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AMOXIL VIALS FOR INJECTION 1G

Active substance(s): AMOXICILLIN SODIUM

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Amoxil Vials for Injection 1 g

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains amoxicillin sodium equivalent to 1 g amoxicillin
Excipient with known effect
Sodium 63 mg (2.74 mmol) per vial.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Powder for solution for injection or infusion
Vials containing a white to off-white sterile powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Amoxil is indicated for the treatment of the following infections in adults and children (see
sections 4.2, 4.4 and 5.1):











Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar
infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and
symptoms)
Acute exacerbations of chronic bronchitis
Community acquired pneumonia
Acute cystitis
Acute pyelonephritis
Severe dental abscess with spreading cellulitis
Prosthetic joint infections
Lyme disease
Bacterial meningitis
Bacteremia that occurs in association with, or is suspected to be associated with, any
of the infections listed above

Amoxil is also indicated for the treatment and prophylaxis of endocarditis.

Consideration should be given to official guidance on the appropriate use of antibacterial
agents.

4.2

Posology and method of administration

Posology
The dose of Amoxil that is selected to treat an individual infection should take into
account:




The expected pathogens and their likely susceptibility to antibacterial agents
(see section 4.4)
The severity and the site of the infection
The age, weight and renal function of the patient; as shown below

The duration of therapy should be determined by the type of infection and the
response of the patient, and should generally be as short as possible. Some infections
require longer periods of treatment (see section 4.4 regarding prolonged therapy).
Adults and children ≥ 40 kg
Indication*
Severe infections of the ear, nose and
throat (such as mastoiditis peritonsillar
infections, epiglottis and sinusitis when
accompanied by severe systemic signs
and symptoms
Acute exacerbations of chronic bronchitis
Community acquired pneumonia
Acute cystitis
Acute pyelonephritis
Severe dental abscess with spreading
cellulitis
Prosthetic joint infections
Prophylaxis of endocarditis

Treatment of endocarditis

Dose*
750 mg to 2 g every 8 hours, or 2 g every
12 hours, maximum of 12 g/day

750 mg to 2 g every 8 hours, or 2 g every
12 hours, maximum of 12 g/day
2 g single dose 30 to 60 minutes before
procedure.

1 g to 2 g every 4 to 6 hours, maximum
of 12 g/day
Bacterial meningitis
1 g to 2g every 4 to 6 hours, maximum of
12 g/day
Lyme disease (see section 4.4)
Late stage (systemic involvement): 2 g
every 8 hours
Bacteraemia that occurs in association
1 g to 2 g every 4, 6 or 8 hours,
with, or is suspected to be associated with, maximum of 12 g/day
any of the infections listed in section 4.1
*Consideration should be given to the official treatment guidelines for each

Indication*
indication.

Dose*

Intramuscular
Maximum daily dosage: 4 g/day.
Maximum single dose: 1 g.
Children < 40 kg
Infants and toddlers >3 months and
children < 40 kg
Indication*
Severe infections of the ear, nose and
throat (such as mastoiditis peritonsillar
infections, epiglottis and sinusitis when
accompanied by severe systemic signs
and symptoms

Dose*

20 to 200 mg/kg/day given in 2 to 4
equally divided doses of up to 25 mg/kg
or infusions of up to 50 mg/kg

Community acquired pneumonia
Acute cystitis
Acute pyelonephritis
Severe dental abscess with spreading
cellulitis
Prophylaxis of endocarditis
Treatment of endocarditis

Bacterial meningitis

Lyme disease (see section 4.4)

50 mg/kg single dose 30 to 60 minutes
before procedure
200 mg/kg/day in 3 to 4 equally divided
does of up to 25 mg/kg or infusions of up
to 50 mg/kg
100 to 200 mg/kg/day in 3 to 4 equally
divided doses of up to 25 mg/kg or
infusions of up to 50 mg/kg
Early stage: 25 to 50 mg/kg/day in three
divided doses for 10 days (range 10 to 21
days)

