Zodon 264 mg Chewable Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Clindamycin (as hydrochloride).........................264 mg

Excipients:

Qualitative composition of excipients and other constituents

Chicken flavour

Yeast extract

Croscarmellose sodium

Copovidone

Magnesium stearate

Silica, colloidal anhydrous

Microcrystalline cellulose

Lactose monohydrate

Clover-shaped scored beige tablet. The tablet can be divided into four equal parts.

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Pharmacological properties

4.1 ATCvet code:

QJ01FF01

4.2 Pharmacodynamics

Mode of action:

Clindamycin is a semi-synthetic antibiotic produced by 7(S)-chloro substitution of the 7(R)-hydroxy group of the natural antibiotic produced by Streptomyces lincolnensis var. lincolnensis.

Clindamycin acts by a bacteriostatic mechanism where the drug interferes with protein synthesis within the bacterial cell, thus inhibiting the growth and multiplication of the bacteria. Clindamycin binds to the 23S ribosomal RNA component of the 50S subunit. This prevents amino acids binding on these ribosomes, and therefore inhibits peptide bond formation. The ribosomal sites are close to those bound by macrolides, streptogramins or chloramphenicol.

Antibacterial spectrum:

Clindamycin is a moderate spectrum antimicrobial drug.

Susceptible microorganisms (S):

Clindamycin has in vitro activity against the following micro-organisms (see the following MICs):

• Aerobic Gram-positive cocci, including: Staphylococcus aureus and Staphylococcus pseudintermedius (penicillinase and non-penicillinase producing strains), Streptococcus spp. (except Streptococcus faecalis).

• Anaerobic Gram-negative bacilli, including: Bacteroides spp., Fusobacterium necrophorum.

• Clostridia: Most Clostridium perfringens are susceptible.

MIC data:

CLSI clindamycin veterinary breakpoints are available for dogs in Staphylococcus spp. and Streptococci-ß-haemolytic group in skin and soft tissue infections: S ≤0.5μg/ml; I=1-2μg/ml; R ≥ 4μg/ml. (CLSI July 2013).

Type and mechanism of resistance

Clindamycin belongs to the lincosamide group of antibiotics. Resistance can develop to the lincosamides alone, but more commonly cross-resistance occurs among macrolides, lincosamides and streptogramin B antibiotics (MLSB group). Resistance is the result of methylation of adenine residues in the 23S RNA of the 50S ribosomal subunit, which prevents drug binding to the target site. Different bacterial species are able to synthesize an enzyme, encoded by a series of structurally related erythromycin ribosomal methylase (erm) genes. In pathogenic bacteria, these determinants are mostly borne by plasmids and transposons that are self-transferable. The erm genes occur predominantly as variants erm(A) and erm(C) in Staphylococcus aureus and as variant erm(B) in Staphylococcus pseudintermedius, streptococci and enterococci. Bacteria resistant to macrolides but initially susceptible to clindamycin, rapidly develop resistance to clindamycin when exposed to macrolides. These bacteria present a risk of in vivo selection of constitutive mutants.

MLSB inducible resistance is not detected by standard in vitro susceptibility testing methods. The CLSI recommends the D-zone test to be routinely performed in veterinary diagnostic laboratories in order to detect clinical isolates with inducible resistance phenotype. Clindamycin use should be discouraged in these patients.

The incidence of resistance to lincosamides in Staphylococcus spp. appears to be wide-ranging in Europe. Literature data (2016) report an incidence between 25 to 40%.

4.3 Pharmacokinetics

Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration.

Serum values:

After oral administration of 13.1 mg/kg bodyweight, the maximal plasma concentration of 6.4 µg/ml (mean Cmax) is reached within 50 minutes (mean Tmax). The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.

Metabolism and Excretion:

Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces.

Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

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Target species

Dogs

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Indications

- For the treatment of infected wounds and abscesses, and oral cavity infections including periodontal disease, caused by or associated with Staphylococcus spp., Streptococcus spp. (except Streptococcus faecalis), Bacteroides spp., Fusobacterium necrophorum, and Clostridium perfringens.

