Patient info Open main menu

Amoxicillin Sodium 500 mg powder for solution for injection – Summary of Product Characteristics (SmPC) for healthcare professionals

Last updated: · Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) Details

The Summary of Product Characteristics (SmPC) is written for healthcare professionals. Patients will find plain advice in the patient information leaflet: how to take, side effects, other medicines, pregnancy and breast-feeding.

Medicine strength:
500 mg
Other strengths and forms:
Contains active substance:
ATC code:
Similar medicines:

Sources: Original (products.mhra.gov.uk) · About this document

Summary of Product Characteristics (SmPC) - Amoxicillin Sodium 500 mg powder for solution for injection

1. NAME OF THE MEDICINAL PRODUCT

Amoxicillin 250mg Powder for Solution for Injection Amoxicillin 500mg Powder for Solution for Injection Amoxicillin 1g Powder for Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Amoxicillin Sodium equivalent to Amoxicillin Ph Eur 250mg Amoxicillin Sodium equivalent to Amoxicillin Ph Eur 500mg Amoxicillin Sodium equivalent to Amoxicillin Ph Eur 1g

3 PHARMACEUTICAL FORM

Powder for solution for injection.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Amoxicillin 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
Amoxicillin 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 Amoxicillin 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*Dose*
Severe infections of the ear, nose and throat750 mg to 2 g every 8 hours, or 2 g
(such as mastoiditis peritonsillar infections,every 12 hours, maximum of 12
epiglottis and sinusitis when accompanied byg/day
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 infections750 mg to 2 g every 8 hours, or 2 g
every 12 hours, maximum of 12
g/day
Prophylaxis of endocarditis2 g single dose 30 to 60 minutes
before procedure.
Treatment of endocarditis1 g to 2 g every 4 to 6 hours,
maximum of 12 g/day
Bacterial meningitis1 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 with,1 g to 2 g every 4, 6 or 8 hours,
or is suspected to be associated with, any ofmaximum of 12 g/day
the infections listed in section 4.1
*Consideration should be given to the official treatment guidelines for each
indication.

Intramuscular

Maximum daily dosage: 4 g/day. Maximum single dose: 1 g.

Children < 40 kg

Infants and toddlers >3 months and childrenDose*
< 40 kg Indication*
Severe infections of the ear, nose and throat20 to 200 mg/kg/day given in 2
(such as mastoiditis peritonsillar infections,to 4 equally divided doses of up
epiglottis and sinusitis when accompanied byto 25 mg/kg or infusions of up to
severe systemic signs and symptoms50 mg/kg

Community acquired pneumonia

Acute cystitis
Acute pyelonephritis
Severe dental abscess with spreading cellulitis
Prophylaxis of endocarditis50 mg/kg single dose 30 to 60
minutes before procedure
Treatment of endocarditis200 mg/kg/day in 3 to 4 equally
divided does of up to 25 mg/kg
or infusions of up to 50 mg/kg
Bacterial meningitis100 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
Lyme disease (see section 4.4)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 with, or is50 to 150 mg/kg/day given in 3
suspected to be associated with, any of theequally divided doses of up to 25
infections listed in section 4.1mg/kg or 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 3Dose*
months
Indication*
Premature Neonates < 4kgDose*
Indication*
Most infectionsUsual 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
Treatment of endocarditis100 mg/kg/day given in two divided
doses
Bacterial meningitis100 mg/kg/day given in two divided
doses
Lyme disease (see section 4.4)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
Bacteraemia that occurs in association with, or isUsual daily dose of 50 to 100
suspected to be associated with, any of themg/kg/day given in 2 equally divided
infections listed in section 4.1doses of up to 25 mg/kg or infusions
of up to 50 mg/kg
*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

Most infectionsUsual 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
Treatment of endocarditis150 mg/kg/day given in 3 equally divided
doses of up to 25 mg/kg or infusions of up to
50 mg/kg
Bacterial meningitis150 mg/kg/day given in three divided doses
Lyme disease (see section 4.4)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 associationUsual daily dose of 50 to 150 mg/kg/day
with, or is suspected to be associated with,given in 3 equally divided doses of up to 25
any of the infections listed in section 4.1mg/kg or infusions of up to 50 mg/kg
*Consideration should be given to the official treatment guidelines for each indication.
Adults and children ≥ 40 kgChildren < 40 kg
GFR (ml/min)IntravenousIntramuscularIntravenousIntramuscular
greater than 30No adjustmentNo adjustmentNo adjustmentNo adjustment
10 to 301g stat, then 500500 mg every 1225 mg/kg twice15 mg/kg
mg to 1 g twicehoursdailyevery 12 hours
day
less than 101 g stat, then 500500 mg/day given25 mg/kg/day15 mg/kg/day
mg/dayas a single dosegiven as a singlegiven as a
dosesingle dose