Late stage (systemic involvement): 50
mg/kg/day in three divided doses
Bacteraemia that occurs in association
50 to 150 mg/kg/day given in 3 equally
with, or is suspected to be associated with, divided doses of up to 25 mg/kg or
any of the infections listed in section 4.1
infusions of up to 50 mg/kg
*Consideration should be given to the official treatment guidelines for each
indication.
Neonates ≥ 4kg and infants up to 3
months
Indication*

Dose*

Most infections

Treatment of endocarditis

Bacterial meningitis
Lyme disease (see section 4.4)

Usual daily dose of 20 to 150 mg/kg/day
given in 3 equally divided doses of up to
25 mg/kg or infusions of up to 50 mg/kg
150 mg/kg/day given in 3 equally divided
doses of up to 25 mg/kg or infusions of
up to 50 mg/kg
150 mg/kg/day given in three divided
doses
Early stage: 25 to 50 mg/kg/day in three
divided doses for 10 days (range 10 to 21
days)
Late stage (systemic involvement):
50 mg/kg/day in three divided doses
Usual daily dose of 50 to 150 mg/kg/day
given in 3 equally divided doses of up to
25 mg/kg or infusions of up to 50 mg/kg

Bacteraemia that occurs in association
with, or is suspected to be associated
with, any of the infections listed in
section 4.1
*Consideration should be given to the official treatment guidelines for each
indication.
Premature Neonates < 4kg
Indication*
Most infections

Treatment of endocarditis
Bacterial meningitis
Lyme disease (see section 4.4)

Dose*
Usual daily dose of 20 to 100 mg/kg/day
given in 2 equally divided doses of up to
25 mg/kg or infusions of up to 50 mg/kg
100 mg/kg/day given in two divided
doses
100 mg/kg/day given in two divided
doses
Early stage: 25 to 50 mg/kg/day in two
divided doses for 10 days (range 10 to 21
days)
Late stage (systemic involvement): 50
mg/kg/day in two divided doses
Usual daily dose of 50 to 100 mg/kg/day
given in 2 equally divided doses of up to
25 mg/kg or infusions of up to 50 mg/kg

Bacteraemia that occurs in association
with, or is suspected to be associated
with, any of the infections listed in
section 4.1
*Consideration should be given to the official treatment guidelines for each
indication.
Intramuscular:
Maximum daily dosage: 120 mg/kg/day as 2 to 6 equally divided doses.
Elderly
No adjustment needed; as for adults.

Renal impairment

GFR
(ml/min)
greater than
30
10 to 30

less than 10

Adults and children ≥ 40 kg
Intravenous
Intramuscular

Children < 40 kg
Intravenous
Intramuscular

No adjustment

No adjustment

No adjustment

No adjustment

1g stat, then
500 mg to 1 g
twice day
1 g stat, then
500 mg/day

500 mg every
12 hours

25 mg/kg twice
daily

15 mg/kg every
12 hours

500 mg/day
25 mg/kg/day
given as a single given as a
dose
single dose

15 mg/kg/day
given as a
single dose

In patients receiving haemodialysis and peritoneal dialysis
Amoxicillin may be removed from the circulation by haemodialysis.

Adults and
children ≥ 40
kg

Children <
40 kg

Haemodialysis
Intravenous
1 g at the end
of dialysis,
then 500 mg
every 24 hours

25 mg/kg stat
and
12.5 mg/kg at
the end of the
dialysis, then
25 mg/kg/day

Intramuscular
500 mg during
dialysis,
500 mg at the
end, then
500 mg every
24 hours
15 mg/kg
during and at
the end of
dialysis, then
15 mg/kg
every 24 hours

Peritoneal dialysis
Intravenous
Intramuscular
1 g stat, then
500 mg/day
500 mg/day
given as a
single dose

25 mg/kg/day
given as a
single dose

15 mg/kg/day
given as a
single dose

Method of administration
The standard recommended route of administration is by intravenous injection or
intravenous infusion. Intramuscular administration should only be considered when
the intravenous route is not possible or less appropriate for the patient.
Intravenous
Amoxil may be administered either by slow intravenous injection over a period of 3 to
4 minutes directly into a vein or via a drip tube or by infusion over 20 to 30 minutes.
Intramuscular
The maximum single dose is 1 g in adults and children ≥ 40 kg.
Do not inject more than 60 mg/kg at one time in children < 40 kg.
4.3
Contraindications

Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients
listed in section 6.1.
History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another betalactam agent (e.g. a cephalosporin, carbapenem or monobactam).

