Noroclav 500 mg Palatable Tablets for Dogs

Composition

Per tablet:

Active Ingredients:

Amoxicillin (as amoxicillin trihydrate) 400 mg

Clavulanic acid (as Potassium clavulanate) 100 mg

Excipients:

Pink divisible circular tablet with score line on one face and figure 500 embossed on opposing face. The tablet can be divided into equal halves.

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Pharmacological properties

4.1 ATCvet code: QJ01CR02

4.2 Pharmacodynamics

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 ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-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, 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.

4.3 Pharmacokinetics

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 (pKa 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 50mg presentation at 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.

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Target species

Dogs.

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Indications

For 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 infection 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.

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Dosage

Oral use.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Administration is via the oral route. The dosage rate is 12.5 mg combined actives/kg bodyweight twice daily. The tablets may be crushed and added to a little food.

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

Duration of therapy:

Routine cases involving all indications: The majority of cases respond to between 5 and 7 days therapy.

Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required in that it allows sufficient time for damaged tissue to repair.

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Contraindications

Do not use in cases of hypersensitivity to the active substances.

Do not use in rabbits, guinea pigs, hamsters or gerbils.

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.

Caution is advised in the use in small herbivores other than those listed above. Do not administer to horses and ruminating animals.

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Adverse reactions

1 In these cases, treatment should be withdrawn.

2 Unrelated to dose.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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.

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.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

For administration only by a veterinarian.

Penicillin’s and cephalosporins may occasionally cause severe allergic reactions.

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Use during pregnancy, lactation or lay

Pregnancy:

Studies in laboratory animals have not produced any evidence of teratogenic, effects. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

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.

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Overdose

No adverse effects have been reported after the daily administration of 3 times the recommended dose for 8 days, and after the daily administration of the recommended dose for 21 days.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

The product is presented as follows:

Aluminium/aluminium blister strips, each containing 5 tablets.

Cartons of 10, 20, 25 and 100 tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 25ºC.

Store in a dry place.

Divided tablets should be stored in the blister pack.

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Shelf life

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

Shelf life after first opening the immediate packaging: 24 hours.

Any divided tablet portion remaining after 24 hours should be discarded.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

7 MARKETING AUTHORISATION NUMBERS

Vm 02000/5013 Vm 02000/3005

8 DATE OF FIRST AUTHORISATION

26 April 2006

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Norbrook Laboratories Limited

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