CaniQuell for Dogs - (Clomipramine Hydrochloride) 80mg (44.1-176 lbs) (per tablet) - [Antidepressant Support]

CaniQuell (clomipramine hydrochloride) Tablets belong to the dibenzazepine class of tricyclic antidepressants. 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.

Key Benefits

• Palatable beef flavor? Chewable for best compliance
• Scored for accurate dosing? Exclusive 40 mg strength now available for dogs 22.1 - 44 lbs
• Clinically proven to reduce the signs of separation anxiety
• Can be used as part of a comprehensive behavioral management program

Indications

CaniQuell is 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 (urination or defecation) may be alleviated by the use of CaniQuell in conjunction with behavior modification.

Separation anxiety is a complex behavior disorder displayed when the owner (or other attachment figure) leaves the dog. The signs of separation anxiety evaluated in controlled trials were vocalization, destructive behavior, excessive salivation, and inappropriate elimination. In the absence of the owner or attachment figure, dogs with separation anxiety may exhibit one or more of these clinical signs. Although the owner (attachment figure) may inadvertently misinterpret this behavior, which only happens in their absence, as spiteful, it is thought to be the result of anxiety experienced by the dog. Punishment is not considered appropriate for a dog with separation anxiety.

Proper recognition of clinical signs, including a complete patient history and assessment of the patient's household environment, is essential to accurately diagnose and treat

The use of CaniQuell should not replace appropriate behavioral and environmental management but should be used to facilitate a comprehensive behavior management program.

The recommended daily dose of CaniQuell 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, CaniQuell may be given with a small amount of food.

The specific methods of behavioral modification used in clinical trials involved desensitization and counterconditioning techniques. Since the manifestation of separation anxiety can vary according to the individual dog, it is advised that a specific behavior modification plan be developed based on a professional assessment of each individual case.

Once the desired clinical effect is achieved and the owners have successfully instituted the appropriate behavioral modification, the dose of CaniQuell may be reduced to maintain the desired effect or discontinued. Withdrawal side effects were not reported in studies with clomipramine hydrochloride tablets in dogs. However, in clinical practice, it is recommended to taper the individual patient dose while continuing to monitor the dog's behavior and clinical status through the dose reduction or withdrawal period. Continued behavioral modification is recommended to prevent recurrence of the clinical signs.

The effectiveness and clinical safety of clomipramine hydrochloride tablets for long-term use (i.e., for more than 12 weeks) has not been evaluated.

Professional judgment should be used in monitoring the patient's clinical status, response to therapy and tolerance to side effects to determine the need to continue treatment with CaniQuell and to continue to rule-out physiological disorders which may complicate the diagnosis and treatment of separation anxiety.

Cautions:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Behavior Modification (Training):

Behavior training is a necessary component of therapy with CaniQuell. 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.

Contraindications:

CaniQuell is contraindicated in dogs with known hypersensitivity to clomipramine or other tricyclic antidepressants.

CaniQuell 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.

CaniQuell 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].

CaniQuell is 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:

It is important that your dog be closely monitored by your veterinarian while on a treatment plan with CaniQuell and behavior training. You must inform your veterinarian of any current or future medications you are administering to your dog. The use of CaniQuell in conjunction with certain other drugs or when your dog has other illnesses may be contraindicated or increase the risks of adverse reactions.

It is important that you inform your veterinarian of any changes in your dog's environment including, but not limited to, a new family member, a new pet, a move to a new location, or a change in your existing daily schedule. Some changes may result in an altered response to therapy.

It is important to inform your veterinarian of any perceived changes in your dog's behavior, appetite, or overall health while administering any medication. Some dogs display a temporary lethargy with the first few days of clomipramine hydrochloride tablets treatment. In some cases, signs of separation anxiety, such as vocalization, may temporarily increase at the initiation of treatment. In an overdose situation, seek veterinary attention for your pet as soon as possible.

The safety and efficacy of clomipramine hydrochloride tablets have not been established in dogs less than 6 months of age or in pregnant or lactating female dogs. CaniQuell should not be used in breeding male dogs (see Contraindications). CaniQuell is not recommended for other behavior problems, such as aggression.

General: CaniQuell is 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 CaniQuell. 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 CaniQuell, 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.

Adverse Reactions:

The following adverse reactions have been reported associated with administration of clomipramine hydrochloride tablets: lethargy/depression, vomiting, diarrhea, elevation in liver enzymes, convulsion(s), increased heart rate, decreased heart rate, increased thirst and confusion. Liver disease has occurred, especially in the presence of pre-existing conditions or with concurrent administration of drugs metabolized by the liver. In overdoses, signs such as vomiting, lethargy or depression, weakness and incoordination, dilated pupils, and vocalization may occur. Consult with your veterinarian if your dog experiences these or any other conditions.

In case of accidental human ingestion or accidental overdose in dogs, call 1-561-570-1875.

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 Illnerss:

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.

Storage:

Store in a dry place at controlled room temperature, between 59 and 77°F (15-25°C). Store unused tablets in the original closed container.