Amoxil

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Amoxicillin sodium 1 g;  
Available from:
GlaxoSmithKline NZ Limited
INN (International Name):
Amoxicillin sodium 1 g
Dosage:
1 g
Pharmaceutical form:
Powder for injection
Composition:
Active: Amoxicillin sodium 1 g  
Prescription type:
Prescription
Manufactured by:
Sandoz GmbH
Therapeutic indications:
Amoxicillin should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Amoxicillin is indicated for the treatment of infections at the following sites, when caused by sensitive organism: · Upper respiratory tract including ear, nose and throat infections, e.g. tonsillitis, sinusitis, otitis media. · Lower respiratory tract, e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia. · Gastrointestinal tract, e.g. typhoid fever. · Genito-urinary tract, e.g. cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gonorrhoea, septic abortion, puerperal sepsis. · Other infections including Borreliosis (Borrelia burgdorferi) (Lyme disease). · Prophylaxis of endocarditis: amoxicillin may be used for the prevention of bacteraemia associated with the development of endocarditis. · Skin and soft tissue infecitons (SSTIs). Susceptibility to amoxicillin with vary with geography and time and local susceptibility data should be
Product summary:
Package - Contents - Shelf Life: Vial, glass, Type I or type III glass vial with halogenobutyl rubber stopper closure - 10 dose units - 24 months from date of manufacture stored at or below 25°C. Store in a cool, dry place
Authorization number:
TT50-2092/6b
Authorization date:
2013-07-29

Read the complete document

AMOXIL

AMOXIL

amoxicillin sodium

250 mg, 500 mg and 1 g intravenous injection

250 mg, 500 mg and 1 g intramuscular injection

New Zealand Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully

before you start using AMOXIL.

This leaflet answers some common

questions about AMOXIL. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking AMOXIL

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What AMOXIL is used

for

AMOXIL contains a penicillin called

amoxicillin as the active ingredient.

AMOXIL is used to treat a range of

infections caused by bacteria.

AMOXIL may be used to treat:

ear, nose and throat infections

lung infections and airway

(leading to the lungs) infections

stomach and intestines infection

reproductive organs and urinary

system infections

gonorrhoea, miscarriage

associated with uterus infection,

infection of the genital tract

occurring after childbirth or

abortion

other infections including

infection spread through ticks and

lice

prevent inflammation of the inner

layer of the heart: AMOXIL may

be used for the prevention of

bacteria in the blood associated

with procedures such as dental

extraction, in patients at risk of

developing bacterial

inflammation of the inner layer of

the heart

infections with bacteria in the

bloodstream, inflammation of the

inner layer of the heart and the

layer protecting the brain and

spinal cord due to susceptible

organisms should be treated

initially with high doses of a

injection therapy and, where

appropriate, in combination with

another antibiotic.

AMOXIL works by preventing,

killing or stopping the growth of

bacteria, which cause infection.

Ask your doctor if you have any

questions about why AMOXIL has

been prescribed for you.

Your doctor may have prescribed

AMOXIL for another reason.

AMOXIL is not addictive.

AMOXIL is available only with a

doctor's prescription.

Before you are given

AMOXIL

When you must not take it

Do not take AMOXIL if you have

an allergy to:

any medicine containing

amoxicillin

any of the ingredients listed at the

end of this leaflet

any other similar antibiotics such

as penicillins and cephalosporins.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Caution should be exercised if you

are pregnant.

The safety of AMOXIL for use in

human pregnancy has not been well

established. Your doctor will discuss

the potential risk and benefits of

taking this medicine during

pregnancy.

Caution should be exercised if you

intend to breast-feed.

Very little active ingredient in

AMOXIL passes into breast milk and

there is a possibility that your baby

may be affected.

AMOXIL is not expected to affect

your ability to drive a car or

operate machinery.

Do not take AMOXIL after the

expiry date printed on the pack or

AMOXIL

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

allergic reaction (such as rash) to

any antibiotics in the past

glandular fever (infectious

mononucleosis), as it may lead to

the development of skin rashes

kidney problems

a blood disorder

decreased urine.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are on a

sodium restricted diet.

