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Microsoft word - 3020 7760 release rev.docNovartis Animal Health US, Inc.
CONTACT: Joseph Burkett
New 5 mg size of CLOMICALM® makes a big difference
for separation anxiety in tiny canines.
GREENSBORO, North Carolina (June 2007) – Veterinarians now have a new option for their smallest canine patients who suffer from separation anxiety. With the introduction of a 5 mg size of Clomicalm® (clomipramine hydrochloride) from Novartis Animal Health US, Inc., treatment is now available for distressed dogs as small as 2.75 pounds. “Separation anxiety can be a big problem for dogs of all sizes and breeds, and that makes life more difficult for thousands of dog owners,” according to Richard Hart, vice president of Marketing, Novartis Animal Health US, Inc. “Now that we can offer four sizes of Clomicalm, ranging from 5 mg to 80 mg, veterinarians have greater flexibility in treating dogs, from the tiniest breeds to the largest.” Most pet owners used to assume that if their dogs destroyed furniture or barked or urinated when they were left alone, they were acting out of anger or spite. The veterinary profession now recognizes these behaviors are often signs of a common disorder known as separation anxiety. And it’s far from uncommon. In fact, separation anxiety in dogs represents 19 percent of cases seen by veterinarians in the United States.1 Since its introduction in 1998, Clomicalm has turned in nearly a decade of proven safety and efficacy in the treatment of canine separation anxiety. In extensive testing, 75 percent of dogs treated with Clomicalm showed improvement at the end of just four weeks. For clients whose dogs are suffering from separation anxiety, these kinds of results make a big difference in the quality of life for both the pet owners and their companions. Clomicalm, the first canine separation anxiety product tested and approved by the FDA,2 affects both the levels of serotonin and norepinephrine in the brain. Serotonin is believed to relax the dog and decrease anxiety, while norepinephrine is thought to increase memory and cognitive learning. With increased serotonin and norepinephrine, the dog becomes less anxious and more responsive to behavior modification techniques, “Treatment of separation anxiety is most effective with a combination of behavior modification and medication,” Hart said. “What makes Clomicalm unique is that it addresses this need for balance, reducing anxiety while, at the same time, enhancing the dog’s ability to learn.” In studies, the following adverse reactions have been reported: lethargy/depression,
elevation in liver enzymes, vomiting, diarrhea, and increased thirst. Please refer to the
product insert for prescribing information. Complete product details can be found at
www.clomicalm.novartis.us, then click on Product Information.
About Novartis Animal Health
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group’s businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com. 1Denenberg S, Landsberg GM, Horwitz D, Seksel, K. A comparison of cases referred to behaviorists in three different countries. In: Mills D, Levine E, Landsberg GM, et al, eds., Current issues and research in veterinary behavioral medicine. West Lafayette, Ind.: Purdue University Press, 2005; 56-62. 2NADA #141-120, Approved by FDA. Caution:
Adverse Reactions Reported in
Federal (USA) law restricts this drug to use by or on the order of a licensed General: CLOMICALM Tablets are not recommended for other behavior
Placebo-Controlled Clinical Field Trials
problems, such as aggression (see Adverse Reactions). Studies to establish CLOMICALM
the safety and efficacy of CLOMICALM Tablets in dogs less than 6 months of age Description:
CLOMICALM (clomipramine hydrochloride) Tablets belong to the dibenzazepine class of tricyclic antidepressants. Clomipramine hydrochloride is Diagnosis: It is critical to conduct a comprehensive physical examination,
3-chloro-5[3-(dimethyl-amino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine including appropriate laboratory tests, and to obtain a thorough history and monohydrochloride. CLOMICALM Tablets are oblong, light brown in color and con- assessment of the patient’s household environment, to rule-out causes of tain clomipramine hydrochloride formulated together with meat components. The inappropriate behavior unrelated to separation anxiety before prescribing molecular weight of clomipramine hydrochloride is 351.3. The structural formula is: CLOMICALM Tablets. 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 CLOMICALM Tablets, i.e., in the absence of a diagnosis or without concurrent behavioral modification, may expose the animal to unnecessary adverseeffects and may not provide any lasting benefit of therapy.
*These dogs displayed growling behavior towards either humans or other dogs.
