AMOXIL CAPSULES 250MG

Active substance: AMOXYCILLIN TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PRODUCT SUMMARY
1.

NAME OF THE MEDICINAL PRODUCT

Amoxil® Capsules 250 mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxil Capsules 250 mg contain 250 mg amoxycillin per capsule
The amoxycillin is present as the trihydrate.

3

PHARMACEUTICAL FORM
Amoxil Capsules: maroon and gold capsules overprinted ‘GS LEX’.

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
Dental abscess (as an adjunct to surgical management)
Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
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.

4.2

Posology and Method of Administration
Treatment of Infection:
Adult dosage (including elderly patients):
Standard adult dosage: 250 mg three times daily, increasing to 500 mg three
times daily for more severe infections.
High dosage therapy (maximum recommended oral dosage 6 g daily in
divided doses): A dosage of 3 g twice daily is recommended in appropriate
cases for the treatment of severe or recurrent purulent infection of the
respiratory tract.
Short course therapy: Simple acute urinary tract infection: two 3 g doses with
10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours
between the doses. Gonorrhoea: single 3 g dose.
Dosage in impaired renal function:
The dose should be reduced in patients with severe renal function impairment.
In patients with a creatinine clearance of less than 30 ml/min an increase in the
dosage interval and a reduction in the total daily dose is recommended (see
section 4.4 and 5.2): Glomerular filtration rate>30ml/min No adjustment
necessary.
Glomerular filtration rate 10-30ml/min: Amoxicillin. max.500mg b.d
Glomerular filtration rate<10ml/min: Amoxicillin. Max. 500mg/day
Helicobacter eradication in peptic (duodenal and gastric) ulcer disease:
Amoxil is recommended at a dose of twice daily in association with a proton
pump inhibitor and antimicrobial agents as detailed below:
Omeprazole 40 mg daily, Amoxicillin 1G BID, Clarithromycin 500mg
BID x 7days
or
Omeprazole 40mg daily, Amoxicillin750mg-1G BID, Metronidazole 400mg
TID x 7 days
Children weighing < 40 kg
The daily dosage for children is 40 - 90 mg/kg/day in two to three divided
doses* (not exceeding 3 g/day) depending on the indication, severity of the
disease and the susceptibility of the pathogen (see special dosage
recommendations below and sections 4.4, 5.1 and 5.2).

* PK/PD data indicate that dosing three times daily is associated with
enhanced efficacy, thus twice daily dosing is only recommended when the
dose is in the upper range.
Children weighing more than 40 kg should be given the usual adult dosage.
Renal impairment in children under 40 kg:
Creatinine
clearance
ml/min
> 30

Dose

Interval between
administration

Usual dose

No adjustment necessary

10 – 30

Usual dose

< 10

Usual dose

12 h
(corresponding to 2/3 of the
dose)
24 h
(corresponding to 1/3 of the
dose)

Amoxil Paediatric Suspension is recommended for children under six months
of age.
Special dosage recommendation
Tonsillitis: 50 mg/kg/day in two divided doses.
Acute otitis media: In areas with high prevalence of pneumococci with reduced
susceptibility to penicillins, dosage regimens should be guided by national/local
recommendations. In severe or recurrent acute otitis media, especially where
compliance may be a problem, 750 mg twice a day for two days may be used as
an alternative course of treatment in children aged 3 to 10 years.

Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three
divided doses, over 14-21days.

Prophylaxis of endocarditis: see table on next page.
Administration:

Oral:

Treatment should be continued for 2 to 3 days following the disappearance of
symptoms. It is recommended that at least 10 days treatment be given for any
infection caused by beta-haemolytic streptococci in order to achieve
eradication of the organism.

Prophylaxis of endocarditis:
CONDITION

ADULTS’ DOSAGE
(INCLUDING ELDERLY)

CHILDREN'S
DOSAGE ( < 40 kg)

NOTES

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

50 mg amoxicillin/kg
body weight given as
a single dose one
hour preceding the
surgical procedure

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

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.

