.Severe infections: 1 g via intravenous injection every 6 hours.
Prophylaxis of endocarditis:
|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 Amoxicillin orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.||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% lidocaine solution (see Administration).|
|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.|
|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.|
|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 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 hours later): 500 mg Amoxicillin orally||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 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 IV or IM, immediately before induction. Followed by (6 hours later): 500 mg Amoxicillin 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 Amoxicillin IV or IM immediately before induction; 500 mg Amoxicillin IV or IM 6 hours later.||See Note 2 above. Note 5. The second dose of Amoxicillin may be administered orally.|
|Patients with prosthetic heart valves.||Initially: 1 g Amoxicillin IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg Amoxicillin IV or IM.||See Notes 2, 3, 4 and 5 above.|
Children weighing < 40 kgThe daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).*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.
Special dosage recommendationTonsillitis: 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.Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.
Dosage in impaired renal function:The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2). 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)|
Administration:Intravenous injection, intravenous infusion, intramuscular injection: See Section 6.6, Instructions for use and handling.
PregnancyAnimal studies with amoxicillin have shown no teratogenic effects. It has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, amoxicillin may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.
LactationAmoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.
Blood and lymphatic system disordersVery rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction)
Immune system disordersVery rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - 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 disordersVery rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disordersCommon: Diarrhoea and nausea. Uncommon: VomitingVery rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). Hepato-biliary disordersVery 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 disordersCommon: Skin rash Uncommon: Urticaria and pruritus 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 disordersVery rare: Interstitial nephritis, crystalluria (See Section 4.9 Overdose).
|Streptococcus faecalis||Haemophilus influenzae|
|Streptococcus pneumoniae||Escherichia coli|
|Streptococcus pyogenes||Proteus mirabilis|
|Streptococcus viridans||Salmonella species|
|Staphylococcus aureus||Shigella species|
|Clostridium species||Brucella species|
|Corynebacterium species||Neisseria gonorrhoeae|
|Bacillus anthracis||Neisseria meningitidis|
|Listeria monocytogenes||Vibrio cholerae|
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