During prolonged therapy, your

doctor should carry out periodic

tests to assess kidney, liver and

formation of blood function.

Be cautious and tell your doctor if

you suspect that you have

superinfections.

This is when a new infection occurs

after having a pre-existing infection.

In this case, AMOXIL should be

discontinued and appropriate therapy

substituted.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

AMOXIL.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

AMOXIL may interfere with:

probenecid and allopurinol used

to treat gout (uric acid builds up

in blood and causes joint

inflammation)

antibiotics such tetracyclines and

other medicines used to treat

bacterial infections

estrogen containing oral

contraceptives used to prevent

pregnancy

diagnostic test such as testing for

glucose in urine

acenocoumarol and warfarin used

to prevent blood clots.

These may be affected by AMOXIL

or may affect how well it works. You

may need different amounts of your

medicines, or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take AMOXIL

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

AMOXIL will be administered as

directed under the supervision of a

doctor or nurse. You will not be

expected to give yourself this

medication.

The usual intravenous dose is as

follows:

Adults, elderly and children over

40 kg: 750 mg to 6 g

administered in divided doses

daily

Children under 40 kg: 20 to 200

mg/kg/day in divided doses.

The usual intramuscular dose is as

follows:

Adults and children over 40 kg:

4 g/day in divided doses

Children under 40 kg: 120

mg/kg/day as 2 to 6 equally

divided doses.

How to take it

Your doctor or nurse will inject the

necessary dose of AMOXIL. It may

be given by injection directly into the

vein or via a drip tube or by infusion.

It may also be given by injection into

a muscle.

How long to take it

AMOXIL should be administered

for as long as recommended by

your doctor. The length of

treatment will be decided by your

doctor.

Do not stop taking AMOXIL, or

change the dose without first

checking with your doctor.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you take too much

(overdose)

Immediately telephone your doctor

or the National Poisons Centre

telephone 0800 POISON or 0800 764

766, or go to accident and emergency

at your nearest hospital, if you think

AMOXIL

that you or anyone else may have

taken too much AMOXIL.

Do this even if there are no signs of

discomfort or poisoning.

Symptoms of an overdose may

include nausea, vomiting and

diarrhoea.

You may need urgent medical

attention.

While you are using

AMOXIL

Things you must do

If you develop nausea, vomiting or

diarrhoea when you are receiving

AMOXIL, tell the doctor or nurse

immediately.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking AMOXIL.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not take AMOXIL to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

AMOXIL affects you.

Be careful when drinking alcohol

while you are taking this medicine.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

AMOXIL.

This medicine helps most people

with bacterial infection, but it may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you get

some of the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

diarrhoea, indigestion, feeling

sick or being sick

soreness of the mouth or tongue

overgrowth of yeast infections

(thrush).

Tell your doctor as soon as possible

if you notice any of the following:

fatigue, headache, fever, hot

flashes, irritability or oral ulcers.

These could be symptoms of

leucopoenia (decrease in white

blood cells which help the body

fight infections and disease)

abdominal pain, loss of appetite,

cramping, urgency and bloating

dizziness

swelling of the skin

itching skin and joint aches

pain around the site of injection

unusual bleeding or bruising

yellowing of the skin or eyes

decreased urine, blood or crystal

in urine, drowsiness and weight

gain

difficulty or pain on passing urine

severe diarrhoea

flu like symptoms with a rash,

fever, swollen glands, and

abnormal blood test results

(including increased white blood

cells (eosinophilia) and liver

enzymes) (Drug Reaction with

Eosinophilia and Systemic

Symptoms (DRESS)).

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

wheezing, swelling of the

lips/mouth, difficulty in

breathing, hayfever, lumpy rash

(hives) or fainting. These could

be symptoms of an allergic

reaction.

convulsion or seizure.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Ask your doctor or pharmacist to

answer any questions you may

have.

After using AMOXIL

Storage

Keep all preparations in a cool dry

place where the temperature stays

below 25°C.

AMOXIL

Do not store AMOXIL or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

AMOXIL injections are supplied as

vials containing sterile white

amoxicillin sodium powder

equivalent to 250 mg, 500 mg or 1 g

of amoxicillin. Upon mixing with

water or other approved diluents, the

solution may or may not develop into

a transient pink colouration.

