Target species:
Dog
Indications for use, specifying the target species
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.
Contraindications
Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants.
Do not use in male breeding dogs.
Special warnings for each target species
The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.
Special precautions for use
Special precautions for safe use in the target species:
It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio. Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention. Clomicalm should be used under veterinary supervision.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In children, accidental ingestion should be regarded as serious. There is no specific antidote. In case of accidental ingestion, seek medical advice immediately and show the product label to the physician. Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.
Adverse events:
Dogs:
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Vomiting1,2, Diarrhoea Appetite disorder2 , Lethargy2 Elevated liver enzymes2 Convulsion, Mydriasis4 Aggression |
Undetermined frequency (cannot be estimated from the available data): | Hepato-biliary disorder3 |
1May be reduced by co-administration of the veterinary medicinal product with a small quantity of food.
2Reversible when the veterinary medicinal product is discontinued.
3Especially with pre-existing conditions, and concurrent administrations of medicinal products metabolised via the hepatic system.
4Can also be observed following overdose.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation.
Pregnancy: Laboratory studies in mice and rats have shown evidence of embryotoxic effects.
Interaction with other medicinal products and other forms of interaction
Recommendations on the interaction between the veterinary medicinal product and other medicaments are derived from studies in species other than dogs. The veterinary medicinal product may potentiate the effects of the anti-arrhythmic medicinal products quinidine, anticholinergic agents (e.g. atropine), other central nervous system (CNS) medicinal products (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarin derivatives. The administration of the veterinary medicinal product is not recommended in combination with, or within 2 weeks of therapy with monoamine oxidase inhibitors. Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine. Plasma levels of certain anti-epileptic medicinal products, such as phenytoin and carbamazepine, may be increased by co-administration with the veterinary medicinal product.
Amounts to be administered and administration route
Oral use.
Clomicalm should be administered orally at a dose of 1-2 mg/kg clomipramine twice daily to give a total daily dose of 2-4 mg/kg according to the following table:
| Dosage per administration |
Bodyweight | Clomicalm 5mg | Clomicalm 20mg | Clomicalm 80mg |
1.25 - 2.5 kg | Half tablet | | |
>2.5 - 5 kg | One tablet | | |
>5 - 10 kg | | Half tablet | |
>10 - 20 kg | | One tablet | |
>20 - 40 kg | | | Half tablet |
>40 - 80 kg | | | One tablet |
To ensure a correct dosage, body weight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended.
The veterinary medicinal product may be given orally with or without food.
In clinical trials, a treatment time of 2-3 months with the veterinary medicinal product in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders. Some cases may require longer treatment. In cases showing no improvement after 2 months, treatment with the veterinary medicinal product should be ceased.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
At overdose with 20 mg/kg of the veterinary medicinal product (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing. Overdose with 40 mg/kg of the veterinary medicinal product (20 times the recommended dose) produced hunched posture, tremors, flushed abdomen and decreased activity in dogs. Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness. Still higher doses (725 mg/kg) produced, in addition, convulsions and death. Post-Approval Experience: in an overdose situation, mydriasis has been reported.