Amoxibactin 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:

Active substance:

Amoxicillin 50 mg (corresponding to 57,50 mg of amoxicillin trihydrate)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

White to off-white round convex flavored tablet with brown spots and a cross-shaped break line on one side.

The tablets can be divided into halves and quarters of equal size.

4. CLINICAL DATA

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

For the treatment of primary and secondary infections of the respiratory tract, such as rhinitis caused by

pasteurella spp. and Streptococcus spp. and bronchopneumonia caused by pasteurella spp., Escherichia coli and Gram positive cocci.

For the treatment of primary infections of the urogenital tract, such as pyelonephritis and lower urinary tract infections caused by Escherichia coli, Proteus spp. and Gram positive cocci, endometritis caused by Escherichia coli, Streptococcus canis y Proteus spp. and vaginitis resulting from mixed infections.

For the treatment of mastitis caused by Gram positive cocci and Escherichia coli.

For the treatment of local skin infections caused by Streptococcus spp.

4.3 Contraindications

Do not use in case of hypersensitivity to penicillins or other substances from the ß-lactam group or to any excipient.

Do not administer to gerbils, guinea pigs, hamsters, rabbits or chinchillas.

Do not use in animals with severe renal dysfunction accompanied by anuria or oliguria.

4.4 Special warnings for each target species

None

4.8 Interaction with other medicinal products and other forms of interaction

Chloramphenicol, macrolides, sulfonamides, and tetracyclines can inhibit the antibacterial effect of penicillins due to the rapid onset of bacteriostatic action. The possibility of allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

4.9 Amounts to be administered and administration route

For oral administration in dogs and cats.

In order to ensure correct dosing, body weight should be determined as accurately as possible to avoid underdosing.

Dosage

The recommended dose is 10 mg amoxicillin per kg of body weight, twice daily for a minimum of 5 consecutive days. Most ordinary cases respond within 5 to 7 days of therapy. If no improvement is seen within 5 – 7 days, the diagnosis should be re-evaluated. In chronic or treatment-resistant cases, a longer course of therapy may be necessary.

4.10 Overdose (symptoms, emergency procedures, antidotes)

In case of overdose, there are no known adverse reactions other than those described in section 4.6.

4.11 Timeout

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Antibacterials for systemic use. Extended spectrum penicillins.

ATCvet code:

QJ01CA04

5.1 Pharmacodynamic properties

General properties

Amoxicillin is a beta-lactam antibiotic whose structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Beta-lactam antibiotics prevent bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyze the cross-linking of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action, but only cause the lysis of cells in the growth phase. Beta-lactam antibiotics can be considered time-dependent antibiotics.

antimicrobial spectrum

Amoxicillin is a broad-spectrum antibiotic that is generally active against some Gram negative and most Gram positive bacteria (Germ vet 2007) such as e.g. eg,

pasteurella spp., Proteuss spp, Streptococcus spp., E. coli, and Gram positive cocci sensitive to penicillin.

5.2 Pharmacokinetic data

Amoxicillin is well absorbed after oral administration. In dogs, systemic bioavailability is 60-70%. Amoxicillin has a relatively small apparent volume of distribution, low plasma protein binding (34% in dogs), and a short elimination half-life due to active tubular excretion by the kidneys.

After absorption, the highest concentrations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart, and spleen.

The distribution of amoxicillin into the cerebrospinal fluid is low unless the meninges are inflamed.

6. PHARMACEUTICAL DATA

6.1 List of excipients

Magnesium stearate

Microcrystalline cellulose

colloidal anhydrous silica

sodium starch glycolate

Lactose monohydrate

Dry yeast)

chicken flavor

6.2 Incompatibilities

Not applicable.

6.3 Validity period

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

6.4. Special storage precautions

Do not store at temperatures above 30?C.

DATA SHEET 

AMOXIBACTIN