Introduction

Chanelle Vet UK Ltd

Address: CBX11 West Wing

382-390 Midsummer Boulevard

Milton Keynes, Bucks MK9 2RG

Telephone: 01908 843636

Fax: 01908 847401

Website: www.chanellevetuk.com

 

Company name: Chanelle Animal Health Limited

7 Rodney Street

Liverpool

L1 9HZ

Tel & Fax: 01568 750432

Website: www.chanellegroup.ie

Presentation

Oblong shaped white tablets with a breakline on one side for oral administration. Each tablet contains 150 mg clindamycin (as clindamycin hydrochloride).

Uses

Clinacin tablets are indicated for the treatment of infected wounds, abscesses, superficial pyoderma and oral cavity/dental infections caused by or associated with clindamycin-sensitive staphylococci, streptococci, bacteroidaceae, Fusobacterium necrophorum, Clostridium perfringens and osteomyelitis caused by Staphylococcus aureus. Clinacin 150 mg tablets can also be used to help provide antimicrobial cover during dental procedures.

Dosage and administration

For oral administration.

1. For treatment of infected wounds, abscesses, oral cavity/dental infections, administer 1 tablet per 27 kg bodyweight twice daily for 7 - 10 days (i.e. 5.5mg clindamycin per kg bodyweight every twelve hours). Treatment may be extended to a maximum of 28 days based on clinical judgement. If no improvement is seen within 4 days, the sensitivity of the pathogens involved should be redetermined.

2. For the treatment of superficial pyoderma administer 2 tablets per 27kg bodyweight once daily (i.e. 11mg clindamycin per kg bodyweight every 24 hours). Continue treatment for at least 21 days.

3. For the treatment of osteomyelitis administer 2 tablets per 27 kg bodyweight twice daily (i.e. 11 mg clindamycin per kg bodyweight every 12 hours) for at least 28 days. If no improvement is seen within 14 days, the sensitivity of the pathogens involved should be redetermined.

4. To help provide antimicrobial cover during dental procedures, a 10 day course of 5.5 mg/kg every 12 hours is recommended (i.e. 1 tablet per 27 kg twice a day beginning 5 days before the intended procedure and continuing for 5 days thereafter).

The minimum bodyweight to be treated with the 150 mg tablets is 13.5 kg.

Contra-indications, warnings, etc

Do not administer to animals with hypersensitivity to clindamycin and lincomycin preparations. Do not administer to rabbits, guinea pigs, chinchillas, hamsters, horses or ruminants.

Before use of Clinacin 150 mg tablets, the identification of causative pathogenic micro-organisms should be carried out and their susceptibility to clindamycin should be established.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides because they may antagonise each other at the site of action.

Symptoms of overdose include vomiting, inappetency and diarrhoea. In such cases, treatment should be stopped immediately and the dogs treated symptomatically.

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

Vomiting and diarrhoea are observed occasionally.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed. Patients 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.

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, safety in gestating bitches or breeding male dogs has not been established.

Neuromuscular blocking effects have been observed with clindamycin possibly leading to an increase of efficacy of other neuromuscular blocking agents. The concomitant use of such drugs must be handled with care.

Environmental warnings

Unused product and container should be disposed of in accordance with national requirements.

General precautions

For animal treatment only.

Keep out of the reach of children.

Pharmaceutical precautions

Clindamycin and lincomycin show parallel-resistance. There is a partial cross-resistance to erythromycin and other macrolide-antibiotics.

Packaging Quantities

Polyethylene bottles containing 10, 16, 20, 30, 50, 80 and 100 tablets.

Legal category

POM-V

Further information

Clindamycin is an antibiotic with bacteriostatic action. Bactericidal actions have also been reported. Clindamycin is rapidly absorbed from the gastro-intestinal tract.

Marketing authorisation number

Vm 11990/ 4026.