AMOXICILLIN 125 MG/5 ML ORAL SUSPENSION

Active substance: AMOXICILLIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Amoxicillin 125 mg/5 ml Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains amoxicillin trihydrate equivalent to 125 mg amoxicillin per 5 ml.
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Powder for Oral Suspension
Pale yellow powder which, when reconstituted gives a yellow suspension with
a sweet lemon flavour and odour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
The treatment of bacterial infections caused by amoxicillin-susceptible
organisms.
Consideration should be given to official guidance regarding the appropriate
use of antibacterial agents.
It is principally indicated for respiratory, middle ear and urinary tract
infections.
Respiratory tract - pneumonia, bronchitis
ENT - otitis media
Urinary tract - cystitis, pyelonephritis
Biliary and intra-abdominal infections
Gynaecological infections
Gonorrhoea

Septicaemia
Bacterial endocarditis
Skin and soft tissue infections
Meningitis (seek expert advice)
Enteric fevers (typhoid and paratyphoid fevers - seek expert advice)
Dental abscess (as an adjunct to surgical management)
The prevention of bacteraemia, associated with procedures (e.g. dental), in
patients at risk of developing bacterial endocarditis

4.2

Posology and method of administration
Route of administration: Oral
Adults and children weighing over 40 kg: 250 mg every 8 hours, increasing to 500 mg
every 8 hours in severe infections
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.
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 – 21 days.
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)

Prophylaxis of Endocarditis
Dental procedures under local or no anaesthesia:
Patients who have not received more than a single dose of penicillin in the previous
month, including those with a prosthetic valve (but not those who have had
endocarditis): Oral amoxicillin 3 g 1 hour before procedure.
Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour
preceding the surgical procedure
Patients who have had endocarditis, amoxicillin + gentamicin, as under general
anaesthesia
Dental procedures under general anaesthesia:
No special risk (including patients who have not received more than a single dose of
penicillin in the previous month): either i/m or i/v amoxicillin 1 g at induction, then
oral amoxicillin 500 mg 6 hours later.
Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour
preceding the surgical procedure
Or
Oral amoxicillin 3 g 4 hours before induction then oral amoxicillin 3 g as soon as
possible after procedure.
Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour
preceding the surgical procedure
Or
Oral amoxicillin 3 g + probenicid 1 g 4 hours before procedure
Special risk (patients with a prosthetic valve or who have had endocarditis): i/v
amoxicillin 1 g + i/v gentamicin 120 mg at induction, then oral amoxicillin 500 mg 6
hours later.
Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour
preceding the surgical procedure
This product should not be used in patients who have received more than a single
dose of penicillin in the previous month, or whom are allergic to penicillin.
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 organism.
Obstetric, gynecological and gastro-intestinal procedures:
(Prophylaxis required for patients with prosthetic valves or those who have had
endocarditis only). As for genito-urinary procedures

4.3

Contraindications
Amoxicillin should not be given to patients with hypersensitivity to
penicillins. Attention should be given to the possibility of cross-sensitivity
with other beta-lactam antibiotics eg: cephalosporins.
It should not be given to patients with infectious mononucleosis (glandular
fever) since they are especially susceptible to amoxicillin-induced skin rashes.

4.4

Special warnings and precautions for use
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been
reported in patients with penicillin therapy. These reactions are most likely in those
with a history of hypersensitivity to beta-lactam antibiotics.
Amoxicillin should be used with caution in those with impaired renal function and
dose reduction may be necessary in severe impairment.
Patients with infectious mononucleosis (glandular fever), lymphatic leukaemia and
possibly with HIV infection are particularly prone to developing erythematous rashes
with amoxicillin. Amoxicillin should be discontinued if a skin rash occurs.
Prolonged use of anti-infectives may result in the overgrowth of non-susceptible
organisms (superinfection).
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
The efficacy of oral contraceptives may be reduced with concurrent
administration of amoxicillin. Patients should be advised accordingly.
Excretion of penicillins is reduced by probenecid.
Prolongation of prothrombin time has been reported. Appropriate monitoring
should be undertaken when anticoagulants are prescribed concurrently

4.6

Pregnancy and lactation
Use in pregnancy:

There is no evidence that amoxicillin is teratogenic or foetotoxic in humans.
The product has been in extensive clinical use for many years and is
considered safe in pregnancy.
Use in Lactation:
Amoxicillin is considered safe in lactation. However, it should be noted that
amoxicillin is excreted in breast milk in small quantities with the possible risk
of sensitisation and subsequent allergic reactions in a sensitised infant.

