Amoxicillin 500mg Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin 500 mg (as trihydrate)
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsules
Red and white capsule printed with “AMX 500”.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of infection
Amoxicillin capsules are indicated for the oral treatment of bacterial infections caused by amoxicillin sensitive organisms. Such indications include infections of the upper and lower respiratory tract, the genito-urinary tract and the gastrointestinal tract. Specific indications include ear and soft tissue infections and gonorrhoea. In the acute stages of life threatening infections a period of parenteral anti-infective therapy would be essential before initiating oral continuation therapy.
Prophylaxis of endocarditis
Amoxicillin capsules may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.
4.2 Posology and method of administration
For oral use.
Treatment of infection
Adults: For less severe infections the usual oral dose is 250 mg three times daily. In more severe conditions the dosage may be doubled. The recommended maximum daily dose is 6g, in divided doses.
Short course therapy:
Simple acute urinary tract infection: Two 3g doses with 10 to 12 hours between the doses.
Gonorrhoea: A single dose of 3g.
Children (under 10 years): The initial children’s dosage is half the adult dosage. 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.
Elderly: As for adults.
Use in renal impairment
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
Adults: The usual dose is 3g, 1 hour prior to the procedure which may result in bacteraemia.
Children: Under 10 years, half the adult dose.
Under 5 years, quarter the adult dose.
4.3 Contraindications
Amoxicillin should not be used in patients with a known or suspected hypersensitivity to penicillins, semi-synthetic penicillins or cephalosporins.
4.4 Special warnings and precautions for use
Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective.
The dosage should be reduced in patients with renal impairment.
4.5 Interaction with other medicinal products and other forms of interaction
When oral contraceptives are given concurrently with amoxicillin there is a possibility of reduced contraceptive effect.
Methotrexate excretion is reduced by penicillins.
4.6 Fertility, pregnancy and lactation
Anti-infectives should not be used during pregnancy unless considered essential by the physician.
4.7 Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
An urticarial rash usually indicative of true penicillin hypersensitivity or an erythematous rash generally specific to ampicillin/amoxicillin may occasionally occur. The latter is particularly common in patients with infectious mononucleosis or chronic lymphatic leukaemia. If a rash occurs, discontinuation of amoxicillin therapy is advisable.
Erythema multiforme, interstitial nephritis, pseudomembranous colitis, angioedema and anaphylaxis have been reported rarely.
4.9 Overdose
Gross overdosage will produce high urinary concentrations. Problems are unlikely if adequate fluid intake and urinary output are maintained, however, crystalluria is a possibility. More specific measures may be necessary in patients with impaired renal function, the antibiotic is removed by haemodialysis.
5.1 Pharmacodynamic properties
Amoxicillin is a broad spectrum semi-synthetic penicillin. It is bactericidal against a wide range of gram-positive and gram-negative micro-organisms. It has been reported that amoxicillin predominantly inhibits side wall synthesis in susceptible bacteria.
5.2 Pharmacokinetic properties
Amoxicillin trihydrate is resistant to inactivation by the acid of gastric secretions and is rapidly absorbed when given by mouth. It is more completely absorbed than ampicillin and is reported to produce peak antibiotic plasma concentrations that are up to 2'A times as high as from the same dose of ampicillin. Peak plasma amoxicillin concentrations of about 5pg per ml have been observed 1 to 2 hours after a dose of 250 mg with detectable amounts present for up to 8 hours. Doubling the dose can produce double the concentrations. The presence of food in the stomach does not appear to diminish absorption significantly.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, other than that presented in other parts of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium Lauryl Sulphate Magnesium Stearate
Capsule shell:
Gelatin
Titanium Dioxide E171 Red Iron Oxide E172 Erythrosine E127.
Incompatibilities
6.2
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Tablet containers: Do not store above 25°C. Store in the original container. Keep the container tightly closed.
Blisters: Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
PP tablet containers with LDPE caps. Pack sizes 21, 100, 250, 500 and 1000 capsules.
Al/PVC blister strips enclosed in a carton. Pack sizes of 15, 21 and 28 capsules.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Northamptonshire NN8 6GT UK
MARKETING AUTHORISATION NUMBER(S)
8
PL 20417/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/02/2001
10 DATE OF REVISION OF THE TEXT
24/08/2001