AMOXIL VIALS FOR INJECTION 500MG

Active substance: AMOXICILLIN SODIUM

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1000000
0092005

Package Leaflet: Information for the User
®

Amoxil Vials for Injection 500 mg
and 1 g
amoxicillin
Read all of this leaflet carefully
before you start taking this
medicine.

2 Before you have Amoxil
Do not have Amoxil if you:

• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor, pharmacist or
nurse.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse.

• are allergic (hypersensitive) to amoxicillin or
penicillin
• have ever had an allergic (hypersensitive)
reaction to any antibiotic. This can include a
skin rash or swelling of the face or neck.
Do not have Amoxil if any of the above apply. If
you are not sure, talk to your doctor, pharmacist
or nurse before having Amoxil.

In this leaflet:

Take special care with Amoxil

1 What Amoxil is and what it is used for
2 Before you have Amoxil
3 How Amoxil is given
4 Possible side effects
5 How to store Amoxil
6 Further information

1 What Amoxil is and what it is
used for
What Amoxil is

Amoxil Vials for Injection 500 mg and 1 g (called
Amoxil in this leaflet) are antibiotics. The vials
contain a medicine called amoxicillin. This
belongs to a group of medicines called
‘penicillins’.

What Amoxil is used for
Amoxil is used to treat infections in different
parts of the body caused by bacteria. It is also
used to stop infections when you have a tooth
removed or other surgery.
Amoxil Vials for Injection are usually used for
urgent treatment of severe infection or if
patients cannot take Amoxil by mouth.

Amoxil may stop the contraceptive pill working.
You will need to use extra contraceptive
precautions, such as using a condom. If you need
any advice, talk to your doctor, pharmacist or
nurse.

Pregnancy and breast-feeding

Ask your doctor, pharmacist or nurse for advice
before taking any medicine if you think you
might be or if you are pregnant or if you are
breast-feeding.

Important information about one of the
ingredients of Amoxil
Each vial of Amoxil Vials for Injection 500 mg
contains 38 mg of sodium.
Each vial of Amoxil Vials for Injection 1 g
contains 76 mg of sodium.
This should be considered if you are on a
controlled sodium diet.

3 How Amoxil is given

Adults, elderly patients and children over
10 years of age

• Most infections: 500 mg every 8 hours into
muscle. This might be given by slow injection
into a vein if this is more convenient.
• Severe infections: 1 g every 6 hours into a vein.
• To prevent infections after surgery: the dose
will vary according to the type of surgery. The
doctor, pharmacist or nurse will advise you
exactly how much medicine and when you will
need it.
You may need to have 1 x 1 g injection into a
vein or muscle before surgery, sometimes with
other medicines. This may be followed by
further Amoxil doses (oral or injection) later in
a 24 hour period or for several days.

Kidney problems
If you have kidney problems the dose might be
lower than the usual dose.

If more Amoxil is given to you than
recommended

Check with your doctor, pharmacist or nurse
before having this medicine if you:
• have glandular fever
• are being treated for kidney problems
• are not passing water regularly.
If you are not sure if any of the above apply to
you, talk to your doctor, pharmacist or nurse
before you have Amoxil.

You will never give yourself this medicine. A
qualified person, like a doctor or a nurse, will
give you this medicine.
• Amoxil will be given as an injection or an
infusion into a vein (intravenously) or muscle
(intramuscularly).
• Your doctor will decide how much you need
each day and how often the injections should
be given.
• Make sure you drink plenty of fluids while
having Amoxil.

Having urine or blood tests

To treat infections

How long will you need to take Amoxil for?

The usual doses are as follows.

You will not normally be given Amoxil for more
than 2 weeks without the doctor reviewing your
treatment.
Thrush (a yeast infection of moist areas of the
body) may develop if Amoxil is used for a long
time. If this occurs and you have been taking
Amoxil for longer than recommended, tell your
doctor, pharmacist or nurse.
If you have any further questions about how this
product is given, ask your doctor, pharmacist or
nurse.

If you are having tests on your water (urine
glucose tests) or blood tests for liver function, let
the doctor or nurse know that you are on
Amoxil. This is because Amoxil can affect the
results of these tests.

