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AMOXICILLIN MIXTURE BP 125MG/5ML

Active substance(s): AMOXICILLIN

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Product Summary

1.

NAME OF THE MEDICINAL PRODUCT

Amoxicillin Mixture BP 125mg/5ml

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Trihydrate equivalent to Amoxicillin 125mg

3.

PHARMACEUTICAL FORM

Powder for reconstitution.
Free flowing powder in two layers, the top layer being white and the bottom layer offwhite.

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 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, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5

Interaction 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
penicilins. 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
epidermal 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

Pharmacokinetic properties

Oral bioavailability of amoxicillin

= 93 ± 10%

Urinary excretion of amoxydilhin

= 52 ± 15%

Plasma binding

= 18%

Half life

1 hour (increased in uremia)

5.3

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 25ºC.

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 06464/1420

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/11/2005

10

DATE OF REVISION OF THE TEXT
17/11/2005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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