1. Name Of The Medicinal Product
Amoxicillin 500 mg Capsules BP.
2. Qualitative And Quantitative Composition
Each capsule contains Amoxicillin 500mg (as the trihydrate).
3. Pharmaceutical Form
Capsule, Hard.
Scarlet (body) and Ivory (cap) capsules. The capsules are printed with K and AMOXI 500.
4. Clinical Particulars
4.1 Therapeutic Indications
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
Dental abscess (as an adjunct to surgical management)
Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
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.
Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents. “Susceptibility of the causative organisms to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.
4.2 Posology And Method Of Administration
Treatment of Infection
Adult dosage (including elderly patients):
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.
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):
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
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 500 mg BID x 7 days or
Omeprazole 40 mg daily, Amoxicillin 750 mg -1G BID, Metronidazole 400 mg TID x 7 days.
Children weighing < 40 kg
The 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.
Renal impairment in children under 40 kg:
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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 of endocarditis: see table on next 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 eradication of the organism.
Prophylaxis of endocarditis
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4.3 Contraindications
Amoxicillin is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be given to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.
4.4 Special Warnings And Precautions For Use
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 (see 4.3).
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 (see Section 4.9 Overdose).
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 (see section 4.2).
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. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see sections 4.5 and 4.8).
Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin 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 reduce efficacy of combined oral contraceptives.
Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin (see sections 4.4 and 4.8).
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.
4.6 Pregnancy And Lactation
Use in pregnancy: Animal studies with Amoxicillin have shown no teratogenic effects. The product 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.
Use in lactation: Amoxicillin may be given during lactation. With the exception of the risk of sensitization associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.
4.7 Effects On Ability To Drive And Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
4.8 Undesirable Effects
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 is not unique to amoxicillin and may occur when using other pencillins.
Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.
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*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
ATC code: J01C A04
Amoxicillin is a broad spectrum antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin.
The wide range of organisms sensitive to the bactericidal action of Amoxicillin include:
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5.2 Pharmacokinetic Properties
Amoxicillin is well absorbed. Oral administration, usually at convenient t.d.s dosage, produces high serum levels independent of the time at which food is taken. Amoxicillin gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.
In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 - 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to those already stated in other section of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Each gelatin capsule contains:
Gelatin (capsule body and cap)
Magnesium stearate
Colloidal anhydrous silica
Capsule colours
Body - Scarlet
Erythrosine (E127)
Patent Blue (E131)
Sunset Yellow (E110)
Titanium Dioxide (E171)
Cap - Ivory
Yellow Iron Oxide (E172)
Titanium Dioxide (E171)
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.
6.5 Nature And Contents Of Container
The product is packed in PVC blister packs bonded to aluminium foil in pack sizes of 10, 15, 21 28 and 105 capsules.
6.6 Special Precautions For Disposal And Other Handling
No special instructions for use/handling.
7. Marketing Authorisation Holder
Accord Healthcare Limited
Sage house , 319 Pinner Road
North Harrow , Middlesex , HA1 4HF
United Kingdom
8. Marketing Authorisation Number(S)
PL 20075/0264
9. Date Of First Authorisation/Renewal Of The Authorisation
24 July 2003
10. Date Of Revision Of The Text
17-Oct-2011
11 DOSIMETRY
IF APPLICABLE
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
IF APPLICABLE
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