Target species
Dogs
Indications for use, specifying the target species
- 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.
- For the treatment of superficial pyoderma associated with Staphylococcus pseudintermedius.
- For the treatment of osteomyelitis, caused by Staphylococcus aureus.
Contraindications
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 or ruminants because ingestion of clindamycin by these species may result in severe gastro-intestinal disturbance.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
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. Official and local antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to clindamycin and may decrease the effectiveness of treatment with lincomycin or macrolide antimicrobials due to the potential for cross-resistance.
Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolide antibiotics.
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to lincosamides (lincomycin and clindamycin) 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 case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Vomiting and diarrhoea have been reported very rarely. Hypersensitivity reactions and thrombocytopenia have been reported very rarely. Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as 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).
Use during pregnancy, lactation or lay
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 or breeding male dogs has not been established. Clindamycin crosses the placental and the blood-milk barrier. Treatment of lactating females can cause diarrhoea in puppies. Use the product only according to the benefit/risk assessment by the responsible veterinarian. The use of the product is not recommended in neonates.
Interaction with other medicinal products and other forms of interaction
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.
Clindamycin should not be combined with erythromycin or other macrolides to prevent macrolide-induced resistance to clindamycin.
Clindamycin may reduce plasma levels of cyclosporin with a risk of lack of activity.
During the simultaneous use of clindamycin and aminoglycosides (eg gentamicin), the risk of adverse interactions (acute renal failure) cannot be excluded.
Amounts to be administered and administration route
For oral administration.
For the treatment of infected wounds and abscesses, and oral cavity/dental infections including periodontal disease, administer either:
- 5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or
- 11 mg/kg of bodyweight every 24 hours for 7-10 days
If no clinical response is seen within 4 days, redetermine the diagnosis.
For the treatment of superficial pyoderma in dogs, administer either:
- 5.5 mg/kg of bodyweight every 12 hours, or
- 11 mg/kg of bodyweight every 24 hours
Therapy of superficial pyoderma is usually recommended for 21 days, with extension of therapy based on clinical judgement.
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.
For example:
For a dose regimen of 11mg/kg
Weight (kg) | Zodon 88 mg No. tablets per administration | Weight (kg) | Zodon 264 mg No. tablets per administration |
1.0-2.0 | 1⁄4 | 4.5-6.0 | 1⁄4 |
2.1-4.0 | 1⁄2 | 6.1-9.0 | Use Zodon 88 mg |
4.1-6.0 | 3⁄4 | 9.1-12.0 | 1⁄2 |
6.1-8.0 | 1 | 12.1-18.0 | 3⁄4 |
8.1-10.0 | 1 ¼ | 18.1-24.0 | 1 |
10.1-12.0 | 1 ½ | 24.1-30.0 | 1 ¼ |
12.1-14.0 | 1 ¾ | 30.1-36.0 | 1 ½ |
14.1-16.0 | 2 | 36.1-42.0 | 1 ¾ |
| | 42.1-48.0 | 2 |
For a dose regimen of 5.5mg/kg
Weight (kg) | Zodon 88 mg Number of tablets per administration | Weight (kg) | Zodon 264 mg Number of tablets per administration |
2.0-4.0 | 1⁄4 | 4.5-6.0 | Use Zodon 88 mg |
4.1-8.0 | 1⁄2 | 6.1-12.0 | 1⁄4 |
8.1-12.0 | 3⁄4 | 12.1-24.0 | 1⁄2 |
12.1-16.0 | 1 | 24.1-36.0 | 3⁄4 |
| | 36.1-48.0 | 1 |
To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under-dosing
The tablets are flavoured. They can be administered directly into the mouth of the animals or with a small quantity of food.
Instruction on how to divide the tablet: Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts
Overdose (symptoms, emergency procedures, antidotes), if necessary
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. In cases of overdose, discontinue treatment immediately and establish symptomatic treatment.
Withdrawal period(s)
Not applicable.