Nisamox Tablets

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/­animalhealth

Presentation

Nisamox 50 mg Tablets are for oral administration to dogs and cats - they are round, pink, biconvex tablets with a score line and 50 embossed on opposing faces. Each Nisamox 50 mg tablet contains Amoxicillin 40 mg (as amoxicillin trihydrate) and 10 mg Clavulanic acid (as Potassium clavulanate).
Nisamox 250 mg Tablets are for oral administration to dogs - they are round, pink, biconvex tablets with a score line and 250 embossed on opposing faces. Each Nisamox 250 mg tablet contains Amoxicillin 200 mg (as amoxicillin trihydrate) and 50 mg Clavulanic acid (as Potassium clavulanate).
Nisamox 500 mg Palatable Tablets are for oral administration to dogs - they are round, pink, divisible tablets with a score line on one face and 500 embossed on opposing faces. Each Nisamox 500 mg tablet contains Amoxicillin 400 mg (as amoxicillin trihydrate) and 100 mg Clavulanic acid (as Potassium clavulanate).

Uses

The tablets are indicated in the treatment of the following infections caused by β-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:
· Skin infections (including superficial and deep pyodermas) caused by susceptible Staphylococci.
· Urinary tract infections caused by susceptible Staphylococci or Escherichia coli.
· Respiratory infections caused by susceptible Staphylococci.
· Enteritis caused by susceptible Escherichia coli.
It is recommended to carry out suitable tests for sensitivity testing when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

Dosage and administration

Administration is via the oral route. The dosage rate is 12.5 mg combined actives/kg body weight twice daily. The tablets may be crushed and added to a little food.
The following tables are intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives per kg twice daily.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group.
Do not use in rabbits, guinea pigs, hamsters, gerbils, horses or ruminating animals.
Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.
Do not use where resistance to this combination is known to occur.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach. Caution is advised in the use in small herbivores other than those mentioned above. Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination. The product is of a low order of toxicity and is well tolerated by the oral route. In dogs no adverse effects have been reported after the daily administration of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 8 days, and after the daily administration of the recommended dose for 21 days. In cats no adverse effects have been reported after the twice daily administration of 3 times the recommended dose of 12.5mg of the combined actives administered for 15 days.
Adverse Reactions (Frequency and seriousness)
Hypersensitivity reactions unrelated to dose can occur with these agents. Gastrointestinal symptoms (diarrhoea, vomiting) may occur after administration of the product. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
In case of occurrence of allergic reaction, the treatment should be withdrawn. Use During Pregnancy or Lactation:
Studies in laboratory animals have not produced any evidence of teratogenic effects. Use only according to the benefit/risk assessment by the responsible veterinarian. Interaction with other Medicinal Products and Other Forms of Interaction: 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.
Operator warnings
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 and wash hands after use.
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.
Environmental Safety:
Any unused product or waste material should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Do not store above 25°C.
Store in the original package in order to protect from moisture.
Any halved tablet should be returned to the open blister and used within one day.

Legal category

POM-V

Packaging Quantities

Nisamox 50 mg tablets – Silver coloured aluminium foil blister strips containing 10 50 mg tablets within a cardboard dispensing carton containing 100 or 500 tablets.
Nisamox 250 mg tablets – Silver coloured aluminium foil blister strips containing 5 250 mg tablets within a cardboard dispensing carton containing 50 or 250 tablets.
Nisamox 500 mg palatable tablets - Silver coloured aluminium foil blister strips containing 5 500 mg tablets within a cardboard dispensing carton containing 100 tablets.

Further information

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.
Beta-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.
Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.
Amoxicillin is susceptible to breakdown by β-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include symbol β-lactamase producing species.
In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:
Gram-positive: Staphylococci (including β-lactamase producing strains), Clostridia and Streptococci. Gram-negative: Escherichia coli (including most β-lactamase producing strains), Campylobacter spp, Pasteurellae, Proteus spp. Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. Dogs diagnosed with Pseudomonas infections should not be treated with this antibiotic combination. A trend in resistance of E. coli is reported. Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed. Clavulanic acid (pK1 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is heavily eliminated by renal excretion (unchanged in urine). After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 6.30 +/-
0.45µg/ml, Tmax of 1.98 +/- 0.135h and AUC of 23.38 +/- 1.39 µg/ml.h for amoxicillin and Cmax of 0.87 +/- 0.1µg/ml, Tmax of 1.57 +/- 0.177hrs and AUC of 1.56 +/- 0.24mg/ml.h for clavulanic acid.
After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 7.12 +/-1.460 µg/ml, Tmax of 2.69 +/- 0.561 h and AUC of 33.54 +/- 7.335 µg/ml.h for amoxicillin and Cmax of 1.67 +/- 0.381 µg/ml, Tmax of 1.83 +/- 0.227 h and AUC of 7.03 +/- 1.493 µg/ml.h for clavulanic acid.

Marketing Authorisation Holder (if different to distributor)

Norbrook Laboratories Limited, Station Works, Camlough Road, Newry, Co. Down, BT35 6JP, Northern Iremand
Distributed by

Marketing authorisation number

Nisamox 50 mg Tablets for Dogs and Cats Vm 02000/4223.
Nisamox 250 mg Tablets for Dogs Vm 02000/4222.
Nisamox Palatable Tablets 500 mg for Dogs Vm 02000/4260.