Manufacturer/Label Information:
Novartis
Disclaimer
This information summarizes the current status of our knowledge and may differ from the legally binding, country specific use instructions provided with the product. Novartis Animal Health Inc. is not liable for damages or injury caused by the use of its products different from those specified on the pack label.
Product Type
Oral tablets as an aid in the treatment of separation-related disorders in dogs.
Description and Composition
Oral, beef flavored tablets of 3 strengths are available:
CLOMICALM 5, 20 and 80 contain 5.00 mg, 20.00 mg and 80.00 mg clomipramine hydrochloride, respectively.
Properties
Clomipramine hydrochloride, the active ingredient of CLOMICALM, has a broad-spectrum of action in blocking the reuptake of neurotransmitters. Clomipramine hydrochloride is metabolized to clomipramine, a potent and selective serotonin (5-HT) reuptake inhibitor and to desmethyl-clomipramine a potent and selective noradrenaline reuptake inhibitor. Clomipramine has, in addition, anticholinergic effects.
CLOMICALM possesses anxiolytic properties and has a very limited sedative effect, thus maintaining the dog’s ability to learn new behaviors.
Indications
As an aid in the treatment of separation-related disorders manifested by destruction and inappropriate elimination (defecation and urination) in combination with behavioral modification techniques.
In some countries, CLOMICALM is also authorized for the control of stereotypies in dogs or of urine spraying in cats.
Dosage and Administration
CLOMICALM is 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:
| Body weight |
Dosage per administration |
| |
Clomicalm 5 mg |
Clomicalm 20 mg |
Clomicalm 80 mg |
| 1.25 - 2.5 kg |
0.5 tablet |
|
|
| >2.5 - 5 kg |
1 tablet |
|
|
| >5 - 10 kg |
|
0.5 tablet |
|
| >10 - 20 kg |
|
1 tablet |
|
| >20 - 40 kg |
|
|
0.5 tablet |
| >40 - 80 kg |
|
|
1 tablet |
CLOMICALM may be given with or without food. Usually, a treatment time of 2-3 months with CLOMICALM in combination with behavioral modification techniques is 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 CLOMICALM should be ceased.
Special Precautions and Warnings
The use of CLOMICALM is not authorized in breeding dogs. In dogs with cardiovascular dysfunction, epilepsy, narrow angle glaucoma, reduced gastrointestinal motility or urinary retention, CLOMICALM should be given with caution and only after an assessment of the benefit risk ratio.
CLOMICALM may potentiate the effects of CNS active drugs. The administration of CLOMICALM is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors.
Formulations and Packages
The 3 tablet strengths are available in color-coded packs containing HDPE bottles with child resistant closure and sealing disk, each containing 30 tablets and a silica gel desiccant.
Storage Recommendations and Shelf Life
2 years in the original container at storage temperatures below 30°C.
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