Ingredients

AMOXIL contains the active

ingredient amoxicillin.

Amoxicillin sodium powder for

injection is mixed with sterile water

before use.

Supplier

AMOXIL is supplied in New

Zealand by:

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland

NEW ZEALAND

Phone:

(09) 367 2900

Facsimile:

(09) 367 2910

This leaflet was prepared on:

on 13 November 2017.

Version 3.0

Trade marks are owned by or

licensed to the GSK group of

companies.

© 2017 GSK group of companies or

its licensor.

Read the complete document

NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

AMOXIL 250 mg, 500 mg and 1 g powder for injection

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains amoxicillin sodium equivalent to 250 mg, 500 mg and 1 g of amoxicillin.

For the full list of excipients, see section 6.1 List of excipients.

3.

PHARMACEUTICAL FORM

Powder for injection.

Vials containing a sterile white powder.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Amoxicillin should be used in accordance with local official antibiotic-prescribing guidelines

and local susceptibility data.

Amoxicillin is indicated for treatment of infections in adults and children at the following

sites, when caused by sensitive organisms:

upper respiratory tract including ear, nose and throat infections, e.g. tonsillitis,

sinusitis, otitis media

lower respiratory tract, e.g. acute exacerbations of chronic bronchitis, lobar and

bronchopneumonia

gastrointestinal tract, e.g. typhoid fever

genito-urinary tract, e.g. cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy,

gonorrhoea, septic abortion, puerperal sepsis

other infections including Borreliosis (Borrelia burgdorferi) (Lyme Disease)

prophylaxis of endocarditis: amoxicillin may be used for the prevention of

bacteraemia associated with the development of endocarditis (see table in section

4.2 Dose and method of administration)

skin and soft tissue infections (SSSIs).

Susceptibility to amoxicillin will vary with geography and time and local susceptibility data

should be consulted where available and microbiological sampling and susceptibility

testing performed where necessary (see section 5.1 Pharmacodynamic properties).

4.2

Dose and method of administration

Dose

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable,

as in the case of severe diarrhoea or vomiting, and particularly for the urgent treatment of

severe infection.

Therapy can be started parenterally and continued with oral amoxicillin.

Amoxicillin 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.

Amoxicillin doses should not be given at intervals of less than 4 hourly.

Treatment should be continued for 48 to 72 hours beyond the time that a clinical response

has been obtained.

It is recommended that at least ten days treatment be given for any infection caused by

beta-haemolytic streptococci to eradicate the infecting organism and prevent the

occurrence of acute rheumatic fever or glomerulonephritis.

Although amoxicillin possesses the characteristic low toxicity of the penicillin group of

antibiotics, periodic assessment of organ system function, including renal, hepatic and

haematopoietic functions, is advisable during prolonged therapy.

Adults and children over 40 kg

Intravenous:

Usual daily dosage of 750 mg to 6 g administered in divided doses.

Maximum recommended daily dosage: 12 g/day.

Maximum single dose: 2 g by infusion or 1 g by bolus injection.

Lyme disease: 4 g/day in isolated erythema chronicum migrans and 6 g/day in the case of

generalised manifestations, both for a minimum of 12 days.

Intramuscular:

Maximum recommended daily dosage: 4 g/day.

Maximum single dose: 1 g.

Children under 40 kg

Intravenous:

Usual daily dose of 20 to 200 mg/kg/day in divided doses.

Maximum daily dosage:

Premature (up to 4 kg)

100 mg/kg/day given as 2 equally divided

doses by 12 hourly infusions.

Greater than 4 kg up to 3 months

150 mg/kg/day given as 3 equally divided

doses by 8 hourly infusions.

3 months to 12 years

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.

Maximum single dose: 50 mg/kg.

Lyme disease: 25 to 50 mg/kg/day in isolated erythema chronicum migrans and

100 mg/kg/day in the case of generalised manifestations, both for a minimum of 12 days.

Intramuscular:

Maximum daily dosage: 120 mg/kg/day as 2 to 6 equally divided doses.

Prophylaxis of Endocarditis

Consideration should be given to official guidelines and/or hospital and dental formularies.

