Clomipramine HCl is a tricyclic antidepressant FDA approved for veterinary use in dogs for the treatment of separation anxiety. Clomipramine (Anafranil), FDA approved for human use, is also used in veterinary medicine to treat aggression and obsessive-compulsive disorders such as tail chasing. Clomipramine may also be useful in cats, but cats tend to be more sensitive to tricyclic antidepressant drugs.
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.
Clomipramine 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 (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. 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 patients household environment, is essential to accurately diagnose and treat separation anxiety.
The use of Clomipramine Hydrochloride Tablets should not replace appropriate behavioral and environmental management but should be used to facilitate a comprehensive behavior management program.
The recommended daily dose of Clomipramine is 2 to 4 mg/kg/day (0.9 - 1.8 mg/lb/day) (see dosing table below). Your veterinarian will instruct you to give the drug either once a day or divide the daily dose into 2 separate doses depending on your dog's response to the drug or tolerance to any side effects. Clomipramine Tablets may be given with a small amount of food in an attempt to reduce the incidence of vomiting that may be experienced by some dogs. If a dose is missed, the next dose should be administered (without doubling) at the next scheduled dosing time.
|Dog Weight (lbs.)||Clomipramine Hydrochloride Tabletsper Day||No. Tablets per Day||Tablet Strength|
|2.75-5.5||5 mg||1||5 mg|
|5.6-10.9||10 mg||2||5 mg|
|11-22||20 mg||1||20 mg|
|22.1-44||40 mg||1||40 mg|
|44.1-88||80 mg||1||80 mg|
|88.1-176||160 mg||2||80 mg|
Your veterinarian may decrease the dose or discontinue treatment with Clomipramine Tablets depending on your dog's response to treatment. Continued behavior training is recommended, even after cessation of drug therapy.
Federal (USA) Law restricts this drug to use by or on the order of a licensed veterinarian.
Clomipramine Tablets are contraindicated in dogs with known hypersensitivity to clomipramine or related tricyclic antidepressants.
Clomipramine 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 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 Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.
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.
It is important that your dog be closely monitored by your veterinarian while on a treatment plan with Clomipramine Tablets and behavior training. You must inform your veterinarian of any current or future medications you are administering to your dog. The use of Clomipramine Tablets 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 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 Tablets have not been established in dogs less than 6 months of age or in pregnant or lactating female dogs. Clomipramine Tablets should not be used in breeding male dogs (see Contraindications). Clomipramine Tablets are not recommended for other behavior problems, such as aggression.
Clomipramine Tablets were tested in clinical trials involving client-owned dogs to determine effectiveness. Clomipramine Tablets, at 2 - 4 mg/kg/day (0.9 - 1.8 mg/pound/day) when used in conjunction with behavior training accelerated both the time to improvement and the final result of separation anxiety therapy compared to behavioral training alone.
The following adverse reactions have been reported associated with administration of Clomipramine 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 1-888-545-5973.
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.