AMOXIL VIALS FOR INJECTION 250MG

Active substance: AMOXICILLIN SODIUM

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Amoxil® Vials For Injection 250 mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxil Vials for Injection 250 mg contain 250 mg amoxycillin
The amoxycillin is present as the sodium salt in Amoxil injections (each 1 g
vial contains approximately 3.3 mmol of sodium).

3.

PHARMACEUTICAL FORM
‘Amoxil’ Vials: vials containing sterile powder for reconstitution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the
treatment of commonly occurring bacterial infections such as:
Upper respiratory tract infections
Otitis media
Acute and chronic bronchitis
Chronic bronchial sepsis
Lobar and bronchopneumonia
Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy
Gynaecological infections including puerperal sepsis and septic abortion
Gonorrhoea
Peritonitis
Intra-abdominal sepsis
Septicaemia
Bacterial endocarditis
Typhoid and paratyphoid fever
Skin and soft tissue infections
In children with urinary tract infection the need for investigation should be
considered.
Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia,
associated with procedures such as dental extraction, in patients at risk of developing
bacterial endocarditis.
Consideration should be given to official local guidance (e.g. national requirements)
on the appropriate use of antibacterial agents. Susceptibility of the causative organism
to the treatment should be tested (if possible), although the therapy may be initiated
before the results are available.
The wide range of organisms sensitive to the bactericidal action of Amoxil include:
Gram-positive

Gram-negative

Streptococcus faecalis

Haemophilus influenzae

Streptococcus pneumoniae

Escherichia coli

Streptococcus pyogenes

Proteus mirabilis

Streptococcus viridans

Salmonella species

Staphylococcus aureus

Shigella species

(penicillin-sensitive)

Bordetella pertussis

Clostridium species

Brucella species

Corynebacterium species

Neisseria gonorrhoeae

Bacillus anthracis

Neisseria meningitidis

Listeria monocytogenes

Vibrio cholerae
Pasteurella septica

4.2

Posology and method of administration
Treatment of infection:

Adult dosage (including elderly patients):
Injectable:
500 mg IM eight hourly (or more frequently if necessary) in moderate
infections. (This dose may be given by slow IV injection if more
convenient.)
1 g IV six hourly in severe infections.
Children's dosage (up to 10 years of age):
Injectable:
50-100 mg/kg body weight a day, in divided doses.
Parenteral therapy is indicated if the oral route is considered impracticable
or unsuitable, and particularly for the urgent treatment of severe infection.
In renal impairment the excretion of the antibiotic will be delayed and,
depending on the degree of impairment, it may be necessary to reduce the
total daily dosage.
Prophylaxis of endocarditis:
CONDITION

ADULT'S DOSAGE
(INCLUDING
ELDERLY)

CHILDREN'S
DOSAGE

NOTES

Dental procedures:
prophylaxis for patients
undergoing extraction,
scaling or surgery involving
gingival tissues and who
have not received a
penicillin in the previous
month.
(N.B. Patients with
prosthetic heart valves
should be referred to
hospital - see below).

Patient not having
general anaesthetic.

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

3 g ‘Amoxil’ orally, 1
hour before procedure. A
second dose may be given
6 hours later, if
considered necessary.

Under 10: half adult
dose.
Under 5: quarter adult
dose.

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.

1 g ‘Amoxil’ IV or IM
immediately before
induction; with 500 mg
orally, 6 hours later.

Note 2.

Patient having general
anaesthetic: if oral
antibiotics not
appropriate.

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.

To minimise pain on
injection, ‘Amoxil’ may
be given as two
injections of 500 mg
dissolved in sterile 1%
lignocaine solution (see
Administration).
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.

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 genito-urinary surgery or instrumentation
under general anaesthesia.

In the case of Obstetric and Gynaecological Procedures
and Gastrointestinal Procedures – routine prophylaxis is
recommended only for patients with prosthetic heart
valves.
Surgery or
Instrumentation of the
Upper Respiratory Tract

Patients other than
those with prosthetic
heart valves.

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.

Under 10: the doses of
‘Amoxil’ should be half
the adult dose; the dose
of gentamicin should be
2 mg/kg.

Under 5: the doses of
‘Amoxil’ should be
quarter the adult dose;
the dose of gentamicin
should be 2 mg/kg.

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

See Note 2.
Note 3. ‘Amoxil’ and
gentamicin should not
be mixed in the same
syringe.
Note 4. Please consult
the appropriate data
sheet for full
prescribing information
on gentamicin.

See Notes 2, 3 and 4
above.

Followed by (6 hours
later): 500 mg ‘Amoxil’
orally or IV or IM
according to clinical
condition.
1 g ‘Amoxil’ IV or IM
immediately before
induction; 500 mg
‘Amoxil’ IV or IM 6
hours later.

Under 10: half adult
dose.

Under 5: quarter adult
dose.

See Note 2 above.
Note 5. The second
dose of ‘Amoxil’ may
be administered orally
as ‘Amoxil’ Syrup SF.

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.

Under 10: the dose of
‘Amoxil’ should be half
the adult dose; the
gentamicin dose should
be 2 mg/kg.

See Notes 2, 3, 4 and 5
above.

Under 5: the dose of
‘Amoxil’ should be
quarter the adult dose;
the dose of gentamicin
should be 2 mg/kg.

Administration:
Intravenous Injection, Intravenous Infusion, Intramuscular:
Using vials for injection (See Section 6.6)

4.3

Contraindications
Amoxil is a penicillin and should not be given to penicillin-hypersensitive
patients. Attention should be paid to possible cross-sensitivity with other
beta-lactam antibiotics, e.g. cephalosporins.

