Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Each gelatin capsule contains 25, 75, 150 or 300 mg clindamycin (as clindamycin hydrochloride).

Uses

Oral antibiotic for dogs and cats*

* 25 mg only

Dogs

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections, caused by or associated with Staphylococcus spp., Streptococcus spp. (except Streptococcus faecalis), Bacteroides spp., Fusobacterium necrophorum and Clostridium perfringens. To help provide antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Cats

For the treatment of infected wounds and abscesses and infected mouth cavity and dental infections, caused by bacteria sensitive to clindamycin. To help provide antimicrobial cover during dental procedures.

Before Antirobe therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.

Clindamycin has been shown to have in vitro activity against isolates of the following organisms:

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

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

Anaerobic Gram-positive non-spore-forming bacilli, including: Propionibacterium spp., Eubacterium spp., Actinomyces spp.

Anaerobic and microaerophilic Gram-positive cocci, including: Peptococcus spp., Peptostreptococcus spp., microaerophilic streptococci.

Clostridia: Most Cl.perfringens are susceptible; other species such as Cl. sporogenes and Cl. tertium frequently are resistant to clindamycin.

Mycoplasma species: Most mycoplasma species are susceptible to clindamycin.

Dosage and administration

For oral administration only.

1.For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs and cats, administer either:

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

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

If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide anti-microbial cover during dental procedures, a 10 day course is recommended. This should be initiated five days before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a maximum of 28 days based on clinical judgement.

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

-5.5 mg/kg of bodyweight every 12 hours

-11 mg/kg of bodyweight every 24 hours

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

3.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.

Dosage table
Bodyweight	Superficial pyoderma1, dental infections, wounds and abscesses, Osteomyelitis1
	5.5 mg/kg ev. 12h	11 mg/kg ev. 24h	11 mg/kg ev. 12h
4.5 kg	1 x 25 mg twice daily	2 x 25 mg once daily	2 x 25 mg twice daily
13.5 kg	1 x 75 mg twice daily	1 x 150 mg once daily	1 x 150 mg twice daily
27.0 kg	1 x 150 mg twice daily	1 x 300 mg once daily	1 x 300 mg twice daily
1 dogs only

Contra-indications, warnings, etc

For animal treatment only.

Keep out of reach of children.

Wash hands after handling capsules.

Contra-indications

The use of Antirobe Capsules is contra-indicated in animals which are hypersensitive to preparations containing clindamycin or 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.

Warnings/Precautions/Side-effects

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolide antibiotics.

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

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.

Vomiting and diarrhoea have occasionally been observed.

Antirobe sometimes causes the 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.

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.

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.

Pharmaceutical precautions

Do not store above 25°C.

Dispose of used packaging in the household refuse. Unused capsules should be returned to the veterinary surgeon.

Legal category

POM-V

Packaging Quantities

The 25 mg, 75 mg and 150 mg presentations are provided in plastic tubs containing 150 capsules. The 300 mg presentation is provided in a plastic tub containing 100 capsules. Also provided in blister packs containing 80 capsules.

Not all pack sizes may be marketed.

Further information

Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastro-intestinal tract following oral administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following administration of the recommended dose.

The maximum dosage which is well tolerated orally by dogs is 300 mg/kg bodyweight. This is 27 times the indicated dosage for treatment of superficial pyoderma, infected wounds, abscesses, mouth cavity and dental infections.

Marketing authorisation numbers

25 mg capsules	Vm 00057/4263
75 mg capsules	Vm 00057/4265 (dog only)
150 mg capsules	Vm 00057/4264 (dog only)
300 mg capsules	Vm 00057/4266 (dog only)

Significant Changes