Drug Interactions: Recommendations on the interaction between
clomipramine and other medications are extrapolated from data generated in
humans. Plasma concentrations of clomipramine have been reported to be Although not all adverse reactions are reported, the following adverse reactions Clomipramine hydrochloride reduces the clinical signs of separation anxiety increased by the concomitant administration of phenobarbital. Plasma levels are based on voluntary post-approval adverse drug experience reporting: by af ecting serotonergic and noradrenergic neuronal transmission in the central of closely related tricyclic antidepressants have been reported to be lethargy/depression, anorexia, elevation in liver enzymes, vomiting and diarrhea.
nervous system. While clomipramine hydrochloride can cause lethargy in increased by the concomitant administration of hepatic enzyme inhibitors Hepatobiliary disease has occurred, especially in the presence of pre-existing dogs (see Adverse Reactions) its mode of action is not as a sedative.
(e.g., cimetidine, fluoxetine). Plasma levels of closely related tricyclic antide- conditions or with concurrent administration of drugs metabolized via the hepatic Clomipramine hydrochloride’s capacity to inhibit re-uptake of serotonin in the cen- pressants have been reported to be decreased by the concomitant administration system. Additionally, in an overdose situation, the following signs have been tral nervous system is believed to be the primary mechanism of action.
of hepatic enzyme inducers (e.g. barbiturates, phenytoin). Caution is advised reported: ataxia, convulsion(s), anticholinergic effects (e.g. mydriasis, bradycardia, Clomipramine hydrochloride is rapidly absorbed when administered oral y. in using clomipramine with anticholinergic or sympathomimetic drugs or with other tachycardia, and arrhythmia) and vocalization.
A single-dose crossover study involving 12 dogs evaluated clomipramine CNS-active drugs, including general anesthetics and neuroleptics.
To report suspected adverse reactions or in case of accidental human ingestion, hydrochloride bioavailability after IV (2 mg/kg) and oral (4 mg/kg) administration Prior to elective surgery with general anesthetics, clomipramine should be in either a fed or fasted state. The administration of clomipramine hydrochloride discontinued for as long as clinical y feasible.
in the presence of food resulted in an increase in the rate and extent of drug Dosage and Administration:
absorption as shown in the following table (mean ± SD): Use in Concomitant Illness: Use with caution in dogs with cardiovascular
disease. At 20 mg/kg/day (5X the maximum recommended dose), bradycardia
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 and arrhythmias (atrioventricular node block and ventricular extrasystole) were daily dose or divided twice daily based on patient response and/or tolerance of observed in dogs. Because of its anticholinergic properties, clomipramine the side effects. It may be prudent to initiate treatment in divided doses to should be used with caution in patients with increased intraocular pressure, a history of narrow angle glaucoma, urinary retention or reduced gastrointestinal 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 motility. Because clomipramine is principally metabolized in the liver, caution is advised in using this medication in the presence of preexisting liver disease.
incidence of vomiting that may be experienced by some dogs, CLOMICALMTablets may be given with a small amount of food.
The absolute bioavailability is approximately 25% greater in fed dogs. The Reproductive Safety: Safety studies to determine the ef ects of CLOMICALM
apparent terminal plasma half-life ranges from approximately 2 to 9 hours in Tablets in pregnant or lactating female dogs have not been conducted.
Dog Weight CLOMICALM
fed and 3 to 21 hours in fasted dogs. The dif erence and variability in apparent CLOMICALM Tablets should not be used in breeding males Strength
half-life estimates may be attributable to prolonged drug absorption in the fasted state. The relatively large volume of distribution (3.8 ± 0.8 L/kg) suggests that Efficacy:
the drug is widely distributed throughout the body. Clomipramine is
Dose Establishment: A 12 week, placebo-controlled, multi-site clinical trial
primarily metabolized in the liver.
was conducted in the US and Europe to establish an ef ective dose of Indications and Usage:
CLOMICALM Tablets in dogs. Treatment with CLOMICALM Tablets, at 2 - 4 CLOMICALM Tablets are to be used as part of a comprehensive behavioral mg/kg/day divided twice daily, in conjunction with behavioral modification The specific methods of behavioral modification used in clinical trials involved management program to treat separation anxiety in dogs greater than 6 (desensitization and counterconditioning) was more ef ective than behavior desensitization and counterconditioning techniques. Since the manifestation of months of age. Inappropriate barking or destructive behavior, as wel as modification alone in reducing the signs of separation anxiety in dogs.
separation anxiety can vary according to the individual dog, it is advised that inappropriate elimination (urination or defecation) may be alleviated by the Dose Confirmation: In another placebo-control ed, multi-site clinical trial,
a specific behavior modification plan be developed based on a professional use of CLOMICALM Tablets in conjunction with behavior modification.
