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AMOXICILLIN 500 MG CAPSULES

Active substance: AMOXICILLIN TRIHYDRATE

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1.

NAME OF THE MEDICINAL PRODUCT
Amoxicillin Capsules 5 00mg BP.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Trihydrate equivalent to Amoxicillin 5 00mg.

3.

Pharmaceutical Form
Maroon /yellow size 2 hard gelatin capsule containing a white to off-white powder. The
capsules are printed with ‘’AX 250’’.

Clinical Particulars
4.1.

Therapeutic Indications

Amoxicillin is indicated in the treatment of otitis media, chronic bronchitis, gonorrhoea and typhoid
fever.
It may also be used to treat susceptible organisms in upper respiratory tract infections, lobar and
bronchopneumonia, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gynaecological
infections including puerperal sepsis and septic abortion, peritonitis, intra-abdominal sepsis,
septicaemia, bacterial endocarditis, skin and soft tissue infections and osteomyelitis.

4.2.

Posology and Method of Administration
Route of administration: Oral
Adults (including the elderly patients):
Standard adult dosage
250mg three times daily, increasing to 500mg three times daily for more severe infections.
High dose therapy
3g twice daily is recommended in appropriate cases for the treatment of severe or recurrent
purulent infection of the respiratory tract (max daily dose 6g).
Short course therapy
Simple acute UTI, two 3g doses with 10-12 hours between the doses.
Gonorrhoea: single 3g dose.
Children up to 10 years of age:
125mg three times daily, increasing to 250mg three times daily for more severe infections.
For these patients, it is more appropriate to use the paediatric presentation, Amoxicillin
Mixture BP.
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.

4.3.

Contra-indications
Hypersensitivity to penicillins.

4.4.

Special Warnings and Precautions for Use
In renal impairment it may be necessary to reduce the total daily dosage.

4.5.

Interactions with other Medicaments and other forms of Interaction
The incidence of skin rashes with Amoxicillin is increased by concomitant Allopurinol. The
excretion of methotrexate can be markedly reduced by concurrent use of penicillins. There is
a considerable risk of methotrexate toxicity. Very infrequently and unpredictably
concurrent use with oral contraceptives may result in contraceptive failure. Probenecid
delays the excretion of Amoxicillin and dietary fibre can reduce the absorption of
Amoxicillin.

4.6.

Pregnancy and Lactation
When antibiotic therapy is required during pregnancy, Amoxicillin may be considered
appropriate. During lactation, trace quantities of Amoxicillin can be detected in breast milk.

4.7.

Effects on Ability to Drive and Use Machines
None.

4.8.

Undesirable Effects
Mild and transitory side effects include diarrhoea, indigestion, occasionally a rash (urticarial
or erythematous). An urticarial rash suggests penicillin hypersensitivity. Erythematous rash
may arise if Amoxicillin is administered to patients with glandular fever. In either case
treatment should be discontinued.

4.9.

Overdose
Overdosage is unlikely but gross overdosage will result in very high urinary concentrations.
Problems occurring as a result of this are unlikely if adequate fluid intake and urinary output
are maintained, however, crystalluria is a possibility. More specific measures may be
necessary in patients with impaired renal function. The antibiotic is removed by
haemodialysis.

Pharmacological Properties

5.1.

Pharmacodynamic Properties

Amoxicillin is a penicillinase-susceptible semisynthetic penicillin. The drug is bactericidal and is
effective against the same range of organisms as ampicillin and has a similar mode of action. It has
been reported that Amoxicillin predominantly inhibits side-wall synthesis in susceptible bacteria.
Amoxicillin has been reported to be slightly more active than ampicillin against some streptococci
and salmonella SPP but less active against shigella SPP.
Amoxicillin is more rapidly and completely absorbed from the GI tract than ampicillin and peak
plasma levels are 2-21/2 times greater for Amoxicillin after oral administration of the same dose.
Food does not interfere with absorption. MIC’s ranging from 0.01 to 5 g/ml have been reported.

5.2.

Pharmacokinetic Properties
The bioavailability of Amoxicillin capsules 250mg and 500mg was compared against that of
Amoxil capsules 250mg and 500mg (manufactured by SmithKline Beecham). The results
showed that the Amoxicillin capsules 250mg and 500mg were bioequivalent to Amoxil
250mg and 500mg respectively.
Oral bioavailability of Amoxicillin: =93+/-10%
Urinary excretion of Amoxicillin: =52 +/-15%
Plasma binding: 18%
Half-life: 1 hour (increased in uraemia)

5.3.

Preclinical Safety Data
None.

6.1.

List of Excipients
Magnesium stearate.
Capsule shell: gelatin, sodium lauryl sulphate, purified water.
Capsule colours: brilliant blue (E133), titanium dioxide (E171), tartrazine (E102), sunset
yellow (E110), carmoisine (E122).
Printing ink: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol,
purified water, strong ammonia, potassium hydroxide, black iron oxide (E172)

6.2.

Incompatibilities
As for penicillins, Amoxicillin should not be mixed with blood products, other
proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.

6.3.

Shelf life
36 months.

6.4.

Special precautions for storage
Store in a dry place below 25°C.

6.5.

Nature and contents of container
Securitainers with white bodies and blue lids. Available in packs of 100,250,500 and 1000.
Blister pack. Available in packs of 21.

6.6.

Instruction for use and handling
None.

7.

MARKETING AUTHORISATION HOLDER
Waymade plc
Trading as Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex SS14 3FR
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 06464/1419

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
4 February 2002

10

DATE OF REVISION OF THE TEXT
23/06/2006

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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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