Prophylaxis of

Endocarditis:

Condition

Adults and

children over 40

kg

Children under 40

kg

Dental

Procedures: In

patients with the

highest risk of

ineffective

endocarditis that

require manipulation

of the gingival or

periapical region of

the teeth, or

perforation of the

oral mucosa

Patients having

general anaesthetic:

oral antibiotics not

appropriate.

2 g as a single

intravenous dose

30-60 minutes

before procedure.

50 mg/kg as a

single intravenous

dose 30-60 minutes

before procedure

Special populations

Renal impairment

Adults and children over 40 kg

Children under 40 kg

GFR (mL/min)

Intravenous

Intramuscular

Intravenous

Intramuscular

greater than 30

No adjustment

No adjustment

No adjustment

No adjustment

10 to 30

1 g stat, then

500 mg to 1 g

twice day

500 mg every

12 hours

25 mg/kg twice

daily

15 mg/kg every

12 hours

less than 10

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

In patients receiving haemodialysis and peritoneal dialysis

Amoxicillin may be removed from the circulation by haemodialysis.

Haemodialysis

Peritoneal dialysis

Intravenous

Intramuscular

Intravenous

Intramuscular

Adults and

children over 40

kg

1 g at the end of

dialysis, then

500 mg every 24

hours

500 mg during

dialysis, 500 mg

at the end, then

500 mg every 24

hours

1 g stat, then

500 mg/day

500 mg/day given

as a single dose

Children under

40 kg

25 mg/kg stat

and 12.5 mg/kg

at the end of the

dialysis, then

25 mg/kg/day

15 mg/kg during

and at the end of

dialysis, then

15 mg/kg every

24 hours

25 mg/kg/day

given as a single

dose

15 mg/kg/day

given as a single

dose

Method of administration

For instructions on reconstitution of the medicine before administration, see section 6.6

Special precautions for disposal and other handling.

4.3

Contraindications

Amoxicillin is a penicillin and should not be given to patients with a history of

hypersensitivity to beta-lactam antiobiotics (e.g.penicillins and cephalosporins).

4.4

Special warnings and precautions for use

Before initiating therapy with amoxicillin, careful enquiry should be made concerning

previous hypersensitivity reactions to penicillins or cephalosporins. Cross-sensitivity

between penicillins and cephalosporins is well documented.

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and

severe cutaneous adverse reactions) have been reported in patients receiving beta-lactam

antibiotics. If an allergic reaction occurs, amoxicillin should be discontinued and

appropriate alternative therapy instituted. Serious anaphylactic reactions may require

immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway

management, including intubation, may also be required.

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.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in

severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in

patients who develop diarrhoea during or after antibiotic use. If prolonged or significant

diarrhoea occurs or the patient experiences abdominal cramps, treatment should be

discontinued immediately and the patient investigated further.

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in

patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be

undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of

oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Dosage should be adjusted in patients with renal impairment (see section 4.2 Dose and

method of administration).

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 (see section 4.9 Overdose).

The sodium content must be taken into account in patients on a sodium restricted diet if

the parenteral administration of high doses is necessary. Each 1 g vial of amoxicillin

contains 3.3 mmol of sodium.

4.5

Interaction with other medicines and other forms of interaction

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with

amoxicillin may result in increased and prolonged blood levels of amoxicillin.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the

likelihood of allergic skin reactions.

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of

amoxicillin.

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.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower

oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

In the literature there are rare 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.

Total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol

concentrations may be transiently decreased following Amoxicillin administration to

pregnant women.

4.6

Fertility, pregnancy and lactation

Pregnancy

The safety of this medicinal product for use in human pregnancy has not been established

by well controlled studies in pregnant women. Reproduction studies have been performed

in mice and rats at doses of up to 10 times the human dose and these studies have

revealed no evidence of impaired fertility or harm to the foetus due to amoxicillin.

Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential

risks associated with treatment.

Breast-feeding

Amoxicillin may be administered during the period of lactation. With the exception of the

risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast

milk, there are no known detrimental effects for the infant.

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

Adverse effects on the ability to drive and operate machinery have not been observed.