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

HaemodialysisPeritoneal dialysis
IntravenousIntramuscularIntravenousIntramuscular
Adults and1 g at the end of500 mg during1 g stat, then 500500 mg/day
children ≥ 40dialysis, then 500dialysis, 500 mgmg/daygiven as a
kgmg every 24at the end, thensingle dose
hours500 mg every 24
hours
Children < 4025 mg/kg stat and15 mg/kg during25 mg/kg/day15 mg/kg/day
kg12.5 mg/kg at theand at the end ofgiven as a singlegiven as a
end of thedialysis, then 15dosesingle dose
dialysis, then 25mg/kg every 24
mg/kg/dayhours

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 Injection: Dissolve 250mg in 5mL Water for Injections Ph Eur (final volume 5.2mL).

Dissolve 500mg in 10mL Water for Injections Ph Eur (final volume 10.4mL).

Dissolve 1g in 20mL Water for Injections Ph Eur (final volume 20.8mL).

Amoxicillin for Injection, when diluted may be injected slowly into a vein or infusion line over a period of three to four minutes.

Intravenous Infusion:

Prepare as above and add to an iv solution in a minibag or in-line burette. Administer over 30 to 60 minutes. Alternatively the appropriate volume of iv fluid may be transferred from the infusion bag into the vial, using a suitable reconstitution device, and drawn back into the bag after dissolution.

Intramuscular Injection: Add 1.5mL Water for Injections Ph Eur to 250mg and shake vigorously (final volume 1.7mL).

Add 2.5mL Water for Injections Ph Eur to 500mg and shake vigorously (final volume 2.9mL).

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 beta-lactam 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 reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see section 4.8). 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.

Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see section 4.8). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after drug <intake> <administration> <use>) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.

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.

Care is also necessary if large doses of sodium (as amoxicillin sodium) are given to patients with impaired renal function or heart failure. Renal and haematological status should be monitored during prolonged and high-dose therapy.

Amoxicillin should preferably not be given to patients with undiagnosed pharyngitis (who may have mononucleosis) or patients with lymphatic leukaemia or possibly HIV infection who may also be at increased risk of developing skin rashes with amoxicillin.

There is a potential for increased serum levels of amoxicillin in the newborn or in young infants due to reduced renal excretion.

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 (AEGP, 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 self-limiting 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 contra-indicated 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 (including acute renal injury) 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.

Amoxicillin 250mg, 500mg and 1g powder for solution for injection contains 0.65mmol (14.9mg), 1.3mmol (29.7mg) and 2.6mmol (59.4mg) of sodium per dose, respectively. To be taken into consideration by patients on a controlled sodium diet.

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.

Breast-feeding

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 rareMucocutaneous candidiasis
Blood and lymphatic system disorders
Very rareReversible 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 rareSevere allergic reactions, including
angioneurotic oedema, anaphylaxis, serum
sickness and hypersensitivity vasculitis (see
section 4.4).
Not knownJarisch-Herxheimer reaction (see section 4.4).
Metabolism and nutrition disorders
Not knownElectrolyte disturbances such as hypokalaemia
(due to administration of large amounts of
sodium).
Nervous system disorders
Very rareHyperkinesia, dizziness, aseptic meningitis and
convulsions (see section 4.4).
Not knownSigns of central nervous system toxicity;
generally associated with large intravenous doses
of amoxicillin or impaired renal function.
Encephalopathy has been reported following
intrathecal administration and can be fatal.
A coma may develop with high doses of
amoxicillin.
Aseptic meningitis
Gastrointestinal disorders
Clinical Trial Data
*CommonDiarrhoea and nausea
*UncommonVomiting
Post-marketing Data
Very rareAntibiotic associated colitis (including
pseudomembraneous colitis and haemorrhagic
colitis see section 4.4).
Not knownSore mouth or tongue, commonly occur after oral
administration but may also occur following
parenteral administration
Drug-induced enterocolitis syndrome
Hepatobiliary disorders
Very rareHepatitis and cholestatic jaundice. A moderate
rise in AST and/or ALT.
Skin and subcutaneous tissue disorders
Clinical Trial Data
*CommonSkin rash
*UncommonUrticaria and pruritus
Not knownLinear IgA disease
Post-marketing Data
Very rareSkin reactions such as erythema multiforme,
Stevens-Johnson syndrome, toxic epidermal
necrolysis, bullous and exfoliative dermatitis,
acute generalised exanthematous pustulosis
(AGEP) (see section 4.4) and drug reaction with
eosinophilia and systemic symptoms (DRESS).
Renal and urinary tract disorders
Very rare:Interstitial nephritis
Crystalluria (see sections 4.4 and 4.9 Overdose)
Not knownCrystalluria (including acute renal injury)
Respiratory, thoracic and mediastinal
disorders
Not knownBronchospasm, Acute severe dyspnoea and
allergic pneumonitis; generally associated with
large intravenous doses of amoxicillin or impaired
renal function.
Psychiatric disorders
Not known:Hallucinations
Cardiac disorders
Not knownKounis syndrome
* 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).