Taking other medicines
Please tell your doctor, pharmacist or nurse if you
are taking or have recently taken any other
medicines. This includes medicines that can be
bought without a prescription and herbal
medicines. This is because Amoxil can affect the
way some other medicines work. Also some other
medicines can affect the way Amoxil works.
• If you are taking allopurinol (used for gout)
with Amoxil, it may be more likely that you’ll
have an allergic skin reaction.
• If you are taking probenecid (used for gout),
your doctor may decide to adjust your dose of
Amoxil.
• If medicines to help stop blood clots (such as
warfarin) are taken with Amoxil then extra
blood tests may be needed.

Children up to 10 years of age

• Most infections: 50 mg to 100 mg for every
kilogram of body weight in divided doses
throughout the day.
• To prevent infections after surgery: the dose
will vary according to the type of surgery. The
doctor, pharmacist or nurse will advise you
exactly how much medicine and when you will
need it.
- For children aged 5 to 10 years, the dose is
usually half the adult dose to prevent
infections after surgery, see below.
- For children to 5 years, the dose is usually
one-quarter of the adult dose to prevent
infections after surgery, see below.

It is unlikely you will be given too much, but if
you think you have been given too much Amoxil,
tell your doctor, pharmacist or nurse
immediately. Signs might be an upset stomach
(feeling sick, being sick or diarrhoea) or crystals
in the urine, which may be seen as cloudy urine
or problems passing urine.

If you think you have missed an injection of
Amoxil

Package Leaflet: Information for the Healthcare Professional
®

Amoxil Vials for Injection 500 mg and 1 g
amoxicillin

Dosage and Administration Information Only
Please refer to the Summaries of Product Characteristics for further information

Presentation
Amoxil Injection is available in vials containing the equivalent of 500 mg or 1 g amoxicillin as amoxicillin sodium, presented as powder for reconstitution.

Dosage and administration
Recommended adult dosage (including elderly patients)
Moderate infections
Severe infections including:
Severe respiratory tract infections
Bacterial endocarditis
Intra-abdominal sepsis
Peritonitis

Puerperal sepsis
Septic abortion
Septicaemia
Typhoid and paratyphoid fever

500 mg IM 8 hourly or more frequently if necessary. (This dose may be given by slow IV injection* if
more convenient).
1 g 6 hourly by slow IV injection*
or by IV infusion over a period of ½ - 1 hour.
* taking 3-4 minutes if injecting directly into an infusion line.

Recommended children’s dosage
Infections in children up to 10 years of age
50-100 mg/kg body weight per day in divided doses
Prophylaxis of endocarditis
See table
Renal impairment
In renal impairment the excretion of Amoxil will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage.
Maximum dosage
For patients with creatinine clearance of:
Maximum dosage
10-30 ml/min
1 g stat. then 500 mg every 12 hours
<10 ml/min
1 g stat. then 500 mg every 24 hours
Amoxil is removed in significant quantities by haemodialysis. In patients receiving haemodialysis a further dose of Amoxil may need to be given at the end of each period of dialysis.
Prophylaxis of endocarditis
Condition

Adult’s dosage (including elderly)

Children’s dosage

Dental procedures: prophylaxis for patients
Patient not having general anaesthetic.
undergoing extraction, scaling or surgery involving
gingival tissues and who have not received a
penicillin in the previous month.

3 g Amoxil orally, 1 hour before Under 10: half adult dose.
procedure. A second dose may be Under 5: quarter adult dose.
given 6 hours later, if considered
necessary.

(N.B. Patients with prosthetic heart valves should
be referred to hospital – see below.)

Patient having general anaesthetic: if
oral antibiotics considered to be
appropriate.

Initially 3 g Amoxil orally 4 hours
prior to anaesthesia, followed by
3 g orally (or 1 g IV or IM if oral
dose not tolerated) as soon as
possible after the operation.

Patient having general anaesthetic: if
oral antibiotics not appropriate.

1 g Amoxil IV or IM immediately
before induction; with 500 mg
orally, 6 hours later.
Initially: 1 g Amoxil IV or IM with
120 mg gentamicin IV or IM
immediately prior to anaesthesia
(if given) or 15 minutes prior to
dental procedure.
Followed by (6 hours later):
500 mg Amoxil orally.