4.8

Undesirable effects

Tabulated list of adverse reactions

The following convention has been utilised for the classification 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)

The majority of the side-effects listed below are not unique to amoxicillin and may occur

when using other penicillins.

Unless otherwise stated, the frequency of adverse events (AE’s) has been derived from

more than 30 years of post-marketing reports.

Blood and Lymphatic System Disorders:

Very rare:

Reversible leucopenia (including severe neutropenia or

agranulocytosis), reversible thrombocytopenia and haemolytic

anaemia.

Prolongation of bleeding time and prothrombin time.

Immune system disorders

Very rare:

As with other antibiotics, severe allergic reactions, including

angioneurotic oedema, anaphylaxis (see section 4.4 Special

warnings and precautions for use), serum sickness and

hypersensitivity vasculitis.

If a hypersensitivity reaction is reported, the treatment must be discontinued

(see also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare:

Hyperkinesia, dizziness and convulsions. Convulsions may occur in

patients with impaired renal function or in those receiving high

doses.

Infections and Infestations

Very rare:

Mucocutaneous candidiasis.

Gastrointestinal disorders

#Common:

Diarrhoea and nausea.

#Uncommon:

Vomiting.

Very rare:

Antibiotic associated colitis (including pseudomembraneous colitis

and haemorrhagic colitis – see section 4.4 Special warnings and

precautions for use).

Hepato-biliary disorders

Very rare:

Hepatitis and cholestatic jaundice. A moderate rise in AST and/or

ALT. The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

#Common:

Skin rash.

#Uncommon:

Urticaria and pruritus.

Very rare:

Skin reactions such as erythema multiforme, Stevens- Johnson

syndrome, toxic epidermal necrolysis, bullous and exfoliative

dermatitis, acute generalised exanthematous pustulosis (AGEP),

and drug reaction with eosinophilia and systemic symptoms

(DRESS).

(See also Immune System disorders)

Renal and Urinary tract disorders

Very rare:

Interstitial nephritis, crystalluria (see section 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 medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions via:

https://nzphvc.otago.ac.nz/reporting.

4.9

Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and

symptoms of water/electrolyte imbalance should be treated symptomatically.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see

section 4.4 Special warnings and precautions for use).

Amoxicillin has been reported to precipitate in bladder catheters after intravenous

administration of large doses. A regular check of patency should be maintained.

Amoxicillin can be removed from the circulation by haemodialysis.

For advice on the management of overdose please contact the National Poisons Centre

on 0800 POISON (0800 764766).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: penicillins with extended spectrum; ATC code: J01CA04.

Mechanism of Action

Amoxicillin is a semi-synthetic aminopenicillin of the beta-lactam group of antibiotics. It has

a broad spectrum of antibacterial activity against many Gram-positive and Gram-negative

micro-organisms, acting through the inhibition of biosynthesis of cell wall mucopeptide.

Amoxicillin is, however, susceptible to degradation by beta-lactamases and therefore the

spectrum of activity does not include organisms which produce these enzymes including

resistant staphylococci, and all strains of Pseudomonas, Klebsiella and Enterobacter.

Pharmacodynamic Effects

The prevalence of acquired resistance is geographically and time dependant and for select

species may be very high. Local information on resistance is desirable, particularly when

treating severe infections.

In vitro susceptibility of micro-organisms to Amoxicillin

Where clinical efficacy of amoxicillin has been demonstrated in clinical trials this is

indicated with an asterisk (*).

†Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

Commonly Susceptible Species

Gram-positive aerobes:

Bacillus anthracis

Enterococcus faecalis*

Beta-hemolytic streptococci*

Listeria monocytogenes

Gram-negative aerobes:

Bordetella pertussis

Other:

Leptospira icterohaemorrhagiae

Treponema pallidum

Species for which acquired resistance may be a problem

Gram-negative aerobes:

Escherichia coli*

Haemophilus influenzae*

Helicobacter pylori*

Proteus mirabilis*

Salmonella spp.

Shigella spp.

Neisseria gonorrhoeae*

Pasteurella spp.

Vibrio cholerae

Gram-positive aerobes:

Coagulase negative staphylococcus*

Corynebacterium spp.

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.