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

MIC breakpoint (mg/L)

≤

SusceptibleResistant >
Enterobacteriaceae818
Staphylococcus spp.Note2Note 2
Enterococcus spp.348
Streptococcus groups A, B, C and GNote 4Note 4
Streptococcus pneumoniaeNote 5Note 5
Viridans group steprococci0.52
Haemophilus influenzae2626
Moraxella catarrhalisNote 7Note 7
Neisseria meningitidis0.1251
Gram positive anaerobes48
except Clostridium difficile8
Gram negative anaerobes80.52
Helicobacter pylori0.12590.1259
Pasteurella multocida11
Non- species related breakpoints1028
1Wild 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

2Most staphylococci are penicillinase producers, which are resistant to amoxicillin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents. 3Susceptibility to amoxicillin can be inferred from ampicillin

4The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility.

5Breakpoints 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. 6Breakpoints are based on intravenous administration. Beta-lactamase positive isolates should be reported resistant.

7Beta lactamase producers should be reported resistant

8Susceptibility to amoxicillin can be inferred from benzylpenicillin.

9The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility.

10The 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 amoxicillin 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
administeredPeak serum conc μT 1/2 (h)AUC (µg.h/ml)Urinary
( g/ml)recovery
(%, 0 to
6 h )
500 mg32.21.0725.566.5
1000 mg105.40.976.377.4
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

Amoxicillin should not be mixed with blood products, other proteinaceous fluids such us 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.

Amoxicillin and aminoglycoside injections should be administered at separate sites.

Amoxicillin should not be mixed with ciprofloxacin.

Amoxicillin solutions should not be mixed with infusions containing dextran or bicarbonate.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25ºC.

Reconstituted solutions should be administered immediately after preparation.

6.5 Nature and contents of container

Vials containing 250mg or 500mg or 1000mg of amoxicillin for injection in packs of 1,

5, 10, 20 or 50 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

The vials are not suitable for multidose use.

All solutions should be shaken vigorously before injection and administered immediately after reconstitution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. MARKETING AUTHORISATION NUMBER(S)

Amoxicillin 250mg Powder for Solution for Injection - PL 29831/0010 Amoxicillin 500mg Powder for Solution for Injection - PL 29831/0012 Amoxicillin 1g Powder for Solution for Injection - PL 29831/0011

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

22 February 2008

10 DATE OF REVISION OF THE TEXT

09/05/2024

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 29831/0012

Last revision stated in the text: 9 May 2024 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Amoxicillin Sodium 500 mg powder for solution for injection

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Amoxicillin
Strength 500 mg
Pharmaceutical form Powder for solution for injection
How is it taken Intravenous, Intramuscular
Excipients None.
Pack sizes 10 vial
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life 3 years
Storage Store below 25°C.
Reconstituted solutions should be administered immediately after preparation.
Drug group (ATC) Penicillins with extended spectrum
  1. J Antiinfectives for systemic use
    1. J01 Antibacterials for systemic use
      1. J01C Beta-lactam antibacterials, penicillins
        1. J01CA Penicillins with extended spectrum
          1. J01CA04 amoxicillin
Marketing authorisation PL 29831/0012 (first authorised 22 February 2008)
Marketing authorisation holder Wockhardt UK Ltd
Codes GTIN 5012727902555 · BNF 05010103

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.