Clindabactin 55 mg: Cats and Dogs

Clindabactin 220 mg and 440 mg: 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.

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

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.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological information about susceptibility of the target bacteria.

Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

Use of the product deviating from the instructions given in this datasheet 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 product is not recommended in neonates.

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.

Vomiting and diarrhoea have been observed uncommonly.

Clindamycin uncommonly 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.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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 diarrhoea in puppies and kittens.

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

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. The 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.

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/kg of body weight every 12 hours for 7-10 days, or

- 11 mg/kg of body weight 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/kg of body weight every 12 hours, or

- 11 mg/kg of body weight 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/kg of body weight 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, body weight 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.

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.