Speak to your doctor, pharmacist or nurse.

Dental procedures: patients for whom referral to hospital is recommended:
a) Patients to be given a general anaesthetic who have been given a penicillin in the previous
month.
b) Patients to be given a general anaesthetic who have a prosthetic heart valve.
c) Patients who have had one or more attacks of endocarditis.

Genitourinary surgery or instrumentation:
prophylaxis for patients who have no urinary tract infection and who are to have
genitourinary surgery or instrumentation under general anaesthesia.
Obstetric and gynaecological
procedures
Gastrointestinal procedures

}

Surgery or instrumentation of the upper
respiratory tract

Notes
Note 1. If prophylaxis with Amoxil is given
twice within one month, emergence of resistant
streptococci is unlikely to be a problem.
Alternative antibiotics are recommended if
more frequent prophylaxis is required, or if the
patient has received a course of treatment with
a penicillin during the previous month.
Note 2. To minimise pain on IM injection,
Amoxil may be given as two injections of
500 mg dissolved in sterile 1% lidocaine
solution (see Preparation and administration).

Under 10: the doses of Amoxil See Note 2.
should be half the adult dose; the
dose of gentamicin should be
Note 3. Amoxil and gentamicin should not be
2 mg/kg.
mixed in the same syringe.
Under 5: the doses of Amoxil
Note 4. Please consult the appropriate data
should be quarter the adult dose; sheet for full prescribing information on
the dose of gentamicin should be gentamicin.
2 mg/kg.

Initially: 1 g Amoxil IV or IM with
120 mg gentamicin IV or IM,
immediately before induction.

See Notes 2, 3 and 4 above.

routine prophylaxis is recommended Followed by (6 hours later):
only for patients with prosthetic heart 500 mg Amoxil orally or IV or IM
valves
according to clinical condition.
Patients other than those with
prosthetic heart valves.

1 g Amoxil IV or IM immediately Under 10: half adult dose.
before induction; 500 mg Amoxil
Under 5: quarter adult dose.
IV or IM 6 hours later.

Patients with prosthetic heart valves.

Initially: 1 g Amoxil IV or IM with
120 mg gentamicin IV or IM,
immediately before induction;
followed by (6 hours later)
500 mg Amoxil IV or IM.

See Note 2 above.
Note 5. The second dose of Amoxil may be
administered orally as Amoxil syrup.

Under 10: the dose of Amoxil
See Notes 2, 3, 4 and 5 above
should be half the adult dose; the
gentamicin dose should be
2 mg/kg.
Under 5: the dose of Amoxil
should be quarter the adult dose;
the dose of gentamicin should be
2 mg/kg.

Preparation and administration

4 Possible side effects

Intravenous injection
Vial strength
500 mg*
1g†

10 ml
20 ml

Recommended volume of Water for Injections BP to be added

10.4 ml
20.8 ml

Final volume

* The product should be dissolved in a smaller volume and after being drawn up should be reconstituted to the total volume required.
† each 1 g vial contains 3.3 mmol (approx.) of sodium.
Amoxil injection, suitably diluted, may be injected directly into a vein or the infusion line over a period of three to four minutes.
Intravenous infusion
Solutions may be prepared as described for intravenous injections and then added to an intravenous solution in a minibag or in-line burette and administered over a period of half to one hour.
Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transferred from the infusion bag into the vial and then drawn back into the bag after dissolution.
Intramuscular injection
Vial strength

500 mg
1 g*

Recommended volume of reconstitution
fluid to be added (shake vigorously)
2.5 ml †
2.5 ml

Water for Injections BP

Final volume

1% Sterile lidocaine hydrochloride solution
2.5 ml


2.9 ml
3.3 ml

* each 1 g vial contains 3.3 mmol (approx.) of sodium.
† If pain is experienced on intramuscular injection, a sterile 1% solution of lidocaine hydrochloride or 0.5% solution of procaine hydrochloride may be used in place of Water for Injections.
‡ The 1 g vial will not dissolve in 1% sterile lidocaine hydrochloride solution at the required concentration (2.5 ml). To minimise pain on injection, 1 g of Amoxil may be given as two separate injections of 500 mg
dissolved in a sterile solution of 1% lidocaine hydrochloride (see above).
A transient pink colouration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.
N.B.
The displacement volume of Amoxil for both intramuscular and intravenous injection is 0.8 ml per gramme. Therefore, to ensure correct dosage when injecting a fraction of a reconstituted vial, account should
be taken of the final volumes shown above, e.g. to administer 125 mg Amoxil IM, 0.85 ml should be injected. The quantity of water may be adjusted slightly, to give a conveniently divisible volume of
solution.
When prepared for intramuscular or direct intravenous injection, Amoxil is not intended for multi-dose use and any residual antibiotic should be discarded.