4.7

Effects on ability to drive and use machines
There is no reason to believe that amoxicillin will have any direct effect on the
ability to drive or use machines.

4.8

Undesirable effects
Hypersensitivity reactions:
When amoxicillin is administered to a hypersensitive patient anaphylactic
shock with collapse and sometimes death may occur within minutes.
If any hypersensitivity reaction occurs the treatment should be discontinued.
Skin rashes are the most common side effects with pruritus and urticaria.
Rarely skin reactions such as erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis and bullous and exfoliative dermatitis
have been reported.
Severe allergic reactions including angioneurotic oedema, anaphylaxis, serum
sickness and vasculitis have been reported rarely.
Interstitial nephritis can occur rarely.
Gastrointestinal reactions:
Mild gastrointestinal upsets: nausea, vomiting diarrhoea. Muco-cutaneous
candidiasis. Antibiotic-associated colitis (including pseudo-membranous
colitis).
Hepatic effects:
Transiently raised liver enzymes (AST and/or ALT) has been noted. As with
other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been
reported rarely.
Haematological effects:
As with other beta-lactams reversible leucopenia (including agranulocytosis),
thrombocytopenia and haemolytic anaemia, and coagulation disorders
(prolonged prothrombin and bleeding times) have been reported rarely.
CNS effects:

Rare effects include dizziness, convulsions and paraesthesia. Convulsions may
occur in patients with impaired renal function or in those receiving high doses.

4.9

Overdose
Problems of overdosage with amoxicillin are unlikely to occur. If encountered,
gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident
and should be treated symptomatically.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Amoxicillin is bactericidal. Like all penicillins it acts by interfering with the
synthesis of the cell wall of the bacterium.
Amoxicillin is inactivated by penicillinase. Penicillinase-producing strains of
Staphylococcus aureus and Gram negative organisms (e.g. Escherichia coli,
Proteus, Klebsiella) are resistant.
Complete cross-resistance has been reported between amoxicillin and
ampicillin.

5.2

Pharmacokinetic properties
Amoxicillin is stable in the acid gastric secretion and is rapidly absorbed from the
gastrointestinal tract after oral administration. The presence of food does not interfere
with this process. Peak plasma concentrations are obtained in about two hours,
producing around 2.5 times the peak concentration resulting from comparable doses
of ampicillin. Protein binding is similar to that of ampicillin: up to 25%.
Effective levels in the cerebrospinal fluid are obtained only in the presence of
inflammation and then irregularly. About 60% of an oral dose of amoxicillin is
excreted unchanged in the urine. It penetrates well into purulent and mucoid sputum.
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 included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium benzoate
Sodium citrate
Colloidal anhydrous silica
Dispersible cellulose
Saccharin sodium
Lemon flavouring powder
Quinoline yellow (E104)
Sucrose

6.2

Incompatibilities
Not Applicable

6.3

Shelf life
3 years before reconstitution
14 days after reconstitution

6.4

Special precautions for storage
Store in the original container. Do not store above 25°C prior to reconstitution.
After reconstitution, store suspension at 2°C - 8°C. Do not freeze.

6.5

Nature and contents of container
Amber glass bottle (Type III) with ROPP cap (aluminium closure / expanded
polyethylene liner): 60 ml and 100 ml
HDPE tamper evident bottle with polypropylene tamper evident lid: 60 ml and
100 ml

6.6

Special precautions for disposal
Shake the bottle well before use.
60 ml bottle: Add 36 ml water, replace the lid and shake the bottle well.
100 ml bottle: Add 59 ml of water, replace the lid and shake the bottle well.
The reconstituted product gives a yellow suspension free from visible signs of
contamination. It has a sweet lemon flavour and odour.
Once reconstituted, use within 14 days.
It is not recommended to further dilute the reconstituted product.

7

MARKETING AUTHORISATION HOLDER
Cheliona Healthcare Limited
Boumpoulinas 11, 3rd floor
Nicosia
Cyprus
P C 1060
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0007

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 September 2001

10

DATE OF REVISION OF THE TEXT
12/01/2011

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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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