Mycinor Tablets are indicated 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. They can also be used for the treatment of superficial pyoderma associated with Staphylococcus intermedius, and for the treatment of osteomyelitis caused by Staphylococcus aureus.
Mycinor Tablets are presented as white to off-white circular tablets that can be divided into equal halves for accurate administration.
Indications for use, specifying the target species:
Mycinor 25 mg Tablets are indicated for use in dogs as follows:
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.
Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to clindamycin established.
Do not use in animals that 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 gastrointestinal disturbance.
Special Warnings for each target species:
Special precautions for use in animals
Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated between clindamycin, erythromycin and other macrolides 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
Wash hands after handling tablets.
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 label to the doctor.
Adverse reactions (frequency and seriousness):
Vomiting and diarrhoea have occasionally been observed.
Clindamycin 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.
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.
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. Mycinor Tablets 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.
Amounts to be administered and administration route:
For oral administration only.
1. For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections in dogs, 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. To help provide antimicrobial 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, or
- 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
In a tolerance study, a dose rate of 3 times the recommended dose of 11 mg/kg bodyweight of Mycinor 25mg Tablets administered twice daily over a period of 30 consecutive days did not demonstrate adverse effects.