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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ampicillin Capsules 500mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ampicillin Trihydrate BP equivalent to 500mg Ampicillin (Anhydrous)

3. PHARMACEUTICAL FORM

Capsules

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Ampicillin is a broad-spectrum antibacterial indicated for treatment of commonly occurring bacterial infections where a sensitive organism is suspected or proven.

Lower respiratory tract - Acute and chronic bronchitis, lobar and

bronchopneumonia

Upper respiratory tract - Bacterial Pharyngitis, otitis media, chronic bronchial

sepsis

Genito-urinary tract - Acute cystitis, pyelonephritis for sensitive infections,

gonorrhoea (in combination with probenecid)

Other    - Skin and soft tissue infections, dental abscess (as an

adjunct to surgical management), enteric fever.

Ampicillin is inactivated by penicillinases including those produced by staph. aureus and gram-negative bacteria such as E. Coli.

Posology and method of administration

Ampicillin capsules are administered orally, half to one hour before food.

Children Under 10 years

If severe (GFR, 10ml/min), a reduced dose is necessary (rashes more common).

4.3 Contraindications

Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

4.4 Special warnings and precautions for use

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.

Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Dosage should be adjusted in patients with renal impairment (see section 4.2).

4.5 Interactions with other medicinal products and other forms of interaction

Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.

In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.

Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.

It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

4.6 Pregnancy and lactation

Animal studies with ampicillin have shown no teratogenic effects. Ampicillin has been in extensive clinical use and suitability in human pregnancy has been well documented in clinical studies.

Breast feeding is not contraindicated with ampicillin. Trace quantities of ampicillin can be detected in breast milk. While adverse effects are apparently rare in theory, the following potential problems could exist for the nursing infant:

-    Modification of bowel flora

-    Direct effects on the infant such as allergy/sensitization

-    Interference with interpretation of culture results when a pyrexia of unknown origin

occurs.

4.7 Effects on ability to drive and use machines

None known

Undesirable effects

Hypersensitivity reactions:

If any hypersensitivity reaction occurs, the treatment should be discontinued.

Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

As with other antibiotics, anaphylaxis (see Item 4.4 - Warnings) has been reported rarely.

Renal effects:

Interstitial nephritis can occur rarely.

Gastrointestinal reactions:

Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely.

Hepatic effects:

As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.

Haematological effects:

As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely.

4.9 Overdose

Large overdosage will produce very high urinary concentrations, particularly after parenteral administration. Problems 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. Ampicillin is removed by haemodialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Ampicillin is bactericidal and acts by inhibiting cell wall synthesis, probably by acylation of membrane - bound transpeptidase enzymes. This prevents cross linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited and lysis and elongation of susceptible bacteria frequently occur. Rapidly dividing bacteria are most susceptible to the action of penicillins.

5.2. Pharmacokinetic properties

Oral absorption of ampicillin (35-50%) is impaired by presence of food in the stomach, When ampicillin is administered IM a much higher peak level is reached within 30 minutes than by the oral route. Ampicillin is evenly distributed throughout most body tissues and with the exception of the kidney and liver, tissue concentrations are lower than simultaneous plasma levels in healthy individuals. Ampicillin exhibits low plasma protein binding (1718%). Twelve to fifty per cent of an ampicillin dose undergoes hepatic biotransformation. About 20-60% of an oral dose and 50-85% of an IM dose of ampicillin is excreted unchanged in the urine. A small amount of ampicillin is excreted in the bile.

5.3. Preclinical safety data

There is no additional data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS 6.1. List of excipients

Talc    BP

Magnesium Stearate    BP

Sodium Starch Glycollate    BP

Colloidal Silicon Dioxide    BP

Capsule Shell Gelatin

Black Iron Oxide E172 Titanium Dioxide E171    BP

Body

Gelatin

Red Iron Oxide E172

Erthrosine E127    BP

Titanium Dioxide E171    BP

6.2. Incompatibilities

None known

6.3. Shelf life

36 months

6.4. Special precautions for storage

Store in a dry place at a temperature not exceeding 25°C.

6.5. Nature and contents of container

Pack types

Polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) and/or amber glass bottles with wadded caps and/or PVC aluminium foil blister and/or high density polyethylene containers (HDPE) with polyethylene snap closures.

Pack sizes

5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 250 and 500.

6.6. Instructions for use, handling and disposal

No special instructions.

7. MARKETING AUTHORISATION HOLDER

Generics [UK] Limited Station Close Potters Bar Herts EN6 1TL

MARKETING AUTHORISATION NUMBER

PL 04569/0079

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/10/2009

10    DATE OF REVISION OF THE TEXT

13/10/2009