Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Nisamox 50mg Tablets are for oral administration to dogs and cats. Each Nisamox 50 mg Tablet contains Amoxicillin 40 mg (as Amoxicillin Trihydrate) and Clavulanic Acid 10 mg (as Potassium Clavulanate).

Uses

Nisamox 50 mg Tablets are indicated for treatment of the following infections caused by b-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.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive:

Staphylococci (including b-lactamase producing strains)

Clostridia

Streptococci

Gram-negative:

Escherichia coli (including most b-lactamase producing strains)

Campylobacter spp Pasteurellae

Proteus spp

Dosage and administration

Administration: By the oral route. The tablets may be crushed and added to a little food.

Dosage Rate: 12.5 mg combined actives/kg bodyweight twice daily. The recommended dose of 12.5 mg per kg bodyweight is equivalent to one 50 mg tablet per 4 kg bodyweight.

Dosage frequency:

The following table is intended as a guide to dispensing Nisamox 50mg Tablets at the standard dose rate of 12.5 mg/kg twice daily.

	Number of tablets per dose twice daily
Bodyweight (kg)	50 mg
1-2	½
3-4	1
5-6	1½
7-8	2
9-10	2½
11-12	3
13-14	3½
15-16	4
17-18	4½

Duration of therapy: Acute cases: 5 to 7 days of treatment. If no improvement is observed after 5 to 7 days, the diagnosis should be re-assessed. Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required so that it allows sufficient time for damaged tissue to repair. If no improvement is observed after two weeks, the diagnosis should be re-assessed.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in the use in any other very small herbivores. Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group. 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. Hypersensitivity reactions unrelated to dose can occur with these agents. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur. In case of allergic reaction, the treatment should be withdrawn. Gastro-intestinal symptoms (diarrhoea, vomiting) may occur after administration. In animals with hepatic and renal failure, the dosing regime should be carefully evaluated. Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination. Do not administer to horses and ruminating animals. Use during pregnancy and lactation: Use only according to 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.

Withdrawal period: Not applicable.

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. 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.

Pharmaceutical precautions

Do not store above 25°C; store in a dry place.

Keep out of the reach of children. Dispose of any unused product in accordance with guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Tubs of 100 and 500 tablets.

Packs of 2, 10 and 50 blister strips containing 10 tablets per strip. Keep the container in the outer carton.

Not all pack sizes may be marketed.

Further information

Resistance to many antibiotics is caused by beta-lactamase enzymes, which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Nisamox Tablets counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the organisms sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body. Inappropriate use of the product may increase the prevalence of bacteria resistance to amoxicillin/clavulanic acid.