Stability and compatibility
When prepared for intramuscular or direct intravenous injection, Amoxil should be administered immediately after reconstitution.
Amoxil maintains a satisfactory degree of activity in various infusion fluids as shown in the table below.
Refrigerated infusion solutions should be restored to ambient temperature before use.
Amoxil is compatible with commonly used aqueous intravenous fluids. Stability is dependent upon the concentration and temperature. Full details of the stability of aseptically prepared Amoxil infusions in
standard IV fluids are available to Centralised Intravenous Additive Services on request.
Stability periods for Amoxil in intravenous fluids at 25°C are shown below.
Intravenous fluid

Stability time (Loss of penicillin activity 10% or less in the time stated)
Amoxil
Amoxil
Amoxil
1% w/v
2% w/v
5% w/v
8 hours
8 hours
3 hours
8 hours
8 hours
3 hours
8 hours
8 hours
3 hours
2 hours
1 ½ hours
1 hour
2 hours
1 ½ hours
1 hour
2 hours
1 ½ hours
1 ½ hours
1 hour
1 hour
1 hour
6 hours
6 hours
3 hours
6 hours
6 hours
3 hours

Water for Injections BP
Sodium Chloride Intravenous Infusion (0.9%)
Potassium Chloride (0.3%) and Sodium Chloride (0.9%) Intravenous Infusion
Glucose Intravenous Infusion
Sodium Chloride (0.18%) and Glucose (4%) Intravenous Infusion
Dextran 40 Intravenous Infusion (10%) in Sodium Chloride Intravenous Infusion (0.9%)
Dextran 40 Intravenous Infusion (10%) in Glucose Intravenous Infusion (5%)
Sodium Lactate Intravenous Infusion (M/6)
Compound Sodium Lactate Intravenous Infusions (Ringer-Lactate: Hartmann’s Solution)

Pharmaceutical precautions
It is preferable to avoid adding Amoxil to a carbohydrate solution since it is relatively less stable under these conditions. It may, however, be injected slowly into the infusion line of such a solution or incorporated
into a small volume of the solution and infused over a period of half to one hour.
Incompatibilities
Amoxil should not be mixed with blood products, other proteinaceous fluids, such as protein hydrolysates, or with intravenous lipid emulsions.
If Amoxil is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur
under these conditions.

Storage
Vials containing Amoxil should be stored in a cool, dry place until required for preparation of an injection.
Package quantities and product licence numbers
Strength
Pack
Product Licence
500 mg
10
00038/0222
1g
10
00038/0225
Leaflet date: December 2007
Amoxil is a registered trademark of the GlaxoSmithKline group of companies
© 2007 GlaxoSmithKline group of companies

Like all medicines, Amoxil can cause side effects,
although not everybody gets them. The following
side effects may happen with this medicine.

