Clomicalm
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CLOMICALM 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 (urination or defecation) may be alleviated by the use of CLOMICALM 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 patient’s household environment, is essential to accurately diagnose and treat separation anxiety.
The use of CLOMICALM Tablets should not replace appropriate behavioral and environmental management but should be used to facilitate a comprehensive behavior management program.
History
There is currently no drug history available for this drug.
Other Information
CLOMICALM (clomipramine hydrochloride) Tablets belong to the dibenzazepine class of tricyclic antidepressants. Clomipramine hydrochloride is 3-chloro-5[3-(dimethyl-amino)propyl]-10,11dihydro-5H dibenz[b,f]azepine monohydrochloride. CLOMICALM Tablets are oblong, light brown in color and contain clomipramine hydrochloride formulated together with meat components. The molecular weight of clomipramine hydrochloride is 351.3. The structural formula is:
Sources
Clomicalm Manufacturers
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Novartis Animal Health Us, Inc.
![Clomicalm (Clomipramine Hydrochloride) Tablet Clomipramine (Clomipramine Hydrochloride) Powder [Novartis Animal Health Us, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clomicalm | Novartis Animal Health Us, Inc.
The recommended daily dose of CLOMICALM 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, CLOMICALM Tablets 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 CLOMICALM Tablets may be reduced to maintain the desired effect or discontinued. Withdrawal side effects were not reported in studies with CLOMICALM 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 CLOMICALM 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 CLOMICALM Tablets and to continue to rule-out physiological disorders which may complicate the diagnosis and treatment of separation anxiety.
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