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NAME OF THE MEDICINAL PRODUCT

Amoxicillin Capsules 250mg BP

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Amoxicillin Trihydrate equivalent to Amoxicillin 250mg

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. Therap euti c Indi cati ons

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, petionitis, 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 elderly patients).

Standard adult dosage

250 mg three times daily, increasing to 500 mg three daily for more severe infections.

High dose therapy

3 g 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 3 g dose

Children (up to 10 years of age)

125 mg three times daily, increasing to 250 mg 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

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 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. Problem 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 penicllinase-susceptible semisynthetic penicillin. The drug is bactericidal and is effective against the same range of organisms as ampicillin and has a smiliar mode of action. It has been reported that Amoxicillin predominantly inhibits sidewall synthesis in susceptible bacteria while ampicillin mainly inhibits cross-wall synthesis. 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 2-2 1/2 times greater for Amoxicillin after oral administration of the some dose. Food does not interfere with absorption. MCI’s ranging from 0.01 to 5 ug/ml have been reported

5.2. Pharmacokinetic Properties

The bioavailability of Amoxicillin capsules 250 mg and 500 mg was compared against that of Amoxil capsules 250 mg and 500 mg (manufactured by Beechams) two groups of eight healthy volunteers aged between 18 - 36 years participated in the study. Capsules were taken on an empty stomach with 250-ml water on days 1 and 8. Venous blood samples collected at 0,51, 1.5, 2,3,4, 6 and 8 hours post dose were analysed by HPLC for levels of Amoxicillin. The results showed that the Amoxicillin capsules 250mg and 500 mg were bio-equivalent to Amoxil 250 mg and 500 mg respectively.

Oral bioavailability of Amoxicillin Urinary erection Amoxicillin Plasma binding Half life1 hr

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)

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.