Clindabactin 55 mg Chewable Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substance:

Clindamycin (as clindamycin hydrochloride) 55 mg

Excipients:

Light brown with brown spots, round and convex chewable flavoured 9 mm tablet with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 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, a mainly time-dependent acting antibiotic, 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.

Clindamycin has in vitro activity against the following micro-organisms:

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

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

• Clostridia: Most C. perfringens are susceptible.

MIC data

CLSI clindamycin veterinary breakpoints are available for dogs in Staphylococcus spp. and Streptococci-β-haemolytic group in skin and soft tissue infections: S≤0.5μg/ml; I=1-2µg/ml; R≥4μg/ml (CLSI February 2018).

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. Studies (2010) report an incidence between 25 to 40%.

4.3 Pharmacokinetics

Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastrointestinal tract following oral administration. After oral administration of the veterinary medicinal product to dogs (10.8 mg/kg), bioavailability was 63%.

Serum values:

After oral administration of 10.6 mg/kg bodyweight to cats, the maximal concentration of 7.2 µg/ml (mean Cmax) is reached within 40 minutes (median Tmax). In dogs, the maximal concentration of 6.1 µg/ml (mean Cmax) is reached within 1 hour (median Tmax) after oral administration of 10.8 mg/kg bodyweight. The plasma elimination half-life of clindamycin is approximately 5 hours in the cat and 3.5 hours in the dog. No accumulation of bioactivity has been observed in dogs or cats 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 and cats.

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Indications

Dogs:

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 susceptible to clindamycin.

For the treatment of superficial pyoderma associated with Staphylococcus pseudintermedius susceptible to clindamycin.

For the treatment of osteomyelitis, caused by Staphylococcus aureus susceptible to clindamycin.

Cats:

For the treatment of infected wounds and abscesses, and oral cavity infections including periodontal disease, caused by bacteria susceptible to clindamycin.

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Dosage

Oral use.

1. For the treatment of infected wounds and abscesses, and oral cavity infections including periodontal disease in dogs and cats, administer either:

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

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

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

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

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

• 11 mg clindamycin/kg bodyweight every 24 hours

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

3. For the treatment of osteomyelitis in dogs, administer:

• 11 mg clindamycin/kg 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.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing.

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing.

Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

2 equal parts: press down with your thumbs on both sides of the tablet.

4 equal parts: press down with your thumb in the middle of the tablet.

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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 and ruminants, because ingestion of clindamycin by these species can cause severe gastro-intestinal disturbance which may result in death.

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Adverse reactions

Dogs, cats:

a Clindamycin causes overgrowth of non-sensitive organisms such as resistant 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 its local representative 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 target bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.

Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.

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 antibacterials due to the potential for cross-resistance.

Cross-resistance has been demonstrated among lincosamides (including clindamycin), erythromycin and other macrolides.

In some cases (localised or mild lesions; to prevent recurrence), superficial pyoderma can be treated topically. The need for and duration of systemic antimicrobial treatment should be based on careful consideration of the individual case.

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.

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

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

Lincosamides (lincomycin, clindamycin, pirlimycin) may cause hypersensitivity (allergy) reactions. People with known hypersensitivity to lincosamides 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 order to reduce the risk of accidental ingestion by children, do not take the tablets out of the blister until ready to administer to the animal. Return part-used tablets into the blister and carton and use at the subsequent administration.

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/queens or breeding male dogs/cats has not been established. Clindamycin crosses the placental and the blood-milk barrier.

Treatment of lactating females can cause diarrhea in puppies and kittens. Use only according to the benefit-risk assessment by the responsible veterinarian.

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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 veterinary medicinal product should be used with caution in animals receiving such agents.

Aluminium salts and hydroxides, kaolin and aluminium-magnesium-silicat complex may reduce the absorption of lincosamides. These digestive substances should be administered at least 2 hours before clindamycin.

Clindamycin should not be used concomitantly with or immediately after erythromycin or other macrolides to prevent macrolide-induced resistance to clindamycin.

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

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

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonise each other at their site of action at the 50S ribosomal sub-unit.

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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. Vomiting was also recorded in cats dosed at 25 or 50 mg/kg/day. 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

Aluminium - Polyamide/Aluminium/PVC blister

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 25 blisters of 10 tablets.

Cardboard box containing 10 separate cardboard boxes, each containing 1 blister of 10 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

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

Shelf life of divided tablets after first opening the immediate packaging: 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 50406/4004

8 DATE OF FIRST AUTHORISATION

16 April 2019.

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

November 2024

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: 26 March 2025

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Registration holder

Dechra Regulatory B.V.

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