Tell your doctor or nurse straight away if you
notice any of the following serious side
effects – you may need urgent medical
treatment:
The following are very rare (affects less than 1 in
10,000 people)
• allergic reactions, the signs may include: skin
itching or rash, swelling of the face, lips, tongue,
body or breathing difficulties. These can be
serious and occasionally deaths have occurred
• rash or pinpoint flat red round spots under the
skin surface or bruising of the skin. This is due
to inflammation of blood vessel walls due to
an allergic reaction. It can be associated with
joint pain (arthritis) and kidney problems
• a delayed allergic reaction can occur usually
7 to 12 days after having Amoxil, some signs
include: rashes, fever, joint pains and
enlargement of the lymph nodes especially
under the arms
• a skin reaction known as ‘erythema
multiforme’ where you may develop: itchy
reddish purple patches on the skin especially
on the palms of the hands or soles of the feet,
‘hive-like’ raised swollen areas on the skin,
tender areas on the surfaces of the mouth,
eyes and private parts. You may have a fever
and be very tired
• other severe skin reactions can include:
changes in skin colour, bumps under the skin,
blistering, pustules, peeling, redness, pain,
itching, scaling. These may be associated with
fever, headaches and body aches
• high temperature (fever), chills, a sore throat
or other signs of an infection, or if you bruise
easily. These may be signs of a problem with
your blood cells
• inflammation of the large bowel (colon) with
diarrhoea sometimes containing blood, pain
and fever
• serious liver side effects may occur which are
often reversible. They are mainly associated
with people having treatment over a long
period, males and the elderly. You must tell
your doctor or nurse urgently if you get:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin

- darker urine or paler stools
- yellowing of the skin or the whites of the
eyes (jaundice). See also anaemia below
which might result in jaundice.
These can happen when having the medicine
or for up to several weeks after.

If any of the above happen to you talk to
your doctor or nurse straight away as your
medicine should be stopped.
Sometimes you may get less severe skin
reactions such as:

• a mildly itchy rash (round, pink-red patches),
‘hive-like’ swollen areas on forearms, legs,
palms, hands or feet. This is uncommon (affects
less than 1 in 100 people).

If you have any of these talk to your doctor or
nurse as Amoxil will need to be stopped.

The other possible side effects are:
Common (affects less than 1 in 10 people)
• skin rash
• feeling sick (nausea)
• diarrhoea.
Uncommon (affects less than 1 in 100 people)
• being sick (vomiting).
Very rare (affects less than 1 in 10,000 people)
• thrush (a yeast infection of the vagina, mouth
or skin folds), you can get treatment for thrush
from your doctor, pharmacist or nurse
• kidney problems
• fits (convulsions), seen in patients on high
doses or with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which may be seen as
cloudy urine, or difficulty or discomfort in
passing urine. Make sure you drink plenty of
fluids to reduce the chance of these symptoms
• an excessive breakdown of red blood cells
causing a form of anaemia. Signs include:
tiredness, headaches, shortness of breath,
dizziness, looking pale and yellowing of the
skin and the whites of the eyes
• the blood may take longer to clot than it
normally would. You may notice this if you
have a nosebleed or cut yourself.
If any of the side effects gets serious, or if you
have any side effects not listed in this leaflet,
please tell your doctor, pharmacist or nurse.

5 How to store Amoxil
Amoxil Vials for Injection are for use in hospital
only and the expiry date and storage instructions
stated on the label are for the doctor, pharmacist
or nurse’s information. The doctor, pharmacist or
nurse will make up your medicine. When
administered directly into a muscle or a vein, it
should be used immediately following
reconstitution (usually this process takes about
5 minutes). (If Amoxil is being administered by
slow infusion this takes about half to one hour.)

Other formats
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)

6 Further information
What Amoxil contains

• Amoxil Vials for Injection are available in
2 strengths.
Amoxil Vials for Injection 500 mg contains
amoxicillin 500 mg.
Amoxil Vials for Injection 1 g each contain
amoxicillin 1,000 mg.
• There are no other ingredients. However, for
information about sodium in Amoxil, please
see section 2 Important information about one
of the ingredients of Amoxil.
• The doctor, nurse or pharmacist will make up
the injection before use using an appropriate
fluid (such as Water for Injections or an
injection/infusion fluid).

What Amoxil looks like and contents of the
pack

Please be ready to give the following
information:
Product name
Amoxil Vials for Injection
500 mg
Amoxil Vials for Injection 1 g
Reference number 00038/0222
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: January 2010
Amoxil is a registered trademark of the
GlaxoSmithKline group of companies
© 2010 GlaxoSmithKline group of companies

Amoxil is supplied as a clear glass vial of sterile
powder for making up as an injection. The vial
has a rubber bung and an aluminium foil
overseal. The vials are packed in cartons of 10.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK,
Stockley Park West,
Uxbridge,
Middlesex UB11 1BT
Manufacturer:
SmithKline Beecham,
Worthing,
West Sussex BN14 8QH

1000000
0092005

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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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