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AMOXICILLIN MIXTURE BP 250G/5ML

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Product Summary

1.

NAME OF THE MEDICINAL PRODUCT

Amoxicillin Mixture BP 250mg/5ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Trihydrate equivalent to Amoxicillin 250mg

3.

PHARMACEUTICAL FORM
Powder for reconstitution
Free flowing powder in two layers, the top layer being white and the bottom
layer off-white.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications
Amoxicillin is indicated in the treatment of otitis media, chronic bronchitis,
gonorrhoea, typhoid fever and biliary tract infections. It may also be used to
treat susceptible organisms in upper respiratory tract infections, lobar and
bronchopneumonia, cystitis, urethritis, pyelonephritis, bacteriuria in
pregnancy, gynaecological infections including puerperal sepsis and septic
abortion, peritonitis, intra-abdominal sepsis, septicaemia, bacterial
endocarditis, skin and soft tissue infections and osteomyelitis.
In patients at risk (heart-valve lesion, septal defect, patent ductus or prosthetic
valve), Amoxicillin can be used for endocarditis prophylaxis when such
procedures are conducted: dental procedures, upper respiratory-tract
procedures, genito-urinary procedures and, obstetric, gynaecological and
gastro-intestinal procedures.

4.2

Posology and method of administration
Route of administration

Oral.
Dosage
Adults (including the elderly patients):
Standard adult dosage:
250mg three times daily, increasing to 500mg 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 acute UTI, two 3g doses with 10 – 12 hours between the doses.
Gonorrhoea: single 3g dose.
Children up to 10 years of age:
125mg three times daily, increasing to 250mg three times daily for more
severe infections.
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:
Note; the dosage instructions given below apply only to patients who are not
penicillin-allergic or to those who have not received more than a single dose
of a penicillin in the previous month.
Dental procedure under local or no anaesthesia:
Adult – oral amoxicillin 3g 1 hour before procedure; Child under 5 year;
quarter adult dose; Child 5 – 10 years: half adult dose.
Remark: patients who have had endocarditis as under general anaesthesia (see
below).
Dental procedure under general anaesthesia:
Adult – oral amoxicillin 3g 4 hours before induction then oral amoxicillin 3g
as soon as possible after procedure; Child under 5 years: quarter adult dose;
Child 5 – 10 years: half adult dose.

In patients with a prosthetic valve or who have had endocarditis (population at
special risk), the recommended dosage is the following: Adult – iv amoxicillin
1g + iv gentamicin 120mg at induction, then oral amoxicillin 500mg 6 hours
later; Child under 5 year: amoxicillin quarter adult dose, gentamicin 2mg/kg;
Child 5 – 10 years: amoxicillin half adult dose, gentamicin 2mg/kg.
Upper respiratory-tract procedures:
As for dental procedures. Post-operative dose may be given parenterally if
swallowing is painful.
Genito-urinary procedures:
As for special risk patients undergoing dental procedures under general
anaesthesia. If urine is infected, prophylaxis should also cover infective
organisms.
Obstetric, gynaecological and gastro-intestinal procedures:
Prophylaxis is required only for patients with prosthetic valves or those who
have had endocarditis; as for genito-urinary procedures.

4.3

Contraindications
Hypersensitivity to penicillins.

4.4

Special warnings and special 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.
At high doses relative to urinary output, adequate fluid intake and urinary
output must be maintained to minimise 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 (see section 4.2).

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine.

4.5

Interactions with other medicinal products and other forms of interaction
The incidence of skin rashes with amoxicillin is increased by concomitant
allopurinol.
The excretion of methotrexate can be markedly reduced by concurrent use of
penicillins. There is a considerable risk of methotrexate toxicity.
Very infrequently and unpredictably concurrent use with oral contraceptives
may result in contraceptive failure.
Probenecid delays the excretion of amoxicillin and dietary fibre can reduce the
absorption of amoxicillin.
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.

4.6

Pregnancy and lactation
When antibiotic therapy is required during pregnancy, amoxicillin may be
considered appropriate. During lactation, trace quantities of amoxicillin can be
detected in breast milk.