4.4

Special warnings and precautions for use

Hypersensitivity reactions
Before initiating therapy with amoxicillin, careful enquiry should be made concerning
previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam
agents (see sections 4.3 and 4.8).
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 penicillin hypersensitivity and in atopic individuals. If an
allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate
alternative therapy instituted.
Non-susceptible microorganisms
Amoxicillin is not suitable for the treatment of some types of infection unless the
pathogen is already documented and known to be susceptible or there is a very high
likelihood that the pathogen would be suitable for treatment with amoxicillin (see
section 5.1). This particularly applies when considering the treatment of patients with
urinary tract infections and severe infections of the ear, nose and throat.
Convulsions
Convulsions may occur in patients with impaired renal function or in those receiving
high doses or in patients with predisposing factors (e.g. history of seizures, treated
epilepsy or meningeal disorders (see section 4.8).
Renal impairment
In patients with renal impairment, the dose should be adjusted according to the degree
of impairment (see section 4.2).
Skin reactions
The occurrence at the treatment initiation of a feverish generalised erythema
associated with pustula may be a symptom of acute generalised exanthemous
pustulosis (AGEP, see section 4.8). This reaction requires amoxicillin discontinuation
and contra-indicates any subsequent administration.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the
occurrence of a morbilliform rash has been associated with this condition following
the use of amoxicillin.

Jarisch-Herxheimer reaction
The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of
Lyme disease (see section 4.8). It results directly from the bactericidal activity of
amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia
burgdorferi. Patients should be reassured that this is a common and usually selflimiting consequence of antibiotic treatment of Lyme disease.
Overgrowth of non-susceptible microorganisms
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents and
may range in severity from mild to life threatening (see section 4.8). Therefore, it is
important to consider this diagnosis in patients who present with diarrhoea during, or
subsequent to, the administration of any antibiotics. Should antibiotic-associated
colitis occur, amoxicillin should immediately be discontinued, a physician consulted
and an appropriate therapy initiated. Anti-peristaltic medicinal products are contraindicated in this situation.
Prolonged therapy
Periodic assessment of organ system functions; including renal, hepatic and
haematopoietic function is advisable during prolonged therapy. Elevated liver
enzymes and changes in blood counts have been reported (see section 4.8).
Anticoagulants
Prolongation of prothrombin time has been reported rarely in patients receiving
amoxicillin. 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 section 4.5 and 4.8).
Crystalluria
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. In patients with bladder
catheters, a regular check of patency should be maintained (see section 4.8 and 4.9).
Interference with diagnostic tests
Elevated serum and urinary levels of amoxicillin are likely to affect certain laboratory
tests. Due to the high urinary concentrations of amoxicillin, false positive readings are
common with chemical methods.
It is recommended that when testing for the presence of glucose in urine during
amoxicillin treatment, enzymatic glucose oxidase methods should be used.

The presence of amoxicillin may distort assay results for oestriol in pregnant women.
Important information about excipients
This medicinal product contains 63 mg (2.74 mmol) of sodium per vial. To be taken
into consideration by patients on a controlled sodium diet.
Lidocaine may be used only when administering amoxicillin by the intramuscular
route.

4.5

Interaction with other medicinal products and other forms of interaction

Probenecid
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular
secretion of amoxicillin. Concomitant use of probenecid may result in increased and
prolonged blood levels of amoxicillin.
Allopurinol
Concurrent administration of allopurinol during treatment with amoxicillin can increase the
likelihood of allergic skin reactions.
Tetracyclines
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of
amoxicillin.
Oral anticoagulants
Oral anticoagulants and penicillin antibiotics have been widely used in practice without
reports of interaction. However, in the literature there are 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. Moreover, adjustments in the dose of oral anticoagulants may be necessary (see
sections 4.4 and 4.8).
Methotrexate
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

4.6

Fertility, pregnancy and lactation

Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive
toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate
an increased risk of congenital malformations. Amoxicillin may be used in pregnancy when
the potential benefits outweigh the potential risks associated with treatment.