5.2

Pharmacokinetic properties

Distribution

Amoxicillin is not highly protein bound, approximately 18% of total plasma drug content is

bound to protein. Amoxicillin diffuses readily into most body tissues and fluids, with the

exception of the brain and spinal fluid. Inflammation generally increases the permeability

of the meninges to penicillins and this may apply to amoxicillin.

Elimination

The major route of elimination for amoxicillin is via the kidney. Approximately 60 to 70% of

amoxicillin is excreted unchanged in urine during the first six hours after administration of

a standard dose. The elimination half-life is approximately one hour.

Amoxicillin is also partly excreted in the urine as the inactive penicilloic acid in quantities

equivalent to 10 to 25% of the initial dose.

Concurrent administration of probenecid delays amoxicillin excretion.

Small amounts of the drug are also excreted in faeces and bile.

5.3

Preclinical safety data

No further information of relevance to add.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

None.

6.2

Incompatibilities

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

protein hydrolysates or with intravenous lipid emulsions. If prescribed concurrently 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 solutions should not be mixed with infusions containing glucose, dextran or

bicarbonate.

6.3

Shelf Life

Dry powder: 2 years.

Reconstituted solution: see section 6.6 Special precautions for disposal and other

handling.

6.4

Special precautions for storage

Store below 25°C. Store in a cool, dry place.

For storage conditions after reconstitution of the medicine, see section 6.3 Shelf life.

6.5

Nature and contents of container

AMOXIL 250 mg, 500 mg and 1 g powder for injections are packaged in a clear Ph.Eur.

Type I or Type III glass vial with a halogenobutyl rubber stopper closure and a tamper

evident sealing ring. Available in packs of 10 vials.

Not all strengths may be distributed in New Zealand.

6.6

Special precautions for disposal and other handling

Intravenous administration

Vial

Diluent (mL)

250 mg

500 mg

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 250 mg, 500 mg or 1 g is to be administered by direct injection, it should be

administered within 15 minutes of reconstitution.

Preparation of intravenous infusions and stability: add without delay the reconstituted

solution of 250 mg, 500 mg (as prepared above - these are minimum volumes) to 50 mL of

infusion fluid or of 1 g 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 (h)

Water for injection

Sodium Chloride BP 0.9%

Compound Sodium Chloride BPC

1959 (Ringers)

Compound Sodium Lactate BP

(Ringer-Lactate Hartmann’s)

Dextrose

NaCl - dextrose

If reconstituted and maintained at room temperature, infusions should be completed within

the times stated.

Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of

amoxicillin may be injected into the drip tubing over a period of 0.5 to 1 hours.

Intramuscular administration

Vial

Diluent

250 mg

1.5 mL water for injections

500 mg

2.5 mL water for injections

Displacement Volume

The displacement volume of Amoxicillin for both intravenous (IV) and intramuscular (IM) is

as below:

Presentation

Displacement values for IV and IM

250 mg

0.2 mL per gram

500 mg

0.4 mL per gram

0.8 mL per gram

All solutions should be shaken vigorously before injection and administered within 15

minutes of reconstitution.

Any residual antibiotic solution should be discarded.

Amoxicillin vials are not suitable for multi-dose use.

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7.

MEDICINE SCHEDULE

Prescription Medicine.

8.

SPONSOR

GlaxoSmithKline NZ Limited

Private Bag 106600

Downtown

Auckland

New Zealand

Phone:

(09) 367 2900

Facsimile:

(09) 367 2910

9.

DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine: 12

November 2015

10.

DATE OF REVISION OF THE TEXT

30 October 2017

Summary table of changes:

Section changed

Summary of new information

Data Sheet re-format

Added age range to indication

Added Method of administration section

Amended hypersensitivity information

Added Fertility section

Added Effects on ability to drive and use machines

section

Added DRESS as a very rare adverse reaction

Added

reporting

suspected

adverse

reactions

information

Added

information

regarding

advice

management of overdose

Added Pharmacotherapeutic group and ATC code

Added Preclinical safety data section

Added List of excipients section

Updated Shelf life section

Updated Special precautions for storage section

Added container closure details

Added information regarding disposal and handling

instructions

Added date of first approval

Version 3.0

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© 2017 GSK group of companies or its licensor.

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