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Clomicalm

Description of Clomicalm

Uses

As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defecation and urination) and only in combination with behavioural modification techniques.

Dosage and Administration

Dosage: Clomicalm is administered twice daily at a dose of 1-2mg/kg to give a total daily dose of 2-4mg/kg according to the following table:

Administration: Clomicalm is given orally with or without food. In clinical trials, a treatment time of 2-3 months with Clomicalm 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 Clomicalm should be ceased.

Contra-indications

Known hypersensitivity to clomipramine and related tricyclic antidepressants. Male breeding dogs.

Warnings

Clomicalm may cause sporadic vomiting, changes in appetite or lethargy. Vomiting may be reduced by co-administration with a small quantity of food.

Special precautions for use

Dog: It is recommended to administer Clomicalm 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. The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25kg or under 6 months of age.

Persons administering the product: 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. Overdose in human beings causes anticholinergic effect although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.

Use during pregnancy and lactation: The safety of Clomicalm has not been established in female dogs during pregnancy and lactation. There was evidence of embryotoxic effects of clomipramine in laboratory animal studies.

Interaction with other medicaments: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs. Clomicalm may potentiate the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives. It is recommended not to administer Clomicalm 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 drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.

Overdose: At overdose with 20mg/kg Clomicalm (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 40mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs. Higher doses (500mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness. Still higher doses (725mg/kg) produced, in addition, convulsions and death.

Environmental precautions: Any unused product or waste material should be disposed of in accordance with local requirements.

Pharmaceutical Precautions

Store below 30°C in a dry place. Sensitive to moisture. Store unused product in the original container. For animal treatment only. Keep out of reach of children.

PLEASE NOTE: Clomicalm is only available by prescription and REQUIRES A VALID PRESCRIPTION be mailed, faxed or emailed to PetDrugs.com to complete your order.

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