Breastfeeding
Amoxicillin is excreted into breast milk in small quantities with the possible risk of
sensitisation. Consequently, diarrhoea and fungus infection of the mucous membranes are
possible in the breast-fed infant, so that breast-feeding might have to be discontinued.
Amoxicillin should only be used during breast-feeding after benefit/risk assessment by the
physician in charge.
Fertility
There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in
animals have shown no effects on fertility.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.
However, undesirable effects may occur (e.g. allergic reactions, dizziness, convulsions),
which may influence the ability to drive and use machines (see section 4.8).

4.8

Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin
rash.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin,
presented by MedDRA System Organ Class are listed below.
The following terminologies have been used in order to classify the occurrence of undesirable
effects.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Infections and infestations
Very rare
Blood and lymphatic system disorders
Very rare

Mucocutaneous candidiasis
Reversible leucopenia (including severe
neutropenia or agranulocytosis), reversible
thrombocytopenia and haemolytic anaemia.
Prolongation of bleeding time and
prothrombin time (see section 4.4).

Immune system disorders
Very rare

Not known
Nervous system disorders

Severe allergic reactions, including
angioneurotic oedema, anaphylaxis, serum
sickness and hypersensitivity vasculitis (see
section 4.4).
Jarisch-Herxheimer reaction (see section 4.4).

Very rare
Gastrointestinal disorders
Clinical Trial Data
*Common
*Uncommon
Post-marketing Data
Very rare

Hepatobiliary disorders
Very rare

Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common
*Uncommon
Post-marketing Data
Very rare

Renal and urinary tract disorders
Very rare:

Hyperkinesia, dizziness and convulsions (see
section 4.4).

Diarrhoea and nausea
Vomiting
Antibiotic associated colitis (including
pseudomembraneous colitis and haemorrhagic
colitis see section 4.4).
Hepatitis and cholestatic jaundice. A moderate
rise in AST and/or ALT.

Skin rash
Urticaria and pruritus
Skin reactions such as erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal
necrolysis, bullous and exfoliative dermatitis
and acute generalised exanthematous
pustulosis (AGEP) (see section 4.4).
Interstitial nephritis

Crystalluria (see sections 4.4 and 4.9
Overdose)
* The incidence of these AEs was derived from clinical studies involving a total of
approximately 6,000 adult and paediatric patients taking amoxicillin.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard

4.9

Overdose

Symptoms and signs of overdose
Gastrointestinal symptoms (such as nausea, vomiting and diarrhoea) and disturbance of the
fluid and electrolyte balances may be evident. Amoxicillin crystalluria, in some cases leading
to renal failure, has been observed. Convulsions may occur in patients with impaired renal
function or in those receiving high doses (see sections 4.4 and 4.8).
Amoxicillin has been reported to precipitate in bladder catheters, predominantly after
intravenous administration of large doses. A regular check of patency should be maintained
(see section 4.4)

Treatment of intoxication
Gastrointestinal symptoms may be treated symptomatically, with attention to the
water/electrolyte balance.
Amoxicillin can be removed from the circulation by haemodialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.
Mechanism of action
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more
enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway
of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall.
Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually
followed by cell lysis and death.
Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria
and therefore the spectrum of activity of amoxicillin alone does not include organisms which
produce these enzymes.
Pharmacokinetic/pharmacodynamic relationship
The time above the minimum inhibitory concentration (T>MIC) is considered to be the major
determinant of efficacy for amoxicillin.
Mechanisms of resistance
The main mechanisms of resistance to amoxicillin are:



Inactivation by bacterial beta-lactamases.
Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target.