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.

50 mg amoxicillin/kg
body weight given as
a single dose one
hour preceding the
surgical procedure

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.

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.

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’
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.

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.

Patient having general
anaesthetic: if oral
antibiotics not
appropriate.

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.

Patients with prosthetic
heart valves.

4.3.

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 Notes 2, 3 and 4
above.

50 mg amoxicillin/kg
body weight given as
a single dose one
hour preceding the
surgical procedure

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

50 mg amoxicillin/kg
body weight given as
a single dose one
hour preceding the
surgical procedure

See Notes 2, 3, 4 and 5
above.

Contra-Indications
Amoxil is a penicillin and should not be given to penicillin-hypersensitive
patients. Attention should be paid to possible cross-sensitivity with other betalactam antibiotics eg. 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, cephalosporins.
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 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)..
In patients with renal impairment, the rate of excretion of amoxicillin will be
reduced depending on the degree of impairment and it may be necessary to
reduce the total daily unit amoxicillin dosage accordingly (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).
Precaution should be taken in premature children and during the neonatal
period: renal, hepatic and haematological functions should be monitored.

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 pencillins.
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).
Black hairy tongue

oral

Superficial tooth discolouration has been reported in children. Good
hygiene may help to prevent tooth discolouration as it can usually be
removed by brushing.

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:
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.
The wide range of organisms sensitive to the bactericidal action of Amoxil include:
Aerobes:
Gram-positive
Streptococcus faecalis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus viridans
Staphylococcus aureus
(penicillin-sensitive strains only)
Corynebacterium species
Bacillus anthracis
Listeria monocytogenes

Gram-negative
Haemophilus influenzae
Escherichia coli
Proteus mirabilis
Salmonella species
Shigella species
Bordetella pertussis
Brucella species
Neisseria gonorrhoeae
Neisseria meningitidis
Vibrio cholerae
Pasteurella septica

Anaerobes: Clostridium species

5.2

Pharmacokinetic Properties
Amoxil is well absorbed by the oral and parenteral routes. Oral administration,
usually at convenient t.d.s. dosage, produces high serum levels independent of

the time at which food is taken. Amoxil gives good penetration into bronchial
secretions and high urinary concentrations of unchanged antibiotic.
In preterm infants with gestational age 26-33 weeks, the total body clearance
after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2
ml/min, very similar to the inuline clearance (GFR) in this population.
Following oral administration, the absorption pattern and the bioavailability of
amoxicillin in small children may be different to that of adults. Consequently,
due to the decreased CL, the exposure is expected to be elevated in this group
of patients, although this increase in exposure may in part be diminished by
decreased bioavailability when given orally.
5.3.

Pre-clinical Safety Data
Not applicable.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Amoxil Capsules 250 Mg
Each capsule contains magnesium stearate (E572) and erythrosine (E127),
indigo carmine (E132), titanium dioxide (E171), yellow iron oxide (E172) and
gelatin.

6.2.

Incompatibilities
None known.

6.3

Shelf-life
Capsules

6.4

3 Years

Special Precautions for Storage
Amoxil Capsules should be stored below 25°C.

6.5.

Nature and Content of Container
Amoxil Capsules: 250 mg Original Pack of 21 with Patient Information
Leaflet; also container of 500. Also packs of 3, 6, 12, 50, 100 and 50,000.

6.6.

Instructions for Use, Handling and Disposal
Not applicable.

7.

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

8.

MARKETING AUTHORISATION NUMBER(S)
Amoxil Capsules 250 mg – PL: 0038/0103

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 April 1972 / 13 January 1998

10

DATE OF REVISION OF THE TEXT

17/11/2010

Expand view ⇕

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.

Severe allergies and anaphylaxis: Learn how epinephrine can save a life. Watch Video

Close
Hide
(web5)