CLOMICALM Tablets at 2 - 4 mg/kg/day given either once daily or divided twice daily Separation anxiety is a complex behavior disorder displayed when the owner showed significant improvement in resolving signs of separation anxiety Once the desired clinical ef ect is achieved and the owners have successful y (or other attachment figure) leaves the dog. The signs of separation anxiety when tested against behavioral modification alone (desensitization and instituted the appropriate behavioral modification, the dose of CLOMICALM evaluated in control ed trials were vocalization, destructive behavior, excessive coun-terconditioning). In this 8 week study, the rate of improvement of the dogs Tablets may be reduced to maintain the desired ef ect or discontinued.
salivation, and inappropriate elimination. In the absence of the owner or receiving CLOMICALM Tablets with behavioral modification was significantly faster Withdrawal side ef ects were not reported in studies with CLOMICALM Tablets attachment figure, dogs with separation anxiety may exhibit one or more of than the rate of improvement of the dogs receiving behavioral modification alone.
in dogs. However, in clinical practice, it is recommended to taper the individual these clinical signs. Although the owner (attachment figure) may inadvertently After one week on trial, 47% of the dogs receiving CLOMICALM patient dose while continuing to monitor the dog’s behavior and clinical status misinterpret this behavior, which only happens in their absence, as spiteful, it Tablets once or twice (divided dose) daily in conjunction with behavioral modification through the dose reduction or withdrawal period. Continued behavioral is thought to be the result of anxiety experienced by the dog. Punishment is showed clinical improvement compared to improvement in 29% of modification is recommended to prevent recurrence of the clinical signs.
not considered appropriate for a dog with separation anxiety. the dogs receiving behavioral modification alone.
The effectiveness and clinical safety of CLOMICALM Tablets for long-term use Proper recognition of clinical signs, including a complete patient history and (i.e., for more than 12 weeks) has not been evaluated. assessment of the patient’s household environment, is essential to accurately CLOMICALM Tablets were demonstrated to be well-tolerated in dogs at the recommended label dose of 2-4 mg/kg/day. In a six month target animal safety Professional judgment should be used in monitoring the patient’s clinical status, study, beagle dogs were dosed daily at 4 (1X), 12 (3X), and 20 (5X) mg/kg/day.
response to therapy and tolerance to side effects to determine the need The use of CLOMICALM Tablets should not replace appropriate Emesis was seen in al groups including the dogs receiving placebo, but to continue treatment with CLOMICALM Tablets and to continue to rule-out behavioral and environmental management but should be used to occurred more frequently in dogs receiving 12 and 20 mg/kg. Decreased physiological disorders which may complicate the diagnosis and treatment of facilitate a comprehensive behavior management program.
activity was also seen in dogs receiving the 12 and 20 mg/kg. There were no Contraindications:
apparent treatment-related alterations in the following: body weights, physical Storage Conditions:
CLOMICALM Tablets are contraindicated in dogs with known hypersensitivity examination findings, electrocardiograph examinations, hematology or Store in a dry place at controled room temperature, between 59° and 86°F (15-30°C).
to clomipramine or other tricyclic antidepressants.
biochemistry parameters, ophthalmoscopic examinations, macroscopic or microscopic organ examinations and organ weights. Average food and water Store unused tablets in the original closed container.
CLOMICALM Tablets should not be used in male breeding dogs. Testicular consumption over the 26 week period was similar for control and treated groups.
hypoplasia was seen in dogs treated for 1 year at 12.5 times the maximum CLOMICALM Tablets are available in 5, 20, 40 and 80 mg tablet strengths in color-coded In a one year study, pure bred dogs were dosed daily at 12.5 (3X), 50 (12.5X), and 100 (25X) mg/kg/day. Emesis and mydriasis were observed within packaging for oral administration to dogs.
CLOMICALM Tablets should not be given in combination, or within 14 days before 15 minutes to one hour after dosing in dogs receiving 12.5, 50, and 100 mg/kg/day Keep this and all drugs out of reach of children.
or after treatment with a monoamine oxidase inhibitor [e.g. selegiline hydrochloride and lethargy was observed within 1 hour of dosing in dogs receiving 50 and 100 mg/kg. Testicular hypoplasia was seen in dogs receiving 50 mg/kg. At 100 CLOMICALM Tablets are contraindicated for use in dogs with a history of mg/kg/day (25X) convulsions and eventual death occurred in five out of the 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
Frequency and category of adverse reactions observed in dogs dosed ingestion seek medical attention immediately. In children, accidental
with CLOMICALM Tablets or placebo were observed in multisite clinical studies ingestion should be regarded as serious. There is no specific antidote for
2006 Novartis Animal Health US, Inc.
clomipramine. Overdose in humans causes anticholinergic effects including
Clomicalm is a registered trademark of Novartis AG.
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.
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