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial
resistance, particularly in Gram-negative bacteria.
Breakpoints
MIC breakpoints for amoxicillin are those of the European Committee on Antimicrobial
Susceptibility Testing (EUCAST) version 5.0.
Organism

Enterobacteriaceae
Staphylococcus spp.
Enterococcus spp.3
Streptococcus groups A, B, C and

Susceptible ≤
81
Note2
4
Note 4

MIC breakpoint (mg/L)
Resistant >
8
Note 2
8
Note 4

G
Streptococcus pneumoniae
Note 5
Note 5
Viridans group steprococci
0.5
2
6
Haemophilus influenzae
2
26
Moraxella catarrhalis
Note 7
Note 7
Neisseria meningitidis
0.125
1
Gram positive anaerobes except
4
8
Clostridium difficile8
Gram negative anaerobes8
0.5
2
Helicobacter pylori
0.1259
0.1259
Pasteurella multocida
1
1
Non- species related breakpoints10 2
8
1
Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some
countries prefer to categorise wild type isolates of E. coli and P. mirabilis as intermediate.
When this is the case, use the MIC breakpoint S ≤ 0.5 mg/L
2
Most staphylococci are penicillinase producers, which are resistant to amoxicillin.
Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.
3
Susceptibility to amoxicillin can be inferred from ampicillin
4
The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the
benzylpenicillin susceptibility.
5
Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to
ampicillin avoid oral treatment with amoxicillin. Susceptibility inferred from the MIC of
ampicillin.
6
Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should
be reported resistant.
7
Beta lactamase producers should be reported resistant
8
Susceptibility to amoxicillin can be inferred from benzylpenicillin.
9
The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish
wild-type isolates from those with reduced susceptibility.
10
The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily
(1.5 to 2 g/day).
The prevalence of resistance may vary geographically and with time for selected species, and
local information on resistance is desirable, particularly when treating severe infections. As
necessary, expert advice should be sought when the local prevalence of resistance is such that
the utility of the agent in at least some types of infections is questionable.
In vitro susceptibility of micro-organisms to Amoxicillin
Commonly Susceptible Species
Gram-positive aerobes:
Enterococcus faecalis
Beta-hemolytic streptococci (Groups A, B, C and G)
Listeria monocytogenes
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Escherichia coli
Haemophilus influenzae

Helicobacter pylori
Proteus mirabilis
Salmonella typhi
Salmonella paratyphi
Pasteurella multocida
Gram-positive aerobes:
Coagulase negative staphylococcus
Staphylococcus aureus£
Streptococcus pneumoniae
Viridans group streptococcus
Gram-positive anaerobes:
Clostridium spp.
Gram-negative anaerobes:
Fusobacterium spp.
Other:
Borrelia burgdorferi
Inherently resistant organisms†
Gram-positive aerobes:
Enterococcus faecium†
Gram-negative aerobes:
Acinetobacter spp.
Enterobacter spp.
Klebsiella spp.
Pseudomonas spp.
Gram-negative anaerobes:
Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
Others:
Chlamydia spp.
Mycoplasma spp.
Legionella spp.


Natural intermediate susceptibility in the absence of acquired mechanism of resistance.
Almost all S.aureus are resistant to amoxilcillin due to production of penicillinase. In
addition, all methicillin-resistant strains are resistant to amoxicillin.

£

5.2

Pharmacokinetic properties

The pharmacokinetic results for studies in which amoxicillin was administered to groups of
healthy volunteers given as a bolus intravenous injection are presented below.
Mean pharmacokinetic parameters
Bolus intravenous injection
Dose
administered
Peak serum
conc (μg/ml)
500 mg
32.2
1000 mg
105.4

T 1/2 (h)
1.07
0.9

AUC
(µg.h/ml)
25.5
76.3

Urinary recovery (%,
0 to 6 h )
66.5
77.4

Distribution
About 18% of total plasma amoxicillin is bound to protein and the apparent volume of
distribution is around 0.3 to 0.4 l/kg.
Following intravenous administration, amoxicillin has been found in gall bladder, abdominal
tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus. Amoxicillin does
not adequately distribute into the cerebrospinal fluid.
From animal studies there is no evidence for significant tissue retention of drug-derived
material. Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6).
Biotransformation
Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities
equivalent to up to 10 to 25% of the initial dose.
Elimination
The major route of elimination for amoxicillin is via the kidney
Amoxicillin has a mean elimination half-life of approximately one hour and a mean total
clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the
amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a
single 250 mg or 500 dose of amoxicillin. Various studies have found the urinary excretion to
be 50 to 85% for amoxicillin over a 24 hour period.
Concomitant use of probenecid delays amoxicillin excretion (see section 4.5).
Gender
Following oral administration of amoxicillin to healthy males and female subjects, gender has
no significant impact on the pharmacokinetics of amoxicillin.
Age
The elimination half-life of amoxicillin is similar for children aged around 3 months to 2
years and older children and adults. For very young children (including preterm newborns) in
the first week of life the interval of administration should not exceed twice daily
administration due to immaturity of the renal pathway of elimination. Because elderly patients
are more likely to have decreased renal function, care should be taken in dose selection, and it
may be useful to monitor renal function.

