Pharmacological properties

Pharmacotherapeutic group: penicillins with extended spectrum. ATCvet code: QJ01CA04.

Pharmacodynamic properties

Amoxicillin is a semi-synthetic penicillin derived from the 6 APA core (6 amino-penicillic acid). It is a broad-spectrum antibiotic, bactericidal against gram + and gram - bacteria, in particular Actinobacillus pleuropneumoniae, isolated in pigs.

Amoxicillin acts by inhibition of bacterial cell wall synthesis or activation of enzymes disrupting cell walls (bactericidal action).

Pharmacokinetic properties

In pigs, after the administration of Stabox 50% Oral Soluble Powder Pig at a dose of 20 mg/kg in liquid feed, amoxicillin maximal plasma concentration of 2.0 μg/ml is reached 1.8 hours after the administration. The repeated administration of the drug does not lead to accumulation. The average absolute bioavailability of amoxicillin in liquid feed is estimated to be 12%.

Clinical particulars

Target species

Pig (pigs after weaning).

Indications for use

Treatment of swine pleuropneumonia due to Actinobacillus pleuropneumoniae (susceptible to amoxicillin).

Contra-indications

Do not use in animals with known hypersensitivity to penicillins or other substances of the ß-lactam group.

Do not use in animals with serious kidney malfunction including anuria and oliguria.

Presence of β-lactamase producing bacteria.

Do not use in lagomorphs and rodents such as rabbits, guinea pigs, hamsters or gerbils.

Do not use in ruminants or horses.

Undesirable effects (frequency and seriousness)

Penicillins and cephalosporins may cause hypersensitivity following administration. Allergic reactions to these substances may occasionally be serious.

Special precautions for use

The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed/water, animals should be treated parenterally.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Use during pregnancy and lactation

Studies performed in laboratory animals (rat, rabbit), did not show a teratogenic, embryotoxic or maternotoxic effect of amoxicillin. Safety of the product in the pregnant and lactating sows was not demonstrated. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Interaction with other veterinary medicinal products and other forms of interaction

The bactericidal effect of amoxicillin is neutralized by simultaneous use of pharmaceuticals with bacteriostatic mode of action.

Not to be used simultaneously with neomycin since it blocks the absorption of oral penicillins.

Posology and method of administration

20 mg of amoxicillin (as trihydrate) per kg body weight daily (i.e. 400 mg of the product per 10 kg body weight per day) administered for 5 consecutive days orally in liquid feed.

Shake the product container well before use.

After dilution of the product in a small quantity of water, the dilution must be mixed in the liquid meal until homogenous.

Whenever possible, the required amount of product should be accurately weighed by the user.

The correct dose of the product can also be measured using the 8 g measuring spoon with pack sizes of 500g and 3000 g according to the following recommendations.

-The level 8 g measuring spoon holds 8 g of product, i.e. the amount of product to treat 200 kg of bodyweight per day.

Use in commercial feed only.

Overdose

No side effects were observed after administration at 5 times the recommended dosage.

Special warnings for each target species

None.

Withdrawal period

Meat and offal: 14 days.

Special precautions to be taken by the person administering the veterinary medicinal product 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.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure, taking all recommended precautions. 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.

Use inhalation protection and gloves during preparation.

Use gloves during the administration of the liquid feed to the pigs.

Wash the exposed skin.

Avoid introduction of contamination during the administration of the product.

Pharmaceutical particulars

Major incompatibilities

None known.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the container: 10 days.

Shelf life after dissolution in liquid feed: 2 hours.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

500g high-density polyethylene jars hermetically closed by thermosealed aluminium polyethylene seal and over screw cap, with a spoon.

3000 g high-density polyethylene barrels closed hermetically by screw caps equipped with an internal rubber seal and an external security compact seal with a spoon.

Special precautions for the disposal of unused medicinal product or waste materials, if any

Any unused product or waste material should be disposed of in accordance with national requirements.