CLINDASEPTIN 75MG 100 CAPSULES | ANTI-INFECTIVE FOR DOG

Clindaseptin 75 mg capsules for dogs.

Anti-infective for systemic use

Laboratory

VETOQUINOL EVSA

PHARMACEUTICAL FORM

Oral capsule (Cap.o.)

COMPOSITION PER CAPSULE:

Clindaseptin 75 mg Capsules for Dogs: Clindamycin (as clindamycin hydrochloride) 75 mg.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-infectives for systemic use, lincosamides

ATCvet: QJ01FF01.

Pharmacodynamic properties: Clindamycin is primarily a bacteriostatic antibiotic belonging to the group of lincosamides, which acts by inhibiting protein synthesis. Clindamycin is a chlorinated analog of lincomycin. The antibiotic activity of clindamycin is based on the inhibition of bacterial synthesis. Reversible coupling to the 50-S subunit of the bacterial ribosome inhibits the translation of tRNA-bound amino acids, thus preventing peptide chain elongation. For this reason, the mode of action of clindamycin is predominantly bacteriostatic.

Most aerobic Gram (-) bacteria are resistant to clindamycin.

Clindamycin has been shown to have in vitro activity against the following organisms: Staphylococcus spp.; Streptococcus spp.; Bacteroides spp.; Fusobacterium spp.; Clostridium spp.

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

Acquired resistance can occur, by methylation of the ribosomal binding site through chromosomal mutation in Gram ( ) organisms, or by plasmid-mediated mechanisms in Gram (-) organisms.

CLSI veterinary clindamycin breakpoints are available for dogs in Staphylococcus spp. and ß-hemolytic Streptococci in skin and soft tissue infections: S=0,5 µg/ml; I=1-2 µg/ml; R = 4 µg/mL (CLSI July 2013).

Pharmacokinetic data: Clindamycin is almost completely absorbed after oral administration. Clindamycin is approximately 93% bound to plasma proteins. Peak serum concentrations are reached approximately 1 hour after dosing at a dose of 10 mg/kg, Cmax 3,3 g/mL (non-fasting)-5,0 g/mL (fasting). Clindamycin penetrates well and can be concentrated in some tissues. Clindamycin t½ is approximately 4 hours.

Approximately 70% of clindamycin is excreted in feces and approximately 30% in urine.

INTERACTIONS AND INCOMPATIBILITIES

• Neuromuscular blocking effects have been observed with clindamycin, which may possibly potentiate the action of other neuromuscular blocking agents. Simultaneous use with such drugs should be done with caution.

• Do not administer clindamycin together with chloramphenicol or macrolides, as they share the same 50s subunit binding site and antagonistic effects may possibly occur.

• When clindamycin and aminoglycosides (eg gentamicin) are used simultaneously, the risk of adverse interactions (acute renal failure) cannot be completely excluded.

• Clindamycin can reduce cyclosporine levels, so its simultaneous use should be avoided.

INDICATIONS

Dogs:

– Treatment of infected wounds, abscesses and oral/dental infections caused by, or associated with species sensitive to clindamycin: Staphylococcus, Streptococcus, Bacteroides, Fusobacterium necrophorum, Clostridium perfringens.

– Osteomyelitis: Staphylococcus aureus.

CONTRAINDICATIONS

• Do not use in case of hypersensitivity to clindamycin, lincomycin, or pirlimycin.

• Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses, or ruminants since ingestion of clindamycin by these species may cause serious gastrointestinal disorders.

ADVERSE REACTIONS

• Occasionally vomiting and diarrhea may be observed.

• Sometimes clindamycin can cause overgrowth of nonsusceptible organisms such as resistant clostridia and yeast. In case of superinfection, appropriate measures should be taken taking into account the clinical status.

ROUTE OF ADMINISTRATION

Orally.

POSOLOGY

Dogs:

Infected wounds, abscesses, and infections of the oral cavity or teeth: clindamycin 5,5 mg/kg every 12 hours for 7-10 days (ie 1 capsule per 27 kg of body weight twice daily).

• If no improvement is observed after 4 days, the susceptibility of the pathogens involved should be reassessed.

• Dental and periodontal infections – in the case of dental/surgical treatment due to infection, administration can be started prior to such treatment.

Osteomyelitis: clindamycin 11 mg/kg every 12 hours for a minimum period of 4 weeks (ie 2 capsules per 27 kg body weight twice daily).

• If no improvement is observed after 14 days, the susceptibility of the pathogens involved should be reassessed.

SPECIAL PRECAUTIONS

Special precautions for use in animals:

• During prolonged therapy of a month or more, periodic analysis of liver and kidney functions and blood counts should be performed.

• In patients with severe renal and/or hepatic problems accompanied by severe metabolic disturbances, the administered dose must be carefully determined and their conditions must be monitored by serum control during treatment with clindamycin.

• Whenever possible, the veterinary medicinal product should only be used on the basis of susceptibility testing.

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

• Wash your hands after administration of the veterinary medicinal product. People with known hypersensitivity to lincosamides (pirlimycin, lincomycin, clindamycin) should not handle the veterinary medicinal product.

• Do not eat, drink or smoke while handling the veterinary medicinal product.

Use during pregnancy, lactation or lay:

Although studies in rats at high doses suggest that clindamycin is not teratogenic and does not significantly affect reproductive activity in males and females, the safety of the veterinary medicinal product during pregnancy and lactation and in breeding male dogs has not been established. Therefore, the administration of the veterinary medicinal product during pregnancy and lactation must be carried out in accordance with the benefit/risk assessment carried out by the responsible veterinarian. Clindamycin can cross the blood-milk barrier. As a consequence, treatment in lactating females can cause puppies to have diarrhea.

WAIT TIME

Not applicable.

PRESERVATION MODE

This veterinary medicinal product does not require special storage conditions.

OBSERVATIONS

Medicine subject to a veterinary prescription.

FORMATS

Box with 100 capsules CN 583082 N. Reg. 3041 ESP

DATA SHEET 

CLINDASEPTIN