Renal impairment
The total serum clearance of amoxicillin decreases proportionately with decreasing renal
function (see section 4.2).
Hepatic impairment
Hepatically impaired patients should be dosed with caution and hepatic function monitored at
regular intervals.

5.3

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety
pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and
development.
Carcinogenicity studies have not been conducted with amoxicillin.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

None.

6.2

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those
mentioned in section 6.6.
Amoxil should not be mixed with blood products, other proteinaceous fluids such as protein
hydrolysates or with intravenous lipid emulsions. If prescribed concomitantly with an
aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid
container or giving set because of loss of activity of the aminoglycoside under these
conditions.
Amoxil solutions should not be mixed with infusions containing dextran or bicarbonate.

6.3

Shelf life

Powder in vials: 3 years
Reconstituted vials (for intravenous injection or before dilution for infusion), see section 6.6.
From a microbiological point of view, the reconstituted and diluted solution should be used
immediately.

6.4

Special precautions for storage

Do not store above 25 °C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5

Nature and contents of container

Amoxil 1 g powder for solution for injection or infusion is packaged in a clear Ph.Eur.
Type I or Type III glass 25 ml vial, with a chlorobutyl rubber stopper closure (Ph.Eur.
Type I) and a tamper evident sealing ring.
Packs of 1, 10 or 30 vials
Not all pack sizes may be marketed.
6.6

Special precautions for disposal

Intravenous administration
Vial
1g

Diluent (ml)
20

Water for injections is the normal diluent.
A transient pink colouration may or may not develop during reconstitution.
Reconstituted solutions are normally colourless or a pale straw colour. All solutions
should be shaken vigorously before injection.
If amoxicillin 1 g is to be administered by direct injection, it should be administered
within 20 minutes of reconstitution.
Preparation of intravenous infusions and stability: add without delay the
reconstituted solution of 1 g (as prepared above) to 100 ml infusion fluid (e.g. using a
mini bag or in-line burette).
Intravenous amoxicillin may be given in a range of different intravenous fluids.
Satisfactory antibiotic concentrations are retained at 20 °C in the recommended
volumes of the following infusion fluids:
Intravenous solution
Stability period at 20 °C
Water for Injection Ph. Eur.
6h
Sodium Chloride BP 0.9% w/v
4h
Compound Sodium Chloride
2h
BPC 1959 (Ringer’s solution)
Compound Sodium Lactate BP
30 min
(Ringer-Lactate: Hartmann’s
solution)
5% Dextrose Injection BP
20 min
0.18% w/v Sodium Chloride
30 min
plus 4% Dextrose BP

If reconstituted and maintained at room temperature, infusions should be completed
within the times stated.

Intramuscular administration
Vial
1g

Diluent
2.5 ml Lidocaine hydrochloride solution

The maximum single dose is 1 g.

All solutions should be shaken vigorously before injection and administered
immediately after reconstitution.
Any residual antibiotic solution should be discarded.
For single use only.

7

MARKETING AUTHORISATION HOLDER

Beecham Group plc
Great West Road, Brentford, Middlesex TW8 9GS
Trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
And/or
Bencard or SmithKline Beecham Pharmaceuticals at Mundells Welwyn Garden City,
Hertfordshire AL7 1 EY

8

MARKETING AUTHORISATION NUMBER(S)

PL 00038/0225

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

Date of first authorisation: 14 September 1977
Date of latest renewal: 11 June 2008

10

DATE OF REVISION OF THE TEXT
15/11/2017

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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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