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CLOMICALM® (Clomipramine Hydrochloride) Tablets

By: Novartis Animal Health

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General

CLOMICALM Tablets are not recommended for other behavior problems, such as aggression (see Adverse Reactions). Studies to establish the safety and efficacy of CLOMICALM Tablets in dogs less than 6 months of age have not been conducted.

Diagnosis

It is critical to conduct a comprehensive physical examination, including appropriate laboratory tests, and to obtain a thorough history and assessment of the patient's household environment in order to rule out causes of inappropriate behavior unrelated to separation anxiety before prescribing CLOMICALM Tablets.

Veterinarians should be familiar with the risks and benefits of the treatment of behavioral disorders in dogs before initiating therapy. Inappropriate use of CLOMICALM Tablets, (i.e., in the absence of a diagnosis or without concurrent behavioral modification), may expose the animal to unnecessary adverse effects and may not provide any lasting benefit of therapy.

Drug Interactions

Recommendations on the interaction between clomipramine and other medications are extrapolated from data generated in humans. Plasma concentrations of clomipramine have been reported to be increased by the concomitant administration of phenobarbital. Plasma levels of closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine). Plasma levels of closely related tricyclic antidepressants have been reported to be decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin). Caution is advised in using clomipramine with anticholinergic or sympathomimetic drugs or with other CNS-active drugs, including general anesthetics and neuroleptics. Prior to elective surgery with general anesthetics, clomipramine should be discontinued for as long as clinically feasible.

Use in Concomitant Illness

Use with caution in dogs with cardiovascular disease. At 20 mg/kg/day (5X the maximum recommended dose), bradycardia and arrhythmias (atrioventricular node block and ventricular extrasystole) were observed in dogs. Because of its anticholinergic properties, clomipramine should be used with caution in patients with increased intraocular pressure, a history of narrow angle glaucoma, urinary retention or reduced gastrointestinal motility.

Reproductive Safety

Safety studies to determine the effects of CLOMICALM Tablets in pregnant or lactating female dogs have not been conducted. CLOMICALM Tablets should not be used in breeding males (See Contraindications).

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