4.7

Effects on ability to drive and use machines

None

4.8

Undesirable effects
Side-effects, as with other penicillins, are uncommon and mainly of a mild and
transitory nature.
Hypersensitivity reactions.

If any hypersensitivity reaction occurs, the treatment should be discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. Rarely, skin
reactions such as erythema multiforme and Stevens-Johnson syndrome, toxic
epidennal necrolysis, bullous and exfoliative dermatitis and acute generalised
exanthematous pustulosis (AGEP) have been reported.
As with other antibiotics, severe allergic reactions including angioneurotic
oedema, anaphylaxis (see 4.4), serum sickness and hypersensitivity vasculitis
have been reported rarely.
Interstitial nephritis can occur rarely.
Gastrointestinal reactions.
Minor gastrointestinal upsets (e.g. nausea, vomiting and diarrhoea) may occur
during treatment. Mucocutaneous candidiasis and antibiotic associated colitis
including pseudomembraneous colitis and haemorrhagic colitis have been
reported rarely. Superficial tooth discolouration has been reported rarely and
mostly with the suspension and chewable tablets. It can usually be removed by
brushing.
Hepatic effects:
A moderate rise in AST and/or ALT has been occasionally noted but the
significance of this is unclear. As with other beta-lactam antibiotics, hepatitis
and cholestatic jaundice have been reported rarely.
Haematological effects:
As with other beta lactams, reversible leucopenia (including severe
neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic
anaemia have been reported rarely. Prolongation of bleeding time and
prothrombin time have also been reported rarely. (See 4.5).
CNS effects:
CNS effects have been seen rarely. They include hyperkinesia, dizziness and
convulsions.
Convulsions may occur in patients with impaired renal function or in those
receiving high
doses.

4.9

Overdose
Overdosage is unlikely but gross overdosage will result in very high urinary
concentrations. Problems occurring as a result of this 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.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Amoxicillin is a penicillinase–susceptible semisynthetic penicillin. The drug is
bactericidal and is effective against the same range of organisms as ampicillin
and has a similar mode of action. It has been reported that amoxicillin
predominantly inhibits side–wall synthesis in susceptible bacteria. Amoxicillin
has been reported to be slightly more active than ampicillin against some
streptococci and salmonella SPP, but less active against shigella SPP.
Amoxicillin is more rapidly and completely absorbed from the GI tract than
ampicillin and peak plasma levels are 2 – 2 ½ times greater for amoxicillin
after oral administration of the same dose. Food does not interfere with
absorption. MIC’s ranging from 0.01 to 5 µg/ml have been reported.

5.2

5.3

Pharmacokinetic properties
Oral bioavailability of amoxicillin

= 93 +/- 10%

Urinary excretion of amoxicillin

= 52 +/- 15%

Plasma binding

= 18%

Half life

1 hour (increased in uremia)

Preclinical safety data
None

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
The mixture contains:
Sodium benzoate
Disodium edetate

Sodium citrate
Flavour orange/bramble
Yellow FD & C no. 6 (E110)
Sucrose

6.2

Incompatibilities
As for penicillins, amoxicillin should not be mixed with blood products, other
proteinaceous fluids such as protein hydrolysates, or with intravenous lipid
emulsions.

6.3

Shelf life
36 months unopened
14 days after reconstitution

6.4

Special precautions for storage
Store in a cool dry place at a temperature not exceeding 25°C.

6.5

Nature and contents of container
Pack size: 100ml, contained in either
150ml amber glass Beatson Clark container with polypropylene screw cap, or,
150ml high density polyethylene bottle with tamper evident cap.

6.6

Instruction for use, handling and disposal
None

Administrative Data

7.

MARKETING AUTHORISATION HOLDER

Waymade Plc
Trading as Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR

8.

MARKETING AUTHORISATION NUMBER
PL 06464/1421

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/11/2005

10

DATE OF REVISION OF THE TEXT
18/11/2005

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