Product contains:
Clomipramine hydrochloride
Product indications:
Clomicalm® Tablets are indicated for use as part of a behavioral management program to treat separation anxiety, inappropriate barking or destructive behavior, as well as inappropriate elimination (urination or defecation) in dogs.
Dosage and administration:
Give 2-4mg/kg/day (0.9-1.8 mg/lb/day) as a single daily dose or divided twice daily, or as directed by your veterinarian. To reduce the incidence of vomiting which may be experienced by some dogs, Clomicalm may be given with a small amount of food.
Once the desired effect is achieved and the appropriate behavioral modification has been successfully implemented, the dose of Clomicalm may be reduced to maintain the desired effect or discontinued altogether. Monitor the dog's behavior during the dose reduction or withdrawal period. Continued behavioral modification is recommended to prevent recurrence of the clinical signs.
Warnings, side effects and potential drug interactions:
Clomicalm tablets are contraindicated in dogs with known hypersensitivity to clomipramine or other tricyclic antidepressants.
Clomicalm Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor (e.g. selegiline, amitraz).
Clomicalm Tablets are contraindicated for use with dogs with a history of seizures or in conjunction with drugs which lower the seizure threshold.
There is no specific antidote for clomipramine. Overdose in humans causes effects on the central nervous (eg. convulsions) and cardiovascular (e.g. rhythm disturbances and elevated heart rate) systems. People with known hypersensitivity to clomipramine should administer the product with caution.
Caution is advised when using clomipramine with phenobarbital, anticholinergic or sympathomimetic drugs or with other drugs with nervous effects. Prior to elective surgery with general anesthetics, clomipramine should be discontinued for as long as possible.
Clomicalm should be used cautiously with dogs with cardiovascular disease, increased pressure within the eye or a history of glaucoma, urinary retention or reduced gut motility.
Because clomipramine is principally metabolized in the liver, caution is advised when using this medication in the presence of preexisting liver disease.
Safety studies to determine the effects of Clomicalm with pregnant or lactating female dogs have not been conducted. Clomicalm should not be used with breeding males.
Adverse reactions seen in post-approval adverse drug experience reporting include: lethargy/depression, anorexia, elevation in liver enzymes, vomiting and diarrhea. Liver and bile duct disease has occurred, especially in the presence of pre-existing conditions or with concurrent administration of drugs metabolized via the liver. Additionally, in an overdose situation, the following signs have been reported: ataxia, enlarged pupils, elevated heart rate and vocalization. In pre-release trials, aggression (growling) was seen in a small proportion of dogs treated with clomipramine.
The effectiveness and clinical safety of Clomicalm for periods greater than 12 weeks has not been evaluated.
Storage:
Store in a dry place at controlled room temperature, between 59° and 86°F (15-30°C).
Manufacturer:
Novartis Animal Health US, Inc.
3200 Northline Ave, Suite 300, Greensboro, NC, 27408
Customer Service: |
|
800-332-2761 |
Professional Services: |
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800-637-0281 |
Fax: |
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336-387-1168 |
Website: |
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www.ah.novartis.com |
NADA # 141-120, approved by the FDA
Federal law restricts this drug to use by or on the order of a licensed veterinarian.