Clomicalm

Clomicalm is a veterinary medicine containing the active substance clomipramine. It is available as tablets containing 5 mg, 20 mg or 80 mg clomipramine. 

Clomicalm is used as an aid in the treatment of dogs that have behavioural problems when separated from their owners, their normal home, or other dogs. These behavioural problems might be expressed for example by destructive behaviour or inappropriate defecation or urination in the house. Clomicalm should not be used on its own but only in dogs that are also undergoing behavioural therapy.

Clomicalm tablets are given twice a day. The strength and number of tablet(s) to use is adjusted according to the dog’s weight, so that the dog is given between 2 mg and 4 mg clomipramine per kg of the dog’s bodyweight per day.

The active substance in Clomicalm, clomipramine, belongs to the group of the tricyclic antidepressants. In the body, clomipramine and its major metabolite, desmethylclomipramine prevent some neurotransmitters from being taken back up into nerve cells in the brain and spinal cord.

Neurotransmitters are substances that transfer chemical signals from one nerve cell to another one. Clomipramine prevents the re-uptake of serotonin (5 hydroxytryptamine) and desmethylclomipramine prevents the re-uptake of noradrenalin. Low levels of neurotransmitters in the central nervous system may be associated with depression, anxiety or aggression. By blocking the re-uptake of serotonin and noradrenalin into nerve cells, clomipramine and its metabolite allow the levels to remain higher. This can improve the clinical signs (behavioural problems) in dogs with separation-related disorders. In order to treat a dog with anxiety, the animal should not only receive medicines but also behavioural therapy. Behavioural modification therapy is the most important part of therapy; however, the use of the medicine allows for a more speedy recovery of the animal patient.

The effective dose of Clomicalm has been established in clinical studies in dogs. The efficacy and tolerance of the medicine in animal patients was confirmed in clinical studies in various veterinary practices or clinics in the USA, and in a number of countries in Europe (“field studies”). In each study, treatment with clomipramine was combined with behaviour modification techniques. The treatment results in these dogs were compared to treatment results in dogs receiving behavioural therapy alone (no medication).

Results of the field studies indicated that the administration of clomipramine in combination with behaviour modification techniques was effective in the relief of clinical signs of separation anxiety. Treatment with clomipramine at twice daily doses of 1 - 2 mg/kg bodyweight was effective, when compared to lower doses or to treatment with behavioural therapy alone (placebo).

Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (sleepiness) or an elevation in liver enzymes, which are reversible when the product is discontinued. Effects on the liver have been reported, especially in dogs with existing liver problems. Vomiting may be reduced by giving the tablets with a small quantity of food.

At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), a reduction in heart rate were observed approximately 12 hours after dosing. Since Clomicalm has not been tested in pregnant or lactating bitches, its use is not recommended during pregnancy and lactation. Due to potential interactions, the administration of Clomicalm is not recommended in combination with a number of other medicines listed in the package leaflet.

Since accidental ingestion might cause serious reactions in children, the tablets are supplied in a bottle fitted with a child resistant closure.

This veterinary medicine has been developed especially for dogs and is not for use in humans. If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Clomicalm exceed the risks when used in combination with behavioural modification techniques as an aid in the treatment of dogs with separation-related disorders, and recommended that Clomicalm be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

The European Commission granted a marketing authorisation valid throughout the European Union, for Clomicalm to Novartis Tiergesundheit GmbH, Germany on 1 April 1998, which was renewed in 2003 and 2008. Information on the prescription status of this product may be found on the label/outer package.