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Date: Saturday, January 23, 2021 17:38

Description: Ceva logo
Release 3.85
Zodon® 88 mg and 264 mg Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Clindamycin
Product:Zodon® 88 mg and 264 mg Tablets for Dogs
Product index: Zodon tablets
Qualitative and quantitative composition
Active ingredient:
Zodon 88 mg Tablet: Each tablet contains: clindamycin 88 mg
Zodon 264 mg Tablet: Each tablet contains: clindamycin 264 mg
Excipients:
For the full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Chewable, clover-shaped scored beige tablet. The tablet can be divided into four equal parts
Clinical particulars
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.
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.
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.
Pharmacological particulars
Pharmacotherapeutic group: Anti-infectives for systemic use, lincosamides. ATCvet code: QJ01FF01
Pharmacodynamic properties
Clindamycin is a semi-synthetic antibiotic produced by 7(S)-chloro substitution of the 7(R)-hydroxy group of the natural antibiotic produced by Streptomyces lincolnensis var. lincolnensis.
Clindamycin acts by a bacteriostatic mechanism where the drug interferes with protein synthesis within the bacterial cell, thus inhibiting the growth and multiplication of the bacteria. Clindamycin binds to the 23S ribosomal RNA component of the 50S subunit. This prevents amino acids binding on these ribosomes, and therefore inhibits peptide bond formation.The ribosomal sites are close to those bound by macrolides, streptogramins or chloramphenicol.
Antibacterial spectrum:
Clindamycin is a moderate spectrum antimicrobial drug.
Clindamycin has in vitro activity against the following micro-organisms (see the following MICs):
Aerobic Gram-positive cocci, including: Staphylococcus aureus and Staphylococcus pseudintermedius (penicillinase and non-penicillinase producing strains), Streptococcus spp. (except Streptococcus faecalis).
Anaerobic Gram-negative bacilli, including: Bacteroides spp., Fusobacterium necrophorum.
Clostridia: Most Clostridium perfringens are susceptible.
MIC data:
CLSI clindamycin veterinary breakpoints are available for dogs in Staphylococcus spp. and Streptococci-β-haemolytic group in skin and soft tissue infections: S ≤0.5 μg/ml; I =1-2 μg/ml; R ≥4 μg/ml (CSLI July 2013).
Type and mechanism of resistance:
Clindamycin belongs to the lincosamide group of antibiotics. Resistance can develop to the lincosamides alone, but more commonly cross-resistance occurs among macrolides, lincosamides and streptogramin B antibiotics (MLSB group). Resistance is the result of methylation of adenine residues in the 23S RNA of the 50S ribosomal subunit, which prevents drug binding to the target site. Different bacterial species are able to synthesize an enzyme, encoded by a series of structurally related erythromycin ribosomal methylase (erm) genes. In pathogenic bacteria, these determinants are mostly borne by plasmids and transposons that are self-transferable. The erm genes occur predominantly as variants erm(A) and erm(C) in Staphylococcus aureus and as variant erm(B) in Staphylococcus pseudintermedius, streptococci and enterococci . Bacteria resistant to macrolides but initially susceptible to clindamycin, rapidly develop resistance to clindamycin when exposed to macrolides. These bacteria present a risk of in vivo selection of constitutive mutants.
MLSB inducible resistance is not detected by standard in vitro susceptibility testing methods. The CLSI recommends the D-zone test to be routinely performed in veterinary diagnostic laboratories in order to detect clinical isolates with inducible resistance phenotype. Clindamycin use should be discouraged in these patients.
The incidence of resistance to lincosamides in Staphylococcus spp. appears to be wide-ranging in Europe. Literature data (2016) report an incidence between 25 to 40%.
Pharmacokinetic properties
Absorption
Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral administration.
Serum values
After oral administration of 13.1 mg/kg bodyweight, the maximal plasma concentration of 6.4 µg/ml (Mean Cmax) is reached within 50 minutes (Mean Tmax). The biological plasma half-life of clindamycin in the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after several oral administrations.
Metabolism and Excretion
Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent molecule as well as bioactive and bio-inactive metabolites are excreted via the urine and faeces. Nearly all bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).
Pharmaceutical particulars
List of excipients
Chicken flavour, Yeast extract, Sodium croscarmellose, Copovidone, Magnesium stearate, Silica, colloidal anhydrous, Microcrystalline cellulose, Lactose monohydrate.
Major incompatibilites
Not applicable
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life for tablet portions after first opening the immediate packaging: 72 hours
Special precautions for storage
Do not store above 30°C
Tablet portions should be stored in the blister pack. Keep the blister in the outer carton.
Nature and composition of immediate packaging
Blister pack: (PVC-TE-PVDC - aluminium heat sealed) containing 10 tablets per blister (88 mg tablets) or 6 tablets per blister (264 mg tablets)
Zodon 88 mg tablets: Cardboard box of 10 tablets containing 1 blister of 10 tablets; Cardboard box of 20 tablets containing 2 blisters of 10 tablets; Cardboard box of 100 tablets containing 10 blisters of 10 tablets; Cardboard box of 120 tablets containing 12 blisters of 10 tablets; Cardboard box of 240 tablets containing 24 blisters of 10 tablets.
Zodon 264 mg tablets: Cardboard box of 6 tablets containing 1 blister of 6 tablets; Cardboard box of 12 tablets containing 2 blisters of 6 tablets; Cardboard box of 96 tablets containing 16 blisters of 6 tablets; Cardboard box of 120 tablets containing 20 blisters of 6 tablets; Cardboard box of 240 tablets containing 40 blisters of 6 tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Zodon 88 mg Tablets: Vm 15052/4128
Zodon 264 mg Tablets: Vm 15052/4127
Significant changes
Date of the first authorisation or date of renewal
22nd May 2014
Date of revision of the text
July 2019
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Zodon 88 mg 12x10T
GTIN:03411112276455
GTIN description:Zodon 264 mg 20x6T
GTIN:03411112276479