Clindaseptin 25 mg/ml Oral Solution for Cats & Dogs

Composition

One ml contains:

Active substances:

Clindamycin 25 mg

(as Clindamycin Hydrochloride 27.15 mg)

Excipients:

Clear, colourless solution.

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Pharmacological properties

4.1 ATCvet code:

QJ01FF01.

4.2 Pharmacodynamics

Clindamycin is mainly a bacteriostatic antibiotic belonging to the group of lincosamides. Clindamycin is a chlorinated analogue of lincomycin. It works by inhibiting bacterial protein synthesis. The reversible coupling to the sub-unit 50-S bacterial ribosome inhibits translation of amino acids linked to the tRNA, thereby preventing elongation of the peptide chain. That is why the mode of action of clindamycin is predominantly bacteriostatic.

Clindamycin and lincomycin have cross-resistance, which is also common between erythromycin and other macrolides.

Acquired resistance can occur, by methylation of the ribosomal binding site via chromosomal mutation in gram positive organisms, or by plasmid-mediated mechanisms in gram negative organisms.

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 ≤ 0.5 μg/ml; I=1-2μg/ml; R ≥ 4 μg/ml. (CLSI July 2013).

The incidence of resistance to lincosamides in Staphylococcus spp. appears to be wide-ranging in Europe. Recent studies (2010) report an incidence between 25 to 40%.

4.3 Pharmacokinetics

Clindamycin is almost completely absorbed after oral administration. Maximum serum concentrations of 8 µg/ml (without influence of the bolus) were obtained 1 hour after a dose of 11 mg per kg.

Clindamycin is widely distributed and can concentrate in certain tissues.

The half-life of clindamycin is about 4 hours. Approximately 70% of clindamycin is excreted in faeces and about 30% in urine.

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Target species

Cats and dogs.

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Indications

Cats:

For the treatment of infected wounds and abscesses caused by clindamycin-sensitive species of Staphylococcus spp. and Streptococcus spp.

Dogs:

- For the treatment of infected wounds, abscesses and oral cavity/dental infections caused by or associated with clindamycin-sensitive species of Staphylococcus spp., Streptococcus spp., Bacteroides spp., Clostridium perfringens, Fusobacterium necrophorum.

- Adjunctive treatment of mechanical or surgical periodontal therapy in the treatment of infections of the gingival and periodontal tissues.

- For the treatment of osteomyelitis caused by Staphylococcus aureus.

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Dosage

For oral administration only.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

Recommended dosage:

Cats:

- Infected wounds, abscesses: 11 mg clindamycin per kg of body weight per 24h or 5.5 mg/kg per 12h for 7 to 10 days

The treatment should be stopped if no therapeutic effect is observed after 4 days.

Dogs:

- Infected wounds, abscesses and oral cavity/dental infections: 11 mg clindamycin per kg of body weight per 24h or 5.5 mg/kg per 12h for 7 to 10 days.

The treatment should be stopped if no therapeutic effect is observed after 4 days.

- Treatment of bone infections (osteomyelitis): 11 mg clindamycin per kg of body weight every 12 hours during a period of 28 days minimum. The treatment should be discontinued if no therapeutic effect is observed in the first 14 days.

A 3 ml graduated syringe is provided to facilitate the administration of the veterinary medicinal product.

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Contraindications

Do not use in rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may cause severe gastro-intestinal disorders, that can sometimes be fatal.

Do not use in cases of hypersensitivity to either clindamycin or lincomycin, or to any of the excipients.

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Adverse reactions

Cats and dogs:

Clindamycin sometimes causes the overgrowth of non sensitive organisms such as resistant clostridia and yeasts. In case of secondary infection, the treatment should be stopped and appropriate measures should be taken based on clinical observations.

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:

Inappropriate use of the product may increase the prevalence of bacteria resistant to clindamycin. Whenever possible, clindamycin should only be used based on susceptibility testing.

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

Clindamycin shows parallel-resistance with lincomycin and co-resistance with erythromycin. There is a partial cross-resistance to erythromycin and other macrolides.

In case of administration of high doses of clindamycin or during prolonged therapy of one month or greater, tests for liver and renal functions and blood counts should be performed periodically.

In dogs and cats with kidney problems and/or liver problems, accompanied by severe metabolic aberrations, the dose to be administered should be carefully determined and their condition should be monitored by performing serum tests during treatment.

The use of the product is not recommended in neonates.

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

Wash hands after administration.

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

In case of accidental ingestion, 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

Fertility and pregnancy

While high dose studies in rats suggests that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, the safety of the veterinary medicinal product in gestating bitches/queens or breeding male dogs/cats has not been established.

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

Lactation:

Clindamycin can pass the blood-milk barrier. As a consequence, treatment of lactating females can cause diarrhoea in puppies and kittens.

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Interactions

- Aluminium salts and hydroxides, kaolin and Aluminium-Magnesium-Silicat complex may reduce lincosamides digestive absorption. These digestive topics should be administered at least 2 hours before clindamycin.

- Cyclosporin: clindamycin may reduce levels of this immunosuppressive drug with a risk of lack of activity.

- Neuro-muscular blocking agents: Clindamycin possesses intrinsic neuromuscular blocking activity and should be used cautiously with other neuromuscular blocking agents (curares). Clindamycin may increase neuromuscular blockade.

- Do not use clindamycin simultaneously with chloramphenicol or macrolides as they both target the ribosome 50S subunit and antagonist effects may develop.

- When using simultaneously clindamycin and aminoglycosides (i.e gentamicin), the risk of adverse interactions (acute renal failure) cannot be excluded.

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Overdose

Doses of 300 mg/kg were tolerated by dogs without having adverse effects. Vomiting, loss of appetite, diarrhoea, leukocytosis and elevations in liver enzymes (AST, ALT) were observed occasionally. In such cases, discontinue treatment immediately and establish a symptomatic treatment.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Do not mix this product with any other veterinary medicinal products.

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Immediate packaging

Carton box containing clear polyethylene terephthalate (PET) bottle or Type III amber glass bottle of 22 ml with HDPE/LDPE or polypropylene tamper proof closure supplied with a low density polyethylene measuring syringe.

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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: 1 year (PET bottle)

Shelf life of the veterinary medicinal product as packaged for sale: 3 years (Glass bottle)

Shelf life after first opening the immediate packaging: 28 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 08749/4032

8 DATE OF FIRST AUTHORISATION

31 May 2012

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

December 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

Chanelle Pharmaceuticals Manufacturing Ltd

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