4.4

Special Warnings and Precautions for Use
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been
reported in patients on penicillin therapy. These reactions are more likely to occur in
individuals with a history of hypersensitivity to beta-lactam antibiotics (see Section
4.3).
Erythematous (morbilliform) rashes have been associated with glandular fever in
patients receiving amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible
organisms.
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).
Amoxicillin has been reported to precipitate in bladder catheters after intravenous
administration of large doses. A regular check of patency should be maintained.

Dosage should be adjusted in patients with renal impairment (see Section 4.2).
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 concomitantly.
Adjustments in the dose of oral anticoagulants may be necessary to maintain the
desired level of anticoagulation (see sections 4.5 and 4.8).
When prepared for intramuscular or direct intravenous injection, Amoxil should be
administered immediately after reconstitution. The stability of Amoxil in various
infusion fluids is given in the Package Enclosure Leaflet.

4.5

Interaction with other Medicinal Products and other Forms of Interaction
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with
Amoxil may result in increased and prolonged blood levels of amoxicillin.
In common with other antibiotics, amoxicillin may affect the gut flora, leading to
lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Concurrent administration of allopurinol during treatment with amoxicillin can
increase the likelihood of allergic skin reactions.
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 (see sections 4.4 and 4.8).
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.

4.6

Pregnancy and lactation
Use in pregnancy:
Animal studies with ‘Amoxil’ have shown no teratogenic effects. The
product has been in extensive clinical use since 1972 and its suitability in
human pregnancy has been well documented in clinical studies. When
antibiotic therapy is required during pregnancy, ‘Amoxil’ may be
considered appropriate when the potential benefits outweigh the potential
risks associated with treatment.

Use in lactation:
Amoxycillin may be given during lactation. With the exception of the risk
of sensitisation associated with the excretion of trace quantities of
amoxycillin in breast milk, there are no known detrimental effects for the
breast-fed infant.

4.7

Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been
observed.

4.8

Undesirable Effects
The following convention has been utilised for the classification of undesirable
effects:Very common ( >1/10), common ( >1/100, <1/10), uncommon ( >1/1000,<1/100),
rare ( >1/10,000, <1/1000), very rare (<1/10,000)
The majority of side effects listed below are not unique to amoxicillin and may occur
when using other penicillins.
Unless otherwise stated, the frequency of adverse events has been derived from more
than 30 years of post-marketing reports.

Infections and infestations
Very Rare:

Mucocutaneous candidiasis

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 (see section 4.4
– Special Warnings and Precautions for Use

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.

Gastrointestinal disorders
Clinical Trial Data
Common:

Diarrhoea and nausea.

Uncommon:

Vomiting.

Post-marketing Data
Very rare:

Antibiotic associated colitis (including pseudomembraneous colitis
and haemorrhagic colitis).

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
Clinical Trial Data
Common:

Skin rash

Uncommon:

Urticaria and pruritus

Post-marketing Data
Very rare:

Skin reactions such as erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis, bullous and exfoliative
dermatitis and acute generalised exanthematous pustulosis (AGEP)

(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.
4.9

Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and
should be treated symptomatically with attention to the water/electrolyte balance.
Amoxycillin crystalluria, in some cases leading to renal failure, has been observed
(see Section 4.4 Special warnings and special precautions for use).
Amoxycillin may be removed from the circulation by haemodialysis.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Amoxil is a broad spectrum antibiotic.
It is rapidly bactericidal and possesses the safety profile of a penicillin.

5.2

Pharmacokinetic properties
Amoxil is well absorbed by the oral and parenteral routes. Amoxil gives
good penetration into bronchial secretions and high urinary concentrations
of unchanged antibiotic.

5.3

Preclinical safety data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
None

6.2

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.

6.3

Shelf life
Injection Vials

6.4

18 months

Special precautions for storage
‘Amoxil’ Vials for Injection should be stored in a cool, dry place.
When prepared for intramuscular or direct intravenous injection, ‘Amoxil’
should be administered immediately after reconstitution. The stability of
‘Amoxil’ in various infusion fluids is dependent upon the concentration and
temperature: stability times are given in the Package Enclosure Leaflet.

6.5.

Nature and contents of container
Amoxil Vials for Injection: Clear Type I glass vials fitted with a chlorobutyl rubber
bung and an aluminium overseal. 250 mg: packs of 5 or 10. Each pack carries
instructions for use.

6.6

Instruction for use/handling
Intravenous Injection:
Dissolve 250 mg in 5.0 ml Water for Injections BP (Final volume=5.2 ml).
‘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:
250 mg: Add 1.5 ml Water for Injections BP † and shake vigorously (Final
volume = 1.7 ml).
† If pain is experienced on intramuscular injection, a sterile 1% solution of
lignocaine hydrochloride or 0.5% solution of procaine hydrochloride may
be used in place of Water for Injections.
A transient pink colouration or slight opalescence may appear during
reconstitution. Reconstituted solutions are normally a pale straw colour.

ADMINISTRATIVE DATA

7.

MARKETING AUTHORISATION HOLDER

Beecham Group plc
980 Great West Road
Brentford
Middlesex TW8 9GS
Trading as:
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

8.

MARKETING AUTHORISATION NUMBER(S)
Amoxil Vials for injection PL 00038/0221

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
Amoxil Vials for Injection 13th October 2003

10

DATE OF REVISION OF THE TEXT
04/01/2012

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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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