NOAH Compendium

Printed from NOAH Compendium ( (c) Copyright NOAH Compendium 2024. All Rights Reserved.
Date: Wednesday, May 29, 2024 18:39

Description: Dechra
Release 4.246
Amoxibactin® Tablets
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Amoxicillin
Product:Amoxibactin® Tablets
Product index: Amoxibactin Tablets
Qualitative and quantitative composition
Amoxibactin 50 mg tablets for dogs and cats:
1 tablet contains: Active substance:
Amoxicillin 50 mg (equivalent to 57.50 mg amoxicillin trihydrate)
Amoxibactin 250 mg tablets for dogs:
1 tablet contains: Active substance:
Amoxicillin 250 mg (equivalent to 287.50 mg amoxicillin trihydrate)
Amoxibactin 500 mg tablets for dogs:
1 tablet contains: Active substance:
Amoxicillin 500 mg (equivalent to 575 mg amoxicillin trihydrate)
Pharmaceutical form
Tablet. White to off-white with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side.
Tablets can be divided into halves and quarters.
Clinical particulars
Target species
Amoxibactin 50 mg - Dogs and cats
Amoxibactin 250 mg and 500 mg - Dogs
Indications for use
Treatment of primary and secondary infections of the airways, such as rhinitis caused by Pasteurella spp. and Streptococcus spp., and bronchopneumonia caused by Pasteurella spp., Escherichia coli and Gram-positive cocci.
Treatment of primary infections of the urogenital tract, such as pyelonephritis and infections of the lower urinary tract caused by Escherichia coli, Proteus spp. and Gram-positive cocci, endometritis caused by Escherichia coli, Streptococcus canis and Proteus spp., and vaginitis as a result of mixed infections.
Treatment of mastitis caused by Gram-positive cocci and Escherichia coli.
Treatment of local skin infections caused by Streptococcus spp.
Do not use in known cases of hypersensitivity to penicillins or other substances of the β-lactam group of to any of the excipients.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.
Do not use in animals with serious renal dysfunction accompanied by anuria or oliguria.
Special precautions for use in animals
In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.
Caution is advised in the use in small herbivores other than those which have been contraindicated in Contraindications. Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for amoxicillin, bacteriological sampling and susceptibility testing are recommended. Increased antimicrobial resistance are reported among E. Coli isolates including multidrug-resistant E. Coli. Special precautions should be taken when multi-drug resistance are suspected based on susceptibility testing. Whenever possible, the product should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to amoxicillin and may decrease the effectiveness of treatment with other β-lactam antimicrobials or other classes of antimicrobials due to the potential for cross resistance.
Official, national and regional anitmicrobial policies should be taken into account when product is used.
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.
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 skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
Wash hands after handling the tablets.
Adverse reactions
Mild gastrointestinal symptoms (diarrhoea and vomiting) may occur very rarely (less than 1 animal in 10,000 animals treated, including isolated reports) after administration of the product. Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occur very rarely. In these cases, administration should be discontinued and a symptomatic treatment given.
Use during pregnancy and lactation
The safety of the product has not been established during pregnancy and lactation. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use only in accordance with the benefit/risk assessment by the responsible veterinarian.
Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. The potential for allergic cross-reactivity with other penicillins should be considered. Penicillins may increase the effect of aminoglycosides.
Amounts to be administered and administration route
For oral administration in dogs and cats.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
The recommended dose is 10 mg amoxicillin per kg body weight, twice daily for a minimum of 5 consecutive days. The majority of routine cases respond after between 5 and 7 days of therapy. If no improvement is observed after 5 to 7 days, the diagnosis should be re-assessed. In chronic or refractory cases, a longer course of therapy may be required.
The following tables are intended as a guide to dispensing the product at the standard dose rate of 10 mg per kg body weight twice daily.
Amoxicillin 50 mg tablets for dogs and cats
Body weight (kg)
Number of tablets twice daily
1 to 1.25
> 1.25 to 2.5
> 2.5 to 3.75
> 3.75 to 5
> 5 to 6.25
Amoxicillin 250 mg tablets for dogs
Body weight (kg)
Number of tablets twice daily
> 5 to 6.25
> 6.25 to 12.5
> 12.5 to 18.75
> 18.75 to 25
> 25 to 31.25
> 31.25 to 37.5
> 37.5 to 50
Amoxicillin 500 mg tablets for dogs
Body weight (kg)
Number of tablets twice daily
> 6.25 to 12.5
> 18.75 to 25
> 31.25 to 37.5
> 37.5 to 50
> 50 to 62.5
> 62.5 to 75
Tablets can be divided into halves or quarters to ensure accurate dosing.
Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.
Halves: press down with your thumbs on both sides of the tablet.
Quarters: press down with your thumb in the middle of the tablet.
In case of overdose no other adverse reactions are known than those described in Adverse reactions.
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use. Penicillins with extended spectrum.
ATCvet code: QJ01CA04
Pharmacodynamic properties
General properties
Amoxicillin is a β-lactam antibiotic and its structure contains the β-lactam ring and thiazolidine ring common to all penicillins. β-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only. β-lactam antibiotics can be referred to as a time-dependent antibiotic.
Antimicrobial spectrum
Amoxicillin is a broad spectrum antibiotic and generally active against some Gram-negative and most Gram-positive bacteria (Germ-vet 2007) e.g. penicillin sensitive Pasteurella spp., Proteus spp., Streptococcus spp., E. coli, and Gram-positive cocci.
Amoxicillin is acid-resistant but is not resistant to the action of β-lactamases, which can hydrolyse the molecules causing the β-lactam ring structure to open, causing inactivity of the antibiotic.
Most Gram-negative bacteria are intrinsically resistant to many β-lactam drugs. This is partly due to the mechanism of action of the drug and the structure of the membrane of the bacteria.
Acquired resistance to β-lactam drugs in clinical isolates may be due to β-lactamase activity specified by plasmids or to mutational changes in chromosomal loci. In some strains a single step mutation may be responsible for resistance, whereas in others resistance may be due to several mutations.
Acquired resistance prevalence may be high in E coli.
Pharmacokinetic properties
Amoxicillin is well absorbed after oral administration. In dogs, the systemic bioavailability is 60-70%. Amoxicillin has a relatively small apparent distribution volume, low plasma-protein binding (34% in dogs) and a short elimination half-life period due to active tubular excretion by the kidneys.
After absorption, highest concentrations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart and spleen.
Distribution of amoxicillin into cerebrospinal fluid is low unless the meninges are inflamed.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Do not store above 30°C.
Any unused tablet portion should be returned to the open blister and used within 4 days.
Immediate packaging
Aluminium - PVC/PE/PVDC blister
Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets.
Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 tablets.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Le Vet. Beheer B.V., Wilgenweg 7, 3421 TV Oudewater, The Netherlands.
Marketing Authorisation Number
Vm 41821/4014: 50 mg
Vm 41821/4015: 250 mg
Vm 41821/4016: 500 mg
Significant changes
Date of the first authorisation or date of renewal
17 December 2014
Date of revision of the text
Amoxibactin 50 mg tablets for dogs and cats: July 2020
Amoxibactin 250 mg tablets for dogs: July 2020
Amoxibactin 500 mg tablets for dogs: June 2020
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN description:Amoxibactin 50 mg Tablets for Dogs and Cats:
GTIN description:Amoxibactin 250 mg Tablets for Dogs:
GTIN description:Amoxibactin 500 mg Tablets for Dogs: