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CLOMICALM Oral tablets as an aid in the treatment of separation-related disorders in dogs. Oral, beef flavored tablets of 3 strengths are available:CLOMICALM 5, 20 and 80 contain 5.00 mg, 20.00 mg and 80.00 mg clomipramine hydrochloride, respectively. 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.
The recommended daily dose of CLOMICALM Tablets is 2 to 4 mg/kg/day (0.9-1.8 mg/lb/day). 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. Tablets may be given with a small amount of food. SIDE EFFECTS: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting: lethargy/depression, anorexia, elevation in liver enzymes, vomiting and diarrhea. Hepatobiliary disease has occurred, especially in the presence of pre-existing conditions or with concurrent administration of drugs metabolized via the hepatic system. Additionally, in an overdose situation, the following signs have been reported: ataxia, anti-cholinergic effects (e.g., mydriasis, bradycardia, tachycardia, and arrhythmia) and vocalization. To report suspected adverse reactions or in case of accidental human ingestion, call 1-800-637-0281.
CLOMICALM Tablets are contraindicated in dogs with known hypersensitivity to clomipramine or other tricyclic antidepressants.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. 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]. 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. 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.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 CLOMICALM Tablets. Periodic reassessment of hematological and serum biochemical data during the administration of this medication is advised.
OCTOBER 27, 2013
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