- For the treatment of superficial pyoderma associated with Staphylococcus pseudintermedius.

- For the treatment of osteomyelitis, caused by Staphylococcus aureus.

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Dosage

Oral use.

- For the treatment of infected wounds and abscesses, and oral cavity infections including periodontal disease, administer either:

• 5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or

• 11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis.

- For the treatment of superficial pyoderma in dogs, administer either:

• 5.5 mg/kg of bodyweight every 12 hours, or

• 11 mg/kg of bodyweight every 24 hours

Therapy of superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.

- For the treatment of osteomyelitis in dogs, administer:

• 11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis redetermined.

For example:

▪ For a dose regimen of 11mg/kg

▪ For a dose regimen of 5.5 mg/kg

Weight (kg), Number of tablets per administration:

4.5 – 6.0: Use Zodon 88 mg

6.1 – 12.0: ¼ tab

12.1 – 24.0: ½ tab

24.1 – 36.0: ¾ tab

36.1 – 48.0: 1 tab

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

The tablets are flavoured. They can be administered directly into the mouth of the animals or with a small quantity of food.

Instruction on how to divide the tablet: Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts.

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Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients or to lincomycin

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastro-intestinal disturbance.

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Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Hypersensitivity reaction; Thrombocytopenia; Vomiting, diarrhoea

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as clostridia and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical situation.

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:

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal.

Official and local antimicrobial policies should be taken into account when the product is used.

Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to clindamycin and may decrease the effectiveness of treatment with lincomycin or macrolide antimicrobials due to the potential for cross-resistance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolide antibiotics. During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to lincosamides (lincomycin and clindamycin) should avoid contact with the veterinary medicinal product.

Wash hands after handling tablets.

Accidental ingestion may result in gastro-intestinal effects such as abdominal pain and diarrhoea. Care should be taken to avoid accidental ingestion

In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or the label to the physician.

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

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established. Clindamycin crosses the placental and the blood-milk barrier. Treatment of lactating females can cause diarrhoea in puppies.

Use the veterinary medicinal product only according to the benefit/risk assessment by the responsible veterinarian.

The use of the veterinary medicinal product is not recommended in neonates.

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Interactions

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. The product should be used with caution in animals receiving such agents.

Clindamycin should not be combined with erythromycin or other macrolides to prevent macrolide-induced resistance to clindamycin.

Clindamycin may reduce plasma levels of cyclosporin with a risk of lack of activity.

During the simultaneous use of clindamycin and aminoglycosides (eg gentamicin), the risk of adverse interactions (acute renal failure) cannot be excluded.

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Overdose

In dogs, oral doses of clindamycin up to 300 mg/kg/day did not result in toxicity. Dogs receiving 600 mg/kg/day of clindamycin developed anorexia, vomiting and weight loss. In cases of overdose, discontinue treatment immediately and establish symptomatic treatment.

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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

Blister pack: (PVC – TE –PVDC – aluminium heat sealed) containing 6 tablets per blister

Cardboard box of 6 tablets containing 1 blister of 6 tablets

Cardboard box of 12 tablets containing 2 blisters of 6 tablets

Cardboard box of 96 tablets containing 16 blisters of 6 tablets

Cardboard box of 120 tablets containing 20 blisters of 6 tablets

Cardboard box of 240 tablets containing 40 blisters of 6 tablets

Not all pack sizes may be marketed.

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Storage

Do not store above 30°C.

Tablet portions should be stored in the blister pack

Keep the blister in the outer carton.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life for tablet portions after first opening the immediate packaging: 72 hours (or 3 days)

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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

Vm 14966/5061

Vm 14966/3060

8 DATE OF FIRST AUTHORISATION

22 May 2014

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

October 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.

Gavin Hall

Approved: 17 October 2025

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Registration holder

Ceva Sante Animale

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