Ampicare 250 Mg Hard Capsules
Revised: April 2010
(ATCVet code amended)
Summary of Product Characteristics
1. Name of the veterinary medicinal product
Ampicare, 250mg, hard capsule
2. Qualitative and quantitative composition
Active Ingredient mg per capsule
(as ampicillin trihydrate)
Erythrosine (E127) 0.952
Quinoline Yellow (E104) 0.004
Patent Blue V (E131) 0.002
Titanium Dioxide (E171) 0.368
Ferric Oxide black (E172) 0.146
Titanium Dioxide (E171) 0.488
Black Iron Oxide (E172)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Red and grey coloured hard gelatine capsule with the logo, AMP 250, in black ink.
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
Indicated in the treatment and control of diseases caused by or associated with bacterial pathogens sensitive to ampicillin. These include the following groups of pathogens:
Streptococcusspp., Pasturella haemolitica, P. multocida, Staphylococcus aureus and other pathogenic staphylococci.
When susceptible organisms are present treatment may be effective in the following indications:
alimentary tract infections
urinary tract infections
Not to be administered to animals known to be sensitive to penicillin.
Not to be administered to small herbivores.
Do not treat dogs of less than 10 kg bodyweight.
4.4 Special warnings for each target species
As with all penicillins, the product may cause hypersensitivity (allergy) following ingestion. It should not be used when the dog is known to be allergic to penicillins.
As with all other penicillins, bacterial resistance to ampicillin may occur. Thus antibiotic sensitivity testing should be considered if a clinical condition fails to respond to treatment within 3 to 5 days.
Special precautions for use
i. Special precautions for use in animals
For oral administration only.
ii. Special precautions to be taken by the person administering the veterinary medicinalproduct to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
No studies have been carried out on pregnant animals, but the evidence provided suggests that ampicillin does not present any particular hazard either to the dam or foetus.
4.8 Interaction with other medicinal products and other forms of interaction
Ampicillin is unlikely to interact significantly with any other drugs commonly administered to dogs. It is not recommended to administer bactericidal and bacteriostatic antibiotics concomitantly.
4.9 Amounts to be administered and administration route
Recommended dose: 10 - 20 mg/kg twice daily.
The higher dose levels are advised when treating infections due to Gram-negative bacteria and in cases involving young animals. Therapy should be repeated every 12 hours and continued for a maximum of 5 days. In severe or acute conditions, the dose levels may be increased.
To be given by the oral route only. The capsules should be administered on an empty stomach.
4.10 Overdose(symptoms, emergency procedures, antidotes) if necessary
The safety of ampicillin is typical of that of other penicillins in that intrinsic toxicity is very low, except in animals with specific allergy to the beta-lactams.
4.11 Withdrawal period(s)
5. Pharmacological Properties
Pharmacotherapeutic group: Antibacterials for systemic use, beta-lactam antibacterials, penicillins, penicillins with extended spectrum
ACTVet code: QJ01CA01
The product contains ampicillin (as the trihydrate) 250 mg per capsule.
It is recommended for the treatment and control of diseases in dogs caused by or associated with bacterial pathogens sensitive to ampicillin.
Ampicillin is a broad spectrum antibiotic of the penicillin group, which is in turn a member of the beta-lactam group. It is well absorbed after oral administration but bioavailability is reduced by food in the stomach.
The mode of action of beta-lactams involves interference with cell wall synthesis and are therefore more effective when the cell wall is growing. At high dose levels the penicillins have additional bactericidal effects within the bacterial cell and may affect dormant bacteria.
Ampicillin is bactericidal against a wide range of Gram-positive and Gram-negative bacterial pathogens found in dogs including the following, provided that they are sensitive to ampicillin:
Streptococcus spp., Pasturella haemolytica, P. multocida, Staphylococcus aureus and other pathogenic staphylococci (non lactamase producing).
6. Pharmaceutical particulars
List of excipients
Quinoline Yellow (E104)
Patent Blue V (E131)
Titanium dioxide (E171)
Ferric Oxide Red (E172)
Titanium dioxide (E171)
Black Iron Oxide (E172)
Strong Ammonia Solution
Industrial Methylated Spirit
6.3 Shelf Life
Shelf life of the veterinary medicinal product as packaged for sale: 3 Years.
6.4 Special precautions for storage
Do not store above 25°C. Store in a dry place.
6.5 Nature and composition of immediate packaging
Polypropylene securitainer with low density polyethylene cap.
Pack sizes of 100, 250 and 500 capsules per container.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. Marketing Authorisation holder
Cross Vetpharm Group Ltd.,
Broomhill Road, Tallaght,
Dublin 24, Ireland
8. Marketing authorisation number
9. Date of the first authorisation/RENEWAL of the authorisation
24thMarch 2000/ 24thMarch 2005
10. Date of revision of the text
April 2010 (ATCVet code amended)
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