Clomipramine HCL Tablets

Clomipramine Hydrochloride Tablets is used to treat separation anxiety in dogs in connection with behavior modification and training. This medication affects chemicals in the brain that may become unbalanced leading to behavioral problems in dogs.

Key Benefits

• Palatable beef flavoring
• Scored for accurate dosing
• Can be used as part of a comprehensive behavior management program
• Clinically proven to reduce the clinical signs of separation anxiety

How it works

Clomipramine Hydrochloride Tablets belong to the dibenzazepine class of tricyclic antidepressants. Clomipramine hydrochloride reduces the clinical signs of separation anxiety by affecting serotonergic and noradrenergic neuronal transmission in the central nervous system.

Indications

Clomipramine Hydrochloride Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. Inappropriate barking or destructive behavior, as well as inappropriate elimination of (urination or defecation) may be alleviated by the use of Clomipramine Hydrochloride Tablets in conjunction with behavior modification.

Separation anxiety is a complex behavior disorder displayed when the owner (or other attachment figure) leaves the dog. In the absence of the owner or attachment figure, dogs with separaton anxiety may exhibit one or more clinical signs. The signs of separation anxiety evaluated in controlled trials were vocalization, destructive behavior, excessive salivation, and inappropriate elimination. Although it may appear that this behavior, which only happens in the dog owner's absence, is a spiteful action, this behavior is thought to be a result of anxiety experienced by the dog. Therefore, punishment would not be appropriate for the dog with this behavior.

Behavior Modification (Training)

Behavior training is a necessary component of therapy with Clomipramine Hydrochloride Tablets. In clinical trials, specific behavior training techniques were used at the following times:

• when the owner interacted with the dog while at home
• when the owner was preparing to leave the home
• when the owner returned home and greeted the dog

Since the methods used for behavior training can vary according to patient needs, it is important that you follow the instructions provided by your veterinarian regarding the specific techniques recommended for modifying your dog's behavior.

The recommended daily dose of Clomipramine Hydrochloride Tablets is 2 to 4 mg/kg/day (0.9 -1.8 mg/lb/day) (see dosing table below). It can be administered as a single daily dose or divided twice daily based on patient response and/or tolerance of the side effects. It may be prudent to initiate treatment in divided doses to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerance does not develop. To reduce the incidence of vomiting that may be experienced by some dogs, Clomipramine Hydrochloride Tablets may be given with a small amount of food.

Important safety information

Clomipramine Hydrochloride Tablets are not recommended for other behavior problems, such as aggression. (see Adverse Reactions). Studies to establish the safety and efficacy of clomipramine hydrochloride tablets in dogs less than 6 months of age have not been conducted. Not for use in humans. Keep out of reach of children. In case of accidental ingestion seek medical attention immediately. In children, accidental ingestion should be regarded as serious. There is no specific antidote for clomipramine. Overdose in humans causes anticholinergic effects including effects on the central nervous (e.g., convulsions) and cardiovascular (e.g., arrhythmia, tachycardia) systems. People hypersensitive to clomipramine should administer the product with caution.

Contraindications

Clomipramine Hydrochloride Tablets are contraindicated in dogs with known hypersensitivity to clomipramine or other tricyclic antidepressants.

Clomipramine Hydrochloride Tablets should not be used in male breeding dogs. Testicular hypoplasia was seen in dogs treated for 1 year at 12.5 times the maximum daily dose.

Clomipramine Hydrochloride Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g. selegiline hydrochloride (L-deprenyl), amitraz].

Clomipramine Hydrochloride Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.

Human Warnings

Not for use in humans. Keep out of reach of children. In case of accidental ingestion seek medical attention immediately. In children, accidental ingestion should be regarded as serious. There is no specific antidote for clomipramine. Overdose in humans causes anticholinergic effects including effects on the central nervous (e.g., convulsions) and cardiovascular (e.g., arrhythmia, tachycardia) systems. People with known hypersensitivity to clomipramine should administer the product with caution.

Precautions

General: Clomipramine Hydrochloride Tablets are not recommended for other behavior problems, such as aggression (see Adverse Reactions). Studies to establish the safety and efficacy of clomipramine hydrochloride 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, to rule-out causes of inappropriate behavior unrelated to separation anxiety before prescribing Clomipramine Hydrochloride Tablets. Periodic reassessment of hematological and serum biochemical data during the administration of this medication is advised. Veterinarians should be familiar with the risks and benefits of the treatment of behavioral disorders in dogs before initiating therapy. Inappropriate use of Clomipramine Hydrochloride 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 levels of tricyclic antidepressants have been reported to be decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin); therefore plasma concentrations of clomipramine may be decreased 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). Tricyclic antidepressants themselves may exhibit hepatic enzyme inhibition and possibly increase plasma levels of barbiturates (phenobarbital). 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. Because clomipramine is principally metabolized in the liver, caution is advised in using this medication in the presence of preexisting liver disease.

Reproductive Safety

Safety studies to determine the effects of clomipramine hydrochloride tablets in pregnant or lactating female dogs have not been conducted. Clomipramine Hydrochloride Tablets should not be used in breeding males.

Behavior Modification (Training)

Behavior training is a necessary component of therapy with Clomipramine Hydrochloride Tablets. In clinical trials, specific behavior training techniques were used at the following times:

• when the owner interacted with the dog while at home
• when the owner was preparing to leave the home
• when the owner returned home and greeted the dog

Since the methods used for behavior training can vary according to patient needs, it is important that you follow the instructions provided by your veterinarian regarding the specific techniques recommended for modifying your dog's behavior.